Finlepsin - all about Finlepsin. Finlepsin: instructions for use, price, reviews, indications, side effects, radar, compatibility with alcohol Finlepsin side effects

A highly effective pharmacological agent from a subgroup of effective antiepileptic drugs - Finlepsin tablets. What does this medicine help with? The drug has the ability to have an anticonvulsant effect. Both normathymic and antidiuretic, as well as antimanic with analgesic effects are observed. Excellent reputation in neurological practice.

Active and auxiliary components, pharmaceutical form of release

In each tablet of the pharmacological agent "Finlepsin", which helps with mental disorders, the active substance is Carbamazepine, in a volume of 200 mg. It is he who plays the main role in providing antiepileptic, antidiuretic, anticonvulsant effects.

The excipients of the drug include: MCC and gelatin, croscarmellose sodium and magnesium stearate. Their purpose is to enhance and maintain the effect of the main active substance.

In the pharmacy network, you can buy the drug "Finlepsin", the instructions for use report this, it is possible in the form of tablets. As a rule, they are packaged in 10 pieces. in a blister, in cardboard packs of 3, 4 or 5 blisters in each pack.

Pharmacological properties

The mechanism of the therapeutic effect of the drug "Finlepsin" is based on blocking the activity of sodium channels. This will help stabilize the membrane of cell neurons.

At the same time, against the background of drug therapy, synaptic conduction in neurons is significantly reduced. This prevents the formation of discharges of neurons. In addition, oral administration of the drug significantly reduces the release of glutamate and stops the likelihood of the formation of an epileptic focus in the nervous structures due to a multiple increase in the convulsive threshold.

The constant use of the drug "Finlepsin", which helps with epilepsy, allows you to reverse the negative personality changes observed in humans due to epileptic pathology. This contributes to a significant improvement in his socialization, helps communicative activity.

The instructions for the pharmacological agent indicate that the drug will be effective in post-traumatic paresthesias, as well as neurogenic pain or post-herpetic neuralgia. Another area of ​​application is alcohol withdrawal therapy, since the drug is able to increase the threshold for convulsive activity while reducing arousal and a significant decrease in tremor of the extremities.

With daily use of the drug in a prolonged form, patients have optimal stabilization of the plasma concentration of carbamazepine parameters. This helps to reduce the frequency of drug complications. Even the transition to maintenance doses of the drug allows you to maintain the therapeutic effect for a long time.

Tablets "Finlepsin": what helps the medicine

The conducted medical studies allowed specialists to outline the range of main and relative indications for the use of the drug "Finlepsin":

• various forms of epileptic pathology;
• post-traumatic and inflammatory nature of neuralgia;
• pain impulses accompanying people with complications of diabetes;
• various types of convulsive conditions, for example, epileptic seizures, neurological spasms;
• severe alcohol withdrawal syndrome;
• variety of psychotic disorders.

Since the above indications for inclusion in the complex therapy of Finlepsin tablets are more neurological in nature, only a neurological specialist should deal with this issue. Self-medication can cause irreparable harm to health.

Contraindications

Among the absolute and relative contraindications to taking the drug "Fenlipsin" in the instructions are the following:

• severe violation of bone marrow hematopoiesis;
• intermittent form of porphyria;
• individual hyperreaction to the active and auxiliary components of the drug "Finlepsin Retard", from which these tablets can cause undesirable effects;
• the need for simultaneous administration of MAO inhibitors;
• presence of AV block.

The use of the drug "Finlepsin" requires special care if a person has:

• decompensated activity of the heart;
• hypopititarism;
• severe insufficiency of the structures of the adrenal glands;
• hypothyroidism;
• active form of alcohol dependence;
• advanced age;
• too high intraocular pressure.

It is on the basis of the above contraindications that only a specialist should decide on the need to take the remedy.

Medicine "Finlepsin": instructions for use

In the instructions for the drug "Finlepsin" the following doses of the drug and the frequency of administration are prescribed:

1. In the adult category of patients with a fixed tendency to epileptic seizures, the starting dose is 200-400 mg. Further, a correction can be carried out - with an increase in the dose to 0.8-0.12 g per day.
2. In pediatric practice, the drug is taken based on the calculation of 10-20 mg / kg of the baby's weight per day.

Epilepsy is most often a lifelong pathology, therefore, therapy with the above remedy can continue for years and even decades. It is possible to stop it, for example, in the absence of epileptic seizures for 2 to 3 years. However, the drug withdrawal scheme is selected by a specialist on an individual basis. Gradually decrease - 1-2 years.

Therapy with Finlepsin Retard, which helps with the active form of alcohol withdrawal with convulsive seizures, is carried out only in stationary conditions - starting from an average daily dose of 600 mg. In severe cases of the pathological condition, a specialist may recommend doses of 1.2 g per day. Termination of treatment is also carried out in stages - with a decrease in doses of at least 8-10 days.

With various types of neuralgia, for example, glossopharyngeal or trigeminal nerve - therapeutic measures with the inclusion of Finlepsin tablets require special attention from specialists. Starting daily doses of 200-400 mg can be gradually increased to 400-800 mg, in 2 divided doses, until the desired effect is achieved.

With a diabetic variant of neuropathy, the medication will be recommended for admission in similar doses - no more than 800 mg per day. With multiple sclerosis, the average daily dose is 400-800 mg - divided into 2 doses. Prevention of various forms of psychosis - 200-400 mg of the drug per day.

Unwanted Effects

The practice of specialists shows that the formation of negative consequences from taking Finlepsin tablets occurs only if the patient has exceeded the recommended doses of the medication, or the frequency of administration. Against this background, the active component of the drug accumulates in the plasma, which provokes various negative disorders of nervous activity.

The list of undesirable effects include:

• persistent dizziness and ataxia;
• previously uncharacteristic drowsiness and general weakness;
• pain impulses in the head of different intensity of localization.

Perhaps the appearance of dermatopathologies, for example, an allergic form of urticaria, epidermis, as well as other variants of rashes. the hematopoietic system may respond with leukopenia, thrombocytopenia, or eosinophelia and lymphadenopathy. There is also a high risk of various disorders of the gastrointestinal tract - the urge to nausea and vomiting, severe dryness of the tissues of the oral cavity, an increase in hepatic transaminases.

Analogs means "Finlepsin"

The same active substance contains analogues:

1. "Karbasan retard".
2. "Epial".
3. Tegretol.
4. "Carbamazepine".
5. Mazepin.
6. "Zagretol".
7. "Carbalepsin retard".
8. "Storylat".
9. "Apo Carbamazepine".
10. "Finlepsin retard" (which helps indicated above in the instructions).
11. "Stazepin".
12. "Karbapin".
13. "Zeptol".
14. "Actinerval".

Price

You can buy Finlepsin tablets in Moscow and other regions of Russia for 211 rubles. The price of the drug in Kyiv reaches 59 hryvnia. In Minsk, the analogue "Finlepsin Retard" costs from 16 to 35 bel. rubles. In Kazakhstan, its price is 3110 tenge.

Catad_pgroup Antiepileptic

Finlepsin 200 retard - instructions for use

carbamazepine

Registration number

P No. 015417/01 dated 12/10/2003

Compound

One retard tablet (long-acting) contains 200 mg of the active ingredient carbamazepine.

Other ingredients: methacrylate copolymers, triacetin, talc, microcrystalline cellulose, highly dispersed silicon dioxide, magnesium stearate, crospovidone.

Indications for use

• epilepsy: partial seizures with elementary symptoms (focal seizures); partial seizures with complex symptoms (psychomotor seizures); grand mal seizures, mostly of focal origin (grand grand mal seizures during sleep, diffuse grand mal seizures); mixed forms of epilepsy;
• trigeminal neuralgia;
• paroxysmal pain of unknown cause, arising on one side of the root of the tongue, pharynx and soft palate (genuine glossopharyngeal neuralgia);
• pain in peripheral nerve lesions in diabetes mellitus (pain in diabetic neuropathy);
• epileptiform convulsions in multiple sclerosis, such as spasms of the facial muscles in trigeminal neuralgia, tonic convulsions, paroxysmal speech and movement disorders (paroxysmal dysarthria and ataxia), discomfort (paroxysmal paresthesias) and pain attacks;
• prevention of the development of convulsive seizures in alcohol withdrawal syndrome;
• psychosis (mainly in manic-depressive states, hypochondriacal depressions). Secondary prevention of affective and schizoaffective psychoses.

Warning: to prevent the development of convulsive seizures in alcohol withdrawal syndrome, finlepsin is used only in a hospital setting.

Contraindications

When should you not use Finlepsin 200 retard?

Finlepsin 200 retard is contraindicated in: the presence of bone marrow damage, disturbances in the conduction of excitation in the heart (atrioventricular blockade), known hypersensitivity to the active substance, tricyclic antidepressants or one of the other components, as well as acute intermittent porphyria (a certain hereditary defect in the exchange of porphyrins). Finlepsin 200 retard should not be used concomitantly with lithium preparations (see "Interactions with other medicinal products"). Since Finlepsin 200 retard can provoke new or intensify existing special forms of seizures (the so-called absences), it is not recommended to prescribe it to patients suffering from these forms of seizures.

In what cases can you take Finlepsin 200 retard only after consulting a doctor?

The following indicates when you may only take Finlepsin 200 retard under certain conditions and only with great caution. Please check with your doctor about this. This also applies to those cases when the named states have already occurred to you.

Finlepsin 200 retard should not be used simultaneously with MAO inhibitors. The ongoing therapy with MAO inhibitors is stopped no later than 14 days before the start of treatment with Finlepsin 200 retard.

Only after a careful comparison of the risk of therapy and the expected beneficial effect, as well as with appropriate precautions, Finlepsin 200 retard can be used for diseases of the hematopoietic organs (hematological diseases), severe disorders of the heart, liver and kidneys (see "Side effects" and "Dosage" ), impaired sodium metabolism.

Use during pregnancy and lactation

During pregnancy, Finlepsin 200 retard is used only after a careful comparison of the risk of therapy and the expected beneficial effect on the part of the attending physician.

With an existing or just onset pregnancy, especially between the 20th and 40th day of pregnancy, Finlepsin 200 retard is prescribed at the lowest seizure-controlling dose. The daily dose, especially during the most sensitive period of pregnancy, is divided into several small doses taken throughout the day. It is recommended to control the level of the active substance in the blood serum.

In rare cases, in connection with the use of the active substance carbamazepine, fetal malformations, as well as congenital spina bifida, have been reported.

If possible, the combination of Finlepsin 200 retard with other antiepileptic drugs or other medicines should be avoided, since this increases the risk of fetal malformations.

In connection with the enzyme-inducing properties of carbamazepine, it may be advisable to prescribe folic acid before and during pregnancy.

In order to avoid hemorrhagic complications in the newborn, prophylactic administration of vitamin K is recommended to the mother in the last weeks of pregnancy or to the newborn immediately after birth. If you want to give birth to a child, be sure to consult your doctor about this.

Finlepsin 200 retard passes into the mother's milk, but in such small amounts that when used in therapeutic doses, in general, it does not pose a danger to the child. Only if the infant has poor weight gain or increased drowsiness (sedation) should breastfeeding be stopped.

The use of the drug in children and elderly patients

Due to the high content of the active substance and the lack of experience with the use of Finlepsin 200 retard tablets, retard should not be prescribed to children under the age of 6 years.

Finlepsin 200 retard is prescribed to elderly patients in lower doses.

Precautions for use and warnings

What precautions should be taken when using the drug?

Due to the possible occurrence of side effects, as well as hypersensitivity reactions to the drug, it is recommended, especially with long-term use, to periodically conduct blood tests and check the function of the liver and kidneys. This is done before the start of treatment, then in the first month of treatment once a week, and after that once a month. After the first 6 months of treatment, these controls are done 2-4 times a year.

In the same way, the concentration of Finlepsin 200 retard and other antiepileptic drugs in blood plasma should be regularly monitored during combination therapy and, if necessary, lower daily doses.

The termination of treatment with Finlepsin 200 retard in patients with epilepsy and their transfer to another antiepileptic drug is not done suddenly, but by gradually lowering its dose.

In patients with glaucoma, intraocular pressure is regularly monitored. It should be borne in mind that the side effects of Finlepsin 200 retard in the treatment of alcohol withdrawal syndrome are similar to withdrawal symptoms and can easily be confused with them.

If, in exceptional cases, for the prevention of manic-depressive phases with insufficient effectiveness of lithium alone, finlepsin 200 retard should be administered together with it, then in order to avoid unwanted interactions (see "Interactions with other drugs"), care must be taken not to exceed a certain concentration of carbamazepine in blood plasma (8 μg/ml), the lithium content was maintained in the low therapeutic range (0.3-0.8 meq/l), the treatment with antipsychotics was carried out more than 8 weeks ago, and also that it should not be carried out simultaneously.

The use of the drug when servicing machines and when performing work without observing safety regulations

Due to the occurrence at the beginning of treatment of such side effects from the central nervous system as dizziness, drowsiness, gait uncertainty and headaches, when using the drug in high doses and / or when combined with other drugs that affect the central nervous system, finlepsin 200 retard, even when used correctly - regardless of the effect on the treated underlying disease - can change your reactivity so much that you can no longer actively participate in traffic or service cars.

You also can no longer react quickly enough and with concentration to unexpected events. You must not drive a car or other vehicle! You must not use electric cutting tools or service machines! You must not perform work without following the safety regulations! Be especially aware that alcohol can further impair your ability to react quickly when participating in traffic.

Interactions

What medicines change the action of Finlepsin 200 retard or what medicines change the action of Finlepsin 200 retard?

In connection with the development of side effects from the central nervous system, the combined use of Finlepsin 200 retard with monoamine oxidase inhibitors (drugs against depression) should be avoided. When switching from one drug to another, a 14-day break in treatment is made!

Influence of Finlepsin 200 retard on plasma concentrations of other drugs

Finlepsin 200 retard may increase the activity of certain liver enzymes and thereby lower plasma levels of other drugs.

Therefore, the effect of some other simultaneously used medications, chemically similar to Finlepsin 200 retard, may weaken or even not appear at all.

With the simultaneous use of Finlepsin 200 retard, according to clinical requirements, if necessary, adjust the doses of the following active substances: clonazepam, ethosuximide, primidone, valproic acid, lamotrigine (other drugs for the treatment of epilepsy), alprazolam, clobazam (drugs that relieve fear), corticosteroids (for example , prednisolone, dexamethasone), cyclosporine (an agent for suppressing the body's immune defenses after organ transplantation), digoxin (an agent for the treatment of heart disease), tetracyclines such as doxycycline (antibiotic), felodipine (a drug that lowers blood pressure), haloperidol ( psychiatric drug), imipramine (an antidepressant), methadone (an analgesic), theophylline (a drug used to treat severe respiratory problems), anticoagulants such as warfarin, phenprocoumone, dicoumarol. Like other antiepileptic drugs, finlepsin 200 retard may weaken the effect of hormonal contraceptives (drugs for contraception, the so-called "pill"). The appearance of intermenstrual bleeding indicates insufficient hormonal protection from pregnancy. Therefore, in such cases, it is recommended to use other non-hormonal contraceptives.

Finlepsin 200 retard can both increase and decrease the concentration of phenytoin in the blood plasma, as a result of which, in exceptional cases, states of confusion may occur up to the development of coma.

Decrease in the concentration of Finlepsin 200 retard in blood plasma by other drugs

The level of Finlepsin 200 retard in the blood plasma can be lowered by: phenobarbital, primidone, valproic acid, theophylline.

On the other hand, valproic acid and primidone can increase the level of the pharmacologically active metabolite (the metabolic product of finlepsin 200 retard) carbamazepine-10,11-epoxide in the blood serum.

In connection with the mutual influence on each other, especially with the combined use of several antiepileptic drugs, it is recommended to control their content in the blood plasma and, if necessary, correct the dosage of Finlepsin 200 retard.

Increasing the concentration of Finlepsin 200 retard in blood plasma by other drugs

The following active substances may increase the concentration of Finlepsin 200 retard in the blood plasma: macrolide antibiotics, such as erythromycin, yosamycin (active substances for the treatment of bacterial infections), isoniazid (drug for the treatment of tuberculosis), calcium antagonists, such as verapamil , diltiazem (drugs used to treat angina pectoris), acetazolamide (drug used to treat glaucoma), viloxazine (antidepressant), danazol (drug to suppress the secretion of the sex hormone gonadotropin), nicotinamide in high doses in adults (B vitamin), possibly also cimetidine (a medicine used to treat stomach ulcers) and desipramine (an antidepressant).

Elevated plasma levels of Finlepsin 200 retard may contribute to the development of the symptoms mentioned in the "Side Effects" section (eg, dizziness, fatigue, unsteady gait, double vision). Therefore, if such symptoms occur, the concentration of carbamazepine in the blood plasma is monitored and, if necessary, the dose is reduced.

Other interactions

The simultaneous use of Finlepsin 200 retard and neuroleptics (drugs for the treatment of mental illness) or metoclopramide (drugs for the treatment of gastrointestinal disorders) may contribute to the occurrence of neurological side effects.

On the other hand, in patients treated with antipsychotics, finlepsin 200 retard can lower the level of these drugs in the blood plasma and thereby worsen the picture of the disease. Therefore, the physician may consider it necessary to increase the dose of the appropriate antipsychotic.

It is pointed out that especially with the simultaneous use of lithium (a drug for the treatment and prevention of certain mental illnesses) and Finlepsin 200 retard, the effect of both active substances affecting the nervous system can be enhanced. Therefore, in such cases, it is necessary to carefully monitor the content of both drugs in the blood plasma. Previous treatment with antipsychotics should be discontinued 8 weeks before the start of therapy with these drugs, and should not be carried out together with them. It is necessary to watch for the following signs of neurotoxic side effects: unsteady gait (ataxia), twitching or twitching of the eyeballs (horizontal nystagmus), increased muscle proprioceptive reflexes, rapid contractions of individual muscle fibers (fibrillar twitches), involuntary contractions of individual bundles of muscle fibers (fasciculations) .

Finlepsin 200 retard may increase the effect of isoniazid, which damages the liver.

The combined use of Finlepsin 200 retard with some diuretics (hydrochlorothiazide, furosemide) may cause a decrease in the sodium content in the blood serum.

Finlepsin 200 retard may affect the effectiveness of medicines that relax muscles (muscle relaxants), such as pancuronium. As a result, more rapid elimination of neuromuscular blockade is possible. Therefore, patients treated with muscle relaxants are monitored and, if necessary, the doses of these medications are increased.

With the simultaneous use of isotretinoin (an active substance for the treatment of acne) and finlepsin 200 retard, the content of finlepsin 200 retard in the blood serum should be monitored.

Finlepsin 200 retard probably increases the secretion (elimination) of thyroid hormones and increases the need for them in patients with reduced thyroid function. Therefore, in these patients receiving replacement therapy, at the beginning and at the end of treatment with Finlepsin 200 retard, indicators of thyroid function are determined. If necessary, adjust the dose of thyroid hormone preparations.

With the simultaneous use of antidepressant drugs such as serotonin reuptake blockers (antidepressive drugs, such as fluoxetine) and finlepsin 200 retard, toxic serotonin syndrome may develop.

Remember that this information may also be relevant for medicines taken shortly before the start of treatment with Finlepsin 200 retard.

What stimulants, foods and drinks should you avoid?

During treatment with Finlepsin 200 retard, you should stop drinking alcohol, as it can unpredictably change and enhance the effect of Finlepsin 200 retard.

Dosage and administration

The following dose regimens are valid for Finlepsin 200 retard without special instructions from your doctor. Please adhere to the doses prescribed by your doctor, because otherwise Finlepsin 200 retard will not have a therapeutic effect!

How much and how often should you take Finlepsin 200 retard

Treatment with Finlepsin 200 retard is started carefully, prescribing the drug in low doses individually for each patient, depending on the nature and severity of the disease picture. The dose is then slowly increased until the most effective maintenance dose is reached. The optimal dose of the drug for the patient, especially in combination therapy, is determined by its level in the blood plasma. According to the accumulated experience, the therapeutic concentration of Finlepsin 200 retard in blood plasma is 4–12 μg / ml.

The replacement of one antiepileptic drug with Finlepsin 200 retard should be done gradually, reducing the dose of the previously used drug. If possible, an antiepileptic agent is used only for monotherapy. The course of treatment is monitored by a specialist doctor.

The generally accepted dose range is 400–1200 mg of finlepsin 200 retard per day, divided into 1–2 single doses per day. Exceeding the total daily dose of 1200 mg does not make sense. The maximum daily dose should not exceed 1600 mg, since higher doses may increase the number of side effects.

In some cases, the dose required for treatment may deviate significantly from the recommended initial and maintenance dose, for example, due to accelerated metabolism due to the induction of microsomal liver enzymes or due to drug interactions in combination therapy.

Without special instructions from the doctor, they are guided by the following approximate scheme for the use of the drug:

Anticonvulsant treatment

In general, in adults, an initial dose of 1-2 retard tablets (corresponding to 200-400 mg carbamazepine) is slowly increased to a maintenance dose of 4-6 retard tablets (corresponding to 800-1200 mg carbamazepine).

In general, the maintenance dose of carbamazepine for children averages 10-20 mg/kg body weight per day.

indication

For children under 6 years of age, non-prolonged-release tablets are available for initial and maintenance treatment. Due to the lack of experience gained with retard tablets, they are not recommended for children at this age.

Prevention of the development of convulsive seizures in alcohol withdrawal syndrome in a hospital

The average daily dose is 1 retard tablet in the morning, 2 retard tablets are prescribed in the evening (corresponding to 600 mg of carbamazepine). In severe cases, in the first days, the dose can be increased to 3 retard tablets 2 times a day (corresponding to 1200 mg of carbamazepine).

Finlepsin 200 retard should not be combined with sedative-hypnotics. In accordance with clinical requirements, however, if necessary, Finlepsin 200 retard can be combined with other substances used to treat alcohol withdrawal.

During treatment, it is necessary to regularly monitor the content of Finlepsin 200 retard in the blood plasma.

In connection with the development of side effects from the central and autonomic nervous system (see the phenomena of alcohol withdrawal in the "Side Effects" section), patients are carefully monitored clinically.

Trigeminal neuralgia, genuine glossopharyngeal neuralgia

The initial dose is 1-2 retard tablets (corresponding to 200-400 mg of carbamazepine), which, until the complete disappearance of pain, is increased by an average of 2-4 retard tablets (corresponding to 400-800 mg of carbamazepine), which are divided into 1-2 single doses in day. After that, in a certain proportion of patients, treatment can be continued with a lower maintenance dose, which can still prevent attacks of pain, which is 1 tablet of retard 2 times a day (corresponding to 400 mg of carbamazepine).

For elderly and sensitive patients, Finlepsin 200 retard is prescribed at an initial dose of 1 tablet retard 1 time per day (corresponding to 200 mg of carbamazepine).

Pain in diabetic neuropathy

The average daily dose is 1 retard tablet in the morning and 2 retard tablets in the evening (corresponding to 600 mg of carbamazepine). In exceptional cases, Finlepsin 200 retard can be prescribed at a dose of 3 retard tablets 2 times a day (corresponding to 1200 mg of carbamazepine).

epileptiform seizures in multiple sclerosis

The average daily dose is 1-2 retard tablets 2 times a day (corresponding to 400-800 mg of carbamazepine).

Treatment and prevention of psychosis

The initial dose, which is usually also sufficient as a maintenance dose, is 1-2 retard tablets per day (corresponding to 200-400 mg of carbamazepine). If necessary, this dose can be increased to 2 retard tablets 2 times a day (corresponding to 800 mg of carbamazepine).

indication

Patients with severe cardiovascular diseases, liver and kidney damage, as well as the elderly, are prescribed lower doses of the drug.

How and when should you take finlepsin 200 retard

Retard tablets are provided with a dividing groove, they are taken during or after a meal with a sufficient amount of liquid (for example, a glass of water).

Retard tablets can be taken after their preliminary disintegration in water (as a suspension). The prolonged action persists even after the disintegration of the tablet in water.

In some cases, the distribution of the daily dose into 4-5 single doses per day has been particularly effective. For this, dosage forms of the drug are not of prolonged action.

How long should you take finlepsin 200 retard

The duration of use depends on the indication and the patient's individual response to the drug.

Treatment for epilepsy takes a long time. The transfer of the patient to Finlepsin 200 retard, the duration of use and its cancellation in each individual case should be decided by a specialist doctor. In general, the dose of medication should be attempted to be reduced or discontinued altogether no sooner than after 2 to 3 years without seizures.

Treatment is stopped by a gradual decrease in the dose of the drug for 1-2 years. In this case, children should take into account the increase in body weight. In this case, the EEG parameters should not worsen.

In the treatment of neuralgia, the appointment of Finlepsin 200 retard in a maintenance dose, just enough to relieve pain, for several weeks turned out to be useful. Careful lowering of the dose is necessary to find out if spontaneous remission of the symptoms of the disease has occurred. With the resumption of pain attacks, treatment is continued with the same maintenance dose.

The duration of treatment for pain in diabetic neuropathy and epileptiform convulsions in multiple sclerosis is the same as in neuralgia.

Treatment of alcohol withdrawal syndrome with Finlepsin 200 retard is stopped by gradual dose reduction within 7-10 days.

Prevention of manic-depressive phases is carried out for a long time.

Errors in the use of the drug and overdose

If you forget to take one single dose of the drug, then as soon as you notice this, immediately take it. If you are due to take your next prescribed dose soon after, then you will skip it and then try to get back into your correct dosing regimen. Never take a double dose of Finlepsin 200 retard after one forgotten dose. In case of doubt, please contact your doctor for help!

What you should consider if you want to temporarily interrupt or stop treatment prematurely

Changing the dose on your own or even stopping the drug without medical supervision is dangerous! This can aggravate your symptoms again. Before you stop taking Finlepsin 200 retard yourself, it is better to consult your doctor about this.

What should be done if Finlepsin 200 retard was taken in very large quantities

An overdose of the drug requires urgent medical attention. The picture of an overdose of Finlepsin 200 retard is characterized by an increase in such side effects as, for example, trembling (tremor), convulsive seizures that occur when the brain is excited (tonic-clonic convulsions), agitation, as well as respiratory and cardiovascular system function disorders with often reduced (sometimes also elevated) blood pressure, increased heart rate (tachycardia) and disturbances in the conduction of excitation in the heart (atrioventricular blockade, ECG changes), disorders of consciousness up to respiratory and cardiac arrest. In isolated cases, leukocytosis, leukopenia, neutropenia, glucosuria or acetonuria were observed, which were established by altered laboratory tests.

There is as yet no specific antidote for the treatment of acute poisoning with Finlepsin 200 retard. Treatment of overdoses of Finlepsin 200 retard, as a rule, is carried out depending on the painful manifestations in a hospital setting.

Side effects

Observed side effects occurred more frequently with combination treatment than with monotherapy. Depending on the dose and mainly at the beginning of treatment, the following side effects may occur:

Central nervous system / Psyche

Dizziness, confusion (drowsiness), dizziness, fatigue, impaired gait and movement (cerebellar ataxia), and headaches can often occur. Elderly patients may develop confusion and anxiety.

In isolated cases, depressive bad mood, aggressive behavior, mental retardation, impoverishment of motives, as well as perceptual disorders (hallucinations) and tinnitus are observed. During treatment with Finlepsin 200 retard, latent psychoses may be activated.

Rarely, involuntary movements occur, such as large-scale tremors, muscle contractions, or twitching of the eyeball (nystagmus). In addition, in elderly patients and with brain lesions, such disorders of coordinated motor acts may occur, such as, for example, involuntary movements in the orofacial region in the form of grimacing (orofacial dyskinesias), rotational movements (choreoathetosis). Isolated cases of speech disturbances, false sensations, muscle weakness, inflammation of the nerves (peripheral neuritis), as well as manifestations of paralysis of the lower extremities (paresis) and disorders of taste perception have been reported.

Most of these events disappear on their own after 8 to 14 days or after a temporary dose reduction. Therefore, if possible, Finlepsin 200 retard is dosed carefully, starting treatment with low doses, then gradually increasing them.

Eyes

In some cases, inflammation of the connective membrane of the eye (conjunctivitis), sometimes transient visual disturbances (disturbances of accommodation of the eye, double vision, blurred vision) occurred. Cases of clouding of the lens have been reported.

In patients with glaucoma, intraocular pressure should be measured regularly.

Propulsion system

In isolated cases, there were pains in the joints and muscles (arthralgia, myalgia), as well as muscle spasms. These phenomena disappeared after discontinuation of the drug.

Skin and mucous membranes

Allergic skin reactions with or without fever have been reported, such as rare or frequent urticaria (urticaria), pruritus, sometimes large-plate or scaly inflammation of the skin (exfoliative dermatitis, erythroderma), necrosis of superficial skin with blistering (syndrome Lyell), photosensitivity (photosensitivity), reddening of the skin with polymorphic rashes in the form of spots and knots, with hemorrhages (exudative erythema multiforme, erythema nodosum, Stevens-Johnson syndrome), petechial hemorrhages in the skin and lupus erythematosus (disseminated lupus erythematosus).

In isolated or rare cases, hair loss (alopecia) and sweating (diaphoresis) have been noted.

Circulatory and lymphatic system

In connection with hypersensitivity reactions during treatment with Finlepsin 200 retard, in addition, the following blood picture disorders may occur: rarely or often an increase (leukocytosis, eosinophilia) or a decrease (leukopenia) in the number of leukocytes or platelets (thrombocytopenia) in the peripheral blood. According to the literature, a benign form of leukopenia most often appears (in about 10% of cases it is transient, and in 2% of cases it is persistent).

Isolated cases of blood diseases, sometimes even life-threatening, such as agranulocytosis, aplastic anemia, along with other forms of anemia (hemolytic, megaloblastic), as well as an increase in the spleen and lymph nodes, have been reported.

With the appearance of leukopenia (most often neutropenia), thrombocytopenia, allergic skin rashes (exanthema) and fever, Finlepsin 200 retard is canceled.

Gastrointestinal tract

Sometimes there is loss of appetite, dry mouth, nausea and vomiting, and rarely diarrhea or constipation. Isolated cases of abdominal pain and inflammation of the mucous membranes of the oropharyngeal cavity (stomatitis, gingivitis, glossitis) have been reported. These phenomena disappear on their own after 8-14 days of treatment or after a temporary decrease in the dose of the drug. They can be avoided by initial administration of low doses of the drug with a gradual increase.

There are indications in the literature that carbamazepine can sometimes cause inflammation of the pancreas (pancreatitis).

Liver and bile

Sometimes changes in liver function tests are detected, in rare cases jaundice appears; in isolated cases, various forms of hepatitis occur (cholestatic, hepatocellular, granulomatous, mixed).

Two cases of acute intermittent porphyria have been described.

Hormonal, water and salt metabolism

Individual cases of breast enlargement in men (gynecomastia) and spontaneous leakage of milk from the mammary glands in women (galactorrhea) have been reported.

Finlepsin 200 retard may affect the parameters of thyroid function (triiodothyronine, thyroxine, thyroid stimulating hormone and free thyroxine), especially when combined with other antiepileptic drugs.

In connection with the action of Finlepsin 200 retard, which reduces the excretion of urine from the body (antidiuretic effect), in rare cases, a decrease in the sodium content in the blood serum (hyponatremia) may be observed, accompanied by vomiting, headache and confusion.

There were isolated cases of edema and weight gain. Finlepsin 200 retard may lower serum calcium levels. In isolated cases, this leads to softening of the bones (osteomalacia).

Respiratory system

Isolated cases of hypersensitivity reactions of the lungs to the drug, accompanied by fever, shortness of breath (dyspnea), pneumonia and pulmonary fibrosis, are described.

urinary tract

Rarely, there are violations of kidney function, expressed by an increased content of protein in the urine (proteinuria), the appearance of blood in the urine (hematuria), reduced urine output (oliguria), in isolated cases they develop up to kidney failure. Perhaps these disorders are due to the drug's own antidiuretic effect. Sometimes there is dysuria, pollakiuria and urinary retention.

In addition, cases of sexual disorders are known, such as impotence and a decrease in sexual desire.

The cardiovascular system

In rare or isolated cases, mainly in the elderly or in patients with known cardiac dysfunction, a slow heart rate (bradycardia), heart rhythm disturbances, and worsening of coronary heart disease may occur.

Rarely, there are disturbances in the conduction of excitation in the heart (atrioventricular blockade), in isolated cases accompanied by fainting. In addition, in some cases, blood pressure is greatly reduced or increased. The drop in blood pressure mainly occurs when the drug is used in high doses.

In addition, vasculitis, thrombophlebitis and thromboembolism have been observed.

Hypersensitivity reactions

Rarely, delayed hypersensitivity reactions to the drug develop, occurring with fever, skin rash, vascular inflammation, swollen lymph nodes, joint pain, an altered number of leukocytes in peripheral blood, an increase in the liver and spleen, a change in liver function tests, which can occur in different combinations, as well as involve other organs in the process, such as the lungs, kidneys, pancreas and myocardium.

In isolated cases, an acute generalized reaction and aseptic inflammation of the meninges with myoclonus and eosinophilia were observed.

If you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist about this.

What measures should be taken in case of side effects

If you notice the above side effects, then immediately inform your doctor, who will determine the severity of them and take measures to combat them (see also the section "Precautions for use"). Especially if fever, sore throat, allergic skin reactions in the form of rashes with swollen lymph nodes and / or flu-like painful symptoms appear during treatment with Finlepsin 200 retard, you should immediately seek medical help and analyze the blood picture.

With the development of severe allergic reactions, Finlepsin 200 retard is immediately canceled.

If certain changes in the blood picture occur (leukopenia, more often neutropenia, thrombocytopenia), allergic skin rashes (exanthema) and fever, Finlepsin 200 retard is canceled.

If there are signs of liver damage or impaired function, such as lethargy, lack of appetite, nausea, yellow skin or liver enlargement, immediately seek medical help.

The shelf life of the medicinal product

3 years.
The expiration date of retard tablets is indicated on the foil of the blister pack and on the cardboard box.
After the expiration of the specified period, do not use any more retard tablets of this package.

Medicines are kept out of the reach of children!

Finlepsin 200 retard comes in a child-proof package with a thicker foil for coating. In case you find it difficult to extrude a retard tablet, we advise you to lightly cut the coating foil before doing so.

Storage conditions

The drug is stored under normal conditions.

Release forms

Finlepsin 200 retard is available in packs of 50, 100 and 200 retard tablets.

Terms of dispensing from pharmacies

Released only by prescription.

Finlepsin is an antiepileptic drug that has analgesic and antipsychotic effects.

Release form and composition

Dosage form Finlepsin - tablets: round, chamfered, white, convex on one side and the risk in the form of a wedge-shaped recess on the other (in blisters of 10 pieces, in a carton pack of 3, 4 or 5 blisters).

Composition of 1 tablet:

• active substance: carbamazepine - 0.2 g;
• auxiliary components: microcrystalline cellulose - 0.06 g; gelatin - 0.011 g; croscarmellose sodium - 0.006 g; magnesium stearate - 0.003 g.

Indications for use

• epilepsy: grand mal seizures mostly of focal origin (grand grand mal seizures during sleep, diffuse grand mal seizures), psychomotor seizures, partial seizures with elementary symptoms (focal seizures) or complex symptoms, mixed forms of the disease;
• trigeminal neuralgia;
• idiopathic glossopharyngeal neuralgia;
• pain in diabetic neuropathy, pain in lesions of peripheral nerves on the background of diabetes mellitus;
• paroxysmal paresthesias and attacks of pain, paroxysmal movement and speech disorders (paroxysmal ataxia and dysarthria), tonic convulsions, facial muscle spasms in trigeminal neuralgia, epileptiform convulsions in multiple sclerosis;
• alcohol withdrawal syndrome (sleep disturbances, anxiety, hyperexcitability, convulsions);
• psychotic disorders (limbic system disorders, psychosis, schizoaffective and affective disorders).

Contraindications

• disorders of bone marrow hematopoiesis (anemia, leukopenia);
• acute intermittent porphyria (including history);
• atrioventricular block;
• simultaneous therapy with lithium preparations and monoamine oxidase inhibitors;
• hypersensitivity to tricyclic antidepressants;
• individual intolerance to the components of the drug.

Diseases / conditions in which Finlepsin is used with caution:

• liver and kidney failure;
• decompensated chronic heart failure;
• prostatic hyperplasia;
• dilutional hyponatremia (adrenal cortex insufficiency, hypothyroidism, hypopituitarism, antidiuretic hormone hypersecretion syndrome);
• increased intraocular pressure;
• active alcoholism (increases the depression of the central nervous system and the metabolism of carbamazepine);
• oppression of bone marrow hematopoiesis when taking drugs (in history);
• simultaneous therapy with sedative-hypnotics;
• elderly age;
• pregnancy and lactation (before starting treatment, the expected benefit of therapy should be compared with possible complications, since taking the drug may increase the risk of hemorrhagic complications in newborns, intrauterine development disorders, including malformations).

Method of application and dosage

Finlepsin is taken orally with a liquid, during or after a meal.

Epilepsy

If possible, the drug is prescribed as monotherapy. If Finlepsin is added to an already ongoing antiepileptic treatment, the introduction is carried out gradually, and the doses of the drugs used are adjusted if necessary.

If you miss the next dose of the drug, it should be taken as soon as the patient remembers about it, while a double dose should not be taken.

Initial dose for adults - 1-2 pcs. per day (it is gradually increased until the optimal therapeutic effect is achieved). Maintenance dose - 4-6 pcs. per day, divided into 1-3 doses. The maximum dose is 8–10 pcs. in a day.

Dosing regimen for children:

• from 1 to 5 years: initial dose - 0.5-1 pc. in a day; maintenance dose - 1-2 pcs. per day, divided into several doses;
• from 6 to 10 years: initial dose - 1 pc. in a day; maintenance dose - 2-3 pcs. per day, divided into 2-3 doses;
• from 11 to 15 years old: initial dose - 0.5–1.5 pcs. in a day; maintenance dose - 3-5 pcs. per day, divided into 2-3 doses.

The dose is gradually increased by 0.5 pcs. per day until the optimal therapeutic effect is achieved. If a child cannot swallow a whole tablet, it can be crushed, chewed, or shaken in a small amount of water.

The duration of therapy is determined depending on the indications and the patient's individual response to the drug. The decision to transfer the patient to Finlepsin, the duration of treatment and its cancellation is made by the doctor on an individual basis. The possibility of reducing the dose of the drug or stopping therapy is considered after 2-3 years of complete absence of seizures.

Cancellation of the drug is carried out gradually, reducing its dose within 1-2 years, under the control of electroencephalography. When reducing the daily dose of the drug in children, it should be taken into account that with age, their body weight increases.

Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia

Initial dose - 1-2 pieces; it is increased to 2–4 pieces, divided into 1–2 doses, until the pain disappears completely. In some patients, therapy may continue with a lower maintenance dose - 1 pc. 2 times a day.

The initial dose for patients with hypersensitivity and for elderly patients is 0.5 pcs. 2 times a day.

Alcohol withdrawal (inpatient therapy)

The average daily dose - 1 pc. 3 times a day. In severe cases, in the first days, the dose can be increased by 2 times.

If necessary, it is possible to use Finlepsin with other substances for the treatment of alcohol withdrawal.

Cancellation of the drug is carried out gradually, reducing the dose within 7-10 days.

Pain in diabetic neuropathy

The average daily dose - 1 pc. 3 times a day. In exceptional cases, the dose may be increased by 2 times.

epileptiform seizures in multiple sclerosis

The average daily dose is 1-2 pcs. 2 times a day.

psychoses

Initial and maintenance dose - 1-2 pcs. per day, with a possible increase in dose up to 2 pcs. 2 times a day.

Side effects

Possible side effects (> 10% - very often; > 1% and< 10% – часто; >0.1% and< 1% – нечасто; >0.01% and< 0,1% – редко; < 0,01% – очень редко):

• central nervous system: often - accommodation paresis, headache, general weakness, drowsiness, ataxia, dizziness; infrequently - nystagmus, abnormal involuntary movements (for example, tics, dystonia, tremor, fluttering tremor); rarely - auditory or visual hallucinations, depression, decreased appetite, anxiety, aggressive behavior, psychomotor agitation, oculomotor disturbances, disorientation, activation of psychosis, orofacial dyskinesia, peripheral neuritis, speech disorders (for example, dysarthria or slurred speech), paresthesia, choreoathetoid disorders , muscle weakness and symptoms of paresis;
• allergic reactions: often - urticaria; infrequently - erythroderma, delayed-type multiorgan hypersensitivity reactions with lymphadenopathy, skin rashes, arthralgias, fever, eosinophilia, leukopenia, signs resembling lymphoma, vasculitis (including erythema nodosum as a manifestation of cutaneous vasculitis), hepatosplenomegaly and altered liver function tests (the indicated manifestations occur in various combinations), other organs may be involved (eg, colon, myocardium, pancreas, kidneys, lungs), angioedema, anaphylactoid reaction, aseptic meningitis with myoclonus and peripheral eosinophilia, eosinophilic pneumonia, or allergic pneumonitis; rarely - photosensitivity, Lyell's syndrome, erythema multiforme exudative (including Stevens-Johnson syndrome), skin itching, lupus-like syndrome;
• hematopoietic organs: often - eosinophilia, thrombocytopenia, leukopenia; rarely - splenomegaly, hemolytic anemia, reticulocytosis, acute intermittent porphyria, megaloblastic anemia, true erythrocyte aplasia, aplastic anemia, agranulocytosis, folic acid deficiency, lymphadenopathy, leukocytosis;
• digestive system: often - dry mouth, nausea, vomiting, increased activity of gamma-glutamyl transferase (due to the induction of this enzyme in the liver) and alkaline phosphatase; infrequently - abdominal pain, diarrhea or constipation, increased activity of hepatic transaminases; rarely - liver failure, granulomatous hepatitis, jaundice, cholestatic hepatitis, parenchymal (hepatocellular) type, pancreatitis, stomatitis, gingivitis, glossitis;
• cardiovascular system: rarely - thromboembolic syndrome, thrombophlebitis, exacerbation of coronary heart disease (including the appearance or increase in angina attacks), aggravation or development of chronic heart failure, collapse, atrioventricular blockade with syncope, arrhythmias, bradycardia, decrease or increase in blood pressure, disorders intracardiac conduction;
• endocrine system and metabolism: often - weight gain, fluid retention, edema, hyponatremia (decrease in plasma osmolarity due to an effect similar to the action of an antidiuretic hormone, which rarely leads to dilution hyponatremia, accompanied by neurological disorders, disorientation, headache, vomiting, lethargy ); rarely - a decrease in the concentration of L-thyroxine and an increase in the concentration of thyroid-stimulating hormone (usually not accompanied by clinical manifestations), an increase in the concentration of prolactin (may be accompanied by galactorrhea and gynecomastia), disorders of calcium-phosphorus metabolism in bone tissue (a decrease in the concentration of Ca2+ and 25-OH-cholecalciferol in blood plasma): hirsutism, hypertriglyceridemia and swollen lymph nodes, hypercholesterolemia (including high-density lipoprotein cholesterol), osteomalacia;
• genitourinary system: rarely - decreased potency, urinary retention, frequent urination, impaired renal function (for example, increased urea / azotemia, oliguria, hematuria, albuminuria), renal failure, interstitial nephritis;
• musculoskeletal system: rarely - convulsions, myalgia or arthralgia;
• sensory organs: rarely - hearing impairment (including changes in pitch perception, hypoacusia, hyperacusis, tinnitus), conjunctivitis, clouding of the lens, increased intraocular pressure, taste disturbances;
• other: alopecia, sweating, acne, purpura, skin pigmentation disorders.

special instructions

Finlepsin in epilepsy monotherapy is started at a low dose, then it is gradually increased until the desired therapeutic effect is achieved.

During the period of selection of optimal doses, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially with combined treatment. There may be a significant deviation in some cases of optimal doses from the recommended initial and maintenance doses, which may be due to the induction of microsomal liver enzymes or interactions with combination therapy.

The drug should not be administered with sedative-hypnotic agents. If necessary, combined use with other substances used for the treatment of alcohol withdrawal is possible. During the treatment period, regular monitoring of the content of carbamazepine in the blood plasma is required. In connection with the development of side effects on the part of the autonomic and central nervous system, patients in a hospital must be carefully monitored. If the patient is transferred to carbamazepine, a gradual reduction in the dose of the previously prescribed antiepileptic drug is required, up to the complete cessation of its administration. It should be borne in mind that the sudden cancellation of carbamazepine can provoke epileptic seizures. If it is necessary to abruptly cancel therapy, it is necessary to transfer the patient to another antiepileptic drug under the cover of the drug indicated in such cases (for example, phenytoin, administered intravenously, or diazepam, administered intravenously or rectally).

There have been reports of vomiting, diarrhea and/or malnutrition, convulsions and/or respiratory depression in newborns whose mothers took carbamazepine in combination with other anticonvulsants (possibly these reactions are a manifestation of neonatal withdrawal syndrome). Before therapy and in the process of taking carbamazepine, a study of liver function is required, especially in elderly patients and patients with a history of liver disease. With the strengthening of existing liver dysfunction or the appearance of active liver disease, immediate withdrawal of the drug is required. Also, before starting treatment, it is necessary to determine the concentration of electrolytes in the blood serum (and periodically during therapy, since hyponatremia may develop), the level of a general analysis of urine, urea and iron in the blood serum, to conduct a study of the blood picture (including counting reticulocytes, platelets) and electroencephalogram. Further, these indicators in the first month of treatment must be monitored weekly, and then monthly.

A transient or persistent decrease in the number of platelets and / or leukocytes for the most part are not harbingers of the onset of agranulocytosis or aplastic anemia. However, before starting treatment and periodically during therapy, a clinical blood test is required, including counting the number of platelets and, possibly, reticulocytes, as well as determining the level of iron in the blood serum. Discontinuation of the drug with non-progressive asymptomatic leukopenia is not required, however, it is necessary when progressive leukopenia or leukopenia appears with clinical symptoms of an infectious disease.

Immediate withdrawal of carbamazepine should be carried out in the event of hypersensitivity reactions or symptoms, presumably indicating the development of Lyell's or Stevens-Johnson syndrome. Mild skin reactions (maculopapular exanthema or isolated macular) in most cases disappear within a few days or weeks, even with continued treatment or after reducing the dose of the drug (the patient during this period should be under close medical supervision).

It is important to take into account the possibility of activation of latent psychoses, and in elderly patients, the possibility of developing psychomotor agitation or disorientation.

In some cases, the use of antiepileptic drugs is accompanied by the occurrence of suicidal intentions / suicide attempts, which was also confirmed by ongoing meta-analyses of randomized clinical trials using antiepileptic drugs. Due to the fact that the mechanism of the occurrence of suicidal attempts when prescribing antiepileptic drugs is not known, it is impossible to exclude their occurrence when taking Finlepsin. Patients and caregivers should be warned to watch for suicidal behavior/ideas and seek immediate medical attention if symptoms develop.

There may be violations of spermatogenesis and / or male fertility, but their relationship with taking carbamazepine has not yet been established.

With the simultaneous use of oral contraceptives, intermenstrual bleeding may occur. Carbamazepine may have a negative effect on the reliability of oral contraceptives, and therefore women of reproductive age should use alternative methods of contraception during the treatment period.

Treatment with carbamazepine should only be carried out under medical supervision. Patients should be alerted to early signs of toxicity and skin and liver symptoms. They should immediately consult a doctor if they experience such adverse reactions as hemorrhages in the form of petechiae or purpura, unexplained bruising, ulceration of the oral mucosa, rash, sore throat, fever.

Before prescribing the drug, an ophthalmological examination is recommended, including measurement of intraocular pressure and examination of the fundus. When used in patients with elevated intraocular pressure, constant monitoring of this indicator is necessary.

In cases of severe cardiovascular diseases, liver and kidney damage, as well as elderly patients, the drug is prescribed in lower doses. Although the relationship between dose, concentration, clinical efficacy or tolerability of carbamazepine is very small, regular determination of its level may be useful in cases such as: a sharp increase in the frequency of seizures; during pregnancy, treatment of children or adolescents, suspected malabsorption of the drug, suspected development of toxic reactions when the patient takes several drugs; to check if the patient is taking the drug properly.

Do not drink alcohol while taking Finlepsin.

Patients during therapy should refrain from conducting potentially hazardous activities that require increased attention and speed of psychomotor reactions.

drug interaction

The effect of drugs / substances on carbamazepine with simultaneous use:

• CYP3A4 inhibitors: increase its concentration in blood plasma, lead to the development of adverse reactions;
• CYP3A4 inducers: can accelerate its metabolism, reduce plasma concentration, reduce the therapeutic effect; their cancellation, on the contrary, can serve to increase its concentration and reduce the rate of biotransformation;
• desipramine, danazol, diltiazem, felodipine, verapamil, acetazolamide, cimetidine, fluvoxamine, fluoxetine, viloxazine, dextropropoxyphene, nicotinamide (high doses in adults), macrolides (erythromycin, josamycin, clarithromycin, troleandomycin), azoles (fluconazole, ketoconazole, itraconazole), terfenadine, loratadine, isoniazid, propoxyphene, viral protease inhibitors used in the treatment of human immunodeficiency virus, grapefruit juice: increase its plasma concentration, which requires monitoring and correction of the dosing regimen;
• felbamate: reduces its concentration in plasma and increases the concentration of carbamazepine-10,11-epoxide, while at the same time the concentration of felbamate in serum may decrease;
• doxorubicin, cisplatin, rifampicin, theophylline, fensuximide, metsuximide, primidone, phenytoin, phenobarbital; possibly - herbal preparations containing St. John's wort, oxcarbazepine, valproic acid, valpromide, clonazepam: reduce its concentration;
• valproic acid, primidone: can displace it from its association with plasma proteins and increase the concentration of carbamazepine-10,11-epoxide. Use with valproic acid in exceptional cases may lead to the development of confusion and coma;
• tetracyclines: may weaken its therapeutic effect;
• myelotoxic drugs: increase the manifestations of its hematotoxicity;
• tricyclic antidepressants, clozapine, maprotiline, haloperidol, molindone, thioxanthenes, pimozide, phenothiazine: increase the inhibitory effect on the central nervous system and weaken its anticonvulsant effect;
• isotretinoin: alters its bioavailability and / or clearance, as well as carbamazepine-10,11-epoxide, which requires monitoring of its plasma concentration.

The effect of carbamazepine on drugs / substances when used in combination:

• theophylline, methadone, haloperidol, tetracyclines (doxycycline), cyclosporine, glucocorticosteroids (prednisolone, dexamethasone), alprazolam, valproic acid, primidone, ethosuximide, digoxin, clonazepam, clobazam, oral preparations containing estrogens and/or progesterone (requires selection alternative methods of contraception), topiramate, lamotrigine, oral anticoagulants (dicumarol, phenprocoumon, warfarin), ziprasidone, tramadol, risperidone, praziquantel, olanzapine, midazolam, levothyroxine, itraconazole, calcium channel blockers (dihydropyridine group such as felodipine), protease inhibitors used in the treatment of human immunodeficiency virus (saquinavir, ritonavir, indinavir), oxcarbazepine, tiagabine, felbamate, clozapine, tricyclic antidepressants (clomipramine, imipramine, nortriptyline, amitriptyline): may reduce their plasma concentration (reduce or even completely eliminate effects), because of what correction of their doses may be required;
• mephenytoin: may increase its plasma levels;
• phenytoin: may increase or decrease its plasma levels;
• paracetamol: may increase the risk of its toxic effects on the liver and reduce therapeutic efficacy (speed up metabolism);
• non-depolarizing muscle relaxants (pancuronium): weakens their effects. The use of such a combination may require an increase in their dose, and careful monitoring of the patient's condition is necessary, since a faster termination of their action is possible;
• ethanol: reduces its tolerance;
• indirect anticoagulants, hormonal contraceptives, folic acid, praziquantel: accelerates their metabolism;
• thyroid hormones: may enhance their elimination;
• anesthetics (halothane, halothane, enflurane): accelerates their metabolism and increases the risk of developing hepatotoxic effects;
• nephrotoxic metabolites of methoxyflurane: enhances their formation;
• isoniazid: enhances its hepatotoxic effect.

The combined use of carbamazepine with lithium preparations can enhance the neurotoxic effects of both active substances; with monoamine oxidase inhibitors - increase the risk of convulsions, hyperpyretic or hypertensive crises, death (they should be canceled at least 14 days before the appointment of carbamazepine, if the clinical situation allows, even for a longer period); with diuretics (furosemide, hydrochlorothiazide) - leads to hyponatremia, accompanied by clinical manifestations.

Analogues

Analogues of Finlepsin are: Zeptol, Carbamazepine, Carbamazepine retard-Akrikhin, Carbamazepine-Akrikhin, Carbamazepine-Ferein, Tegretol, Tegretol CR, Finlepsin retard.

Terms and conditions of storage

Store at temperatures up to 30 °C. Keep away from children.

Shelf life - 3 years.

Terms of dispensing from pharmacies

Released by prescription.

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And for the prevention of neuralgic pathologies, pharmacological agents with a complex effect are used.

The drug showed high effectiveness in therapy Finlepsin .

To achieve the desired therapeutic effect is possible only if the rules for the use of the drug are observed, which can be found below.

radar

The antiepileptic drug has been successfully registered and approved for sale in the territory of the Russian Federation.

The main data entered into the help system contains the following information:

• INN - Carbamazepine;
• official trade name - Finlepsin;
• group of medications - antiepileptic;
• a substance that provides a therapeutic effect - carbamazepine;
• pharmacological actions of the drug - antipsychotic, antiepileptic, analgesic;
• dosage form - tablets;
• short description - rounded tablets of white color, on one side of the plane there is a risk, on the other - a wedge-shaped recess, along the circumference of the chamfer;
• packing - 30/40/50 pcs. packaged.

Compound

The pharmaceutical product is based on carbamazepine.

For better assimilation of the main component by the body in production, the following are used:

• croscarmellose sodium;
• magnesium stearate;
• gelatin.

Pharmacology

The therapeutic effect of the drug is achieved due to the physical and chemical properties of the main component of the composition.

Carbamazepine has a wide spectrum of action:

• antidiuretic;
• antidepressant;
• analgesic;
• antipsychotic
• antiepileptic.

The principle of operation of the drug is based on the blocking of voltage-gated sodium channels. This has a stabilizing effect on the membranes of overexcited neurons.

The treatment process is supported by a decrease in the manifestations of serial discharges of neurons, a decrease in the synoptic conduction of impulses.

Carbamazepine prevents the release of the neurotransmitter amino acid glutamate, increases the convulsive threshold of the central nervous system to normal, as a result of which the risk of development is minimized.

Price

You can buy medicine at a pharmacy or by leaving a request in an online store.

One of the main conditions for the sale of medicines of this pharmacological group is the presence prescription in Latin.

Finlepsin Retard (400 mg) will cost 285 rubles th.

The cost of regular Finlepsin - 206-219 rubles.

Indications for use

In the official instructions, the manufacturer indicates a number of pathologies, the treatment regimen of which may include the agent in question.

The medicine received the greatest recognition in therapy:

• trigeminal neuralgia;
• diabetic polyneuropathy (with pain syndrome);
• idiopathic neuralgia of the glossopharyngeal nerve;
• multiple sclerosis (to prevent epileptiform seizures).

The active ingredient of the drug is effective in various types, psychomotor / focal / partial / convulsive seizures and other symptoms characteristic of epilepsy and mental disorders.

Finlepsin increases the effectiveness of complex therapy with.

Tablets eliminate convulsive seizures, stabilize the psycho-emotional background.

Instructions for use

Before starting therapy, it is important to familiarize yourself with the annotation for the drug, in particular, what the remedy helps with, how to take it correctly. These factors are one of the fundamental factors that ensure successful treatment.

The tablets should be taken orally with meals. They are also allowed to be consumed after meals.

The pill must not be crushed or chewed. The whole tablet is washed down with a glass of purified water.

The treatment regimen provides for a gradual increase in the dose at the initial stage with a weekly increase in the initial amount of the drug by 50-150 mg.

The daily dose rate is determined taking into account the type of disease:

• When Finlepsin is included in complex treatment or used for monotherapy. In order to obtain a maintenance effect for adult patients, the daily norm is 800-1200 mg. For medicinal purposes, it is recommended to start using tablets with a minimum dose (200-400 mg), which is divided into 2-3 servings. The maximum rate should not be more than 2 g / day. Children under the age of five are prescribed 100-200 mg, from 5 to 12 years - 200-600 mg.
• Pain syndrome in the pathology of the nerve against the background of diabetes, the daily norm is 600 mg. Sometimes, to achieve the effectiveness of therapy, the doctor increases the dose to 1200 mg.
• Neuralgia of the glossopharyngeal nerve- the starting rate does not exceed 400 mg, then the dose is set in the range of 600-800 mg per day.
• Epileptic convulsions on the background multiple sclerosis- it is recommended to divide the daily intake of 400-800 mg into 2-3 servings.
• - therapy should begin with 600 mg, then the amount of the active ingredient gradually increases to 1200 mg. The norm is divided into 3 servings.
• - at the initial stage, experts advise taking 200 mg / day, then the rate increases to 800 mg.

Application restrictions

The developers have identified a number of pathologies in the presence of which the drug therapy should be used Not recommended.

Among the main ones:

• genetic diseases of the liver, especially at the stage of exacerbation;
• changes in bone marrow hematopoiesis;
• atrioventricular block;
• allergy to the constituent components of the product;
• intolerance to tricyclic antidepressants;
• combination of carbamazepine with MAO inhibitors, pharmacological products containing lithium.

There is also a group of patients who are prescribed Finlepsin individually considering possible threats.

The list includes people with the following health problems:

• thyroid dysfunction, Parkhon's syndrome, decrease / cessation of pituitary hormone production;
• heart diseases;
• disorders in the liver / kidneys, insufficiency of the adrenal cortex;
• intense pathological changes in the central nervous system, obstacles created during the breakdown of carbamazepine, etc.

When prescribing the remedy for the elderly, it is recommended to exercise caution.

Side effects

When testing a pharmacological agent, the following side effects were identified:

• unreasonable aggression;
• hallucinations;
• changes in blood parameters (neutrophils, platelets, leukocytes);
• jumps in blood pressure;
• allergy;
• sinus rhythm disorder.

A negative reaction to carbamazepine from the urinary system is not excluded.

Occasionally observed:

• puffiness;
• nephritis;
• hematuria;
• urination disorders, etc.

Finlepsin and alcohol: compatibility

Combining an antiepileptic drug with ethanol Not recommended .

The action of the drug is aimed at blocking the depressive state and arousal, and alcoholic beverages just cause them. This neutralizes the pharmacological properties of the active ingredient, provokes the development complications due to increased stress on the liver and kidneys.

In addition, during the period of taking strong drinks, the body actively reproduces the production of adrenaline, as a result of which the heartbeat increases, and the blood pressure indicator increases. In this state, a person automatically falls into the risk group due to the possible manifestations of spasms, hypertensive crisis.

Finlepsin is often included in the complex of measures against. The active substance of the drug blocks the pathological craving for alcohol. This is important for patients who, after detoxification, have a strong desire to drink something from strong drinks.

Ignoring the warning regarding the combined use of medication and alcohol leads to liver dysfunction, intoxication organism and other complications.

The negative impact of a toxic cocktail extends to the functioning of the brain, the hematopoietic system. If such problems occur, therapy should be interrupted.

You can restore the use of the product after cleaning the body of ethanol products.

There are contraindications. Please consult your doctor before taking.

Commercial names abroad (abroad) - Biston, Calepsin, Carbatrol, Epitol, Equetro, Sirtal, Stazepine, Telesmin, Tegretal, Tegrital, Epitab XR, Teril, Trimonil, Epimaz, Carbama, Carbamaze, Amizepin, Carzine, Mazetol, Tegrita, Zeptol, Karbapin, Hermolepsin, Degranol, Equetro.

All antiepileptic drugs.

All drugs used in neurology and psychiatry,.

You can ask a question or leave a review about the medicine (please do not forget to indicate the name of the drug in the text of the message).

Preparations containing Carbamazepine (Carbamazepine, ATC code (ATC) N03AF01):

Common forms of release (more than 100 offers in Moscow pharmacies)
Name	Release form	Packing, pcs	Producing country	Price in Moscow, r	Offers in Moscow
Apo-Carbamazepine	tablets 200mg	50	Canada, Apotex	29-(middle 40)-49	191↗
Carbamazepine (Carbamazepine)	tablets 200mg	50	Various	29-(middle 40)-58	417↘
Carbamazepine-Acri	tablets 200mg	50	Russia, Akrikhin	33-(medium 39)-49	229↗
Tegretol (Tegretol)	tablets 200mg	50	Italy, Novartis	292- (medium 372) -505	355↗
Tegretol CR (Tegretol CR)	sustained release tablets 200mg	50	Italy, Novartis	256-(medium 292)-430	302↘
Tegretol CR (Tegretol CR)	sustained release tablets 400mg	30	Italy, Novartis	199-(medium 301)-355	301↘
Finlepsin (Finlepsin)	tablets 200mg	50	Germany, AVD and Poland, Pliva	190-(medium 247)-302	562↗
		50		178-(medium 211)-321	500
Finlepsin Retard (Finlepsin Retard)		50	Germany, Menarini and Poland, Pliva	265-(medium 310)-403	494↗
Rare forms of release (less than 100 offers in Moscow pharmacies)
Zeptol (Zeptol)	tablets 200mg	30	India, San	122-259	2
	delayed release tablets. 200mg	50	Russia, Akrikhin	100-176	24↗
Carbalepsin retard (Carbalepsin Retard)	delayed release tablets. 400mg	50	Russia, Akrikhin	135-(average 165)-186	49↘
Carbamazepine-Nycomed	tablets 200mg	50	Denmark, Nycomed	34-(medium 49)-44	20↘
Carbamazepine-Rivo	tablets 200mg	50	Switzerland, Rivofarm	29-(middle 38)-47	64↘
Carbatol	tablets 100mg	100	India, Torrent Pharmaceuticals Ltd	173-203	2
Carbatol	tablets 200mg	100	Jordan, Dar al Dawa	76-113	2↘
Timonil (Timonil)	tablets 200mg	100	Germany, Desitin	5200	1
Timonil (Timonil)	tablets 300mg	50	Germany, Desitin	221-250	2

Finlepsin (Carbamazepine) - official instructions for use. Prescription drug, information intended for healthcare professionals only!

Clinico-pharmacological group:

Anticonvulsant drug.

pharmachologic effect

An antiepileptic drug (a derivative of dibenzazepine), which also has an antidepressant, antipsychotic and antidiuretic effect, has an analgesic effect in patients with neuralgia. The mechanism of action is associated with the blockade of voltage-dependent sodium channels, which leads to stabilization of the membrane of overexcited neurons, inhibition of the occurrence of serial discharges of neurons and a decrease in synaptic conduction of impulses. Prevents the re-formation of Na+-dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the reduced convulsive threshold of the CNS and thus reduces the risk of developing an epileptic seizure. Increases K+ conductivity, modulates voltage-dependent Ca2+ channels, which may also contribute to the anticonvulsant effect of the drug.

It is effective in focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective in small seizures - petit mal, absences and myoclonic seizures ). Patients with epilepsy (especially children and adolescents) showed a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness. The effect on cognitive function and psychomotor performance is dose dependent. The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

In essential and secondary trigeminal neuralgia, carbamazepine in most cases prevents the onset of pain attacks. Relief of pain in trigeminal neuralgia is observed after 8-72 hours.

With alcohol withdrawal syndrome, it increases the threshold for convulsive readiness, which in this state is usually reduced and reduces the severity of the clinical manifestations of the syndrome (irritability, tremor, gait disturbances).

Antipsychotic (anti-manic) action develops after 7-10 days, may be due to inhibition of the metabolism of dopamine and norepinephrine.

Pharmacokinetics

Suction

Absorption is slow, but complete (food intake does not significantly affect the rate and extent of absorption). After a single dose of the tablet, Cmax is reached after 12 hours. The average Cmax of the unchanged active substance after a single dose of carbamazepine at a dose of 400 mg is about 4.5 μg / ml. The time to reach Cmax is 4-5 hours.

Distribution

Css of the drug in plasma is achieved in 1-2 weeks (the rate of achievement depends on the individual characteristics of metabolism: autoinduction of liver enzyme systems, heteroinduction by other simultaneously used drugs), as well as on the patient's condition, the dose of the drug and the duration of treatment. There are significant interindividual differences in Css values ​​in the therapeutic range: in most patients, these values ​​range from 4 to 12 μg / ml (17-50 μmol / l). The concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of the concentration of carbamazepine. Plasma protein binding in children - 55-59%, in adults - 70-80%. Apparent Vd - 0.8-1.9 l / kg. In the cerebrospinal fluid and saliva, concentrations are created in proportion to the amount of active substance not bound to proteins (20-30%). Penetrates through the placental barrier. The concentration in breast milk is 25-60% of that in plasma.

Metabolism

It is metabolized in the liver, mainly along the epoxy pathway with the formation of the main metabolites: active - carbamazepine-10.11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme that provides the biotransformation of carbamazepine to carbamazepine-10,11-epoxide is cytochrome P450 (CYP3A4). As a result of metabolic reactions, an inactive metabolite 9-hydroxy-methyl-10-carbamoylacridan is also formed. May induce its own metabolism. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine.

breeding

T1 / 2 after taking a single oral dose is 25-65 hours (on average, about 36 hours), after repeated administration, depending on the duration of treatment, 12-24 hours (due to autoinduction of the liver monooxygenase system). In patients receiving additionally other anticonvulsant drugs-inducers of the monooxygenase system (phenytoin, phenobarbital), T1 / 2 averages 9-10 hours. After a single dose of carbamazepine, 72% of the dose taken is excreted in the urine and 28% in the feces. About 2% of the dose is excreted in the urine as unchanged carbamazepine, about 1% as the 10,11-epoxy metabolite.

Pharmacokinetics in special clinical situations

In children, due to accelerated elimination, it may be necessary to use relatively higher doses of the drug per kg of body weight compared to adults.

There are no data on changes in the pharmacokinetics of carbamazepine in elderly patients.

Indications for use of the drug FINLEPSIN®

• epilepsy: partial seizures with elementary symptoms (focal seizures), partial seizures with complex symptoms, psychomotor seizures, major convulsive seizures, mainly of focal origin (grand convulsive seizures during sleep, diffuse grand mal seizures), mixed forms of epilepsy;
• trigeminal neuralgia;
• idiopathic neuralgia of the glossopharyngeal nerve;
• pain in diabetic polyneuropathy;
• epileptiform convulsions in multiple sclerosis, facial muscle spasms in trigeminal neuralgia, tonic convulsions, paroxysmal dysarthria and ataxia, paroxysmal paresthesias and pain attacks;
• alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disturbances);
• psychotic disorders (affective and schizoaffective disorders, psychosis, dysfunction of the limbic system).

Dosing regimen

The drug is administered orally, during or after a meal, drinking plenty of fluids.

Epilepsy

Whenever possible, Finlepsin® should be administered as monotherapy.

Joining Finlepsin to the ongoing antiepileptic therapy should be carried out gradually, while the doses of the drugs used are corrected if necessary.

If the patient has forgotten to take the next dose of the drug in a timely manner, the missed dose should be taken immediately, as soon as this omission has become noticed, and a double dose of the drug should not be taken.

adults

The initial dose is 200-400 mg (1-2 tablets) per day, then the dose is gradually increased until the optimal effect is achieved. The maintenance dose is 800-1200 mg per day, which are divided into 1-3 doses.

The maximum daily dose is 1.6-2 g.

If the child is unable to swallow the tablet whole, it can be chewed, crushed or shaken in a small amount of water.

The initial dose for children aged 1 to 5 years is 100-200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved; for children from 6 to 10 years old - 200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved; for children from 11 to 15 years old - 100-300 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved.

Maintenance doses: for children aged 1-5 years - 200-400 mg per day (in divided doses), 6-10 years - 400-600 mg per day (in 2-3 doses); 11-15 years - 600-1000 mg per day (in 2-3 doses).

The duration of use depends on the indication and the patient's individual response to the drug. The decision to transfer the patient to Finlepsin®, the duration of its use and the cancellation of treatment is made by the doctor individually. The possibility of reducing the dose of the drug or stopping treatment is considered after a 2-3-year period of complete absence of seizures.

Treatment is stopped, gradually reducing the dose of the drug over 1-2 years, under the control of the EEG. In children, with a decrease in the daily dose of the drug, an increase in body weight with age should be taken into account.

Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia

The initial dose is 200-400 mg (1-2 tablets), which is increased to 400-800 mg (2-4 tablets) in 1-2 doses, until the pain disappears completely. In a certain proportion of patients, treatment can be continued with a lower maintenance dose of 200 mg (1 tablet) 2 times a day (corresponding to 400 mg per day).

Elderly patients and patients with hypersensitivity Finlepsin® is prescribed in an initial dose of 100 mg (1/2 tablet) 2 times a day (corresponding to 200 mg per day).

Treatment of alcohol withdrawal in a hospital setting

The average daily dose is 200 mg (1 tablet) 3 times a day (corresponding to 600 mg per day). In severe cases, in the first days, the dose can be increased to 400 mg (2 tablets) 3 times a day (corresponding to 1200 mg per day).

If necessary, Finlepsin® can be combined with other substances used to treat alcohol withdrawal.

Treatment of alcohol withdrawal syndrome with Finlepsin is stopped, gradually reducing the dose over 7-10 days.

During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.

In connection with the possible development of adverse reactions from the central and autonomic nervous system, patients are carefully monitored in a hospital setting.

Pain in diabetic neuropathy

The average daily dose is 200 mg (1 tablet) 3 times a day (corresponding to 600 mg per day). In exceptional cases, Finlepsin® can be prescribed 400 mg (2 tablets) 3 times a day (corresponding to 1200 mg per day).

epileptiform seizures in multiple sclerosis

The average dose is 200 mg (1 tablet) 3 times a day (corresponding to 600 mg per day).

Treatment and prevention of psychosis

The initial dose and the maintenance dose are usually the same: 200-400 mg (1-2 tablets) per day. If necessary, the dose can be increased to 400 mg (2 tablets) 2 times a day (corresponding to 800 mg per day).

Side effect

When assessing the frequency of occurrence of various adverse reactions, the following criteria were used: very often (> 10%), often (> 1%, but<10%), иногда (>0.1% but<1%), редко (>0.01% but<0.1%), очень редко (<0.01%).

From the side of the central nervous system and peripheral nervous system: often - dizziness, ataxia, drowsiness, general weakness, headache, paresis of accommodation; sometimes - abnormal involuntary movements (for example, tremor, "fluttering" tremor - asterixis, dystonia, tics), nystagmus; rarely - hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation; activation of psychosis, orofacial dyskinesia, oculomotor disorders, speech disorders (eg, dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesias, muscle weakness, and symptoms of paresis. The role of the drug in the development of NMS, especially in combination with antipsychotics, remains unclear.

The development of adverse reactions from the central nervous system may be due to a relative overdose of the drug or significant fluctuations in plasma concentrations of carbamazepine.

Allergic reactions: often - urticaria; sometimes - erythroderma, delayed-type multiorgan hypersensitivity reactions with fever, skin rashes, vasculitis (including erythema nodosum, as a manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, and altered liver function tests (these manifestations occur in various combinations). Other organs (eg, lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis, or eosinophilic pneumonia may also be involved. If the above allergic reactions occur, the use of the drug should be discontinued. Rarely - lupus-like syndrome, pruritus, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

On the part of the hematopoietic organs: often - leukopenia, thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocyte aplasia, megaloblastic anemia, acute "intermittent" porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

From the digestive system: often - nausea, vomiting, dry mouth, increased activity of GGT (due to the induction of this enzyme in the liver), which usually has no clinical significance, increased activity of alkaline phosphatase; sometimes - increased activity of hepatic transaminases, diarrhea or constipation, abdominal pain; rarely - glossitis, gingivitis, stomatitis, pancreatitis, hepatitis of cholestatic, parenchymal (hepatocellular) or mixed type, jaundice, granulomatous hepatitis, liver failure.

From the side of the cardiovascular system: rarely - intracardiac conduction disturbances, a decrease or increase in blood pressure, bradycardia, arrhythmias, AV blockade with syncope, collapse, aggravation or development of chronic heart failure, exacerbation of coronary artery disease (including the appearance or increase in angina attacks) , thrombophlebitis, thromboembolic syndrome.

On the part of the endocrine system and metabolism: often - edema, fluid retention, weight gain, hyponatremia (decrease in plasma osmolarity due to an effect similar to the action of ADH, which in rare cases leads to dilution hyponatremia, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders) rarely - an increase in the level of prolactin (may be accompanied by galactorrhea and gynecomastia), a decrease in the concentration of L-thyroxine and an increase in the concentration of thyroid-stimulating hormone (usually not accompanied by clinical manifestations), disorders of calcium-phosphorus metabolism in bone tissue (a decrease in the concentration of Ca2 + and 25-OH-colcalciferol in plasma), osteomalacia, hypercholesterolemia (including HDL-cholesterol), hypertriglyceridemia and swollen lymph nodes, hirsutism.

From the genitourinary system: rarely - interstitial nephritis, renal failure, impaired renal function (for example, albuminuria, hematuria, oliguria, increased urea / azotemia), frequent urination, urinary retention, decreased potency.

From the musculoskeletal system: rarely - arthralgia, myalgia or convulsions.

From the senses: rarely - taste disturbances, clouding of the lens, conjunctivitis, hearing impairment, incl. tinnitus, hyperacusis, hypoacusis, changes in pitch perception.

Other: skin pigmentation disorders, purpura, acne, sweating, alopecia.

Contraindications to the use of the drug FINLEPSIN®

• disorders of bone marrow hematopoiesis (anemia, leukopenia);
• acute intermittent porphyria (including history);
• AV block;
• simultaneous appointment of lithium preparations and MAO inhibitors;
• hypersensitivity to the components of the drug;
• hypersensitivity to tricyclic antidepressants.

With caution, the drug should be used in decompensated chronic heart failure, with impaired liver and / or kidney function, in elderly patients, in patients with chronic alcoholism (increased CNS depression, increased metabolism of carbamazepine), with dilution hyponatremia (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, insufficiency of the adrenal cortex), with oppression of bone marrow hematopoiesis while taking drugs (in history), with prostatic hyperplasia, increased intraocular pressure; when used simultaneously with sedative and hypnotic drugs.

The use of the drug FINLEPSIN® during pregnancy and lactation

For women of reproductive age, Finlepsin®, if possible, is prescribed as monotherapy, in the minimum effective dose, because. the frequency of congenital anomalies in newborns from mothers taking combined antiepileptic treatment is higher than with monotherapy.

When pregnancy occurs, it is necessary to compare the expected benefits of therapy and possible complications, especially in the first trimester of pregnancy. It is known that children of mothers suffering from epilepsy are predisposed to intrauterine development disorders, including malformations. Finlepsin® is able to increase the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including non-fusion of the vertebral arches (spina bifida). Antiepileptic drugs exacerbate folic acid deficiency, often observed during pregnancy, which can increase the frequency of birth defects in children, so folic acid is recommended before the planned pregnancy and during pregnancy.

In order to prevent hemorrhagic complications in newborns, women in the last weeks of pregnancy, as well as newborns, are recommended to prescribe vitamin K.

Carbamazepine passes into breast milk, so the benefits and possible undesirable consequences of breastfeeding in the context of ongoing therapy should be compared. With continued breastfeeding while taking Finlepsin, the child should be monitored in connection with the possibility of developing adverse reactions (for example, severe drowsiness, allergic skin reactions).

special instructions

Epilepsy monotherapy begins with the appointment of a low initial dose, gradually increasing it until the desired therapeutic effect is achieved.

When selecting the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially in combination therapy. In some cases, the optimal dose may deviate significantly from the recommended initial maintenance dose, for example, due to the induction of microsomal liver enzymes or due to interactions in combination therapy.

In some cases, treatment with antiepileptic drugs was accompanied by the occurrence of suicidal attempts / suicidal intentions. This was also confirmed in a meta-analysis of randomized clinical trials with antiepileptic drugs. Since the mechanism of occurrence of suicidal attempts when using antiepileptic drugs is not known, their occurrence cannot be excluded during treatment with Finlepsin®. Patients and caregivers should be warned to watch for suicidal thoughts/suicidal behavior and seek immediate medical attention if symptoms occur.

Finlepsin® should not be combined with sedative-hypnotics. If necessary, it can be combined with other substances used to treat alcohol withdrawal. During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma. In connection with the development of side effects from the central nervous system and the autonomic nervous system, patients are carefully monitored in a hospital setting.

When transferring a patient to carbamazepine, the dose of the previously prescribed antiepileptic agent should be gradually reduced until it is completely canceled. Sudden discontinuation of carbamazepine may provoke epileptic seizures. If it is necessary to abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug under the cover of the drug indicated in such cases (for example, diazepam, administered intravenously or rectally, or phenytoin, administered intravenously).

Several cases of vomiting, diarrhea and / or malnutrition, seizures and / or respiratory depression have been described in newborns whose mothers took carbamazepine concomitantly with other anticonvulsants (possibly these reactions represent neonatal manifestations of withdrawal syndrome).

Before prescribing carbamazepine and during treatment, it is necessary to study liver function, especially in patients with a history of liver disease, as well as in elderly patients. In the event of an increase in already existing liver dysfunction or the appearance of active liver disease, the drug should be immediately discontinued.

Before starting treatment, it is necessary to conduct a study of the blood picture (including counting platelets, reticulocytes), the level of iron in the blood serum, a general urine test, the level of urea in the blood, an electroencephalogram, the determination of the concentration of electrolytes in the blood serum (and periodically during treatment, because possible development of hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment weekly, and then monthly.

In most cases, a transient or persistent decrease in the number of platelets and / or leukocytes is not a precursor to the onset of aplastic anemia or agranulocytosis. However, before starting treatment, and periodically during treatment, clinical blood tests should be performed, including counting the number of platelets and possibly reticulocytes, as well as determining the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require discontinuation, however, treatment should be discontinued if hypersensitivity reactions or symptoms appear, presumably indicating the development of Stevens-Johnson syndrome or Lyell's syndrome. Mild skin reactions (isolated macular or maculopapular exanthema) usually disappear within a few days or weeks, even with continued treatment or after a dose reduction (the patient should be under close medical supervision at this time).

The possibility of activation of latent psychoses should be taken into account, and in elderly patients, the possibility of developing disorientation or psychomotor agitation.

Possible violations of male fertility and / or violations of spermatogenesis, however, the relationship of these disorders with taking carbamazepine has not yet been established.

Perhaps the appearance of intermenstrual bleeding with the simultaneous use of oral contraceptives. Carbamazepine may adversely affect the reliability of oral contraceptives, so women of reproductive age should use alternative methods of contraception during the period of treatment. Carbamazepine should only be used under medical supervision.

Patients should be informed about early signs of toxicity, as well as skin and liver symptoms. The patient is informed of the need to immediately consult a doctor in the event of such adverse reactions as fever, sore throat, rash, ulceration of the oral mucosa, causeless bruising, hemorrhages in the form of petechiae or purpura.

Before starting treatment, it is recommended to conduct an ophthalmological examination, including a study of the fundus with a slit lamp and measurement of intraocular pressure. In the case of prescribing the drug to patients with an increase in intraocular pressure, constant monitoring of this indicator is required.

Patients with severe cardiovascular diseases, liver and kidney damage, as well as the elderly, are prescribed lower doses of the drug.

Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very small, nevertheless, regular determination of the level of carbamazepine may be useful in the following situations: with a sharp increase in the frequency of seizures; in order to check whether the patient is taking the drug properly; during pregnancy; in the treatment of children or adolescents; if you suspect a violation of the absorption of the drug; if the development of toxic reactions is suspected if the patient is taking several medicines.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: usually reflect disorders of the central nervous system, cardiovascular and respiratory systems.

From the side of the central nervous system and sensory organs: depression of the central nervous system, disorientation, drowsiness, agitation, hallucinations, coma, blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (at the beginning), hyporeflexia (later), convulsions, psychomotor disorders , myoclonus, hypothermia, mydriasis.

From the side of the cardiovascular system: tachycardia, decreased blood pressure, sometimes - increased blood pressure, intraventricular conduction disturbances with the expansion of the QRS complex, fainting, cardiac arrest.

From the respiratory system: respiratory depression, pulmonary edema.

From the digestive system: nausea and vomiting, delayed evacuation of food from the stomach, decreased motility of the colon.

From the urinary system: urinary retention, oliguria or anuria, fluid retention, hyponatremia.

Laboratory indicators: leukocytosis or leukopenia, hyponatremia, metabolic acidosis is possible, hyperglycemia and glucosuria are possible, an increase in the muscle fraction of CPK.

Treatment: There is no specific antidote. Symptomatic supportive treatment in the ICU is necessary, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder functions, and correction of electrolyte disorders. It is necessary to determine the concentration of carbamazepine in plasma to confirm poisoning with this agent and assess the degree of overdose, gastric lavage, administration of activated charcoal. Late evacuation of gastric contents can lead to delayed absorption on days 2 and 3 and reappearance of symptoms of intoxication during the recovery period. Forced diuresis, hemodialysis, and peritoneal dialysis are ineffective, but dialysis is indicated for a combination of severe poisoning and renal failure. Young children may need a blood transfusion.

drug interaction

Simultaneous administration of carbamazepine with CYP3A4 inhibitors can lead to an increase in its concentration in blood plasma and the development of adverse reactions.

The combined use of CYP3A4 inducers can lead to an acceleration of the metabolism of carbamazepine, a decrease in its plasma concentration and a decrease in the therapeutic effect; on the contrary, their cancellation can reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

Increase the concentration of carbamazepine in plasma: verapamil, diltiazem, felodipine, dextropropoxyphene, viloxazine, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses), macrolides (erythromycin, josamycin, clarithromycin, troleandomycin), azoles (itraconazole, ketoconazole, fluconazole), terfenadine, loratadine, isoniazid, propoxyphene, grapefruit juice, viral protease inhibitors used in the treatment of HIV infection (for example, ritonavir) - correction of the dosing regimen or monitoring of plasma concentrations of carbamazepine is required.

Felbamate reduces the plasma concentration of carbamazepine and increases the concentration of carbamazepine-10,11-epoxide, while a simultaneous decrease in the serum concentration of felbamate is possible.

The concentration of carbamazepine is reduced by phenobarbital, phenytoin, primidone, metsuximide, fensuximide, theophylline, rifampicin, cisplatin, doxorubicin, possibly clonazepam, valpromide, valproic acid, oxcarbazepine and herbal remedies containing St. John's wort (Hypericum perforatum).

There is a possibility of displacement of carbamazepine by valproic acid and primidone from its association with plasma proteins and an increase in the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). With the combined use of Finlepsin with valproic acid, in exceptional cases, coma or confusion may occur.

Isotretinoin alters the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (monitoring of plasma concentrations of carbamazepine is necessary).

Carbamazepine may reduce plasma concentrations (reduce or even completely eliminate effects), which may require dose adjustment of the following drugs: clobazam, clonazepam, digoxin ethosuximide, primidone, valproic acid, alprazolam, corticosteroids (prednisolone, dexamethasone), cyclosporine, tetracyclines (doxycycline) , haloperidol, methadone, oral preparations containing estrogens and / or progesterone (selection of alternative methods of contraception is necessary), theophylline, oral anticoagulants (warfarin, phenprocoumon, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriptyline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in the treatment of HIV infection (indinavir, ritonavir, saquinavir), calcium channel blockers (dihydropyridine group, such as felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tramadol, ziprasidone.

There is a possibility of an increase or decrease in the level of phenytoin in the blood plasma against the background of carbamazepine and an increase in the level of mephenytoin.

With the simultaneous use of carbamazepine and lithium preparations, the neurotoxic effects of both active substances may increase.

Tetracyclines may weaken the therapeutic effect of carbamazepine.

When used together with paracetamol, the risk of its toxic effect on the liver increases and the therapeutic efficacy decreases (acceleration of the metabolism of paracetamol).

The simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to an increase in the inhibitory effect on the central nervous system and a weakening of the anticonvulsant effect of carbamazepine.

MAO inhibitors increase the risk of developing hyperpyretic crises, hypertensive crises, seizures, death (before prescribing carbamazepine, MAO inhibitors should be canceled at least 2 weeks in advance or, if the clinical situation allows, even longer).

Simultaneous administration with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations.

Weakens the effects of non-depolarizing muscle relaxants (pancuronium). In the case of using such a combination, it may be necessary to increase the dose of muscle relaxants, while careful monitoring of the patient's condition is necessary due to the possibility of a faster cessation of the action of muscle relaxants.

Carbamazepine reduces the tolerance to ethanol.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid, praziquantel, may increase the elimination of thyroid hormones.

Accelerates the metabolism of anesthetic agents (enflurane, halothane, halothane) and increases the risk of developing hepatotoxic effects.

Enhances the formation of nephrotoxic metabolites of methoxyflurane.

Enhances the hepatotoxic effect of isoniazid.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

List B. The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 3 years.

The instruction is cited from the materials of the pharmaceutical site