Requip Modutab - official* instructions for use. Rules of therapy and dosage

One tablet contains:

Active substance: ropinirole hydrochloride 2.28 mg, 4.56 mg, 9.12 mg (equivalent to 2 mg, 4 mg, 8 mg ropinirole, respectively).
Excipients: hypromellose-2208, Castor oil hydrogenated, carmellose sodium, povidone-K29-32, maltodextrin, magnesium stearate, lactose monohydrate, colloidal silicon dioxide, mannitol, iron oxide (yellow) (E172), glyceryl dibehenate;
Tablet shell:

In tablets with a dosage of 2 mg (pink dye Opadry QY-S-24900): Hypromellose-2910, titanium dioxide (E171), macrogol-400, iron oxide (red) (E172), iron oxide (yellow) (E172);
In tablets with a dosage of 4 mg (light brown opadry dye OY-272Q7): Hypromellose-2910, titanium dioxide (E171), macrogol-400, sunset yellow dye (E110), indigo carmine (E132);
In tablets with a dosage of 8 mg (red dye opadry 03B25227): Hypromellose-2910, titanium dioxide (E171), macrogol-400, iron oxide (red) (E172), iron [H]oxide (black) (E172), iron oxide ( yellow) (E172)

Extended-release film-coated tablets, 2 mg, 4 mg and 8 mg.

21 tablets with a dosage of 2 mg in a blister made of PVC/A1 or PCTFE/A1. 2 blisters along with instructions for use in a cardboard pack.

14 tablets (all dosages) in a blister made of PVC/A1 or PCTFE/A1. 2 or 6 blisters along with instructions for use in a cardboard pack.

Description dosage form

Biconvex capsule-shaped tablets, coated film-coated, with GS engraving on one side. The color of the tablet shell and the type of engraving on the other side are determined by the dosage:

2 mg - pink 3V2;
4 mg - light brown WXG;
8 mg - red 5CC.

pharmachologic effect

Antiparkinsonian drug, dopamine agonist.

Mechanism of action

Ropinirole is an effective and highly selective non-ergoline agonist of dopamine D2-, D3-receptors, which has peripheral and central action.

The drug does not act on decaying presynaptic dopaminergic neurons of the substantia nigra and acts directly as a synthetic neurotransmitter. Thus, ropinirole reduces the degree of physical inactivity, rigidity and tremor, which are symptoms of parkinsonism.

Pharmacokinetics

The pharmacokinetics of ropinirole are similar in healthy people, patients with Parkinson's disease and patients with the syndrome restless legs and varies depending on the dosage form.

Suction.

Bioavailability of ropinirole after oral administration low and amounts to approximately 50% (36%-57%). After oral administration of ropinirole extended-release tablets, its plasma concentration increases slowly, the average time to reach maximum concentration (Tmax) is 6 hours. equilibrium state in patients with Parkinson's disease, after oral administration of 12 mg of ropinirole once daily in combination with a meal rich in fat, an increase in the systemic exposure of ropinirole was observed, with an increase in the area under the concentration-time curve (AUC) and maximum concentration (Cmax) by 20% and 44%, respectively, Tmax was extended by 3 hours. However, in clinical studies efficacy and safety of ropinirole was taken regardless of food intake.

Plasma protein binding and distribution. Plasma protein binding is low (10-40%). Due to its high lipophilicity, ropinirole has a large volume of distribution (approximately 7 l/kg).

Metabolism. Ropinirole is mainly metabolized by the CYP1A2 isoenzyme.

The metabolite of ropinirole is mainly excreted by the kidneys.

Excretion. On average, the half-life of ropinirole from systemic blood flow is about 6 hours. The increase in the duration of systemic action of ropinirole (Cmax and AUC) is approximately proportional to the increase in dose. There is no difference in the elimination of ropinirole after a single oral dose or with regular use.

Special groups patients

Elderly patients

Oral clearance of ropinirole is reduced by approximately 15% in elderly patients aged 65 years and older compared with younger patients. No dose adjustment is required in this category of patients.

Patients with impaired renal function

Pharmacokinetic parameters do not change in patients with impaired function kidney lung And medium degree and Parkinson's disease.

In patients with end stage renal failure patients on chronic hemodialysis, the clearance of ropinirole when taken orally is reduced by approximately 30%.

Pharmacodynamics

Ropinirole compensates for dopamine deficiency in the substantia nigra and striatum systems by stimulating dopamine receptors in striatum.

Ropinirole enhances the effects of levodopa, including control of the frequency of the on/off phenomenon and the end-of-dose effect associated with long-term therapy levodopa preparations, and allows you to reduce the daily dose of levodopa. Ropinirole acts at the level of the hypothalamus and pituitary gland, inhibiting the secretion of prolactin.

Indications for use: Requip modutab

Parkinson's disease:

Monotherapy early stages diseases in patients requiring dopaminergic therapy to delay the administration of levodopa drugs.
As a combination therapy in patients receiving levodopa, to enhance the effectiveness of levodopa, including control of on-off fluctuations and end-of-dose effects. chronic therapy levodopa, as well as in order to reduce the daily dose of levodopa.

Contraindications for use of Requip modutab

Hypersensitivity to ropinirole or any of the components of the drug.
Pregnancy and lactation.
Liver dysfunction.
Severe violations renal function (creatinine clearance less than 30 ml/min) who do not undergo regular hemodialysis.
Rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose.
Childhood up to 18 years old.
Acute psychosis.

With caution: Due to pharmacological action ropinirole should be used with caution in patients with severe cardiovascular failure.

Ropinirole should only be prescribed to patients with a history of psychotic disorder if the expected benefit outweighs the potential risk.

Requip modutab Side effects

Desirable reactions are described below by organ system and frequency. Frequency criteria adverse reactions: very often (>1/10), often (>1/100, 1/1000, 1/10,000,

Evidence from clinical studies in patients with Parkinson's disease

From the mental side: Often - Hallucinations - Hallucinations, confusion.

From the outside nervous system: Very common - Drowsiness - Dyskinesia. Often - Dizziness (up to severe) - Drowsiness, dizziness (up to severe).

From the outside of cardio-vascular system: Often - Orthostatic hypotension, decreased blood pressure. Sometimes - Orthostatic hypotension, decreased blood pressure.

From the outside gastrointestinal tract: Very often - Nausea. Often - Abdominal pain, dyspepsia, vomiting, constipation. Nausea, constipation.

General and local reactions: Common - Peripheral edema (including swelling of the legs) - Peripheral edema.

In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa drugs, motor coordination disorders may develop during the dose titration period. It has been shown that discontinuation of levodopa drugs can lead to a decrease in these symptoms.

Post-marketing data

From the outside immune systems: Very rarely - hypersensitivity reactions, including urticaria, angioedema, rash and itching.

Mental disorders: Sometimes - psychotic conditions, including delirium and delirium. Disorders of perception, including illusions (excluding hallucinations). Increased impulsivity, increased libido, including hypersexuality, pathological attraction to gambling.

From the nervous system: Very rarely - severe drowsiness, episodes of sudden falling asleep (as with the use of other dopaminergic drugs, these symptoms were very rarely recorded in patients with Parkinson's disease. When the dose was reduced or the drug was discontinued, all symptoms disappeared. In most cases, concomitant sedatives).

From the cardiovascular system: Often - orthostatic hypotension, decreased blood pressure.

Drug interactions

Typical antipsychotics and other centrally acting dopamine antagonists, such as sulpiride or metoclopramide, may reduce the effectiveness of ropinirole and, therefore, co-administration of these drugs with ropinirole should be avoided.

There was no pharmacokinetic interaction observed between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs. Ropinirole does not interact with other drugs commonly used to treat Parkinson's disease.

In patients with Parkinson's disease taking concomitant digoxin, there was no interaction between digoxin and ropinirole that would require dose adjustment.

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme of the cytochrome P450 enzyme system. Pharmacokinetic studies in patients with Parkinson's disease showed that ciprofloxacin increased the Cmax and AUC of ropinirole by approximately 60% and 84%, respectively. In connection with. Therefore, in patients receiving ropinirole, its dose should be adjusted when prescribing and discontinuing drugs that inhibit the CYP1A2 isoenzyme, for example, ciprofloxacin, enoxacin or fluvoxamine.

Pharmacokinetic study drug interactions in patients with Parkinson's disease between ropinirole and theophylline, which is a substrate of the CYP1A2 isoenzyme, showed that the pharmacokinetics of the drugs did not change.

In this connection, when simultaneous use ropinirole with other substrates of the CYP1A2 isoenzyme, the pharmacokinetics of ropinirole does not change.

Increased plasma concentrations of ropinirole were observed in patients receiving estrogens during high doses. In patients receiving hormone replacement therapy prior to initiation of treatment with ropinirole, treatment with ropinirole may be initiated at the usual scheme. However, in case of termination of substitution hormone therapy or initiated during therapy with ropinirole, a dose adjustment may be required.

There is no information about the possibility of interaction between ropinirole and alcohol. As with other centrally acting drugs, patients should be warned to avoid drinking alcohol during treatment with ropinirole.

Nicotine is known to induce the CYP1A2 isoenzyme, so if the patient starts or stops smoking during treatment with ropinirole, dose adjustment may be required.

Dosage of Requip modutab

Adults - inside.

Requip Modutab should be taken once a day at the same time, regardless of taking Pici. Take the tablets whole, without chewing or breaking.

The need for dose titration should be considered if one or more doses are missed.

If other adverse reactions develop, it is necessary to reduce the dose of the drug followed by a gradual increase in dose.

Week - 1/2/3/4.
Daily dose - 2/4/6/8 mg.

Maintenance dose.

The dose may be changed depending on the therapeutic effect and increased to maximum dose 24 mg 1 time per day.

Combination therapy

When using the drug "Requip Modutab" in doses used for monotherapy, in combination with levodopa drugs, the dose of levodopa can be gradually reduced (depending on clinical effect). In clinical studies in patients concomitantly receiving Requip Modutab extended-release tablets, the dose of levodopa was gradually reduced by approximately 30%. In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa, dyskinesia may occur during dose titration of ropinirole. Reducing the dose of levodopa may reduce these symptoms.

Cancellation of therapy

As with other dopaminergic drugs, Requip Modutab should be discontinued by gradually reducing the daily dose over at least 1 week. If treatment was interrupted for 1 day or longer, the need for dose titration should be considered when resuming therapy.

Special patient groups

Elderly patients.

Despite possible reduction clearance of the drug in patients aged 65 years and older, dose titration of ropinirole in this category of patients is carried out as usual.

Patients with impaired renal function.

Mild to moderate renal dysfunction.

In patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min), the clearance of ropinirole does not change, and no dose adjustment of ropinirole is required.

Patients with end-stage renal failure undergoing hemodialysis.

Subsequent dose increases should be based on assessment of tolerability and effectiveness. Maximum daily dose in patients on constant hemodialysis, it is 18 mg. Administration of maintenance doses after hemodialysis is not required.

Overdose

Symptoms: In general, symptoms of ropinirole overdose are associated with dopaminergic effects (nausea, vomiting, dizziness, drowsiness).

Treatment: These symptoms can be corrected by appropriate treatment with dopamine antagonists, such as typical antipsychotics and metoclopramide.

Catad_pgroup Antiparkinsonian drugs

Requip Modutab - official* instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

INSTRUCTIONS

By medical use drug

REQUIP MODUTAB

Registration number : LSR-010923/09-311209

Trade name of the drug: Requip Modutab

International generic name(INN): ropinirole

Dosage form: extended-release, film-coated tablets.

Compound: One tablet contains:
Active substance: ropinirole hydrochloride 2.28 mg, 4.56 mg, 9.12 mg (equivalent to 2 mg, 4 mg, 8 mg ropinirole, respectively).
Excipients: hypromellose-2208, hydrogenated castor oil, carmellose sodium, povidone-K29-32, maltodextrin, magnesium stearate, lactose monohydrate, colloidal silicon dioxide, mannitol, iron oxide (yellow) (E172), glyceryl dibehenate.
Tablet shell:
In tablets with a dosage of 2 mg (pink dye opadry QY-S-24900):
Hypromellose-2910, titanium dioxide (E171), macrogol-400, iron oxide (red) (E172), iron oxide (yellow) (E172)
In tablets with a dosage of 4 mg (light brown opadry dye OY-272Q7):
Hypromellose-2910, titanium dioxide (E171), macrogol-400, sunset yellow dye (E110), indigo carmine (E132)
In tablets with a dosage of 8 mg (red dye opadry 03B25227)
Hypromellose-2910, titanium dioxide (E171), macrogol-400, iron oxide (red) (E172), iron [H] oxide (black) (E172), iron oxide (yellow) (E172)

Description: Biconvex, capsule-shaped, film-coated tablets with GS engraving on one side. The color of the tablet shell and the type of engraving on the other side are determined by the dosage:
2 mg - pink 3V2;
4 mg - light brown WXG;
8 mg - red 5CC;

Pharmacotherapeutic group: antiparkinsonian drug, dopamine agonist.
ATX code N04BC04

PHARMACOLOGICAL PROPERTIES
Mechanism of action
Ropinirole is an effective and highly selective non-ergoline agonist of dopamine D 2 -, D 3 -receptors, which has peripheral and central effects.
The drug does not act on decaying presynaptic dopaminergic neurons of the substantia nigra and acts directly as a synthetic neurotransmitter. Thus, ropinirole reduces the degree of physical inactivity, rigidity and tremor, which are symptoms of parkinsonism.

Pharmacodynamics
Ropinirole compensates for dopamine deficiency in the substantia nigra and striatal systems by stimulating dopamine receptors in the striatum.
Ropinirole enhances the effects of levodopa, including control of the frequency of the on/off phenomenon and the end-of-dose effect associated with long-term levodopa therapy, and allows for a reduction in the daily dose of levodopa. Ropinirole acts at the level of the hypothalamus and pituitary gland, inhibiting the secretion of prolactin.

Pharmacokinetics
The pharmacokinetics of ropinirole are similar in healthy subjects, patients with Parkinson's disease and patients with restless legs syndrome and vary depending on the dosage form.
Suction.
The bioavailability of ropinirole after oral administration is low and is approximately 50% (36%-57%). After oral administration of ropinirole in delayed-release tablets, its plasma concentration increases slowly, the average time to reach maximum concentration (Tmax) is 6 hours. At steady state in patients with Parkinson's disease, after oral administration of 12 mg of ropinirole once daily in combination with food, rich in fat, there was an increase in the systemic exposure of ropinirole, with an increase in the area under the concentration-time curve (AUC) and maximum concentration (Cmax) by 20% and 44%, respectively, and Tmax was prolonged by 3 hours. However, in clinical studies of the effectiveness and safety, ropinirole was taken regardless of food intake.
Plasma protein binding and distribution. Plasma protein binding is low (10-40%). Due to its high lipophilicity, ropinirole has a large volume of distribution (approximately 7 l/kg).
Metabolism. Ropinirole is mainly metabolized by the CYP1A2 isoenzyme.
The metabolite of ropinirole is mainly excreted by the kidneys.
Removal. On average, the half-life of ropinirole from the systemic circulation is about 6 hours. The increase in the duration of systemic action of ropinirole (Cmax and AUC) is approximately proportional to the increase in dose. There is no difference in the elimination of ropinirole after a single oral dose or with regular use.
Special patient groups
Elderly patients
Oral clearance of ropinirole is reduced by approximately 15% in elderly patients aged 65 years and older compared with younger patients. No dose adjustment is required in this category of patients.
Patients with impaired renal function
Pharmacokinetic parameters do not change in patients with mild to moderate renal impairment and Parkinson's disease.
In patients with end-stage renal disease on chronic hemodialysis, the oral clearance of ropinirole is reduced by approximately 30%.

Indications for use

Parkinson's disease:
- Monotherapy in early stages of the disease in patients requiring dopaminergic therapy to delay the initiation of levodopa.
- As a combination therapy in patients receiving levodopa, to improve the effectiveness of levodopa, including control of on-off and end-dose effects during chronic levodopa therapy, and to reduce the daily dose of levodopa.

Contraindications

Hypersensitivity to ropinirole or any of the components of the drug.
Pregnancy and lactation.
Liver dysfunction.
Severe renal impairment (creatinine clearance less than 30 ml/min) who do not undergo regular hemodialysis.
Rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose.
Children under 18 years of age.
Acute psychosis.

Carefully
Due to the pharmacological effects of ropinirole, it should be administered with caution to patients with severe cardiovascular insufficiency.
Ropinirole should only be prescribed to patients with a history of psychotic disorder if the expected benefit outweighs the potential risk.

Directions for use and doses
Adults
Inside.
Requip Modutab should be taken once a day at the same time, regardless of taking Pici. Take the tablets whole, without chewing or breaking.
The need for dose titration should be considered if one or more doses are missed.
A dose reduction is recommended if the patient experiences drowsiness at any stage of dose selection.
If other adverse reactions develop, it is necessary to reduce the dose of the drug followed by a gradual increase in dose.
It is recommended to individually select the dose in accordance with the effectiveness and tolerability of the drug.
Monotherapy
Start of treatment
The recommended starting dose of Requip Modutab is 2 mg once daily for one week. Subsequently, the dose is increased by 2 mg at intervals of at least 1 week to 8 mg/day.

Maintenance dose
If, after selecting the dose, the therapeutic effect is not sufficiently pronounced or is unstable, you can continue to increase the daily dose of the drug by 4 mg at intervals of 1-2 weeks (until the required therapeutic effect is achieved).
The dose may be adjusted depending on the therapeutic effect and increased to a maximum dose of 24 mg once daily.
Combination therapy
When using the drug "Requip Modutab" in doses used for monotherapy, in combination with levodopa drugs, the dose of levodopa can be gradually reduced (depending on the clinical effect). In clinical studies in patients concomitantly receiving Requip Modutab extended-release tablets, the dose of levodopa was gradually reduced by approximately 30%. In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa, dyskinesia may occur during dose titration of ropinirole. Reducing the dose of levodopa may reduce these symptoms.
Cancellation of therapy
As with other dopaminergic drugs, Requip Modutab should be discontinued by gradually reducing the daily dose over at least 1 week. If treatment was interrupted for 1 day or longer, the need for dose titration should be considered when resuming therapy.
Special patient groups
Elderly patients
Despite a possible decrease in drug clearance in patients aged 65 years and older, dose titration of ropinirole in this category of patients is carried out as usual.
Patients with impaired renal function
Mild to moderate renal impairment
In patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min), the clearance of ropinirole does not change, and no dose adjustment of ropinirole is required.
Patients with end-stage renal disease undergoing hemodialysis
The recommended starting dose of ropinirole is 2 mg once daily.
Subsequent dose increases should be based on assessment of tolerability and effectiveness. The maximum daily dose in patients on continuous hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

SIDE EFFECT
Adverse reactions are described below by organ system and frequency. Criteria for the frequency of adverse reactions: very often (> 1/10), often (> 1/100,<1/10), иногда (> 1/1000, <1/100), редко (> 1/10 000, <1/1000), очень редко (<1/10 000), включая отдельные случаи.
Evidence from clinical studies in patients with Parkinson's disease

	Use as monotherapy	Application in composition combination therapy
From the mental side
Often	Hallucinations	Hallucinations, confusion
From the nervous system
Often	Drowsiness	Dyskinesia 1
Often	Dizziness (even severe)	Drowsiness, dizziness (up to severe)

Often		Orthostatic hypotension, decreased blood pressure
Sometimes	Orthostatic hypotension, decreased blood pressure
From the gastrointestinal tract
Often	Nausea
Often	Abdominal pain, dyspepsia, vomiting, constipation.	Nausea, constipation
General and local reactions
Often	Peripheral edema (including swelling of the legs)	Peripheral edema

1 In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa drugs, impaired coordination of movements may develop during the dose titration period. It has been shown that discontinuation of levodopa drugs can lead to a decrease in these symptoms.

Post-marketing data
From the immune system:
Very rare: hypersensitivity reactions, including urticaria, angioedema, rash and itching.
Mental disorders:
Sometimes: psychotic states, including delirium and delirium. Disorders of perception, including illusions (excluding hallucinations). Increased impulsivity, increased libido, including hypersexuality, pathological attraction to gambling.
From the nervous system
Very rare: severe drowsiness, episodes of sudden falling asleep (as with the use of other dopaminergic drugs, these symptoms were very rarely recorded in patients with Parkinson's disease. When the dose was reduced or the drug was discontinued, all symptoms disappeared. In most cases, concomitant sedatives were used).
From the cardiovascular system
Often: orthostatic hypotension, decreased blood pressure.

Overdose
Symptoms
In general, symptoms of ropinirole overdose are associated with dopaminergic effects (nausea, vomiting, dizziness, drowsiness).
Treatment
These symptoms can be corrected by appropriate treatment with dopamine antagonists, such as typical antipsychotics and metoclopramide.

Interaction with other drugs
Typical antipsychotics and other centrally acting dopamine antagonists, such as sulpiride or metoclopramide, may reduce the effectiveness of ropinirole and, therefore, co-administration of these drugs with ropinirole should be avoided.
There was no pharmacokinetic interaction observed between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs. Ropinirole does not interact with other drugs commonly used to treat Parkinson's disease.
In patients with Parkinson's disease taking concomitant digoxin, there was no interaction between digoxin and ropinirole that would require dose adjustment.
Ropinirole is mainly metabolized by the CYP1A2 isoenzyme of the cytochrome P450 enzyme system. Pharmacokinetic studies in patients with Parkinson's disease showed that ciprofloxacin increased the Cmax and AUC of ropinirole by approximately 60% and 84%, respectively. In connection with. Therefore, in patients receiving ropinirole, its dose should be adjusted when prescribing and discontinuing drugs that inhibit the CYP1A2 isoenzyme, for example, ciprofloxacin, enoxacin or fluvoxamine.
A pharmacokinetic study of drug interactions in patients with Parkinson's disease between ropinirole and theophylline, which is a substrate of the CYP1A2 isoenzyme, showed that the pharmacokinetics of the drugs did not change.
Therefore, with the simultaneous use of ropinirole with other substrates of the CYP1A2 isoenzyme, the pharmacokinetics of ropinirole does not change.
Increased plasma concentrations of ropinirole were observed in patients receiving high doses of estrogens. In patients receiving hormone replacement therapy before starting treatment with ropinirole, treatment with ropinirole can be started as usual. However, if hormone replacement therapy is stopped or started during therapy with ropinirole, dosage adjustments may be necessary.
There is no information about the possibility of interaction between ropinirole and alcohol. As with other centrally acting drugs, patients should be warned to avoid drinking alcohol during treatment with ropinirole.
Nicotine is known to induce the CYP1A2 isoenzyme, so if the patient starts or stops smoking during treatment with ropinirole, dose adjustment may be required.

special instructions
Patients should be warned about the possible development of drowsiness or episodes of sudden falling asleep, sometimes not preceded by drowsiness. If such reactions occur, discontinuation of therapy should be considered. Monitoring of blood pressure is recommended due to the possibility of developing orthostatic hypotension.
Appetite disorders, including compulsive behavior such as pathological gambling and hypersexuality, have been reported in patients taking dopaminergic drugs, including ropinirole. According to the literature, similar undesirable effects of therapy were observed in patients with Parkinson's disease receiving high doses of dopaminergic drugs; other risk factors may include a history of compulsive behavior or concomitant use of multiple dopaminergic drugs. In this case, the possibility of reducing the dose or discontinuing therapy should be considered.
A paradoxical worsening of restless legs syndrome has been reported with ropinirole (earlier onset, increased severity, or progression of symptoms to involve previously unaffected limbs) or early morning rebound syndrome (recurrence of symptoms in the early morning hours). If these symptoms appear, it is necessary to reconsider the treatment tactics with ropinirole, adjust the dosage, and possibly discontinue the drug.

Effect on the ability to drive a car and/or other mechanisms
Patients should be warned about possible adverse reactions during therapy with ropinirole.
Patients should be informed that there are very rare cases of episodes of sudden falling asleep without any previous or obvious signs of daytime sleepiness and cases of dizziness (sometimes severe).
If the patient develops daytime sleepiness or episodes of falling asleep during the day that require active intervention, the patient should be warned not to drive and should avoid other activities requiring high psychomotor speed and attention.

Release form
Extended-release film-coated tablets, 2 mg, 4 mg and 8 mg.
21 tablets with a dosage of 2 mg in a blister made of PVC/A1 or PCTFE/A1. 2 blisters along with instructions for use in a cardboard pack.
14 tablets (all dosages) in a blister made of PVC/A1 or PCTFE/A1. 2 or 6 blisters along with instructions for use in a cardboard pack.

Best before date
3 years - for dosages of 4 mg, 8 mg;
2 years - for a dosage of 2 mg
Do not use after the expiration date stated on the package.

Storage conditions
In original packaging at a temperature not exceeding 25°C.
Keep out of the reach of children.

Conditions for dispensing from pharmacies
On prescription.

Manufacturer
1. SmithKline Beecham PLC, UK
Legal address:
Manor Royal, Crawley, West Sussex, RH10 9QJ, United Kingdom.
2. GlaxoSmithKline Pharmaceuticals CA / GlaxoSmithKline Pharmaceuticals SA
Legal address:
189 Grunwaldzka Street, 60-322 Poznan, Poland / 189 Grunwaldzka Street, 60-322 Poznan, Poland.

Organization accepting claims for a drug in the Russian Federation :
CJSC GlaxoSmithKline Trading,
121614, Moscow, st. Krylatskaya, 17, Krylatskie Hills Business Center, building 3, 5th floor.

Release form

extended-release film-coated tablets

Owner/Registrar

GlaxoSmithKline Trading, JSC

International Classification of Diseases (ICD-10)

G20 Parkinson's disease

Pharmacological group

Antiparkinsonian drug - stimulator of dopaminergic transmission in the central nervous system

pharmachologic effect

Antiparkinsonian drug, a highly selective non-ergoline agonist of dopamine D 2 -, D 3 - receptors, which has peripheral and central effects.

Ropinirole compensates for dopamine deficiency in the substantia nigra and striatal systems by stimulating dopamine receptors in the striatum.

Ropinirole enhances the effects of levodopa, including control of the frequency of the on/off phenomenon and the end-of-dose effect associated with long-term levodopa therapy, and allows for a reduction in the daily dose of levodopa.

Ropinirole acts at the level of the hypothalamus and pituitary gland, inhibiting the secretion of prolactin.

Pharmacokinetics

The pharmacokinetics of ropinirole are similar in healthy subjects, patients with Parkinson's disease and patients with restless legs syndrome and vary depending on the dosage form.

Suction

After oral administration, the bioavailability of ropinirole is low and is approximately 50% (36-57%). After oral administration of ropinirole in delayed-release tablets, its concentration in plasma increases slowly, the average Tmax time is 6 hours. In patients with Parkinson's disease, after oral administration of ropinirole at a dose of 12 mg 1 time / day in combination with a meal rich in fat, in equilibrium condition, an increase in the systemic exposure of ropinirole was observed, with an increase in AUC and Cmax by 20% and 44%, respectively, Tmax was extended by 3 hours. However, in clinical studies of the effectiveness and safety of ropinirole, ropinirole was taken regardless of food intake.

The increase in the duration of systemic action of ropinirole (Cmax and AUC) is approximately proportional to the increase in dose.

Distribution

Plasma protein binding is low (10-40%). Due to its high lipophilicity, ropinirole is characterized by a large Vd (approximately 7 l/kg).

Metabolism

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme.

Removal

On average, T1/2 of ropinirole from the systemic circulation is about 6 hours. The ropinirole metabolite is mainly excreted by the kidneys. There is no difference in the elimination of ropinirole after a single oral dose or with regular use.

Pharmacokinetics in special clinical situations

The clearance of ropinirole after oral administration is reduced by approximately 15% in elderly patients (65 years and older) compared to younger patients. No dose adjustment is required in this category of patients.

Pharmacokinetic parameters do not change in patients with mild to moderate renal impairment and Parkinson's disease. In patients with end-stage renal disease on chronic hemodialysis, the oral clearance of ropinirole is reduced by approximately 30%.

Indications

Parkinson's disease:

Monotherapy in early stages of the disease in patients requiring dopaminergic therapy to delay the initiation of levodopa;

As part of combination therapy in patients receiving levodopa drugs, in order to increase the effectiveness of levodopa, including control of fluctuations in the therapeutic effect of levodopa (the “on-off” phenomenon) and the “end-of-dose” effect during chronic levodopa therapy, as well as to reduce the daily dose Levodopa.

Contraindications

Acute psychosis;

Liver dysfunction;

Severe renal dysfunction (creatinine clearance less than 30 ml/min), who do not undergo regular hemodialysis;

Rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose;

Pregnancy;

Lactation;

Children and adolescents up to 18 years of age;

Hypersensitivity to the components of the drug.

WITH caution the drug should be used in patients with severe cardiovascular insufficiency. Ropinirole should only be prescribed to patients with a history of psychotic disorders if the expected benefit outweighs the potential risk.

Side effects

The adverse reactions presented below are listed according to organ system involvement and frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10); often (≥1/100,<1/10); иногда (≥1/1000, <1/100); редко (≥1/10 000, <1/1000); очень редко (<1/10 000, включая отдельные случаи).

Clinical trial data

The table lists adverse reactions that occurred at a higher frequency with ropinirole compared to placebo or at a higher or comparable frequency with respect to the comparator drug.

Frequency of occurrence of adverse reactions

Frequency	Use as monotherapy	Use as part of combination therapy
Mental disorders
Often	hallucinations	hallucinations, confusion,
From the nervous system
Often	drowsiness	dyskinesia 1
often	dizziness (including vertigo)	drowsiness, dizziness (including vertigo)
From the cardiovascular system
often
infrequently	orthostatic hypotension, hypotension
From the digestive system
Often	nausea
often	abdominal pain, dyspepsia, vomiting, constipation	nausea, constipation
General reactions
often	peripheral edema (including swelling of the legs)	peripheral edema

1 In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa drugs, during the dose titration period, the development of impaired motor coordination may occur. It has been shown that discontinuation of levodopa drugs can lead to a decrease in these symptoms.

Post-registration observation data

From the immune system: very rarely - hypersensitivity reactions, including urticaria, angioedema, rash, itching.

Mental disorders: uncommon - psychotic reactions (excluding hallucinations), including delirium, paranoia, delirium; impulsive drive syndrome, increased libido, including hypersexuality, pathological gambling, compulsive shopping, overeating, aggression*.

From the nervous system: very rarely - severe drowsiness, episodes of sudden falling asleep**

From the cardiovascular system: often - orthostatic hypotension, hypotension***.

Allergic reactions: very rarely - urticaria, angioedema, rash, itching.

* Aggression is associated with psychotic reactions and compulsive symptoms.

** As with other dopaminergic agents, severe blues and episodes have been reported very rarely, primarily in patients with Parkinson's disease during post-marketing surveillance. There are cases of sudden falling asleep without any previous or obvious signs of drowsiness and fatigue. When the dose was reduced or the drug was discontinued, all symptoms disappeared. In most cases, concomitant sedatives were used.

*** As with other dopamyergic agents, hypotension, including orthostatic hypotension, has been observed during treatment with ropinirole.

Overdose

Symptoms: mainly due to dopaminergic effects - nausea, vomiting, dizziness, drowsiness.

Treatment: use of dopamine antagonists, such as typical antipsychotics and metoclopramide.

special instructions

In patients taking dopaminergic drugs, incl. ropinirole, a syndrome of impulsive drives, including compulsive behavior, has been reported, incl. pathological gambling, hypersexuality, irresistible shopping urge, overeating. Desire disorders are usually reversible after reducing the dose or discontinuing the drug. In some cases, when using the drug Requip Modutab ®, other risk factors may include a history of compulsive behavior or the combined use of several dopaminergic drugs.

Paradoxical worsening of restless legs syndrome has been reported with ropinirole (earlier onset, increased severity, or progression of symptoms to involve previously unaffected limbs) or early morning rebound syndrome (recurrence of symptoms in the early morning hours). If these symptoms appear, it is necessary to reconsider the treatment tactics with ropinirole, adjust the dose, and possibly discontinue the drug.

Prenarat Requip Modutab ® is available in the form of extended-release film-coated tablets with the property of releasing the active substance within 24 hours. In the case of rapid passage of the drug through the gastrointestinal tract, there is a risk of incomplete release of the drug and the transfer of its residue into the stool

Impact on the ability to drive vehicles and operate machinery

Patients should be warned about possible adverse reactions during therapy with ropinirole.

Patients should be informed that there are very rare cases of episodes of sudden falling asleep without any previous or obvious signs of daytime sleepiness and cases of dizziness (sometimes severe). If the patient develops daytime sleepiness or episodes of falling asleep during the day that require active intervention, the patient should be warned about the need to stop driving vehicles and avoid other activities that require high concentration and speed of psychomotor reactions.

For renal failure

The recommended starting dose of ropinirole is 2 mg 1 time/day. Subsequent dose increases should be based on assessment of tolerability and effectiveness. The maximum daily dose in patients on continuous hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

In case of liver dysfunction

Contraindication: liver dysfunction.

Elderly

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding).

Drug interactions

Typical antipsychotics and other centrally acting dopamine antagonists, such as sulpiride or metoclopramide, can reduce the effectiveness of ropinirole (co-administration should be avoided).

There was no pharmacokinetic interaction observed between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs.

Ropinirole does not interact with other drugs that are often used to treat Parkinson's disease.

In patients with Parkinson's disease taking concomitant digoxin, there was no interaction between digoxin and ropinirole that would require dose adjustment.

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme. Pharmacokinetic studies in patients with Parkinson's disease showed that ciprofloxacin increased the Cmax and AUC of ropinirole by approximately 60% and 84%, respectively. In this regard, in patients receiving ropinirole, its dose should be adjusted when prescribing and discontinuing drugs that inhibit the CYP1A2 isoenzyme, for example, ciprofloxacin, enoxacin or fluvoxamine.

A pharmacokinetic study of drug interactions in patients with Parkinson's disease between ropinirole and theophylline, which is a substrate of the CYP1A2 isoenzyme, showed that the pharmacokinetics of the drugs did not change. With simultaneous use of ropinirole with other substrates of the CYP1A2 isoenzyme, the pharmacokinetics of ropinirole does not change.

Increased plasma concentrations of ropinirole were observed in patients receiving high doses of estrogens. In patients receiving hormone replacement therapy before starting treatment with ropinirole, treatment with ropinirole can be started as usual. However, if hormone replacement therapy is discontinued or started during therapy with ropinirole, dosage adjustments may be necessary.

There is no information about the possibility of interaction between ropinirole and ethanol. As with other centrally acting drugs, patients should be warned to avoid drinking alcohol during treatment with ropinirole.

Nicotine is known to induce the CYP1A2 isoenzyme, so if the patient starts or stops smoking during treatment with ropinirole, dose adjustment may be required.

Mode of application

The drug is prescribed orally 1 time/day at the same time, regardless of food intake. The tablets are taken whole, without chewing or breaking.

A dose reduction is recommended if the patient experiences drowsiness at any stage of dose selection. If other adverse reactions develop, it is necessary to reduce the dose of the drug followed by a gradual increase in dose.

It should be borne in mind the need to titrate the dose when missing a dose (one or more).

Monotherapy

Maintenance dose

If, after selecting the dose, the therapeutic effect is not sufficiently pronounced or is unstable, you can continue to increase the daily dose of the drug by 4 mg at intervals of 1-2 weeks (until the required therapeutic effect is achieved). The dose can be changed depending on the therapeutic effect and increased to a maximum dose of 24 mg 1 time / day.

Combination therapy

When using Requip Modutab ® in doses used for monotherapy in combination with levodopa drugs, the dose of levodopa can be gradually reduced (depending on the clinical effect). In clinical studies in patients concomitantly receiving Requip Modutab ® extended-release tablets, the dose of levodopa was gradually reduced by approximately 30%. In patients with a progressive form of the disease taking Requip Modutab ® in combination with levodopa drugs, dyskinesia may occur during the dose titration period of ropinirole. Reducing the dose of levodopa may reduce these symptoms.

Cancellation of therapy. Requip Modutab ® (like other dopaminergic drugs) should be discontinued by gradually reducing the daily dose over at least 1 week. If treatment was interrupted for 1 day or more, the need for dose titration should be considered when resuming therapy.

Despite a possible decrease in drug clearance in patients aged 65 years and older, dose titration of ropinirole in this category of patients is carried out as usual.

U patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min) The clearance of ropinirole does not change, and no dose adjustment of ropinirole is required.

For patients with end-stage renal failure on hemodialysis, The recommended starting dose of ropinirole is 2 mg 1 time / day. Subsequent dose increases should be based on assessment of tolerability and effectiveness. The maximum daily dose in patients on continuous hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

Storage conditions and shelf life

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25°C. The shelf life for 2 mg tablets is 2 years, for 4 mg and 8 mg tablets - 3 years.

Parkinson's disease:

Monotherapy in early stages of the disease in patients requiring dopaminergic therapy to delay the initiation of levodopa;

As part of combination therapy in patients receiving levodopa, to increase the effectiveness of levodopa, including control of on-off and end-dose effects during chronic levodopa therapy, as well as to reduce the daily dose of levodopa.

Release form of the drug Requip Modutab

Extended-release tablets, film-coated 2 mg; contour packaging 14, cardboard pack 2;

Extended-release tablets, film-coated 2 mg; contour packaging 14, cardboard pack 6;

Extended-release tablets, film-coated 2 mg; contour packaging 21, cardboard pack 2;

Extended-release tablets, film-coated 4 mg; contour packaging 14, cardboard pack 2;

Extended-release tablets, film-coated 4 mg; contour packaging 14, cardboard pack 6;

Extended-release tablets, film-coated 8 mg; contour packaging 14, cardboard pack 2;

Extended-release tablets, film-coated 8 mg; contour packaging 14, cardboard pack 6;

Pharmacokinetics of the drug Requip Modutab

The pharmacokinetics of ropinirole are similar in healthy subjects, patients with Parkinson's disease and patients with restless legs syndrome and vary depending on the dosage form.

Suction

After oral administration, the bioavailability of ropinirole is low and is approximately 50% (36-57%). After oral administration of ropinirole in sustained-release tablets, its concentration in plasma increases slowly, the average Tmax time is 6 hours. In patients with Parkinson's disease, after oral administration of ropinirole at a dose of 12 mg 1 time / day in combination with a meal rich in fat, in an equilibrium state, an increase in the systemic exposure of ropinirole, with an increase in AUC and Cmax by 20% and 44%, respectively, Tmax was extended by 3 hours. However, in clinical studies of the effectiveness and safety of ropinirole, ropinirole was taken regardless of food intake.

The increase in the duration of systemic action of ropinirole (Cmax and AUC) is approximately proportional to the increase in dose.

Distribution

Plasma protein binding is low (10-40%). Due to its high lipophilicity, ropinirole has a large Vd (approximately 7 l/kg).

Metabolism

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme.

Removal

Pharmacokinetics in special clinical situations

Using Requip Modutab during pregnancy

Contraindicated for use during pregnancy and lactation (breastfeeding).

Contraindications to the use of Requip Modutab

Acute psychosis;

Liver dysfunction;

Severe renal dysfunction (creatinine clearance less than 30 ml/min), who do not undergo regular hemodialysis;

Rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose;

Pregnancy;

Lactation;

Children and adolescents up to 18 years of age;

Hypersensitivity to the components of the drug.

The drug should be used with caution in patients with severe cardiovascular insufficiency. Ropinirole should only be prescribed to patients with a history of psychotic disorders if the expected benefit outweighs the potential risk.

Side effects of the drug Requip Modutab

In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa drugs, impaired motor coordination may develop during dose titration. It has been shown that discontinuation of levodopa medications may lead to a decrease in these symptoms.

Determination of the frequency of adverse reactions: very often (≥ 1/10); often (≥ 1/100,<1/10); иногда (≥1/1000, <1/100); редко (≥ 1/10 000, <1/1000); очень редко (< 1/10 000, включая отдельные случаи).

In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa drugs, during the dose titration period, impaired motor coordination may develop. It has been shown that discontinuation of levodopa drugs can lead to a decrease in these symptoms.

Post-marketing data

From the central nervous system and peripheral nervous system: sometimes - psychotic states (including delirium and delirium), perception disorders (including illusions, excluding hallucinations), increased impulsivity, increased libido, including hypersexuality, pathological attraction to gambling; very rarely - severe drowsiness, episodes of sudden falling asleep (as with the use of other dopaminergic drugs, these symptoms were very rarely recorded in patients with Parkinson's disease). When the dose was reduced or the drug was discontinued, all symptoms disappeared. In most cases, concomitant sedatives were used.

From the cardiovascular system: often - orthostatic hypotension, decreased blood pressure.

Allergic reactions: very rarely - urticaria, angioedema, rash, itching.

Method of administration and dosage of the drug Requip Modutab

The drug is prescribed orally 1 time / at the same time, regardless of food intake. The tablets are taken whole, without chewing or breaking.

It should be borne in mind the need to titrate the dose when missing a dose (one or more).

Monotherapy

Start of treatment

The recommended starting dose of Requip Modutab is 2 mg 1 time per week. Subsequently, the dose is increased by 2 mg at intervals of at least 1 week to 8 mg/day.
Week 1 2 3 4
Daily dose (mg) 2 4 6 8

Maintenance dose

Combination therapy

When using Requip Modutab in doses used for monotherapy in combination with levodopa drugs, the dose of levodopa can be gradually reduced (depending on the clinical effect). In clinical studies in patients concomitantly receiving Requip Modutab extended-release tablets, the dose of levodopa was gradually reduced by approximately 30%. In patients with a progressive form of the disease taking Requip Modutab in combination with levodopa, dyskinesia may occur during the dose titration period of ropinirole. Reducing the dose of levodopa may reduce these symptoms

Cancellation of therapy. Requip Modutab (like other dopaminergic drugs) should be discontinued by gradually reducing the daily dose over at least 1 week. If treatment was interrupted for 1 day or more, the need for dose titration should be considered when resuming therapy.

Despite the possible decrease in drug clearance in patients aged 65 years and older, dose titration of ropinirole in this category of patients is carried out as usual.

In patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min), the clearance of ropinirole does not change, and no dose adjustment of ropinirole is required.

For patients with end-stage renal failure on hemodialysis, the recommended starting dose of ropinirole is 2 mg once a day. Subsequent dose increases should be based on assessment of tolerability and effectiveness. The maximum daily dose in patients on continuous hemodialysis is 18 mg. Administration of maintenance doses after hemodialysis is not required.

Overdose of Requip Modutab

Symptoms: mainly due to dopaminergic effects - nausea, vomiting, dizziness, drowsiness.

Treatment: Dopamine antagonists such as typical antipsychotics and metoclopramide

Interactions of the drug Requip Modutab with other drugs

Typical antipsychotics and other centrally acting dopamine antagonists, such as sulpiride or metoclopramide, can reduce the effectiveness of ropinirole (co-administration should be avoided).

There was no pharmacokinetic interaction observed between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs.

Ropinirole does not interact with other drugs that are often used to treat Parkinson's disease.

In patients with Parkinson's disease taking concomitant digoxin, there was no interaction between digoxin and ropinirole that would require dose adjustment.

Nicotine is known to induce the CYP1A2 isoenzyme, so if the patient starts or stops smoking during treatment with ropinirole, dose adjustment may be required.

Special instructions when taking Requip Modutab

Patients should be warned about the possible development of drowsiness or episodes of sudden falling asleep, sometimes not preceded by drowsiness. If such reactions occur, discontinuation of therapy should be considered. Blood pressure monitoring is recommended due to the possibility of developing orthostatic hypotension.

In patients taking dopaminergic drugs, incl. ropinirole, appetite disorders have been reported, including compulsive behavior such as pathological gambling and hypersexuality. According to the literature, similar side effects of therapy were observed in patients with Parkinson's disease receiving high doses of dopaminergic drugs; Other risk factors may include a history of compulsive behavior or concomitant use of multiple dopaminergic drugs. In this case, the possibility of reducing the dose or discontinuing therapy should be considered.

A paradoxical worsening of restless legs syndrome has been reported with ropinirole (earlier onset, increased intensity of symptoms, or progression of symptoms to involve previously unaffected limbs) or early morning rebound syndrome (recurrence of symptoms in the early morning hours). If these symptoms appear, it is necessary to reconsider the treatment tactics with ropinirole, adjust the dose, and possibly discontinue the drug.

Impact on the ability to drive vehicles and operate machinery

Patients should be warned about possible adverse reactions during therapy with ropinirole; that there are very, very rare cases of episodes of sudden falling asleep without any previous or obvious signs of daytime sleepiness and cases of dizziness (sometimes severe). If daytime sleepiness or episodes of falling asleep during the day develop, which requires active intervention, the patient should be warned about the need to stop driving vehicles and other activities that require high concentration and speed of psychomotor reactions.

Storage conditions for the drug Requip Modutab

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25°C.

Shelf life of the drug Requip Modutab

The drug Requip Modutab belongs to the ATX classification:

N Nervous system

N04 Antiparkinsonian drugs

N04B Dopaminergic drugs

N04BC Dopamine receptor stimulants

pharmachologic effect

Antiparkinsonian drug, a highly selective non-ergoline agonist of dopamine D 2 -, D 3 - receptors, which has peripheral and central effects.

Ropinirole compensates for dopamine deficiency in the substantia nigra and striatal systems by stimulating dopamine receptors in the striatum.

Ropinirole acts at the level of the hypothalamus and pituitary gland, inhibiting the secretion of prolactin.

Pharmacokinetics

The pharmacokinetics of ropinirole are similar in healthy subjects, patients with Parkinson's disease and patients with restless legs syndrome and vary depending on the dosage form.

Suction

The increase in the duration of systemic action of ropinirole (Cmax and AUC) is approximately proportional to the increase in dose.

Distribution

Plasma protein binding is low (10-40%). Due to its high lipophilicity, ropinirole is characterized by a large Vd (approximately 7 l/kg).

Metabolism

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme.

Removal

Pharmacokinetics in special clinical situations

Indications

Parkinson's disease:

- monotherapy in early stages of the disease in patients requiring dopaminergic therapy to delay the administration of levodopa;

- as part of combination therapy in patients receiving levodopa drugs, in order to increase the effectiveness of levodopa, including control of fluctuations (on-off) and the end-of-dose effect during chronic levodopa therapy, as well as to reduce the daily dose of levodopa.

Dosage regimen

The drug is prescribed orally 1 time/day at the same time, regardless of food intake. The tablets are taken whole, without chewing or breaking.

It should be borne in mind the need to titrate the dose when missing a dose (one or more).

Monotherapy

Maintenance dose

Combination therapy

Side effect

Determination of the frequency of adverse reactions: very often (≥1/10); often (≥1/100,<1/10); иногда (≥1/1000, <1/100); редко (≥1/10 000, <1/1000); очень редко (<1/10 000, включая отдельные случаи).

Evidence from clinical studies in patients with Parkinson's disease

Frequency	Use as monotherapy	Use as part of combination therapy
From the side of the central nervous system
Often	drowsiness	dyskinesia 1
often	hallucinations, dizziness (even severe)	hallucinations, confusion, drowsiness, dizziness (even severe)
From the cardiovascular system
often
Sometimes	orthostatic hypotension, decreased blood pressure
From the digestive system
Often	nausea
often	abdominal pain, dyspepsia, vomiting, constipation	nausea, constipation
General reactions
often	peripheral edema (including swelling of the legs)	peripheral edema

Post-marketing data

From the central nervous system and peripheral nervous system: sometimes - psychotic states (including delirium and delirium), perception disorders (including illusions, excluding hallucinations), increased impulsivity, increased libido, including hypersexuality, pathological attraction to gambling; very rarely - severe drowsiness, episodes of sudden falling asleep (as with the use of other dopaminergic drugs, these symptoms were very rarely recorded in patients with Parkinson's disease). When the dose was reduced or the drug was discontinued, all symptoms disappeared. In most cases, concomitant sedatives were used.

From the cardiovascular system: often - orthostatic hypotension, decreased blood pressure.

Allergic reactions: very rarely - urticaria, angioedema, rash, itching.

Contraindications for use

- acute psychosis;

- liver dysfunction;

- severe renal dysfunction (creatinine clearance less than 30 ml/min), who do not undergo regular hemodialysis;

- rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose;

- pregnancy;

- lactation;

- children and adolescents up to 18 years of age;

- hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in children

Contraindicated: children and adolescents under 18 years of age.

Overdose

Symptoms: mainly due to dopaminergic effects - nausea, vomiting, dizziness, drowsiness.

Treatment: use of dopamine antagonists, such as typical antipsychotics and metoclopramide.

Drug interactions

Typical antipsychotics and other centrally acting dopamine antagonists, such as sulpiride or metoclopramide, can reduce the effectiveness of ropinirole (co-administration should be avoided).

There was no pharmacokinetic interaction observed between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs.

Ropinirole does not interact with other drugs that are often used to treat Parkinson's disease.

In patients with Parkinson's disease taking concomitant digoxin, there was no interaction between digoxin and ropinirole that would require dose adjustment.

Nicotine is known to induce the CYP1A2 isoenzyme, so if the patient starts or stops smoking during treatment with ropinirole, dose adjustment may be required.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

Use for liver dysfunction

Contraindication: liver dysfunction.

Use for renal impairment

U patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min) The clearance of ropinirole does not change, and no dose adjustment of ropinirole is required.

Use in elderly patients

Despite a possible decrease in drug clearance in patients aged 65 years and older, dose titration of ropinirole in this category of patients is carried out as usual.

special instructions

Impact on the ability to drive vehicles and operate machinery

Patients should be warned about possible adverse reactions during therapy with ropinirole.

Patients should be informed that there are very rare cases of episodes of sudden falling asleep without any previous or obvious signs of daytime sleepiness and cases of dizziness (sometimes severe). If daytime sleepiness or episodes of falling asleep during the day develop, which requires active intervention, the patient should be warned about the need to stop driving vehicles and other activities that require high concentration and speed of psychomotor reactions.