Regulon side effects bleeding what to do. Regulon: side effects and clinical outcome

Content

"Regulon" belongs to the category of monophasic contraceptives. It is used to prevent unwanted pregnancy and regulate menstrual cycle. Since the effect of the drug is determined by the content of hormones, the instructions for use are carefully studied before taking it. "Regulon" is sold in packs of 21 pieces. This amount is calculated for 1 month of use.

Manufacturer Regulon

The medicine is produced by Hungarian pharmaceutical company GEDEON RICHTER Plc. It is available in tablet form intended for oral use. Packages are available for sale, including 1 or 3 blisters. Each of them contains 21 tablets.

Composition of Regulon

The contraceptive effect of the drug is achieved due to the content of desogestrel (150 mcg) and ethinyl estradiol (30 mcg). Auxiliary functions are performed by the following components:

• carboxylic acid;
• lactose monohydrate;
• vitamin E;
• colloidal silicon dioxide;
• potato starch;
• polyvinylpyrrolidone.

The outer shell consists of hypromellose, propylene glycol and macrogol 6000.

How does Regulon work?

Regulon birth control pills replenish the level of estrogen and progesterone in the body. According to the instructions for use, ovulation is blocked by suppressing the production of gonadotropins. In addition to this active ingredients change the consistency of cervical mucus. For this reason, unfavorable conditions are created for the movement of sperm through the cervix.

With long-term use of the medication, the process of growth of the endometrium slows down, which makes the process of embryo attachment impossible. Due to increased concentrations of HDL (lipoproteins high density) renders positive impact for fat metabolism. As a result, the menstrual cycle is normalized.

Why is Regulon prescribed?

According to the instructions for use, hormonal pills"Regulon" is prescribed if it is necessary to obtain a contraceptive effect. In some cases it is prescribed for treatment purposes. Optimal duration Therapy in this case is 3 months. After discontinuation of the drug, a rebound effect is observed. It involves the active maturation of eggs, which often leads to multiple ovulation. This type of treatment is relevant for infertility.

Regulon after abortion

To bring the reproductive system back to normal after an abortion, contraceptives are often prescribed. They help protect against unwanted pregnancy and help restore the menstrual cycle. The duration of treatment in this case is 6 months. It is important to follow the instructions for use and doctor's recommendations.

Regulon before IVF

IVF is a procedure artificial insemination. It is carried out under general anesthesia after carrying out preparatory manipulations. Initially, laboratory tests and instrumental examinations. The ovaries are then put into a dormant state for several months using a contraceptive. It balances hormonal levels and stimulates a positive ovarian response.

Regulon after a frozen pregnancy

After an unsuccessful pregnancy, a woman is strictly prohibited from becoming pregnant for six months. Interrupted sexual intercourse does not guarantee the proper degree of protection. Therefore, doctors prescribe taking the drug "Regulon" in accordance with the instructions. It prevents the growth of the endometrium and evens out the cycle. This helps to track the appearance of atypical bloody discharge that may appear after ST (frozen pregnancy).

Regulon for cycle restoration

Constant stress wrong image life and various diseases provoke menstrual irregularities. To restore it you need hormone therapy. According to the instructions, the contraceptive helps to regulate the frequency of menstruation in following cases:

• polycystic ovary syndrome;
• abnormalities in the structure of the uterus;
• nervous disorders;
• endometrial polyps;
• adrenal dysfunction;
• oncology;
• liver diseases.

Regulon for endometriosis

Endometriosis is a pathological process of growth of the uterine layers beyond its boundaries. The disease is accompanied by spotting bloody discharge and pain in the abdomen. Instructions for use indicate that 3rd generation progestogens, which include the medication, block the growth of the uterine epithelium. As a result, pathological bleeding disappears. The patient’s well-being is normalized.

Contraindications to Regulon

Contraceptives interfere with a woman's hormonal balance. To avoid unwanted consequences, you must go through comprehensive examination to identify contraindications. The instructions for use indicate the following:

• history of venous thromboembolism;
• migraine;
• dyslipidemia;
• cholelithiasis;
• lactation period;
• intolerance to the constituent components;
• the presence of hormone-dependent tumors;
• bloody discharge from the genitals of unknown origin;
• liver diseases;
• thrombosis and suspicion of its presence.

Instructions for use of Regulon tablets

Before taking it, you must carefully study how to take Regulon. Abstract implies oral administration. The blister contains 21 tablets, designed for 1 month of use. The tablets are taken daily, at the same time. They need to be taken with a small amount clean water. Within a week after completion of packaging, spotting occurs.

The instructions for use indicate that exactly one week after taking last pill, it is necessary to start next package medicine. There is no need to focus on the duration of bleeding. The drug is taken even if your period has not ended. The contraceptive effect lasts not only for the duration of use, but also for a 7-day period.

How to take Regulon for the first time

The course of treatment begins on the first day of the menstrual cycle. There is no need to use additional contraception. It is allowed to take pills from days 2 to 5 of the cycle. But in this case, additional protection against pregnancy will be required, since contraceptive effect decreases.

How to take Regulon birth control pills correctly

Contraceptive pills are taken strictly in accordance with the instructions for use. Violation of the rules of administration leads to a decrease in the effectiveness of the drug. It is important to consider the possibility of combination with other medications. Some of them can affect the rate of absorption of the active components of the drug.

What to do if you missed a Regulon tablet

The interval between doses is 24 hours. What you do if you miss a pill depends on how long it has been since your last dose. This is discussed in the instructions for use. The next pill is taken as soon as the woman remembers it. If less than 12 hours have passed, the contraceptive effect does not decrease; if more, additional contraceptive measures are taken.

When does Regulon start to work?

If the instructions for use are followed, the contraceptive effect is observed from the first day of taking the drug. The following can reduce its effectiveness:

• antibiotics;
• medicines based on St. John's wort;
• vomit;
• drugs that affect liver enzymes.

How long can you take Regulon?

According to the instructions for use, the duration of use depends on the woman’s need for contraceptive action. If side effects are absent, treatment can take years. The ability to bear children is completely restored after discontinuation of the drug.

Is it possible to drink Regulon without interruption?

It is not necessary to take breaks between doses. But periodically, a woman should undergo a comprehensive examination of the body to exclude the possibility of developing side effects.

Some women do not take a 7-day break between packs. This is practiced if the arrival of menstruation is undesirable for some reason. The instructions for use allow for the possibility of such actions. But it is not recommended to abuse this.

Side effects of Regulon

The instructions for use indicate the consequences that Regulon can lead to. Side effects are common. In most cases, they appear in the first months of use. This period is considered an adaptation period for the body. The most common side effects include:

• arterial hypertension;
• epigastric pain and nausea;
• migraine;
• fluid retention in the body;
• allergic reaction;
• increased appetite;
• exudative erythema;
• change in the nature of vaginal discharge;
• increased volume and sensitivity of the mammary glands.

Important! If side effects occur, you should consult a doctor.

Is it possible to get better from Regulon?

There is an opinion that you can get better from Regulon. The contraceptive slows down metabolism and promotes fluid retention in the body. Because of this, it may seem that the woman has gained several kilograms. In some cases, appetite increases, which indirectly affects weight gain. It is recommended to monitor your diet while taking the medication. In this case, it is possible to avoid changes in the figure.

Chest hurts when taking Regulon

The effect of the drug is due to the content of progesterone and estrogens. The levels of these hormones change in the body throughout the menstrual cycle. Therefore, after ovulation, a woman may notice soreness in the mammary glands. Instructions for use indicate that when taken hormonal agent The breasts may be sensitive in the first half of the cycle. This is considered completely normal.

Drug interactions

The instructions for use indicate that combining the medication with drugs that induce liver enzymes is undesirable. In this case, the risk of intermenstrual discharge increases and the contraceptive effect decreases. Has a similar effect joint use contraceptive with tetracycline and ampicillin.

Attention! Women suffering from diabetes should take into account that Regulon increases the need for insulin.

Compatibility of Regulon and alcohol

The instructions for use do not prohibit combination alcoholic drinks with oral contraceptives. On the effectiveness of tablets ethanol does not affect. But it is not recommended to abuse alcohol-containing drinks. They have a destructive effect on liver cells. "Regulon" only aggravates this process.

Regulon and smoking

Instructions for use indicate that the drug is contraindicated for use by women over 35 years of age who are addicted to smoking. This is due to its ability to thicken blood. During smoking, vasospasm occurs, which, together with thick blood may lead to thrombosis. This phenomenon is considered dangerous to life and health.

Pregnancy and lactation

During the period of bearing and breastfeeding a child, the use of the drug is strictly prohibited. IN postpartum period Admission is possible only if the child is transferred to artificial feeding.

Terms and conditions of storage

Instructions for use indicate the need to store the medication in a dark place, out of reach of children. The optimal storage temperature is no more than 30°C and no less than 15°C. The shelf life is 3 years.

How much does Regulon cost?

Every woman is interested in how much Regulon costs. The price in pharmacies may vary, depending on the number of tablets in the package and the location of the point of sale. In the capital's pharmacies the price is higher. On average, the cost for a package of 21 pieces is 380 rubles, 63 tablets - 1100 rubles.

Regulon's analogs

The instructions for use do not indicate alternative replacements for the drug. Their doctor selects them individually. This is necessary if a woman cannot use Regulon. TO similar drugs The composition includes the following:

• "Marvelon";
• "Mersilon";
• "Novinet."

If there is intolerance to the active ingredient, products are selected that are similar in effectiveness, but different in composition. In this case, the following is prescribed:

• "Belara";
• "Lindynet 20";
• "Yarina";
• "Janine";
• "Logest";
• "Jess."

Regulon or Janine: which is better?

"Regulon" belongs to the category of low-dose medicines. Most often it is prescribed to young women who are not experiencing pregnancy. “Janine” is often prescribed after the birth of a child. It is less cost effective. The price of the drug is 900 rubles.

Regulon or Jess: which is better?

"Jess", unlike its analogue, is prescribed in case of problems with skin condition or in preparation for pregnancy. It is impossible to say which is better. It all depends on the characteristics of the woman’s body and the purpose of use.

Regulon or Logest: which is better?

“Logest” is more difficult for patients to tolerate. This is due to more high dosage active substances. According to the instructions for use, the drug is ideal for those with endometriosis. The price varies from 700 to 1900 rubles.

Regulon or Lindinet 20: which is better?

Lindinet 20 is often prescribed as an alternative option. Contraceptives differ in composition. "Regulon" is considered more a strong drug. Therefore, the risk of developing side effects when taking it is higher.

Regulon or Tri Regol: which is better?

The main advantage of “Three Regola” is its cost – no more than 200 rubles. Because of this, it is in great demand. It is not inferior to its counterpart in efficiency. The principle of influence on the body, which can be found in the instructions for use, is the same. The main difference lies in the constituent components.

Conclusion

Regardless of how well the instructions for use are followed, Regulon can also cause harm to health. Therefore, before using it, it is necessary to study contraindications and take hormone tests. Only in this case will taking the drug be justified.

Compound

active ingredients: desogestrel, ethinyl estradiol;

1 film-coated tablet contains desogestrel 0.15 mg and ethinyl estradiol 0.03 mg

Excipients: alpha-tocopherol (all-rac-α-tocopherol), magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose;

shell composition: propylene glycol, macrogol 6000, hypromellose.

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Dosage form

Film-coated tablets.

Pharmacological group

Hormonal contraceptives for systemic use. Desogestrel and estrogen. ATC code G03A A09.

Indications

Oral contraception.

Contraindications

Combined oral contraceptives (COCs) should not be used for the conditions listed below. If this condition occurs for the first time while taking an oral contraceptive, its use should be stopped immediately.

• Pregnancy is known or pregnancy is possible.
• Moderate or severe hypertension.
• Hyperlipoproteinemia.
• Presence or history of venous thromboembolism (for example, thrombosis

deep veins, embolism pulmonary artery).

• Presence or history of arterial thromboembolism (for example, myocardial infarction)

myocardium, cerebrovascular disorders), or a condition that precedes it (for example, angina pectoris, transient ischemic attack).

• The presence of severe or multiple risk factors for arterial or

venous thrombosis(see section “Application Features”).

• Hereditary or acquired tendency to arterial or venous thrombosis, for example

resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

• Diabetes mellitus with vascular complications.
• Pancreatitis currently or in history, accompanied by severe

hypertriglyceridemia.

• Severe liver disease, cholestatic jaundice or hepatitis, including a history (in

In the absence of normalization of liver tests and within 3 months after their normalization), a history of jaundice during pregnancy, jaundice due to steroid use, Rotor syndrome, Dubin-Johnson syndrome, hepatocellular tumors and porphyria.

• Cholelithiasis.
• Liver tumors, including a history (benign or malignant).
• Identification or suspected estrogen- dependent tumors(for example, genitals and

mammary glands), endometrial hyperplasia.

• Bleeding from the vagina of unknown etiology.
• Migraine with focal neurological symptoms(see Section “Application Features”).
• Systemic lupus erythematosus, including history.
• Severe itching, herpes during pregnancy, the appearance or progression of otosclerosis during

previous pregnancy or while taking steroids.

• Hypersensitivity to the active substances or to any of the excipients

drug (see section "Composition").

Directions for use and doses

The tablets must be taken in the order indicated on the blister pack. Start taking pills on the first day of the menstrual cycle and take 1 tablet per day for 21 days without a break, if possible at the same time of day. Then you should take a 7-day break, during which withdrawal bleeding occurs. On the 8th day after

After a 7-day break (4 weeks after taking the first tablet, on the same day of the week), start taking the drug from the next package, which also contains 21 tablets, even if the bleeding has not stopped. Follow this dosage regimen as long as there is a need for contraception. If you follow the doctor's instructions, the contraceptive effect remains during the break in taking the pills.

First dose of Regulon

Taking the first Regulon tablet should start on the first day of menstruation, in this case there is no need to use additional methods contraception.

You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, additional (barrier) methods of contraception should be used in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, you should delay starting Regulon until your next menstruation.

Taking the drug after an abortion in the first trimester

After a miscarriage or abortion, you should start taking the pills immediately. In this case, there is no need to use additional methods of contraception.

Taking the drug after childbirth or abortion in the second trimester

Women who are not breastfeeding can start taking oral contraceptives at

21-28 days after childbirth or abortion in the second trimester. In this case, there is no need to use other methods of contraception.

If you start taking Regulon tablets later, then in the first 7 days it is necessary to use additional (barrier) methods of contraception.

If you have already had sexual intercourse after childbirth, taking the pills should be postponed until your first menstruation.

Note: Women who are breastfeeding should not take combined oral contraceptives as this may reduce the amount breast milk(See Section “Use during pregnancy or lactation”).

Switching to Regulon from other birth control pills.

Switching to taking Regulon tablets from other tablets that are used for 21 or

22-day scheme

You should take all the tablets from the previous package of the contraceptive drug.

Switching to taking Regulon tablets from other birth control pills, which are used on a 28-day schedule

The first Regulon tablet should be taken after taking the last active (hormone-containing) tablet from the previous package; there is no need to take a break or wait for the start of menstruation. In this case, there is no need to use additional methods of contraception.

Switching to Regulon tablets after use hormonal drugs containing only progestogen (mini-pill, injection or implant) or with intrauterine system(IUD), which releases progestogen

The first Regulon tablet should be taken on the first day of the menstrual cycle. In this case, there is no need to use additional methods of contraception.

If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Regulon on any day of the cycle. But in this case, in the first 7 days it is necessary to use additional methods of contraception.

You can start using Regulon on the day of removal of the implant or IUD, or in the case of an injection, instead of the next injection. In these cases, the woman should use an additional barrier method during the first 7 days of taking the pills.

In all the described cases, if additional methods of contraception are necessary, the following may be recommended: a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse.

Application calendar method in these cases it is not recommended.

Delayed onset of menstruation

If there is a need to delay the onset of menstruation, you should continue taking Regulon tablets the next day after the end of the current package, without interruption. The delay can be continued until the end of the second package. If menstruation is delayed, breakthrough bleeding or spotting may occur, but this does not reduce the contraceptive effect of the drug. Regular use of Regulon can be resumed after the usual 7-day break.

missed pills

If more than 12:00 passes after missing a pill, the contraceptive effect of the drug is not reduced. A woman needs to take it right away forgotten pill, and then continue taking the drug at the usual time.

If more than 12:00 passes after missing a pill, the contraceptive effect of the drug may decrease. In case of omission, two basic rules must be taken into account:

1. Do not stop taking the pills for more than 7 days.

2. To achieve sufficient suppression of the hypothalamic-pituitary-ovarian axis, 7 days of continuous use of the drug is necessary.

In accordance with this, when taking tablets, you must follow the following recommendations.

week 1

A woman should take the forgotten pill immediately, even if this means taking two pills at the same time. Then you should continue taking it regularly at the usual time of day. In this case, over the next 7 days you need to use a barrier method of contraception, such as a condom. If you have had sexual intercourse in the previous 7 days, you should consider the possibility of pregnancy. The more pills you miss and the closer they are to the break, the higher the risk of pregnancy.

week 2

A woman should take the forgotten pill immediately, even if this means taking two pills at the same time. Then you should continue taking it regularly at the usual time of day. Provided that the tablets are used correctly within 7 days before the forgotten tablet is needed, additional measures There is no contraception, but if more than 1 tablet is missed, an additional method of contraception should be used for 7 days.

week 3

The risk of a decrease in contraceptive effect is very high given the proximity of the break in taking the pills. However, this can be prevented by adjusting the pill regimen. So, there is no need for additional contraceptive measures if one of the following two options is used, provided that all pills are taken correctly within 7 days before the forgotten pill. Otherwise, the woman is recommended to follow the first option and simultaneously use an additional method of contraception for 7 days.

1. You should immediately take the forgotten pill, even if this means taking two pills at the same time. Then you should continue taking it regularly at the usual time of day. Start a new pack immediately after taking the last tablet from the current pack, that is, do not take a break between packs. It is unlikely that menstrual bleeding will occur before finishing the second pack of tablets, but breakthrough bleeding or spotting may occur while taking the tablets.

2. You can stop taking tablets from the current package. In this case, the woman should take a 7-day break, including those days when she forgot to take the pills, and then start a new pack.

If a woman forgot to take the pills, and then bleeding did not occur during the first normal break in taking the pills, the possibility of pregnancy should be considered.

Measures for vomiting and diarrhea

If vomiting or diarrhea occurs after taking the drug, absorption of the drug may be incomplete. If the symptoms stop within 12:00, you should take an additional tablet from the reserve package, and then continue taking the tablets from the old package as usual. If symptoms continue for more than 12:00, then it is necessary to use additional methods of contraception until the stomach and intestines resume function, as well as in the next 7 days.

Adverse reactions

Severe adverse reactions requiring discontinuation of the drug

• It is known that a connection has been identified between taking oral contraceptives And

increased risk of venous and arterial thrombotic and thromboembolic diseases, including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism. These adverse reactions occur rarely.

Thrombosis of other veins or arteries, including hepatic, mesenteric, renal and retinal, is very rarely reported. There is no consensus on the effect of taking oral contraceptives on the incidence of these adverse reactions No.

• If arterial hypertension occurs, the drug should be discontinued immediately.
• The use of COCs containing estrogen may cause the growth of tumors dependent on

sex steroid hormones, therefore the use of such drugs in women with such tumors is contraindicated.

• The possible increased risk of developing breast cancer should be discussed with the patient and

weigh the benefits and risks of taking COCs, given that they have been shown to reduce the risk of developing other types of cancer, such as ovarian and endometrial cancer.

• The use of oral contraceptives can lead to the development of cholestatic

jaundice or cholelithiasis.

• Women with hypertriglyceridemia or a family history of the condition

are at increased risk of developing pancreatitis when using COCs.

• For acute and chronic liver dysfunction, the drug should be

discontinue until liver function test results return to normal.

• Cholestatic jaundice that developed in early pregnancy or during

previous use of sex steroid hormones requires discontinuation of birth control pills.

• Although birth control pills may affect peripheral insulin resistance and

glucose tolerance, there are no indications for the need to change the dosage regimen for patients with diabetes and taking birth control pills. However, women with diabetes should be closely monitored while taking birth control pills.

• Chloasma may sometimes appear, especially in women with a history of chloasma.

diseases during pregnancy. Those women who are at risk of developing chloasma should avoid direct sunlight or ultraviolet radiation while taking the pills.

• Very rarely, the use of oral contraceptives can activate reactive

systemic lupus erythematosus.

• One more rare complication developing as a result of taking

oral contraceptives, there is Sydenham's chorea, which goes away after discontinuation of the drug.

Other less severe adverse reactions that develop when taking Regulon

From the reproductive system: intermenstrual bleeding, amenorrhea after withdrawal

the drug, changes in the condition of vaginal mucus, an increase in the size of uterine fibroids, worsening of endometriosis and some vaginal infections, such as candidiasis.

• From the mammary glands: tension, pain, enlargement, secretion.
• From the outside gastrointestinal tract: nausea, vomiting.
• Skin: erythema nodosum, rash, chloasma.
• On the part of the visual organs: increased sensitivity of the cornea when wearing contact lenses.
• From the nervous system: headache, migraine, mood lability,

depression.

• From the metabolic side: fluid retention in the body, change in body weight, decrease

glucose tolerance.

There are reports of the occurrence or worsening of the following conditions during pregnancy or taking COCs, but their connection with taking birth control pills is inconclusive: jaundice and/or itching due to cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea; herpes in pregnant women is associated with otosclerosis, hearing loss, Crohn's disease, ulcerative colitis, epilepsy, uterine fibroids.

Adverse reactions that occur when using the drug Regulon:

From the outside immune system: hypersensitivity.

From the side of nutrition and metabolism: fluid retention.

Mental disorders: depression, mood lability, decreased libido, increased libido.

From the nervous system: headache, nervousness, dizziness, migraine.

On the part of the visual organs: intolerance to contact lenses.

From the organs of hearing and balance: otosclerosis.

From the vascular system: arterial hypertension, thrombosis, embolism.

From the outside digestive system: nausea, abdominal pain, vomiting, diarrhea.

From the skin and subcutaneous tissues: acne, rash, urticaria, erythema nodosum,

erythema multiforme, alopecia.

From the reproductive system and mammary glands: breakthrough bleeding, spotting, tenderness of the mammary glands, engorgement of the mammary glands, dysmenorrhea, premenstrual syndrome, amenorrhea, breast enlargement, vaginal discharge, breast discharge.

Systemic disorders and complications at the injection site: weight gain, weight loss.

Some adverse reactions that develop in women when using combined oral contraceptives are described in detail in the section “Peculiarities of use”). These include: venous thromboembolic disorders; arterial thromboembolic disorders; AG; hormone-dependent tumors (eg liver tumors, breast cancer) chloasma.

Overdose

No serious adverse reactions were observed after taking a large dose of oral contraceptives. Symptoms that may occur in this case: nausea, vomiting, and in young girls - slight vaginal bleeding. However, if an overdose is detected within

2-3 hours or accepted a large number of tablets, gastric lavage should be done. There is no antidote; symptomatic treatment should be used.

Use during pregnancy or breastfeeding

Pregnancy. Regulon is contraindicated during pregnancy. Before starting to take Regulon, pregnancy must be ruled out. If pregnancy occurs while taking Regulon, the drug should be discontinued immediately.

It is known that the frequency birth defects in children of women who took oral contraception before pregnancy, it does not increase; no teratogenic or mutagenic effect was detected when using tablets in early pregnancy.

Breastfeeding period. Oral contraceptives may decrease the quantity and composition of breast milk and are excreted in breast milk (with no evidence of adverse effects on the health of newborns), so their use during breastfeeding is not recommended.

Children

Regulon is not intended for use in children.

Features of application

relative contraindications

If any of the following conditions are present while taking the drug, the benefits of taking the oral contraceptive should be weighed against possible risks in each individual case, and discuss them with the patient before making a decision on the use of the drug.

The woman's health condition must be carefully monitored. If any of the following conditions worsen, become aggravated, or appear while taking the pills, a woman should consult a doctor. The doctor decides to stop using the PDA and recommends other, non-hormonal methods of contraception.

• Blood clotting disorder.
• Other conditions that increase the risk of developing circulatory diseases include

for example, latent or overt heart failure, renal failure or a history of these diseases.

• Epilepsy, incl. in the anamnesis.
• Migraine, incl. in the anamnesis.
• History of cholelithiasis.
• Presence of risk factors for the development of estrogen-dependent tumors, estrogen-sensitive ones

disorders, such as uterine fibroids or endometriosis.

• Diabetes.
• Severe depression, incl. in the anamnesis. If depression is associated with metabolic disorders

tryptophan, then vitamin 6 can be used for correction.

• Sickle cell anemia, because in some cases, such as infections,

hypoxia, estrogen-containing drugs in this pathology can provoke thromboembolism.

• If liver test results are abnormal, tablets should be discontinued.

thromboembolic diseases

It is known that there is an association between taking oral contraceptives and an increased risk of developing arterial and venous thromboembolic diseases, including myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism). However, these phenomena rarely develop.

Driven increased risk development of venous thromboembolism (VTE) when using oral contraceptives. However, it develops much less frequently than during pregnancy, when its frequency is estimated at 60 cases per 100,000 pregnancies. It is known that the risk of developing venous thromboembolism in women taking oral contraceptives containing desogestrel and gestodene (the so-called “third generation pills”) is higher than in women taking pills containing levonogestrel (the so-called “second generation pills”).

The incidence of VTE in healthy non-pregnant women not taking oral hormonal contraceptives is 5-10 cases per 100,000 women per year. The risk of developing VTE is especially high in the first year of contraception among women who have never taken combined oral contraceptives before. 1-2% of VTE cases are fatal. The incidence in women taking second- and third-generation pills is approximately 15 cases per 100,000 women per year and 25 cases per 100,000 women per year, respectively. The risk of VTE increases with age and with other risk factors, such as obesity.

It is known that in women taking COCs containing ethinyl estradiol, more often in the amount

30 mcg and a progestin such as desogestrel, the risk of developing VTE is higher compared to women taking COCs containing less than 50 mcg ethinyl estradiol and the progestin levonorgestrel.

For drugs containing 30 mcg ethinyl estradiol in combination with desogestrel or gestodene, compared with drugs containing less than 50 mcg ethinyl estradiol and levonorgestrel, the overall relative risk of developing VTE is estimated to be 1.5-2. The incidence of VTE with oral contraceptives containing less than 50 mcg of levonorgestrel with ethinyl estradiol is approximately 20 cases per 100,000 woman-years of use. For Regulon, the incidence is approximately 30-40 per 100,000 women-years of use: that is, an additional 10-20 cases per 100,000 women-years of use. The proportion of relative risk for additional cases is higher in women taking combined oral contraceptives for the first year, in which the risk of developing VTE is greatest for all combined oral contraceptives.

There is evidence of very in rare cases the occurrence of arterial or venous thrombosis in the hepatic, mesenteric, renal area or in the retinal area.

The risk of developing arterial and/or venous thromboembolism increases:

• with age;
• when smoking (heavy smoking and age increase the risk, especially in women aged over

• if there is a family history of thromboembolic disease (eg

arterial thrombosis or venous thromboembolism in a sibling or parent in at a young age). If you suspect a genetic predisposition, you should consult a specialist before using the drug;

• for obesity (body mass index more than 30 kg/m2);
• with dyslipoproteinemia;
• with arterial hypertension;
• for migraine
• for diseases of the heart valves
• atrial fibrillation
• for diabetes
• with prolonged immobilization, after a major surgical intervention, operational

interventions on the lower extremities, severe trauma. In these cases, it is recommended to temporarily discontinue the use of oral contraceptives (no later than 4 weeks before surgery) and resume use no earlier than 2 weeks after complete remobilization).

There is no consensus on the possible connection of varicose veins and superficial thrombophlebitis with VTE.

IN postpartum period the increased risk of venous thromboembolism should be taken into account (see Section “Use during pregnancy or lactation”).

Other diseases that may be accompanied by adverse reactions from the circulatory system include: diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory disease intestines (Crohn's disease or ulcerative colitis) and sickle cell anemia.

If the frequency or severity of migraine increases while using oral contraceptives (which may be a precursor or stroke event), the drug should be stopped immediately.

Hereditary or acquired factors that may indicate venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that adequate treatment of this condition reduces the risk of thrombosis and the risks associated with pregnancy are higher than the risks associated with the use of oral contraceptives.

Symptoms indicating the development of thrombosis are:

• sudden strong pain in the chest, which can give in left hand;
• sudden shortness of breath, sudden cough;
• any unusual, severe, prolonged headache, especially if it occurs

for the first time is more pronounced than usual, or in combination with the following symptoms: sudden complete or partial loss of vision or diplopia, aphasia, vertigo, severe dizziness, collapse, possibly with focal epilepsy, weakness or severe numbness of half the body, motor disturbances, severe unilateral pain in calf muscle and an “acute” stomach.

oncological diseases

Hormonal contraceptives containing estrogen stimulate the growth of hormonal tumors. Therefore, the use of hormonal contraceptives in patients with such tumors is contraindicated. A number of studies have been conducted in women taking oral contraceptives to investigate the incidence of ovarian, endometrial, cervical and breast cancer. According to the results, oral contraceptives provide good protection against the development of both ovarian and endometrial cancer.

Some studies report an increased risk of cervical cancer in women who for a long time took hormonal contraceptives, but the research results are very contradictory. Sexual behavior (for example, differences in the number of sexual partners or the use of barrier contraceptives) and other factors (for example, infection with the human papillomavirus (HPV)) play a significant role in the development of cervical cancer.

Studies have shown that the relative risk of developing breast cancer is higher in women taking oral hormonal contraceptives.

The additional risk gradually disappears within 10 years after stopping COC use. Breast cancer is rare in women under 40 years of age, and the additional incidence of breast cancer in women currently or recently taking COCs is small compared to overall risk. There was no evidence of a cause-and-effect relationship in these studies. Higher detection of breast cancer may be associated with more early detection breast cancer in women taking COCs, the biological effects of such contraceptives or a combination of both factors. Breast cancer that occurs in women who have ever used such contraceptives is usually clinically less severe than cancer in women who have never used such contraceptives.

The risk increases with age. The incidence of breast cancer in women taking the pill is low, and pill use may be considered one of many risk factors. However, the woman should be informed of the possible risk of developing breast cancer, and the decision to take the pill should be based on an assessment of the benefit/risk ratio (CPCs provide good protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant tumor liver in women taking oral contraceptives for a long time. This should be kept in mind in the differential diagnostic assessment of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

other conditions

Women with hypertriglyceridemia or a family history of such disease are at increased risk of developing pancreatitis when using COCs.

Although many women taking COCs experience a slight increase blood pressure, a clinically significant increase is very rare. The connection between taking COCs and arterial hypertension has not been established. However, if persistent clinically significant arterial hypertension develops in women taking COCs, it is advisable to stop taking COCs and begin treatment for arterial hypertension. If normal pressure is achieved with antihypertensive therapy it is possible that you can resume taking COCs (if this is considered appropriate).

There are reports of the occurrence or worsening of the following conditions during pregnancy or taking COCs, but their connection with taking birth control pills is inconclusive: jaundice and / or itching due to cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham chorea; Herpes of pregnancy is associated with otosclerosis, hearing loss (Hereditary) angioedema.

Acute or chronic disorders liver function may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which occurred during pregnancy or previous use of sex steroid hormones, requires discontinuation of COC use.

Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence that dosage changes should be made in diabetic patients taking COCs. However, women with diabetes should be closely monitored while taking COCs.

The development of Crohn's disease and ulcerative colitis is associated with the use of COCs.

Regulon contains lactose. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should take this into account.

The above information should be taken into account when choosing a contraceptive method(s).

medical checkup

Before starting or re-prescribing a contraceptive, it is necessary to carefully study the family and personal history, conduct a physical and gynecological examination, including blood pressure measurement, laboratory research, examination of the mammary glands, pelvic organs, cytological analysis cervical smear. Such examination should be carried out regularly. Pregnancy must be excluded.

Periodic medical examination is also important, taking into account contraindications and risk factors that may be detected during the initial period of taking an oral contraceptive.

The woman should be warned that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Changes in laboratory parameters

Under the influence of oral contraceptive pills, due to the content of the estrogen component, the level of some laboratory parameters may change, including functional indicators of the liver, kidneys, adrenal glands, thyroid gland, coagulation and hemostasis indicators, the level of lipoproteins and transport proteins in the blood plasma.

chloasma

Chloasma may develop, especially in women with a history of chloasma in pregnancy. Women at risk of developing chloasma should avoid direct sunlight or ultraviolet radiation while taking the pills.

decreased efficiency

The effectiveness of COCs may be reduced in cases of missed pills, vomiting, or concomitant use of other medications.

• forgotten pills

If the patient forgets to take the tablet at the usual time, the tablet should be taken within

12:00. Next pills should be taken at the usual time. In such cases, there is no need for additional contraceptive measures.

If one or more tablets are not taken within 12:00, the contraceptive effect of the drug will be reduced. A woman should take the last forgotten pill, even if it means taking two pills in one day, and then continue taking the pills at her usual time. In such cases, additional contraceptive measures will be required for the next 7 days.

• Vomiting and diarrhea

If vomiting or diarrhea occurs after taking the tablet, absorption of the drug may be reduced. If the symptoms stop within 12:00, you should take an additional tablet from the reserve package, and then continue taking the tablets from the old package as usual. If symptoms continue for more than 12:00, it is necessary to use additional methods of contraception until the stomach and intestines resume function and for the next 7 days.

• Concomitant use of drugs

If the patient is taking other medications, which may reduce the contraceptive effect of Regulon tablets, you should use an additional method of contraception while taking such a drug.

When taking Regulon tablets, you should not take herbal preparations, containing St. John's wort (Hypericum perforatum) due to possible reduction concentrations active ingredients in plasma and a decrease in the clinical effect of tablets (see Section “Interaction with other drugs and other types of interactions”).

The contraceptive effect may be reduced if, after several months of taking Regulon, irregular, spotting or breakthrough bleeding appears. If withdrawal bleeding does not occur or bleeding disturbances are noted, then pregnancy is unlikely and you should continue taking the pills until the end of the next package. If withdrawal bleeding does not occur at the end of the second cycle or if bleeding problems persist, you should stop taking the pills and resume it only after pregnancy has been ruled out.

Insufficient cycle control

When taking any COC, irregular bleeding (spotting or breakthrough bleeding) may occur, especially in the first months of using the drug. In this regard, the assessment of any irregular bleeding is significant only after an adaptation period of approximately three cycles. With persistent irregular bleeding or its occurrence with regular cycles non-hormonal causes need to be considered and appropriate measures taken diagnostic measures to exclude a malignant tumor or pregnancy, including diagnostic curettage.

In some women, withdrawal bleeding may not occur after a break in use. If the COC was used in accordance with the section “Method of administration and dosage,” then pregnancy is unlikely. However, if the instructions in the section “Dosage and Administration” were not followed before the first absence of withdrawal bleeding or if there are no two withdrawal bleedings in a row, then pregnancy should be excluded before continuing to take the COC.

The ability to influence the reaction rate when driving vehicles or other mechanisms

The effect of Regulon on the ability to drive vehicles or operate machinery has not been identified, but the possibility of adverse reactions such as headache and dizziness should be taken into account (see Section “Adverse Reactions”).

Interaction with other drugs and other types of interactions

Drug interactions may result in breakthrough bleeding and/or decreased contraceptive effectiveness. This has been established for drugs that induce microsomal enzymes, which leads to increased clearance of sex hormones (for example, hydantoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin and oxcarbazepine, possibly topiramate, felbamate, ritanovir, griseofulvin and preparations containing St. John's wort). The maximum level of induction is usually achieved no earlier than 2-3 weeks after the start of treatment, but can last up to 4 weeks after discontinuation of the drug. When using drugs that induce microsomal enzymes, the barrier method should be used as an addition to COC throughout the entire course of treatment and during

28 days after the end of their use.

It has also been found that antibiotics such as ampicillin and tetracycline reduce the contraceptive effect, but the mechanism of interaction is not clear. Women who take any of these drugs must additionally use a barrier method of contraception or another method of contraception.

Women receiving antibiotic treatment (except rifampicin and griseofulvin) must additionally use a barrier method of contraception during the entire course of treatment and for 7 days after discontinuation of the antibiotic.

If the duration of use of the concomitant drug exceeds the number of contraceptive pills in the package, the next package should be started without a break between them.

Experts recommend increasing the dose of steroid contraceptives for women who receive long-term treatment drugs that induce liver enzymes. If a high-dose contraceptive is not recommended or the high dose is insufficient or harmful, such as causing irregular bleeding, another method of contraception is recommended.

Herbal preparations containing St. John's wort (Hypericum perforatum) may lead to loss of contraceptive effect, with this effect remaining for at least

2 weeks after discontinuation of treatment with St. John's wort.

Oral contraception may decrease glucose tolerance and increase the need for insulin or oral antidiabetic agents.

Oral contraceptives may affect the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacological.

Regulon is a combined hormonal contraceptive drug For oral administration, the effect of which is primarily to suppress gonadotropins and suppress ovulation. In addition, it slows down the movement of sperm through cervical canal and prevents the implantation of a fertilized egg.

Ethinyl estradiol is a synthetic estrogen.

Desogestrel is a synthetic progestogen, which, after oral administration, strongly inhibits ovulation, exhibits a pronounced progestogen and antiestrogens effect, does not exhibit estrogenic activity and has weak androgenic and anabolic activity.

Pharmacokinetics.

desogestrel

Suction. Desogestrel is rapidly and almost completely absorbed, followed by transformation into 3-keto-desogestrel (etonogestrel), which is a biologically active metabolite of desogestrel. The maximum plasma concentration (Cmax) is approximately

2 ng/ml and is achieved after 1.5 hours (t max). The bioavailability of desogestrel is 62-81%.

Distribution. 3-keto-desogestrel binds well to plasma proteins, mainly albumin and sex hormone binding globulin (SHBG). Only 2-4% of the total amount of desogestrel in the blood serum appears as free steroids, and 40-70% is specifically associated with SHBG. The increase in SHBG concentration caused by ethinyl estradiol affects the distribution of serum proteins, which leads to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The expected volume of distribution is 1.5 l/kg.

Metabolism. Etonogestrel is completely broken down by known pathways of steroid metabolism. The rate of elimination of metabolites from blood serum is approximately

2 ml/min/kg. No interaction of etonogestrel with ethinyl estradiol has been identified.

In addition to 3-keto-desogestrel, which is formed in the liver and in the intestinal wall, other metabolites of desogestrel are also formed: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (the so-called phase I metabolites) . These metabolites have no pharmacological activity; they are successively converted into polar metabolites, primarily sulfates and glucuronides, partly by conjugation (phase II metabolism).

Conclusion. The half-life of 3-keto-desogestrel is about 30 hours. Metabolites are excreted by the kidneys and through the intestines in a ratio of 6:4.

Equilibrium state. The pharmacokinetics of etonogestrel is influenced by the content of SHBG in the serum, which increases threefold when taking ethinyl estradiol. At daily intake an equilibrium state is achieved in the second half of the cycle, when the concentration of etonogestrel in the blood serum increases by 2-3 times.

ethinylestradiol

Suction. Ethinyl estradiol is rapidly and almost completely absorbed. The maximum plasma concentration (Cmax) is 80 pg/ml and is achieved after 1-2 hours (tmax). Bioavailability due to presystemic conjugation and the “first pass” effect is about 60%.

Distribution. Ethinyl estradiol almost completely binds to plasma proteins, mainly albumin, and activates SHBG in the blood serum. The expected volume of distribution of ethinyl estradiol is 5 L/kg.

Metabolism. Ethinyl estradiol undergoes presystemic conjugation in the mucous membrane of the small intestine and liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, but many other hydroxylated and methylated metabolites are also formed, which occur as free metabolites, as well as conjugated sulfates and glucuronides. The metabolic clearance rate is approximately 5 ml/min/kg.

Storage conditions

Store at a temperature not exceeding 30 °C. Keep out of the reach of children.

Package

21 (21x1) tablets in a blister, 1 (21x1) or 3 (21x3) blisters in a cardboard package.

The cardboard packaging contains a flat cardboard case for storing the blister.

Name:

Regulon

Pharmacological
action:

Monophasic oral contraceptive. Basics contraceptive effect consists of inhibiting the synthesis of gonadotropins and suppressing ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of sperm through the cervical canal slows down, and changes in the condition of the endometrium prevent the implantation of a fertilized egg.
Ethinyl estradiol is a synthetic analogue of endogenous estradiol.
Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity.
Regulon has a beneficial effect on lipid metabolism: increases the concentration of HDL in the blood plasma without affecting the content of LDL.
When taking the drug losses are significantly reduced menstrual blood (with initial menorrhagia), the menstrual cycle is normalized, a beneficial effect on skin, especially in the presence of acne vulgaris.

Indications for
application:

Contraception;
- treatment of menstrual disorders such as dysmenorrhea, PMS, dysfunctional uterine bleeding.

Mode of application:

The drug is prescribed orally: Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet/during 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.
First dose of the drug: The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills.
If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.
Taking the drug after childbirth: Women who are not breastfeeding can start taking the pill no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If there has already been sexual contact after childbirth, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then additional methods of contraception must be used in the first 7 days.
Taking the drug after an abortion: After an abortion, in the absence of contraindications, you should start taking pills from the first day after surgery, and in this case there is no need to use additional methods of contraception.
Switching from another oral contraceptive: When switching from another oral drug (21- or 28-day): it is recommended to take the first Regulon tablet the day after completing the course of the 28-day package of the drug. After completing the 21-day course, you must take the usual 7-day break and then start taking Regulon. There is no need to use additional methods of contraception.
Switching to Regulon after using oral hormonal drugs containing only progestogen ("mini-pills")
The first Regulon tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.
If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Regulon on any day of the cycle, but in this case, in the first 7 days it is necessary to use additional methods of contraception (using a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.
Delay of the menstrual cycle: If there is a need to delay menstruation, you must continue taking tablets from new packaging, without a 7-day break, by the usual scheme. When menstruation is delayed, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular use of Regulon can be resumed after the usual 7-day break.
Missed pills: If a woman forgot to take a pill on time, and no more than 12 hours have passed since the omission, she needs to take the forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking pills, this is considered a missed pill; the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.
If you miss one tablet in the first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.
If you miss a pill in the third week of the cycle, you should take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to minimum dose estrogen increases the risk of ovulation and/or spotting when missing a pill and therefore the use of additional methods of contraception is recommended.
Vomiting/diarrhea: If vomiting or diarrhea occurs after taking the drug, then absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take one more tablet. After this, you should continue taking the tablets as usual. If vomiting or diarrhea continues for more than 12 hours, then it is necessary to use additional methods of contraception during vomiting or diarrhea and for the next 7 days.

Side effects:

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.
From the senses: Hearing loss due to otosclerosis.
Others: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).
Other side effects, which are more common, but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.
From the reproductive system: acyclic bleeding/spotty discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.
From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.
Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma.
From the side of the central nervous system: headache, migraine, mood lability, depression.
From the side of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).
Metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.
Others: allergic reactions.

Contraindications:

The presence of severe and/or multiple risk factors for venous or arterial thrombosis(including severe arterial hypertension or medium degree severity with blood pressure ≥ 160/100 mm Hg);
- presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
- migraine with focal neurological symptoms, incl. in the anamnesis;
- venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
- a history of venous thromboembolism;
- diabetes mellitus (with angiopathy);
- pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
- dyslipidemia;
- serious illnesses liver, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
- jaundice when taking GCS;
- gallstone disease currently or in history;
- Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
- liver tumors (including in history);
- severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
- hormone dependent malignant neoplasms genitals and mammary glands (including if they are suspected);
- vaginal bleeding unknown etiology;
- smoking over the age of 35 (more than 15 cigarettes per day);
- pregnancy or suspicion of it;
- lactation period;
- increased sensitivity to the components of the drug.

Carefully the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valve defects heart, atrial fibrillation, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, the postpartum period, the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein deficiency C or S, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including .h. in the family history), acute and chronic liver diseases.

Interaction
other medicinal
by other means:

Medicines, liver enzyme inducing, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort preparations, reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks after discontinuation of the drug.
Ampicillin and tetracycline reduce the effectiveness of Regulon (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the entire course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.
Oral contraceptives

Storage conditions:

The drug should be stored out of the reach of children at a temperature of 15° to 30°C.
Best before date- 3 years.
Conditions for dispensing from pharmacies: The drug is dispensed on prescription.

Pills, covered film-coated, biconvex white or almost white, disc-shaped, marked “P8” on one side, “RG” on the other side.

1 tablet contains:
0.03 mg ethinyl estradiol and 0.15 mg desogestrel;
Excipients: alpha tocopherol, magnesium stearate, colloidal silica anhydrous, stearic acid, povidone, potato starch, lactose monohydrate;
shell: propylene glycol, macrogol 6000, hypromellose;
21 pcs in a blister, 1 or 3 blisters in a box.

Among the ways to prevent unplanned pregnancy, birth control pills are considered one of the most reliable. Contraceptive Regulon rightfully enjoys the trust of many gynecologists. The progestogens and estradiol included in the drug do not allow the egg to leave the follicle, which makes conception impossible. The instructions describe the dosage regimen.

Composition of Regulon

The drug is available in the form of biconvex tablets round shape, which are placed in 21 pieces in blisters (in a cardboard pack of 3 or 1 plate). The tablets are coated (film) and are white. Compound:

Pharmacodynamics and pharmacokinetics

Instructions for use of Regulon state that the drug belongs to the group of combined monophasic oral contraceptives and has an estrogen-progestogen contraceptive effect. The mechanism of its work is associated with the suppression by the active components of the synthesis of gonadotropins by the pituitary gland (follicle-stimulating hormone, luteinizing hormone).

This leads to difficulty in ovulation, increased density of cervical mucus, and prevention of sperm penetration into the internal space of the uterine body. Ethinyl estradiol is a synthetic analogue of estradiol produced in a woman’s body during her first menstruation. Desogestrel has pronounced antiestrogenic and gestagenic effects, equal to the properties of endogenous progesterone. This substance is weak in androgenic and anabolic activity.

For menorrhagia, taking the drug reduces blood loss during menstruation and improves skin condition, especially in the presence of acne vulgaris. Both active ingredients are quickly and completely absorbed digestive tract. Desogestrel is metabolized to form the active metabolite keto-desogestrel, reaching its maximum concentration after an hour and a half.

Ethinyl estradiol reaches maximum levels after 1–2 hours. Desogestrel has 62–81% bioavailability, for ethinyl estradiol this figure is 60%, which is associated with presystemic conjugation, the effect of the first passage through the liver. The half-life for desogestrel is 30 hours (metabolites are excreted in urine and feces in a ratio of 4:6), for ethinyl estradiol - a day (in the same ratio).

Indications for use

The main indication for the use of the drug is oral contraception(prevention of unplanned pregnancy). The drug has confirmed its effectiveness in a number of painful conditions that are the reason for its use:

• premenstrual syndrome;
• dysfunctional uterine bleeding;
• dysmenorrhea;
• pain in the lower abdomen during menstruation;
• excessive menstrual bleeding;
• dark discharge during the premenstrual period;
• dyspaurenia;
• soreness of the mammary glands;
• enhancing the effectiveness of endometriosis treatment;
• counteracting the development of tumors in uterine fibroids (effective at the stage when the tumor does not exceed 2 cm);
• support for resorption of ovarian retention cysts;
• Negative consequences abortion.

How to take Regulon

According to the instructions, the tablets are taken from the first day of the menstrual cycle at the same time every day for 21 days. After the last tablet, a one-week interval is maintained, during which the menstrual bleeding. On the eighth day, even if the bleeding has not stopped yet, you need to start the next cycle of 21 tablets. The use regimen is maintained as long as there is a need for contraception.

If you follow the instructions, then contraceptive effect remains even during seven day break. The first pill is taken on the first day of the menstrual cycle; there is no need for additional methods of contraception at this time. If use begins between 2-5 days of the cycle, then the first week you need to use barrier contraceptives(condoms). If your period started more than five days ago, it is better to take the pills from the next cycle.

Taking pills after childbirth

If a woman who has given birth is not breastfeeding, then 21 days after giving birth she can start taking pills after consultation with a gynecologist. There is no need to use condoms at this time. If there was sexual intercourse after childbirth, then the start of taking the medicine, according to the instructions, is postponed until the next menstrual cycle. If the drug is taken later than three weeks after birth, then additional protection must be used for the first 7 days.

Regulon after abortion

Regulon birth control pills are taken after an abortion on the first day, unless there are contraindications. There is no need to use other contraceptives. According to the instructions, the drug is prescribed after curettage for the purpose of restoration normal function ovaries and preventing the development of inflammatory complications (a third of women who undergo a repeat abortion experience them).

The medicine contains a highly active gestagenic component that does not cause side effects. It compensates for progesterone deficiency caused by abortion and the development of hormone-related proliferative processes in the organs of the reproductive system. These include mastopathy, polycystic ovary disease, hyperthecosis, tectal tissue hyperplasia, endometriosis, fibromyoma, endometrial hyperplasia.

Switching from other hormonal drugs

According to the instructions, when switching to Regulon from another hormonal drug, the first tablet is taken the next day after completing the package for 28 days. Additional contraception is not needed. When switching from a mini-pill, the tablet is taken on the first day of the cycle. If there was no menstruation during the use of the mini-pill, Regulon is taken on any day of the cycle after pregnancy has been ruled out. During the first week, you need to use additional protection (condoms, caps with spermicidal gel) or abstain. The calendar method of contraception does not work.

Delay of menstruation

Regulon can be used when there is a need to delay menstruation. To do this, according to the instructions, doses are taken without a seven-day break. With this option, a woman may experience breakthrough bleeding or spotting, which does not lead to a decrease in the effectiveness of the drug. After seven days of use, a new package begins. It is not recommended to repeat this regularly unless otherwise prescribed by your doctor.

Taking Regulon if you miss a pill

If up to 12 hours have passed since the pill was missed, take it immediately after remembering, then take it as standard. According to the instructions, if the missed interval is more than 12 hours, the reliability of the drug in the cycle is less than 100%, until next time use additional funds protection. If a dose is missed in the first 7-14 days of the cycle, then 2 pieces are taken the next day, then use is standard, accompanied by comprehensive protection.

If a medication is missed between days 14 and 21 of the cycle, use continues with the forgotten dose without a seven-day break. If missed, the risk of ovulation and the appearance of bloody vaginal discharge increases, which is associated with the presence of a minimum dose of estrogen in the composition. It requires the use of additional measures to protect against unwanted pregnancy.

special instructions

The instructions for use of Regulon talk about its special instructions:

1. If liver test results worsen while taking the medication, it should be discontinued.
2. During the first months of using Regulon, acyclic intermenstrual bleeding is possible. Their appearance is not a reason to stop therapy, but if they continue for more than three months, you should consult a doctor for examination.
3. It is recommended to stop smoking while taking the drug, as it increases the risk of thromboembolism.
4. If after taking the drug in the second cycle there are no periods, you should take a pregnancy test.
5. The teratogenic activity of Regulon has not been proven, therefore, if pregnancy occurs while taking the medication, the pregnancy is not interrupted.
6. While taking medication in female body changes characteristic of the first weeks of pregnancy are observed. You can take the pills for a long time.
7. When treated with medication, intermenstrual bleeding becomes scanty; this can be used in the treatment of endometriosis. Cancellation of Regulon leads to increased work of the ovaries, so against this background the abundance of menstruation may increase. If there are no periods after discontinuation, a failure of ovarian function can be suspected; it recovers on its own a month after the end of use.
8. Some women claim that taking hormonal drugs causes weight gain. This may occur because desogestrel retains fluid in the body. If you follow the rules of nutrition and daily routine, there will be no effect on weight. Sex hormones in the composition accelerate biochemical reactions lipids and carbohydrates. At a regular sufficient level physical activity calories are converted into energy, and in their absence they are deposited extra pounds on the body.
9. At correct intake means the probability of pregnancy is negligible, the effectiveness of Regulon is almost 100%. The risk of conception is high if you change the drug, skip pills, violate the dosage regimen, or neutralize the effect.

During pregnancy

If pregnancy occurs, a ban on taking Regulon is introduced. During breastfeeding, you cannot take the drug, otherwise you will need to switch to artificial feeding. This is due to the fact that the active components of the medication have a depressing effect on the baby’s growth and cause a decrease in the volume of breast milk. Regulon can be taken as a contraceptive for several years.

The pressing question is how taking it will affect the ability to get pregnant in the future and the functions of the reproductive system. Gynecologists indicate that if you follow the regimen prescribed by the doctor and the instructions, no problems with planning a pregnancy will arise. Standard term pregnancy is equal to six months after stopping the medication. For women who have planned a pregnancy, the instructions recommend stopping taking Regulon three months before conception.

Drug interactions

1. The effectiveness of the drug is leveled by Griseovulfine, Rifampicin, St. John's wort, Hydantoin, Topiramate, Carbamazepine, Primidone, barbiturates, Felbamate, Oxcarbazepine, α-tocopherol. They also increase the likelihood of breakthrough bleeding.
2. Combinations of tablets with antibiotics (Ampicillin, Tetracycline), antispasmodics, antidepressants, and laxatives can disrupt the menstrual cycle and reduce the contraceptive effect.
3. The combination of Regulon with anticoagulants is prescribed with caution due to possible increase prothrombin time.
4. The combination of tablets with hepatotoxic drugs is prohibited.
5. While taking Regulon, tolerance to carbohydrates decreases and the need for insulin and oral antidiabetic medications increases.

Side effects of Regulon

Taking Regulon carries a risk of side effects. The most undesirable and dangerous to health include the following:

• increased blood pressure (arterial hypertension);
• thromboembolism of arteries and veins (thrombosis in deep veins, myocardial infarction, stroke);
• thromboembolism of the circulatory system of the kidneys and liver;
• thromboembolism of mesenteric or retial arteries and veins;
• porphyrin disease;
• hearing loss due to otospongiosis;
• hemolytic-uremic syndrome;
• rheumatic chorea (disappearing after stopping the drug);
• exacerbation of lupus erythematosus.

There is a list with less dangerous side effects problems that occur when taking Regulon:

• amenorrhea (occurs after stopping the pills);
• acyclic bleeding;
• bloody vaginal discharge;
• soreness of the mammary glands against the background of their enlargement and tension;
• nausea and vomiting;
• angiopathy;
• change in the density of cervical discharge;
• galactorrhea;
• cholelithiasis;
• chloasma;
• the appearance of inflammation in the vagina;
• the appearance or exacerbation of jaundice and itching due to cholestasis;
• exudative or erythema nodosum;
• thrush;
• Crohn's disease;
• migraine;
• skin rash;
• carbohydrate rejection;
• change in emotional mood;
• depression;
• fluid retention in the body;
• increased sensitivity of the cornea;
• weight gain.

Overdose

The drug does not have a specially developed antidote, so counteracting an overdose is based on eliminating negative symptoms. At very high doses - gastric lavage, which is recommended to be carried out immediately, and intake of absorbents. Overdose symptoms are as follows:

• cramps of the calf muscles;
• dyspepsia;
• vomit;
• adenomyosis;
• hepatosis;
• nausea;
• bloody vaginal manifestations, pain in the intestines;
• Strong headache.

Contraindications

The peculiarities of Regulon's effect on the body determine the presence of a list of contraindications. To take pills this is:

• severe disorders liver;
• pregnancy;
• breast-feeding;
• familial types of hyperlipidemia;
• thromboembolism and thrombosis, as well as the risk of their development;
• history of pregnancy jaundice;
• benign hyperbilirubinemia;
• moderate and severe forms of arterial hypertension;
• herpes type 2;
• pregnancy diabetes;
• migraine;
• severe itching and otospongiosis caused by previous pregnancy or treatment with glucocorticosteroids;
• vaginal bleeding of unknown nature;
• identified estrogen-dependent tumors or suspicion of their presence;
• severe stage of diabetes mellitus;
• hemocoagulation dysfunction.

Terms of sale and storage

Regulon is sold in pharmacies with a doctor's prescription. Storage is carried out out of reach of children at a temperature of 15-30 degrees Celsius. Shelf life – 3 years.

Analogs

You can choose other hormonal contraceptives to replace the drug. These include:

• Marvelon - tablets based on desogestrel, ethinyl estradiol;
• Novinet - contraceptives with the same composition as the analogue;
• Belara - tablets containing ethinyl estradiol, chlormadinone;
• Janine - monophasic tablets based on dienogest, ethinyl estradiol;
• Lindinette - tablets containing gestodene, ethinyl estradiol;
• Femoden is a pill containing gestodene and ethinyl estradiol.

Regulon price

The medicine Regulon is a drug sold online and in pharmacies at a cost depending on the number of tablets in the pack and pricing policy. Approximate Moscow prices.

White or almost white, round, biconvex, film-coated tablets (marked “P8” on one side and “RG” on the other). 1 tablet contains ethinyl estradiol 30 mcg, desogestrel 150 mcg. Excipients: α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate. There are 21 pieces in a currency box, 1 or 3 coins in a box.

Pharmacological action

Monophasic oral contraceptive. The main contraceptive effect is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of sperm through the cervical canal slows down, and changes in the condition of the endometrium prevent the implantation of a fertilized egg. Ethinyl estradiol is a synthetic analogue of endogenous estradiol. Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, and weak androgenic and anabolic activity. Regulon has a beneficial effect on lipid metabolism: it increases the concentration of HDL in the blood plasma without affecting the content of LDL. When taking the drug, the loss of menstrual blood is significantly reduced (in case of initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.

Indications for use

• oral contraception;
• functional disorders of the menstrual cycle;
• premenstrual syndrome.

Directions for use and doses

The drug is prescribed orally. Taking pills starts on the 1st day of the menstrual cycle. Prescribe 1 tablet for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), resume taking the drug from the next package, also containing 21 tablets, even if the bleeding has not stopped. This pill regimen is followed as long as there is a need for contraception. If you follow the rules of administration, the contraceptive effect remains during the 7-day break.

Start taking the drug

• In the absence of previous use of hormonal contraceptives
  The first tablet should be taken on the first day of the menstrual cycle. In this case, it is not necessary to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, you must use additional methods of contraception in the first 7 days of taking the pills. If more than 5 days have passed since the start of menstruation, you should delay starting the drug until your next menstruation.
• Taking the drug after childbirth
  Women who are not breastfeeding can start taking the pill no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If there has already been sexual contact after childbirth, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then additional methods of contraception must be used in the first 7 days.
• Taking the drug after an abortion
  After an abortion, in the absence of contraindications, you should start taking pills from the first day after surgery, and in this case there is no need to use additional methods of contraception.
• Switching from another oral contraceptive
  When switching from another oral drug (21- or 28-day): it is recommended to take the first Regulon tablet the day after completing the course of the 28-day package of the drug. After completing the 21-day course, you must take the usual 7-day break and then start taking Regulon. There is no need to use additional methods of contraception.
• Switching to Regulon after using oral hormonal drugs containing only progestogen ("mini-pills")
  The first Regulon tablet should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception. If menstruation does not occur while taking the mini-pill, then after excluding pregnancy, you can start taking Regulon on any day of the cycle, but in this case, in the first 7 days it is necessary to use additional methods of contraception (using a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.

How to shift or delay the onset of menstrual bleeding

If there is a need to delay menstruation, you must continue taking the tablets from the new package, without a 7-day break, according to the usual regimen. When menstruation is delayed, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular use of Regulon can be resumed after the usual 7-day break.

If you miss pills

If a woman forgot to take the pill on time, and after missing it, no more than 12 hours, You need to take the forgotten pill, and then continue taking it at the usual time. If there is a gap between taking pills more than 12 hours - This is considered a missed pill; contraceptive reliability in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss one tablet per first or second week of the cycle, you must take 2 tablets the next day and then continue regular use, using additional methods of contraception until the end of the cycle.

If you miss a pill third week of the cycle you need to take the forgotten pill, continue taking it regularly and not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and/or spotting increases if you miss a pill and therefore the use of additional methods of contraception is recommended.

If vomiting or diarrhea occurs after taking the drug, then absorption of the drug may be inadequate. If the symptoms stop within 12 hours, then you need to take one more tablet. After this, you should continue taking the tablets as usual. If vomiting or diarrhea continues for more than 12 hours, then it is necessary to use additional methods of contraception during vomiting or diarrhea and for the next 7 days.

Side effect

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

Others: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects that are more common but less severe.

The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/spotty discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina, candidiasis, tension, pain, enlarged mammary glands, galactorrhea.

From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.

Dermatological reactions: Erythema nodosum, exudative erythema, rash, chloasma.

From the side of the central nervous system: headache, migraine, mood lability, depression.

From the side of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.

Others: allergic reactions.

Contraindications for use

• the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);
• presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, incl. in the anamnesis;
• venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
• a history of venous thromboembolism;
• diabetes mellitus (with angiopathy);
• pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking GCS;
• gallstone disease currently or in history;
• Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including history);
• severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
• hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);
• vaginal bleeding of unknown etiology;
• smoking over the age of 35 (more than 15 cigarettes per day);
• pregnancy or suspicion of it;
• lactation period;
• hypersensitivity to the components of the drug.

Carefully

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart defects, atrial fibrillation, prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, the postpartum period, the presence of severe depression (including a history), changes in biochemical parameters ( activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease , ulcerative colitis, sickle cell anemia, hypertriglyceridemia (incl. family history), acute and chronic liver diseases.

Use of Regulon during pregnancy and breastfeeding

The use of the drug during pregnancy and breastfeeding is contraindicated. During breastfeeding, it is necessary to resolve the issue of either discontinuing the drug or stopping breastfeeding.

Use for liver and kidney dysfunctions

• Contraindicated in liver failure.
• At renal failure(including history) the drug should be prescribed with caution and only after a thorough assessment of the benefits and risks of use.

special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) with correct use is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects their reception. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

• diseases of the hemostatic system;
• conditions/diseases predisposing to the development of cardiovascular and renal failure;
• epilepsy;
• migraine;
• the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
• diabetes mellitus not complicated by vascular disorders;
• severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);
• sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies).

Some researchers suggest that the likelihood of venous thromboembolic disease is greater with drugs containing desogestrel and gestodene (third generation drugs) than with drugs containing levonorgestrel (second generation drugs).

The incidence of spontaneous occurrence of new cases of venous thromboembolic disease in healthy non-pregnant women not taking oral contraceptives is about 5 cases per 100 thousand women per year. When using second generation drugs - 15 cases per 100 thousand women per year, and when using third generation drugs - 25 cases per 100 thousand women per year.

When using oral contraceptive drugs very rarely, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is observed.

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (heavy smoking and age over 35 years are risk factors);
• if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
• for obesity (body mass index more than 30 kg/m2);
• with dislipoproteinemia;
• with arterial hypertension;
• for diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus complicated by vascular lesions;
• with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of developing venous thromboembolic diseases.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, motor disorders, severe unilateral pain in the calf muscle, acute abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there was a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher incidence of breast cancer may have been associated with more regular use. medical examination. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sun rays or ultraviolet radiation while taking Regulon.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After suffering an acute viral hepatitis the drug should be taken after normalization of liver function (not earlier than 6 months).

For diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive a car or operate machinery.

Overdose

Symptoms: nausea, vomiting, and in girls - bleeding from the vagina.

Treatment: In the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

Drug interactions

Medicines that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, and St. John's wort preparations reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2-3 weeks, but can last up to 4 weeks after discontinuation of the drug.

Ampicillin and tetracycline reduce the effectiveness of Regulon (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the entire course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.