Instructions for use of regulon. Regulon - instructions for the use of birth control pills, composition, side effects, analogues and price

Name:

Regulon

Pharmacological
action:

Monophasic oral contraceptive. The main contraceptive effect is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, due to the increase in viscosity cervical mucus the movement of sperm through cervical canal, 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 disorders menstrual cycle 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 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, 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). Application calendar method in these cases it is not recommended.
Delay of the menstrual cycle: 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.
Missed pills: If a woman forgot to take a pill on time, and no more than 12 hours have passed since the omission, she should take 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 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.
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 pills in the usual way. 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 outside cordially- vascular system : arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis lower limbs, thromboembolism pulmonary artery); 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 inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.
From the outside digestive system : nausea, vomiting, Crohn's disease, ulcerative colitis, the 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 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);
- 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 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 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, valvular heart disease , atrial fibrillation, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, 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, incl. h. lupus anticoagulant), diabetes mellitus, uncomplicated vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic diseases liver.

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 necessary joint reception 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, 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.

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, pulmonary embolism).

• 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).
• Identified or suspected estrogen-dependent tumors (eg genital 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 in pregnant women, 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 begin on the first day of menstruation; in this case, there is no need 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, 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 using hormonal drugs containing only progestogen (mini-pill, injection or implant) or from an intrauterine system (IUD) that 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.

The use of the calendar method in these cases 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 should immediately take the 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 taken correctly within 7 days before the forgotten tablet, there is no need for additional contraceptive measures, but if more than 1 tablet is missed, an additional method of contraception should be used for 7 days.

week 3

Downside risk contraceptive action very large considering the proximity of the break in taking 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

• There is a known connection between the use of 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.

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

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

• Should be discussed with the patient possible increase risk of developing breast cancer 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. Women at risk of developing chloasma should avoid direct sun rays or ultraviolet radiation while taking pills.

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

systemic lupus erythematosus.

• Another 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 outside 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 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 outside 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; education 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 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 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 a large number of tablets are taken, 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 development estrogen-dependent tumors, estrogen-sensitive

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.

There has been a reported increased risk 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”).

Incidence of VTE in healthy people 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).

Unanimous opinion about a possible connection varicose veins veins and superficial thrombophlebitis no with VTE.

During the 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 associated with adverse reactions in the circulatory system include: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (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 this state 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 radiate into 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, movement disorders, severe unilateral pain in the calf muscle and a “sharp” abdomen.

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 obtained, oral contraceptives provide good protection from the development of both ovarian and endometrial cancer.

Some studies have reported an increased risk of cervical cancer in women who have taken hormonal contraceptives for a long time, but the results of the studies are very inconsistent. 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 the 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 who take COCs experience 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 achievements normal pressure with the help of antihypertensive therapy is possible, then 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. For patients with rare hereditary intolerance galactose, 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, you must carefully examine your family and personal history, conduct a physical and gynecological examination, including measuring blood pressure, 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, indicators of coagulation and hemostasis, 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. The following tablets 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, within the next 7 days you will need additional measures contraception.

• 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 that may reduce the contraceptive effect of Regulon tablets, an additional method of contraception should be used while taking this drug.

When taking Regulon tablets, you should not take herbal preparations containing St. John's wort (Hypericum perforatum) due to a possible decrease in concentration 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 is set for medicines, which 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 are receiving long-term treatment with drugs that induce liver enzymes. If a high dose of contraception is not recommended or if the high dose is insufficient or harmful, such as causing irregular bleeding, it is recommended to use another method of contraception.

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 contraceptives 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

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 the 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. When taken daily, 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 mucosa 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.

Among the variety of modern hormonal-based birth control pills, Regulon is distinguished. The components of the pill disrupt the production of gonadotropins. The viscosity of the mucus increases, the components prevent ovulation, and sperm lose the ability to penetrate the uterus.

The drug has an effect on the endometrium, preventing the implantation of a fertilized egg into the uterine mucosa. The use of a contraceptive drug not only protects against unwanted pregnancy, but also improve metabolic processes in a woman’s body.

Taking the Regulon tablet, strictly following the instructions, a woman improves her condition not only reproductive organs, but also metabolism in general. Lipid metabolism improves, lipoprotein concentration increases high level blood plasma density without affecting the state of low-density lipoproteins.

Contraception reduces blood loss during menstruation, normalizes the menstrual cycle, and gets rid of acne and rashes.

Before starting to use a contraceptive, a woman undergoes an examination by a gynecologist and a general check of the body. Special attention They analyze a cervical smear, mammary glands, and pelvic organs. The inspection is carried out every six months.

Composition and release form

Film-coated pills are packaged in 21 pieces in a blister pack. A cardboard box contains 1-3 blisters. The main components of the dragee:

• Ethinyl estradiol – 30 mcg;
• Desogestrel – 150 mcg.

Effect of the drug

The contraceptive belongs to the category of oral combined monophasic contraceptives. Inhibits the synthesis of gonadotropins, suppresses the ovulation process. When using Regulon, the viscosity of the cervical mucus increases, sperm lose the ability to fertilize the egg, and the endometrium, which has changed its structure, does not allow it to attach.

Purpose

The instructions for use state that the main purpose of the product is to protect against unwanted conception. Medical practice and patient reviews state that when taking the drug Regulon, the instructions do not tell about all possible positive effects.

Regular use of pills affects the condition and functioning of the reproductive organs. If a woman has dysfunctional uterine bleeding, suffers from pain during the premenstrual period. The pain that appears from time to time during menstruation in the lower abdomen goes away completely if one main rule of administration is followed - strictly following the instructions without skipping the use of the pills.

The discomfort and sensation of pain in the mammary glands disappears.

Women suffering from endometriosis are familiar with these pills and are often prescribed to improve their effectiveness in treating the disease. A well-known pathology, uterine fibroids, is treated in the early stages with the hormonal contraceptive Regulon. The tumor stops growing if its size does not exceed 20 mm. When an ovarian retention cyst occurs, the pills promote the resorption of the formations.

Women who have reached the age of 40 usually already have resolved issues regarding family and number of children, and therefore most doctors advise using hormonal contraceptives. Regulon prevents abortion, Negative consequences. Pregnancy at this age often ends in miscarriages, and pills allow you to avoid them and maintain good health.

Contraindications

• The presence of individual intolerance to the components in the composition of the contraceptive;
• Pregnancy of a woman;
• Breastfeeding period;
• Severe liver diseases;
• The presence of functional hyperbilirubinemia, including a form of pigmentary hepatosis that is inherited;
• Presence of jaundice;
• Familial form of hyperlipidemia;
• Persistent increase in blood pressure, severe form of arterial hypertension;
• Predisposition, severe symptoms of onset or presence of thrombosis, thromboembolism;
• If the patient suffers from herpes type 2;
• The appearance of bleeding from the vagina, the nature of which is unknown;
• Suspicion or presence of estrogen-dependent tumors;
• Diabetes;
• Migraine;
• If the hemocoagulation system is disrupted;
• Severe itching associated with pregnancy or use of glucocorticosteroids.

Side effects

The drug is discontinued in cases where at least one of the following side effects occurs:

• The appearance of arterial hypertension;
• If thromboembolism of veins or arteries occurs, taking into account deep veins, strokes, myocardial infarctions, etc.;
• The occurrence of thromboembolism of arteries and veins in the kidneys and liver;
• Deterioration or loss of hearing caused by otospongiosis;
• The appearance of porphyrin disease;
• The occurrence of hemolytic-uremic syndrome;
• If the course of a disease called reactive systemic lupus erythematosus worsens;

Less dangerous side effects:

• Cervical fluid, mucus in the vagina, has changed condition;
• The occurrence of heavy bleeding, bleeding from the vagina, not related to the menstrual cycle;
• The mammary glands are enlarged, cause discomfort, and pain is felt;
• Inflammatory processes began in the vagina;
• A woman discovers the appearance of thrush;

• A feeling of nausea appears, the woman vomits;
• Jaundice and itching associated with cholestasis develop or worsen;
• Crohn's disease;
• Headaches appear;
• Mood changes quickly, depression appears;
• The cornea of ​​the eyes becomes more sensitive;
• Carbon tolerance decreases;
• A rash appears;
• Body weight gradually increases;
• Liquid is poorly removed from the body;
• Allergic reactions occur.

Admission rules

The drug is used from the first day of the onset of menstruation, swallowing one tablet every day at the same time. Use contraceptives for 21 days without skipping.

Upon completion of using the package, take a week off so that bleeding, similar to menstruation, passes within a seven-day period. On the 8th day after the final pill taken, even with still ongoing bloody discharge, open a new blister pack and take the tablet at the same time as before.

While the woman needs the contraceptive effect, the pills are taken. When taking the pills in accordance with the instructions given in the manual, Regulon has a protective effect against unwanted conception even during a week's rest period.

The dose is taken on the first day of the cycle; there is no need for additional protective drugs. When the reception begins on days 2-5, then during the first seven days of use other barrier-type agents are used additionally, for example, condoms. If more than 5 days have passed since the start of menstruation, then the drug begins to be used from the next cycle.

Reception after birth

If a young mother does not feed her baby breast milk, then after 3 weeks you can start using the pills, but it is strictly forbidden to start taking them without consultation and examination with a gynecologist. There is no need to use other types of contraceptives.

In a situation where a woman has had sex after giving birth, the pills begin to be taken from the next cycle. When starting to use Regulon after more than 21 days, condoms are additionally used for the first week.

If there was an abortion

When the doctor, after examining the patient, does not find any contraindications, the pills can be taken from the first day after the abortion. No additional contraception is needed. In case of curettage, Regulon is often prescribed.

The essence of using the drug after curettage, abortion, or if there was a frozen pregnancy is to start the process of restoring ovarian function, their full functioning, to avoid the appearance of pathologies, inflammatory processes, which, according to statistics, appear in every third girl after the 2nd abortion .

The lack of progesterone is compensated by hormonal agents. Proliferative processes in the organ system responsible for reproductive function. The list consists of theca tissue hyperplasia, polycystic ovary syndrome, mastopathy, endometriosis, endometrial hyperplasia, fibroids, adenomyosis and others.

How to switch to Regulon

The transition from one type of contraceptive pill to another is carried out according to the scheme of using the first pill of a new type on the next day of the completed course of the previous pills. The first day after 28 days of use (three weeks of use and a week of rest) is the countdown for the course of taking Regulon. There is no need to use other contraceptives.

When a woman switches from a single-component mini-pill, the pill is swallowed on the first day of the cycle. If there is no bleeding during the use of the mini-pill, the new drug can be started any day if the girl does not become pregnant. During the initial week, it is advisable to use secondary contraceptive drugs: condoms, caps with spermicide, or abstain from sex; the calendar method does not work.

Changing the time of your period

If the days of menstruation change, the tablets are taken without a break for a week, this period there is a high probability of breakthrough type menstrual bleeding, staining type, which does not reduce the protective effect.

Skipping funds

A woman who has forgotten about the pill has missed a dose; she uses the pill as soon as she remembers it, if no more than 12 hours have passed since the scheduled dose. Nothing changes in the pattern of contraceptive use; they are used at the previously appointed hour.

If a pill is missed, more than 12 hours have passed since the prescribed time of use, then the effectiveness of protection may noticeably decrease; doctors recommend using secondary types of contraception before the start of a new cycle.

If a girl missed 1 pill in the first week or two, then she takes 2 pills the next day, then the course is carried out according to the usual regimen, but with other contraceptives. A pill missed between the 2nd and 3rd week is continued with the consumption of the missed pill and without a week's break.

Symptoms of overdose

• The woman becomes depressed;
• Experiences a feeling of nausea, vomiting;
• A severe headache appears;
• IN calf muscles spasm occurs from time to time;
• There is bloody discharge that is not related to menstruation.

Regulon - instructions for the drug, you can read the contraindications, indications for use, dosage of the drug Regulon. Useful reviews o Regulon -

Monophasic hormonal contraceptive drug for oral administration.
Drug: REGULON
Active substance of the drug: desogestrel, ethinylestradiol
ATX coding: G03AA09
KFG: Monophasic oral contraceptive
Registration number: P No. 015054/01-2003
Registration date: 06/18/03
Owner reg. cert.: GEDEON RICHTER Ltd. (Hungary)

White or almost white, film-coated tablets, biconvex, disc-shaped, marked “P8” on one side and “RG” on the other side.
1 tab.
ethinylestradiol
30 mcg
desogestrel
150 mcg

Excipients: -tocopherol, magnesium stearate, colloidal anhydrous silicon, stearic acid, povidone, potato starch, lactose monohydrate.

Shell composition: propylene glycol, macrogol 6000, hypromellose.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Regulon

A monophasic hormonal contraceptive for oral administration containing a combination of estrogen (ethinyl estradiol) and a progestin (desogestrel). Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system.

Desogestrel is a synthetic gestagen that, when taken orally, inhibits the synthesis of LH and FSH in the pituitary gland and, by preventing follicle maturation, effectively blocks ovulation. It has an antiestrogenic, weak androgenic (anabolic) effect, and does not have an estrogenic effect.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, involved together with the hormone corpus luteum in the formation of the menstrual cycle. Prevents the maturation of an egg capable of fertilization.

The contraceptive effect is due, on the one hand, to a decrease in the susceptibility of the endometrium to the blastocyte, and on the other hand, to an increase in the viscosity of mucus in the cervix, which prevents the advancement of sperm.

The drug has a beneficial effect on lipid metabolism: it increases the HDL content in plasma without affecting the LDL content.

When taking the drug, the loss of menstrual blood is significantly reduced. Regular use of the drug normalizes the menstrual cycle, helps prevent the development of a number of gynecological diseases, incl. oncological

It has a beneficial effect on the skin, significantly improves the condition of the skin with acne vulgaris.

Pharmacokinetics of the drug.

Desogestrel

Suction

Desogestrel is quickly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized in the liver and intestinal wall into 3-keto-desogestrel, which is a biologically active metabolite of desogestrel.

Cmax is reached after 1.5 hours and is 2 ng/ml. Bioavailability - 62-81%.

Distribution

3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone binding globulin (SHBG). Vd is 5 l/kg. Css is established by the second half of the menstrual cycle. The level of 3-keto-desogestrel increases 2-3 times.

Metabolism

The products of further metabolism of ketodesogestrel are pharmacologically inactive; some of them are converted by conjugation into polar metabolites, primarily sulfates and glucuronides.

Removal

T1/2 is 38 hours. Metabolites are eliminated in the urine and feces (in a ratio of 6:4).

Ethinyl estradiol

Suction

Ethinyl estradiol is quickly and completely absorbed from the gastrointestinal tract. Cmax is reached 1-2 hours after taking the drug and is 80 pg/ml. The bioavailability of the drug due to presystemic conjugation and the “first pass” effect through the liver is about 60%.

Distribution

Ethinyl estradiol is completely bound to plasma proteins, mainly albumin.

Vd is 5 l/kg. Css is established by the 3-4th day of administration, while the level of ethinyl estradiol in the serum is 30-40% higher than after a single dose of the drug.

Metabolism

Presystemic conjugation of ethinyl estradiol is significant. Bypassing the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinyl estradiol and its conjugates of the first phase of metabolism (sulfates and glucuronides) are excreted into bile and enter the enterohepatic circulation. Clearance from blood plasma is about 5 ml/min/kg body weight.

Removal

T1/2 of ethinyl estradiol averages about 26 hours. About 40% is excreted in the urine and about 60% in feces.

Indications for use:

Oral contraception.

Dosage and method of administration of the drug.

The drug is prescribed 1 tablet/day (if possible at the same time), starting from the 1st day of the menstrual cycle for 21 days. This is followed by a 7-day break, during which menstrual-like bleeding occurs. Then the pills from the next pack are resumed (even if the bleeding has not stopped yet). If the rules of administration are followed, the contraceptive effect remains during the 7-day break.

If the first tablet is taken on day 1 of the menstrual cycle, then additional methods of contraception are not required. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle, 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.

After childbirth, non-breastfeeding women can be prescribed the drug after 21 days. In this case, there is no need to use other methods of contraception. If the drug is prescribed later than 21 days after birth, then additional methods of contraception must be used in the first 7 days of administration. If in postpartum period sexual contact preceded oral contraception, then you need to wait until your first menstruation to take the pills. In women who continue breastfeeding, the use of combined oral contraceptives is not recommended, as taking the drug may reduce milk production.

When switching to Regulon after taking another estrogen-progestin hormonal contraceptive, the first Regulon tablet should be taken the day after completing the course of the previous drug. There is no need to use additional methods of contraception.

When switching to Regulon after taking another hormonal contraceptive containing only gestagen, the first Regulon tablet should be taken on the first day of the menstrual cycle; there is no need to use additional methods of contraception. If menstruation does not occur while taking the previous drug, you can start taking Regulon on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days of use.

As additional methods of contraception, it is recommended to use a cervical cap with spermicidal gel, a condom, or abstain from sexual intercourse. The use of the calendar method as an additional method of contraception is not recommended.

If it is necessary to delay menstruation, taking the pills should be continued without a 7-day break. In this case, intermenstrual bleeding may appear, 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 a dose of the drug, if the delay in taking the tablet is no more than 12 hours, then you need to take the missed tablet and then continue taking it at the usual time. If the delay in taking the pill is more than 12 hours, this is considered a missed pill. The reliability of contraception during this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss 1 tab. in the first or second week of the cycle you need to 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 1 tab. in the third week of the cycle, in addition to the listed measures, a 7-day break is excluded.

If vomiting or diarrhea occurs after taking the drug, absorption of the drug may be incomplete. If the symptoms stop within 12 hours, then you need to take 1 additional tablet. After this, you should continue taking the tablets as usual. If symptoms continue for more than 12 hours, then it is necessary to use additional methods of contraception in the next 7 days.

Side effects of Regulon:

Severe side effects, which are extremely rare, requiring discontinuation of the drug

From the cardiovascular system: myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism, arterial hypertension.

From the digestive system: cholestatic jaundice, cholelithiasis.

Other: exacerbation of systemic lupus erythematosus; in some cases - Sydenham's chorea, which disappears after discontinuation of the drug.

Other side effects that occur more often, but do not require discontinuation of the drug

From the reproductive system: intermenstrual bleeding, amenorrhea after discontinuation of the drug, changes in the nature of vaginal mucus, vaginal candidiasis, changes in the size of uterine fibroids, worsening of endometriosis, tension, pain, enlarged mammary glands, milk secretion, changes in libido.

From the digestive system: nausea, vomiting, gastralgia, hepatocellular adenoma.

Dermatological reactions: erythema nodosum, rash, generalized itching, chloasma (with long-term use).

From the central nervous system: headache, migraine, mood lability, depression, hearing loss.

From the organ of vision: swelling of the eyelids, conjunctivitis, blurred vision, flickering before the eyes, increased sensitivity of the cornea (when wearing contact lenses).

On the metabolic side: fluid retention in the body, changes in body weight, decreased tolerance to carbohydrates.

From the laboratory parameters: the estrogenic component of Regulon tablets can change some indicators of the function of the liver, kidneys, adrenal glands, thyroid gland, the level of blood coagulation factors and fibrinolysis, lipoproteins and transport proteins.

Contraindications to the drug:

Pregnancy or suspicion of it;

Arterial hypertension is severe or moderate;

Familial forms of hyperlipidemia;

Thromboembolism (including a history) or predisposition to it (myocardial infarction, cerebrovascular diseases (ischemic and hemorrhagic stroke), severe form of atherosclerosis);

IHD, decompensated heart defects, myocarditis;

Personal or family history of venous thromboembolism;

Diabetic angiopathy (including retinopathy);

Severe liver diseases (including a history): cholestatic jaundice, hepatitis (before normalization of laboratory parameters and in the first 6 months after their normalization), jaundice during pregnancy or while taking corticosteroids, Dubin-Johnson syndrome, Rotor syndrome, cholelithiasis disease, liver tumor, porphyria;

Estrogen-dependent tumors or suspicion of them: breast and endometrial cancer, endometrial hyperplasia, endometriosis, breast fibroadenoma;

Genital bleeding of unknown etiology;

Systemic lupus erythematosus (including history);

Genital herpes, pregnancy herpes;

Heavy itchy skin with a history of pregnancy;

Otosclerosis (aggravated during a previous pregnancy or while taking corticosteroids);

Hypersensitivity to the components of the drug.

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for diseases of the blood coagulation system, heart failure (including a history), renal failure (including a history), epilepsy, migraine, increased risk development of estrogen-dependent tumors, diabetes mellitus, sickle cell anemia (during infection or in a state of hypoxia, taking an estrogen-containing drug can trigger thromboembolism), with severe depression (including a history).

Use during pregnancy and lactation.

Regulon is contraindicated for use during pregnancy. Regulon should be stopped 3 months before the planned pregnancy. If pregnancy occurs, the drug should be discontinued.

Epidemiological studies have shown that among children, born by women who took hormonal contraceptives before pregnancy, the incidence of malformations does not increase. In cases of taking the drug in the early stages of pregnancy, no teratogenic effect was detected.

The use of Regulon is contraindicated during lactation ( breastfeeding), because it reduces the secretion of breast milk and changes its composition. Besides, active substances excreted in small quantities in breast milk.

Special instructions for use of Regulon.

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). A similar study during the period of taking the drug is carried out regularly, every 6 months.

The effectiveness of Regulon is reduced if pills are missed, with vomiting and diarrhea, as well as with simultaneous administration with other drugs.

The effectiveness of Regulon may decrease if intermenstrual bleeding appears after several months of its use. If menstrual-like bleeding does not appear during the break, taking the pills can be continued only after pregnancy has been ruled out.

The risk of arterial or venous thromboembolic diseases increases with age, with smoking, with a family history of thromboembolic diseases, with obesity (body mass index above 30 kg/m2), with dyslipoproteinemia, with arterial hypertension, with heart valve diseases, with atrial fibrillation , with diabetes mellitus, with prolonged immobilization (after major surgery, after surgery on the lower extremities, after severe trauma).

In the presence of congenital or acquired biochemical defects (resistance to activated protein C, hyperchromocysteinemia, deficiency of proteins C, S, deficiency of antithrombin III, the presence of antiphospholipid antibodies), the risk of developing thromboembolic diseases also increases. Targeted treatment of the above conditions reduces the risk of blood clots.

Pregnancy poses a greater risk of blood clots than taking hormonal contraceptives.

Regulon should be stopped immediately in the following cases:

New onset of severe headache or worsening of regular migraines;

Acute deterioration of visual acuity;

Suspicion of myocardial infarction or thrombosis;

A sharp increase in blood pressure;

The appearance of jaundice or hepatitis without jaundice, intense generalized itching;

The occurrence of epilepsy or increased frequency of epileptic seizures;

4 weeks before the planned surgical intervention and in case of prolonged immobilization (Regulon can be resumed after 2 weeks from the moment of remobilization);

Development of pregnancy.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Regulon on the abilities necessary to drive a car or operate machinery.

Drug overdose:

Symptoms: metrorrhagia. Taking the drug in high doses was not accompanied by the appearance of severe symptoms.

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

Interaction of Regulon with other drugs.

With simultaneous use of Regulon with antispasmodics, phenobarbital derivatives, antibiotics (tetracycline, ampicillin, rifampicin, isoniazid, neomycin, penicillin, chloramphenicol), carbamazepine, phenylbutazone, analgesics, anxiolytics, activated carbon, sulfonamides, nitrofurans, antimigraine drugs, griseofulvin, laxatives and some medicinal plants(for example, St. John's wort) it is possible to change the nature of menstruation and reduce the contraceptive effect of Regulon.

Regulon reduces effectiveness when used simultaneously oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, guanethidine, theophylline, caffeine, vitamins, clofibrate, glucocorticosteroids, paracetamol.

When Regulon is used simultaneously with oral hypoglycemic drugs or insulin, the control of carbohydrate metabolism may be impaired, because Regulon may reduce carbohydrate tolerance and increase the need for insulin or oral hypoglycemic agents, which may require dose adjustment.

Terms of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions for the drug Regulon.

The drug should be stored out of the reach of children at a temperature of 15° to 30°C. Shelf life - 3 years.

If you have any difficulties or problems, you can contact a certified specialist who will definitely help!

It is not surprising that in modern society hormonal contraception is a popular method of preventing highly unwanted and unplanned conceptions. One of the most prominent representatives of this pharmacological group is the drug "Regulon", the side effects of which have been reduced to a minimum by the well-known Hungarian pharmaceutical manufacturer.

Let us determine the mechanism of action of this contraceptive in the female body. First of all, it is necessary to clarify that it includes two such synthetic hormone, like desogestrel and ethinyl estradiol. The dynamics of the “protective” process consists in inhibiting the production of pituitary hormones due to an excess of female sex hormones. How to achieve this? With a deficiency of sex hormones, a huge number of pituitary hormones are produced, which, in turn, stimulate the production of female sex hormones, but with an excess, the production of similar ones is noticeably inhibited. Considering this pattern, we can safely say that regulon promotes an increased supply of sex hormones, as a result of which the number of pituitary hormones that stimulate their production is significantly reduced.

Moreover, very often medicinal purposes the drug "Regulon" is prescribed, side effects which is often not noticeable female body. So, in particular, it is recommended for normalizing the menstrual cycle, in the presence of periodic uterine hemorrhages, as well as in cases of pronounced dysmenorrhea. However, in this case, one should not forget that such treatment should be prescribed exclusively by a leading specialist; in addition, in each clinical case, an individual dosage of the drug “Regulon” is selected, the side effects of which are extremely undesirable for the sick organism.

The hormonal drug It is very convenient to use for contraception, because each blister contains 21 pills, one package contains as many as three blisters. To increase reliability, the space above each tablet is numbered, the arrow shows the direction, so it is almost impossible to get anything wrong when taking it.

However, it is important to remember that detailed instructions contains its own restrictions on use, and also informs about all possible side effects that may occur during the use of the drug "Regulon". Side effects rarely occur, but unfortunately they also occur in modern medical practice. Whether to stop taking a contraceptive or not depends entirely on the specifics and nature of the side effects.

Thus, in women, blood pressure may rise sharply, and myocardial infarction, thromboembolism, stroke, and blockage of the deep veins of the lower extremities are also possible. Also, such protection can significantly affect the functioning of the liver, provoking attacks and exacerbating jaundice. In such clinical situations, it is necessary to immediately stop taking it and consult a specialist to change the method of contraception or select another, more gentle medication of this pharmacological group.

But you should not stop taking Regulon if intermenstrual bleeding occurs, changes in the nature of vaginal mucus, sensations of pain and enlargement of the mammary glands. Also, do not panic too much if you have indigestion, nervous disorders, or changes in body weight. Such alarming symptoms are observed exclusively at the beginning of taking Regulon tablets; side effects disappear after the body adapts.

When deciding to plan a family, you shouldn’t worry either, since pregnancy after the regulon, or rather after its cancellation, will occur in a timely manner. One way or another, the drug really enjoys significant popularity among the majority modern women different age categories.