Regulon: instructions for use and what it is for, price, reviews, analogues. Regulon - instructions for use, analogs, testimonials and release forms (contraceptive pills) of a drug for contraception in women, including during pregnancy

Oral contraceptives in recent years are increasingly used by the fairer sex. Some women take pills to avoid unwanted pregnancies. Other ladies are forced to use hormonal drugs for treatment purposes. This article will tell you about the medicine with the trade name "Regulon". Analogues, instructions for use will be presented to your attention.

Description of the drug

Before you find out what analogues the drug "Regulon" has, it is worth saying a few words about the medication itself. The drug belongs to the group of monophasic hormonal contraceptives. It is created on the basis of a combination of estrogen and gestagen. These substances in the medicine are 0.03 and 0.15 mg, respectively.

The medicine is available in tablets, which are packed in blisters of 21 capsules. There may be one or three such records in a pack. The price of the drug will be 500 and 1,300 rubles, respectively.

"Regulon": similar drugs in composition

Currently, there are a wide variety of hormonal contraceptives for oral use. All of them differ in composition and appearance. If we talk about substitutes for Regulon tablets, then the following medicines can be distinguished:

• Mercilon.
• "News".
• Marvelon.
• "Munali" and so on.

It is worth noting that the described preparations may have a slightly different dosage of both active substances. However, they are absolutely identical and have the same method of application. The amount of both hormonal agents is selected depending on the age and clinical condition of the patient.

Other substitutes

It has the drug "Regulon" drugs similar in action, but at the same time they will have a different composition. These include Logest, Lindinet, Yarina, Rigevedon, Zhanin, Ovosept and so on. All of these drugs contain ethinylestradiol (estrogen). The second component is replaced by another.

Indirectly, other biphasic oral contraceptives can be attributed to analogues of the described drug. Such drugs must be taken strictly according to the specified scheme. These include tablets "Anteovin" and "Neo-eunomine". There are also three-phase preparations. They also have a similar effect, but have a different composition ("Trikvilar", "Triregol").

Indications for the use of tablets

The drug "Regulon" and its analogues are prescribed to women to protect against unwanted pregnancy. Taking the capsules regularly according to the indicated scheme, the fairer sex creates a blockage of the ovaries.

Medicines are also recommended for use by doctors during heavy menstruation, during hormonal failure, to restore the cycle. Compositions are taken with pronounced premenstrual syndromes. Often medicines are used to improve the condition of the skin.

Tablets "Regulon", analogues and substitutes for the drug are prescribed for certain gynecological diseases (endometriosis, uterine fibroids, ovarian cysts, and so on). It should be noted that the independent use of the described compositions is unacceptable.

Limitations and adverse reactions

The medicine "Regulon" (including analogues) should not be used in case of hypersensitivity to the components. With varicose veins or the presence of vein thrombosis, it is strictly forbidden to take pills. It is also not necessary to carry out a correction for severe liver damage, some diseases of the digestive system. During pregnancy and breastfeeding, Regulon tablets are prohibited. With extreme caution, the medication is prescribed to smoking women and the fairer sex after 35 years. With arterial hypertension, it is worth constantly monitoring your condition.

Among the side effects are allergic reactions, breakthrough bleeding. More often, the establishment of regular menstruation occurs from the second cycle of admission. If thrombosis occurs during therapy, there is an increase in pressure and blood sugar, then it is worth canceling the medication. Possible hearing loss, heart rhythm disturbance. There is a possibility of developing apathy, fatigue.

How to use

Medication "Regulon", monophasic analogues are taken one capsule per day. In this case, it is worth taking the medicine strictly at the same time. When used for contraception, the composition is taken from the first to the fifth day of the cycle. After finishing 21 tablets, take a week break.

In some situations, the medication is prescribed without interruption. This is usually necessary to create the illusion of an artificial menopause. Doctors use this tactic in the treatment of endometriosis, uterine fibroids and other diseases.

The regimen and duration of therapy are always set by the doctor after laboratory tests. I wish you success!

The hormonal drug Regulon is an oral medication aimed at preventing unwanted pregnancy. Tablets belong to the group of monophasic contraceptives. Regulon has established itself as one of the most popular medicines among combined oral contraceptives. Such popularity is primarily due to the high level of efficiency and ease of use. The drug does an excellent job not only with its main function - preventing unwanted conception, but also favors the formation of a more even menstrual cycle, and also reduces the intensity of pain caused by endometrial rejection.

Dosage form

The drug Regulon is a round biconvex tablet. They are film-coated and marked ("RG", "P8") on both sides of each tablet. The color of the drug is white or close to it.

Packs of Regulon tablets contain one or three blisters, 21 tablets each.

Description and composition

Among the active components in the composition of Regulon there are:

• 0.03 mg ethinyl estradiol;
• 0.15 mg desogestrel.

List of excipients:

• stearic acid;
• alpha-tocopherol;
• lactose monohydrate;
• povidone;
• magnesium stearate;
• potato starch;
• colloidal silicon dioxide.

The composition of the film shell includes three components, among them:

• macrogol 6000;
• hypromellose;
• propylene glycol.

Pharmacological group

Regulon is classified as a combined estrogen-gestagen-containing hormonal contraceptive, while at the same time ranking it as a group of monophasic contraceptives for oral use. The main contraceptive effect of the drug is the suppression of ovulatory processes, as well as inhibition of the synthesis of gonadotropins. Substances contained in Regulon make cervical mucus more viscous. In this regard, there is a slowdown in the movement of sperm cells through the canal in the cervix. And even in the case of fertilization, attachment of the egg to the endometrial layer becomes impossible due to changes in the endometrium caused by the action of the active components of the drug.

Ethinylestradiol, which is part of Regulon, is a synthetic analogue of endogenous estradiol. The second active ingredient, Desogestrel, has pronounced antiestrogenic and progestogenic effects.

Regulon is also characterized by a general positive effect on lipid metabolism, this is due to an increase in the amount of high density lipoproteins. At the same time, the concentration of low-density lipoprotein remains unchanged.

When using Regulon tablets by women with excessively heavy menstrual bleeding, a decrease in the total amount of blood released is observed. Another positive result of the use of the drug is the normalization of the menstrual cycle and improvement of the skin condition.

Indications for use

The drug Regulon has a certain list of indications for use, but none of them provides for the lack of consultation with a doctor before starting use. Take only after prescription by your doctor.

for adults

The tool is used for:

• preventing the occurrence of unwanted conception;
• normalization of a disrupted menstrual cycle;
• therapy;
• relief of painful periods.

for children

Acceptance of Regulon by children and adolescents is possible only after the onset of menarche.

The ability of the components of the drug to penetrate into breast milk causes a complete ban on the use of Regulon by women who are carrying a child or breastfeeding him.

Contraindications

The hormonal remedy Regulon has an impressive list of conditions and pathologies that act as contraindications for use. Among them:

• allergic reactions to the active components of the tablets;
• pregnancy, the period of breastfeeding a child;
• myocardial infarction;
• thrombosis;
• stroke;
• cancerous tumors in the uterus or mammary glands;
• pulmonary embolism;
• serious liver pathology;
• complicated diabetes;
• hypertonic disease;
• otosclerosis, manifested during a previous pregnancy;
• serious disorders of lipid metabolism;
• urolithiasis disease;
• nodular erythema.

Applications and doses

The drug is used in the absence of contraindications and after mandatory consultation with the attending physician.

for adults

Regulon should be taken orally for 21 days, one tablet each. The best solution is to take the remedy at the same time.

You should start taking it on the first day of your cycle. Then, within 21 days, a reception is carried out, after which a break in the use of the drug for seven days should be taken. During this period, there is bleeding similar to menstruation. After a seven-day break, the medication is resumed on day 21, even if bleeding is still ongoing. The scheme of application is absolutely the same for the entire further period while the woman needs protection from unwanted pregnancy. When taking the drug in accordance with all the rules, the contraceptive effect is maintained both during the 21-day intake of the drug and during the break.

You can also start drinking Regulon tablets from the 2nd to the 5th day of the cycle. This initiation option requires the use of barrier methods of contraception for the first seven days.

If a woman has given birth to a child, then after 21 days she can start taking Regulon. Prior consultation with a specialist is required. However, subject to the presence of sexual intercourse after childbirth, which occurred before the start of taking a combined oral contraceptive, it is necessary to postpone the start of use for one menstrual cycle. This is necessary in order to exclude the possibility of fertilization.

In the case of an abortion, the use of the drug should be started on the day of the operation. This does not apply to cases where there are contraindications.

When a woman switches to this drug from contraceptives that contain only progestogen, the Regulon tablet is taken on the first day of the cycle. Additional precautions are not required. However, in the absence of menstruation before the onset of pregnancy is excluded, the use of Regulon should not be started. After exclusion of pregnancy, it is possible to start taking pills, but for the first seven days it is necessary to use additional barrier contraceptives.

Tablets must be taken on time and not missed doses. If you still missed taking a contraceptive, then you need to take immediate action.

• You are less than twelve hours late in taking your medicine.

In this case, immediately take the tablet and continue using the drug according to the usual schedule.

• You are more than twelve hours late in taking your medicine.
  • This happened during the first or second week of the menstrual cycle.

Take two tablets at once and use barrier contraception until the end of the cycle.

• This happened on the third week of the cycle.

Continue to use as usual and after the end of the blister, start taking it without a break for seven days. There is a risk of conception. Use other methods of contraception.

If you experience stomach upset or upset after taking the tablet, you should take an additional tablet within the next 12 hours. If the symptoms do not disappear within the prescribed period, a seven-day additional protection is necessary.

for children

The use of funds by children is allowed only after the first menstruation. The choice of dosage and method of application is carried out by the doctor individually.

for pregnant women and during lactation

Taking Regulon during childbearing and lactation is not provided and is extremely dangerous for the health of the baby.

Side effects

The hormonal drug Regulon has a fairly extensive list of side effects. The occurrence of any of these symptoms requires immediate discontinuation of the use of the medication.

Gastrointestinal tract:

• feeling of nausea, urge to;
• liver dysfunction (rare).

reproductive system:

• bleeding between periods;
• denormalization of the vaginal microflora;
• discomfort in the mammary glands;
• decreased libido;
• uterine fibroids (rare).

Circulatory system:

• hypertension;
• thrombosis (very rare).

Nervous system:

• unstable mood;
• headache like migraine;
• depressive mood.

Endocrine system:

• weight gain.

Other side effects:

• skin rashes;
• erythema nodosum;
• discomfort in the eyes when wearing contact lenses;
• systemic lupus erythematosus.

Interaction with other drugs

The likelihood of bleeding becomes greater if you take drugs that induce liver enzymes at the same time. At the same time, the contraceptive effect of Regulon becomes less pronounced.

In patients with diabetic disease, Regulon is able to increase the need for substances that reduce blood sugar levels.

special instructions

The drug can be used after general medical and gynecological examinations. During the reception, it is necessary to carry out preventive examinations every six months. If you experience any side effects or complication of existing diseases, you should immediately contact a medical institution.

Requires discontinuation of the drug in case of surgery.

Regulon does not provide protection against the transmission of sexually transmitted infectious diseases, as well as HIV infection.

Overdose

An overdose of Regulon was observed extremely rarely in clinical practice. However, if you take a high dose of the drug, you may experience:

• severe pain in the head;
• difficult and painful digestion;
• cramps in the calf muscles.

If an overdose of this medication is detected, symptomatic treatment is carried out.

Analogues

Instead of Regulon, the following drugs can be used:

1. is a monophasic oral contraceptive with antiandrogenic properties. The drug contains dienogest and ethinylestradiol as active ingredients. It is produced in pills, which are recommended as a contraceptive.
2. is a substitute for Regulon in the clinical and pharmacological group. The drug is recommended as a means of preventing the onset of unwanted pregnancy. The contraceptive can be taken after the arrival of the first menstruation.

The cost of the drug is an average of 792 rubles. Prices range from 363 to 1500 rubles.

In this article, you can read the instructions for using the drug Regulon. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Regulon in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Regulon in the presence of existing structural analogues. Use for contraception in women, as well as during pregnancy and lactation. Side effects (bleeding, discharge) and contraindications to taking a contraceptive. Joint reception with alcohol, as well as other drugs.

Regulon- monophasic oral contraceptive. The main contraceptive action is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg. Composition of the drug: ethinylestradiol + desogestrel + excipients.

Ethinylestradiol is a synthetic analog of endogenous estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, 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 (with initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.

Pharmacokinetics

Desogestrel

Desogestrel is rapidly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized to 3-keto-desogestrel, which is the biologically active metabolite of desogestrel. Metabolites are excreted in the urine and feces (in a ratio of 4:6).

Ethinylestradiol

Ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. About 40% is excreted in the urine and about 60% in the feces.

Indications

• contraception.

Release form

Film-coated tablets.

Instructions for use and regimen

The drug is prescribed inside.

Reception of tablets is begun from the 1st day of a menstrual cycle. Assign 1 tablet per day for 21 days, if possible at the same time of day. After taking the last pill from the package, a 7-day break is taken, 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), the drug is resumed from the next package, also containing 21 tablets, even if the bleeding has not stopped. This scheme of taking pills is followed as long as there is a need for contraception. Subject to the rules of admission, the contraceptive effect persists for the duration of the 7-day break.

First dose of the drug

The first tablet should be taken from the first day of the menstrual cycle. In this case, you do not 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 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 postpone the start of taking the drug until the next menstruation.

Taking the drug after childbirth

Women who are not breastfeeding can start taking pills 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 after childbirth there was already sexual contact, 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 in the first 7 days it is necessary to use additional methods of contraception.

Taking the drug after an abortion

After an abortion, in the absence of contraindications, pills should be started from the first day after the operation, and in this case there is no need to use additional methods of contraception.

Switching from another oral contraceptive

When switching from another oral preparation (21- or 28-day): the first tablet of Regulon is recommended to be taken the next day after the completion of 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 progestogen-only oral hormonal preparations ("mini-pill")

The first tablet of Regulon 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 when taking the "mini-pill", then after the exclusion of pregnancy, 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 (use of 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.

Postponement of the menstrual cycle

If there is a need to delay menstruation, it is necessary to continue taking the tablets from the new package, without a 7-day break, according to the usual scheme. With a delay in menstruation, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular intake of Regulon can be restored after the usual 7-day break.

Missed pills

If a woman forgot to take a pill in a timely manner, and no more than 12 hours have passed after the missed one, you need to take the forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking the 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 one tablet is missed in the first or second week of the cycle, it is necessary to take 2 tablets the next day and then continue regular intake using additional methods of contraception until the end of the cycle.

If you miss a pill in the third week of the cycle, you must take the forgotten pill, continue to take it regularly and do 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 bleeding increases when a pill is missed, and therefore the use of additional methods of contraception is recommended.

Vomiting/diarrhea

If vomiting or diarrhea occurs after taking the drug, then the absorption of the drug may be defective. If the symptoms have stopped within 12 hours, then you need to take another tablet in addition. After that, you should continue taking the tablets in the usual way. If vomiting or diarrhea continues for more than 12 hours, then additional methods of contraception should be used during vomiting or diarrhea and for the next 7 days.

Side effect

• arterial hypertension;
• arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism);
• arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins;
• hearing loss due to otosclerosis;
• exacerbation of reactive systemic lupus erythematosus;
• acyclic bleeding and / or spotting from the vagina;
• amenorrhea after discontinuation of the drug;
• change in the state of vaginal mucus;
• development of inflammatory processes of the vagina;
• candidiasis;
• tension, pain, breast enlargement;
• nausea, vomiting;
• Crohn's disease;
• ulcerative colitis;
• erythema nodosum;
• exudative erythema;
• rash;
• headache;
• depression;
• increased sensitivity of the cornea (when wearing contact lenses);
• fluid retention in the body;
• change (increase) in body weight;
• allergic reactions.

Contraindications

• 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);
• the presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, incl. in history;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in history;
• the presence of venous thromboembolism in history;
• diabetes mellitus (with angiopathy);
• pancreatitis (including history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in history (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking GCS;
• cholelithiasis at present or in history;
• Gilbert's syndrome, Dubin-Johnson syndrome, Rotor's 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.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

During lactation, it is necessary to resolve the issue of either discontinuing the drug or stopping breastfeeding.

special instructions

Before starting the use of the drug, it is necessary to conduct a general medical (detailed family and personal history, measurement of blood pressure, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). A similar examination during the period of taking the drug is 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 for 1 year), when used correctly, is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. 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 state of health of women 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 hemostasis system;
• conditions/diseases predisposing to the development of cardiovascular, 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 to correct it);
• sickle cell anemia, tk. in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests for 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 disease has been proven, but it is significantly less than during pregnancy (60 cases per 100,000 pregnancies).

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

The frequency of spontaneous occurrence of new cases of venous thromboembolic disease in healthy non-pregnant women not taking oral contraceptives is about 5 cases per 100,000 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 contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of developing arterial or venous thromboembolic diseases increases:

• with age;
• when smoking (heavy smoking and age over 35 are risk factors);
• if there is a family history of thromboembolic diseases (for example, in parents, a brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
• with obesity (body mass index over 30 kg/m2);
• with dyslipoproteinemia;
• with arterial hypertension;
• in 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 a severe injury.

In these cases, a temporary discontinuation of the drug is expected (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

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

It should be borne in mind 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 borne in mind that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin 3, 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. The symptoms of thromboembolism are:

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that lasts 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 one side of the body, movement disorders, severe unilateral pain in the calf muscle, sharp abdomen.

Tumor diseases

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

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection of breast cancer could be associated with more regular medical examinations. 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 regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian and endometrial cancer).

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

Chloasma

Chloasma can develop in women who have a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with the sun's 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 of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that can 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 are finished in the next package. If at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets 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 parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

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

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking 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) and on the number of cigarettes smoked.

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

Influence on the ability to drive vehicles and control mechanisms

The drug does not affect the ability to drive a car and work with mechanisms.

drug interaction

Hepatic enzyme-inducing drugs such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually reached no earlier than 2-3 weeks, but may 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 course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

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

Ethanol (alcohol) does not affect the absorption or metabolism of Regulon. But like any hepatotoxic agent, it can cause an increase in the frequency of hepatic complications when taking Regulon together.

Regulon's analogues

Structural analogues for the active substance:

• Marvelon;
• Mercilon;
• Novinet;
• Tri Mercy.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

International name

Ethinylestradiol + Desogestrel (Ethinylestradiol + Desogestrel)

Group affiliation

contraceptive

Dosage form

Tablets, coated tablets

pharmachologic effect

contraceptive drug. Inhibits pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system. Ethinylestradiol is a synthetic analogue of the follicular hormone estradiol, which, together with the corpus luteum hormone, is involved in the implementation of the menstrual cycle. The progestogen drug (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland (preventing the maturation of the follicle), and thus. blocks ovulation. Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa.

It has a beneficial effect on lipid metabolism: it increases the concentration of HDL in plasma, without affecting the content of LDL. During treatment, there is a significant decrease in the amount of blood lost (with initial menorrhagia). It has a beneficial effect on the skin, especially improving its condition with acne vulgaris, with regular use it also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Indications

Contraception.

Contraindications

Hypersensitivity, pregnancy, liver failure, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), liver tumors (hemangioma, liver cancer), thromboembolism (including history and increased risk of its development), cerebrovascular accident (ischemic stroke, hemorrhagic stroke), ischemic heart disease, arterial hypertension (severe forms), atherosclerosis, decompensated heart defects, myocarditis, diabetes mellitus, retinopathy, angiopathy, sickle cell anemia, breast and endometrial cancer, endometrial hyperplasia, endometriosis, breast fibroadenoma, metrorrhagia (of unknown etiology), disorders of fat metabolism, jaundice or itching during a former pregnancy, otosclerosis with worsening during pregnancy, porphyria, smokers over 35 years of age.

Side effects

Headache, gastralgia, nausea, vomiting; soreness and engorgement of the mammary glands; weight gain, impaired glucose tolerance, fluid retention in the body, changes in libido, decreased mood, swelling of the eyelids, skin rash, erythema nodosum, conjunctivitis, discomfort when wearing contact lenses, impaired perception (impaired vision, hearing loss, flickering before the eyes ), thrombophlebitis, thromboembolism, generalized itching, cholestatic jaundice, cholelithiasis, increased blood pressure, intermenstrual bleeding, changes in vaginal secretion (possible development of vaginal candidiasis).

With prolonged use (extremely rare) - chloasma, hepatocellular adenoma.

Application and dosage

Inside, 1 tablet per day (starting no later than the 5th day of the cycle; 1st day of the cycle is the 1st day of menstruation) daily, at the same time, without interruption, for 21 days, then a break is taken for 7 days. In the first 14 days, additional contraceptive measures must be used.

If more than 5 days have passed since the onset of menstruation, then the pills are started from the next cycle. After childbirth, the drug should be started on the first day of the first independent menstruation. After a miscarriage or induced abortion, the drug must be taken immediately. The full contraceptive effect is maintained if the tablets are taken systematically (the maximum delay is no more than 12 hours). If more time has passed, then the next day at the usual time, you should take 2 tablets of the drug, but you must use additional contraception for the next 14 days or until the next menstruation.

special instructions

Before starting and every 6 months of using the drug, a general medical and gynecological examination is recommended (including gynecological control, examination of the mammary glands, liver function, control of blood pressure and cholesterol concentration in the blood, urinalysis). It is a reliable contraceptive drug: Pearl index (the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 1 year) - 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by day 14, it is recommended to additionally use non-hormonal methods of contraception in the first 2 weeks of treatment.

After acute viral hepatitis, it should be taken after normalization of liver function (not earlier than after 6 months). With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping 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) and on the number of cigarettes smoked. During lactation, the excretion of milk may decrease, in small quantities it is excreted in breast milk. Estrogen-containing drugs increase the risk of thrombosis in women undergoing surgery or prolonged immobilization. Women who have chloasma should avoid sun exposure.

Interaction

Rifampicin, isoniazid, ampicillin, neomycin, penicillins, tetracycline, chloramphenicol, griseofulvin, barbiturates, carbamazepine, activated charcoal, and laxative drugs reduce efficacy and contribute to breakthrough bleeding.

Reduces the effectiveness of oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate, corticosteroids.

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Compound

Active ingredients: 0.03 mg ethinylestradiol and 0.15 mg desogestrel per film-coated tablet
Tablet core: all-rac-a-tocopherol, magnesium stearate, anhydrous colloidal silicon dioxide, stearic acid, povidone K-30, potato starch, lactose monohydrate.
Sheath: propylene glycol, macrogol 6000, hypromellose.

Description

White or almost white, round, biconvex film-coated tablets, marked "P8" on one side, and"RG" - on the other side.

Indications for use

Regulon is an oral contraceptive preparation containing a synthetic follicular hormone and progesterone, which is used to prevent pregnancy. The effect of the drug is due to the suppression of ovulation.
The use of oral contraceptives has a number of advantages over other methods of contraception, which are listed below:
- It is a reliable method of contraception; after stopping the drug, you can become pregnant.
- Menstruation will become shorter and easier to bear.
- Menstrual pain may become less pronounced or disappear completely.
- Use of the drug may reduce the incidence of anemia (blood loss), pelvic organ infections, ectopic pregnancies (ectopic pregnancies), and some uterine, ovarian, and breast complications.
Regulon, like other hormonal contraceptives, does not protect you from HIV infection (AIDS) and other sexually transmitted diseases.

Contraindications

If you are allergic (hypersensitive) to the active ingredients (desogestrel or ethinyl estradiol) or any of the other ingredients of Regulon.
If you are pregnant or breastfeeding.
If you currently or at any time in the past have had any of the following conditions:
Myocardial infarction.
Stroke.
Thrombosis (formation of blood clots in the vessels).
Pulmonary embolism.
Malignant tumors of the mammary glands or uterus.
Vaginal bleeding of unknown origin.
Severe liver disease or liver tumor.
Hearing impairment (otosclerosis) that worsened during a previous pregnancy.
Severe disorders of fat metabolism.
Moderate or severe hypertension.
Severe forms of diabetes with complications.
Bile spillage or itching during a previous pregnancy or while taking another oral contraceptive drug.
In the case of hepatitis (inflammation of the liver caused by a virus), until the liver function tests return to normal values. An autoimmune disease that affects certain organ systems (erythema nodosum).
Gallbladder stones.

Pregnancy and lactation

Before you start taking Regulon, pregnancy must be excluded. If you become pregnant, you should stop taking Regulon immediately.
Since the active substance of the drug Regulon can penetrate into breast milk and lead to a decrease in the amount of milk, it is not recommended to use Regulon during breastfeeding.

Dosage and administration

One tablet should be taken every day, preferably at the same time, starting on the first day of the menstrual cycle, for 21 days. This is followed by a 7-day break during which no pills need to be taken and during which menstrual-like withdrawal bleeding occurs. The next series of 21 tablets should be started on the eighth day, even if the withdrawal bleeding has not ended.
Taking Regulon for the first time
. Wait until your period starts and use additional barrier methods of contraception (condom or birth control cap and spermicide). The first tablet should be taken on the first day of your period.
If you are already on your period, you can start taking the tablets from day 2 to day 5 of your cycle, whether or not the bleeding has stopped. In this case, use additional barrier methods of contraception for the first 7 days of the first pill cycle.
If menstruation began earlier than 5 days ago, you should wait until the first day of the next menstruation and use additional barrier methods of contraception. Start taking the tablets on the first day of your next period.
If You Want No Withdrawal Bleeding Next Cycle You may find yourself in a situation where you want no withdrawal bleeding, such as when you are planning to go on vacation, take an exam, or for some other reason. In this case, you should start taking the tablets from the next package of Regulon without taking a 7-day break. You can skip as many withdrawal bleeds as you like, however it is not recommended to skip more than 3 cycles in a row as this can lead to bleeding disorders (spotting or breakthrough bleeding).
Switching from another oral contraceptive to Regulon
You should stop taking the previous package of oral contraceptive drug. The first tablet of Regulon should be taken the next day, that is, without taking a 7-day break between packs of tablets, it is not necessary to wait for withdrawal bleeding. It is also not necessary to use additional barrier methods of contraception.
If you switch to Regulon from a minipill, the first Regulon tablet should be taken on the first day of your period. If your period has not started, you can start taking Regulon any day, but you should use additional barrier methods of contraception during the first 7 days of taking Regulon.
After childbirth
The use of the drug Regulon can be started on the 21-28th day after childbirth. If intercourse occurs during this period, additional barrier methods of contraception should be used, and you can start taking the pills with the onset of your first period. If you started taking the pill later than 3 weeks after giving birth, you must use additional barrier methods of contraception for the first 7 days.

Side effect

Like all medicines, Regulon can cause side effects, although not everyone experiences them.
When taking the drug Regulon, the following undesirable effects may occur more often than usual:
. Genital organs - bleeding between periods, absence or decrease in the usual amount of menstrual bleeding after taking the drug, change in the nature of vaginal discharge, increase in the size of uterine fibroids (benign uterine tumor), worsening of endometriosis (abnormal thickening of the inner lining of the uterus) and certain vaginal infections, for example , thrush (candidiasis).
Mammary glands: tenderness, soreness, enlargement, discharge.
Gastrointestinal tract: nausea, vomiting (xc lelitiasis),
yellowing of the skin (cholestatic jaundice).
Skin: rash, yellowish brown spots
Eyes: Discomfort when wearing contact lenses.
Central nervous system: headache, migraine, mood changes, depression. metabolic
changes: glucose tolerance.
fluid retention, changes in body weight, decreased
Rare adverse events: Symptoms due to otosclerosis (ossification
labyrinth of the inner ear), such as tinnitus, dizziness, hearing loss; thrombosis (formation of blood clots in the vessels); embolism (blockage of a blood vessel).
Yellowish-brown spots on the skin (chloasma) sometimes appear, especially in women with a history of chloasma during pregnancy. Women with a tendency to develop chloasma should refrain from sunbathing and avoid exposure to ultraviolet rays while taking contraceptives.
In the first few months of taking the pills, there may be irregularities in menstrual bleeding, such as irregular bleeding, bleeding between two withdrawal bleeds, which may be heavy (breakthrough bleeding) or light (spotting), or withdrawal bleeding may not start at the scheduled time. These fluctuations do not mean that the drug is not suitable for you. However, if necessary, you can discuss this with your healthcare provider.

System organ class	Very common >1/10 (occurs in more than 10 out of 100 patients)	Frequent >1/100 to<1/10 (наблюдается у 1-10 из 100 пациентов)	Uncommon >1/1,000 to<1/100 (наблюдается у 1-10 из 1,000 пациентов)	Rare >1/10,000 up to<1/1,000 (наблюдается у 1-10 из 10,000 пациентов)	Very rare<1/10,000 (наблюдается менее, чем у 1 из 10,000 пациентов)
Psychiatric violations		Depression, changeable mood, decline libido
Nervous System Disorders		Migraine Headache Nervousness Dizziness
Hearing and balance disorders				Symptoms caused by otosclerosis (ossification of the labyrinth of the inner ear), such as ringing in the ears, dizziness, hearing loss
Vascular disorders			High arterial pressure	Thrombosis (education blood clots in vessels) Embolism (blockage circulatory vessel)

				AGREED MINISTKRP’VPM YTTVLPLO-^PLirmmn
Gastrointestinal disorders		Nausea Vomit		REPMing Rwe's Order	UBLIKI BELARUSAdrpvoohra hysteria*1 audience Belarus	eniya
Skin and subcutaneous tissue disorders		acne, rash
Genital and breast disorders	Breakthrough bleeding, smearing allocation	painful menses. Absence normal menstrual period foot bleeding. engorgement dairy glands, especially in early menses.
Are common disorders and disorders at the injection site	Increase weight

If any of the side effects become serious, or if you notice an side effect that is not listed in this package leaflet, please tell your doctor.
If you smoke, you should tell your doctor about it, as smoking increases the risk of developing thrombotic diseases, especially in women over 35 years of age.
You should stop taking Regulon immediately and contact your healthcare provider if you experience any of the following signs or symptoms:
If you notice possible signs of thrombosis, such as sudden severe chest pain that may spread to the left arm, unusually severe pain in the legs, weakness or numbness in any part of the body, shortness of breath, unusual cough, especially with hemoptysis, dizziness or fainting, visual impairment, hearing or speech impairment, migraine that started for the first time, or migraine worsening.
If you develop jaundice (yellowing of the skin).
If your blood pressure rises while taking Regulon, stop taking the drug.
In case of acute or chronic liver disease, the use of combined oral contraceptives should be discontinued until the results of the analysis of liver function tests return to normal values.
In case of violation of fat metabolism.
If you feel a lump in your chest.
If you feel a sudden sharp pain in your lower abdomen or stomach.
If you have unusual, heavy bleeding from your vagina, or if your period
did not start twice in a row.
In case of prolonged bed rest or 4 weeks before a planned operation.
If pregnancy is suspected.
In case of acute or chronic liver disease, the use of the drug
should be discontinued until liver function test results return to normal. If you are taking medicines that may reduce the contraceptive effectiveness of Regulon, you should additionally use a barrier method of contraception while taking another medicine.
If you have diabetes, you may need to increase your dose of insulin or an antidiabetic drug.

Precautionary measures

If you forget to take your pill on time
Do not stop taking the tablets for more than 7 days.
If you forget to take a tablet at the usual time, you should take it within 12 hours. The next tablet should be taken at the usual time. In this case, additional barrier methods of contraception are not required.
If you forget to take one or more tablets and do not take them within 12 hours, the contraceptive effect may decrease. It is recommended that you take the last missed tablet as soon as you remember it, even if it means that you have to take two tablets on the same day and then take the tablets as usual. In this case, you must use additional barrier methods of contraception for the next 7 days.
If you decide to stop taking Regulon
If you stop taking Regulon tablets before the end of the package, the contraceptive effect may not be complete, so it is recommended to use additional barrier methods of contraception.
If you have any questions about taking this drug, ask your doctor.
What to do if you have vomiting or diarrhea
If you have an upset stomach and intestines, accompanied by vomiting and diarrhea, the reliability of the contraceptive effect of the drug Regulon may decrease. If the symptoms of the disorder disappear within 12 hours, take an additional tablet from the spare pack and continue taking the remaining tablets at the usual time. If the symptoms of the disorder persist for more than 12 hours, use additional barrier methods of contraception while you are suffering from a gastrointestinal disorder and for the next 7 days.

Best before date

Do not use Regulon after the expiry date which is stated on the package. The expiration date refers to the last day of the month.