Regulon: instructions for use

Structure

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

Description

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

Indications for use

Regulon is an oral contraceptive preparation containing 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 drugs for oral contraception has several advantages over other methods of contraception, which are listed below:
  - It reliable method   contraception after discontinuation of the drug, you can become pregnant.
  - Menses will become shorter and easier to carry.
  - Menstrual pain may become less pronounced or completely disappear.
  - The use of the drug can reduce the incidence of anemia (blood loss), pelvic infections, ectopic pregnancy (ectopic pregnancies) and some complications from the uterus, ovaries and mammary glands.
  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 active substances (desogestrel or ethinyl estradiol) or any other components of the drug Regulon.
   If you are pregnant or breastfeeding.
   If in this moment   or have you ever had the following illnesses in the past:
  Myocardial infarction.
  Stroke.
  Thrombosis (the formation of blood clots in blood vessels).
  Pulmonary embolism.
  Malignant tumors of the mammary glands or uterus.
  Vaginal bleeding of unknown origin.
  Severe liver disease or swelling of the liver.
  Hearing impairment (otosclerosis), which worsened during a previous pregnancy.
  Severe impairment of fat metabolism.
  Moderate or severe hypertension.
  Severe diabetes with complications.
  Spillage of bile or itching during a previous pregnancy or while taking another oral contraceptive.
  In the case of hepatitis (inflammation of the liver caused by a virus), before the restoration of the functional tests of the liver to normal values. An autoimmune disease that affects certain organ systems (erythema nodosum).
  Gall bladder stones.

Pregnancy and lactation

Before taking Regulon, pregnancy must be excluded. If you have become pregnant, you should immediately stop taking Regulon.
  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.

Self-medication can be harmful to your health.
It is necessary to consult a doctor, as well as read the instructions before use.

Film-coated tablets of white or almost white color, round, biconvex, (marked "P8" on one side and "RG" on the other). 1 tablet contains ethinyl estradiol 30 mcg, desogestrel 150 mcg. Excipients: α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate. There are 21 pcs in the convolute, 1 or 3 convolutes in the box.

Pharmacological action

Monophasic oral contraceptive. The main contraceptive effect is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity cervical mucus   sperm movement through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg. Ethinyl estradiol is a synthetic analogue of endogenous estradiol. Desogestrel has a pronounced progestogen 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 plasma, without affecting the content of LDL. When taking the drug, the loss of menstrual blood is significantly reduced (with the initial menorrhagia), the menstrual cycle is normalized, a beneficial effect on skin integument, especially in the presence of acne vulgaris.

Indications for use

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

Dosage and administration

The drug is prescribed orally. Taking pills begins on the 1st day of the menstrual cycle. Assign 1 tablet 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 bleeding occurs due to drug withdrawal. The 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. Such a pill regimen is adhered to as long as there is a need for contraception. Subject to the rules of admission, contraceptive effect   persists for the duration of the 7-day break.

The start of the drug

• In the absence of prior use hormonal contraceptives
  The first pill should be taken on 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 2nd to 5th day of menstruation, but in this case, additional methods of contraception should be used in the first 7 days of taking the tablets. If more than 5 days have passed since the onset of menstruation, you should delay the start of taking the drug until the next menstruation.
• Taking the drug after childbirth
    Non-breastfeeding women can start taking pills no earlier than 21 days after birth, after consulting with a doctor. In this case, there is no need to use other methods of contraception. If there was already sexual contact after childbirth, then taking the tablets should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after the 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, the start of taking the pills should be 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 drug (21- or 28-day): it is recommended to take the first pill of Regulon the day after the completion of the course of 28-day packaging of the drug. After completing the 21-day course, you must take the usual 7-day break and then proceed with taking Regulon. There is no need to use additional methods of contraception.
• Transition to Regulon after using oral hormonal drugscontaining only progestogen ("mini-drank")
    The first pill 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 "mini-drank", then after excluding pregnancy, you can start taking Regulon on any day of the cycle, but in this case, additional contraceptive methods (using a cervical cap with spermicidal gel, a condom, or abstinence should be used in the first 7 days) from sex). Application calendar method   in these cases is not recommended.

How to move or delay the onset of menstrual bleeding

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

In case of missing tablets

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

When skipping pills on third week of the cycle   you need to take a forgotten pill, continue regular intake 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 when you miss a pill and therefore it is recommended that you use additional methods of contraception.

If vomiting or diarrhea appears after taking the drug, then absorption of the drug may be inferior. If the symptoms stopped within 12 hours, then you need to take another pill additionally. After this, you should continue taking the tablets in the usual way. If vomiting or diarrhea lasts more than 12 hours, then additional contraceptive methods should be used during vomiting or diarrhea and for the next 7 days.

Side effect

Side effects requiring discontinuation of the drug

By of cardio-vascular system:   arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, 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.

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

Other side effectsthat are more common, but less severe.

The appropriateness of continuing the use of the drug is decided individually after consulting a doctor, based on the benefit / risk ratio.

From the reproductive system:   acyclic bleeding / bloody issues   from the vagina, amenorrhea after discontinuation of the drug, a change in the condition of the vaginal mucus, development inflammatory processes vagina, candidiasis, tension, pain, breast enlargement, galactorrhea.

By digestive system:   nausea, vomiting, Crohn’s disease, ulcerative colitisthe occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.

Dermatological reactions:   erythema nodosum, exudative erythemarash, chloasma.

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

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

From the side of metabolism:   fluid retention in the body, a change (increase) in body weight, a decrease in carbohydrate tolerance.

Other: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 history of the precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, including in the anamnesis;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
• history of venous thromboembolism;
• diabetes   (with angiopathy);
• pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, including in the anamnesis (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking corticosteroids;
• cholelithiasis at present or in history;
• gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including history);
• severe itching, otosclerosis or its progression in a previous pregnancy or taking corticosteroids;
• hormone-dependent malignant neoplasms of the genitals and mammary glands (including if they are suspected);
• vaginal bleeding of unknown etiology;
• smoking over the age of 35 years (more than 15 cigarettes per day);
• pregnancy or suspicion of it;
• lactation period;
• hypersensitivity to the components of the drug.

Carefully

The drug should be prescribed with caution in conditions that increase the risk of venous or arterial thrombosis / thromboembolism: age older than 35 years, smoking, family history, obesity (body mass index more than 30 kg / m 2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart defects, atrial fibrillation, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, severe trauma, varicose veins   veins and superficial thrombophlebitis, the postpartum period, the presence of severe depression (including a history), changes in biochemical parameters (resistance of activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including including lupus anticoagulant), diabetes mellitus, not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including a family history), acute and chronic diseases   the liver.

The use of Regulon during pregnancy and lactation

The use of the drug during pregnancy and during lactation is contraindicated. During breastfeeding, it is necessary to decide whether to discontinue the drug or to stop breastfeeding.

Use for impaired liver and kidney function

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

special instructions

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

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

In each case, before the appointment of hormonal contraceptives, the advantages or possible negative effects of their administration are individually evaluated. 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 health status of a woman must be carefully monitored. If any of the following conditions / diseases appears or worsens while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

• diseases of the hemostatic system;
• conditions / diseases predisposing to the development of cardiovascular, 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 a violation of tryptophan metabolism, then vitamin B6 can be used to correct it);
• sickle cell anemia, as at individual cases   (for example, infections, hypoxia) estrogen-containing drugs with this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests evaluating liver function.

Thromboembolic disease

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

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

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 thousand women per year. When using second-generation drugs, 15 cases per 100 thousand women per year, and when using third-generation drugs, 25 cases per 100 thousand women per year.

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

The risk of arterial or venous thromboembolic diseases is increased:

• with age;
• when smoking (intensive smoking and age over 35 years old are risk factors);
• in the presence of a family history of thromboembolic diseases (for example, parents, brother or sister). If you suspect a genetic predisposition, it is necessary to consult a specialist before using the drug;
• with obesity (body mass index more than 30 kg / m 2);
• with dyslipoproteinemia;
• with arterial hypertension;
• with diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes complicated by vascular lesions;
• with prolonged immobilization, after a large surgical intervention, 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 resume no earlier than 2 weeks after remobilization).

Postpartum women have an increased risk of venous thromboembolic disease.

It should be borne in mind that diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of venous thromboembolic diseases.

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

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

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

Tumor diseases

Some studies have reported an increase in cervical cancer in women who have been taking hormonal contraceptives for a long time, but the results are contradictory. In the development of cervical cancer, sexual behavior, human papillomavirus infection and other factors play a significant role.

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 a higher detection of breast cancer could be associated with a more regular medical examination. Breast cancer is rare among women under the age of 40, regardless of whether they take hormonal contraceptives or not, and increases with age. Taking pills can be regarded as one of many risk factors. However, a woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

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

Chloasma

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

Efficiency

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

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

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

Laboratory changes

Under the influence of oral contraceptive pills - in connection with the estrogen component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis, lipoprotein and transport protein levels) may change.

Additional Information

After acute viral hepatitis   the drug should be taken after normalization of liver function (not earlier than 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 disease   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.

Overdose

Symptoms   nausea, vomiting, in girls - spotting from the vagina.

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

Drug interaction

Medicines that induce liver enzymes, 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 (no interaction mechanism established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the entire course of treatment and within 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives can reduce carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.