Mikroginon - monophasic oral contraceptive drug.
Release form and composition
Mikroginon produced in the form of coated tablets (21 pieces in blisters, 1 or 3 blisters in a cardboard box).
The composition of 1 tablet contains the active substances:
- Ethinyl estradiol - 0.03 mg;
- Levonorgestrel - 0.15 mg.
Auxiliary components: lactose - 32.97 mg; corn starch - 18 mg; polyvidone 25,000 - 2.1 mg; talc - 1.65 mg; magnesium stearate - 0.1 mg.
The composition of the shell: titanium dioxide (E171) - 0,274 mg; sucrose - 19.371 mg; glycolic wax mountain - 0.05 mg; polyvidone 700000 - 0.189 mg; polyethylene glycol 6000 to 2.148 mg; calcium carbonate - 8,606 mg; talc - 4.198 mg; 85% glycerol - 0.137 mg; the dye iron oxide yellow (E172) - 0,027 mg.
Indications for use
Mikroginon used for contraception.
- Thrombosis (venous and arterial) and thromboembolism, including myocardial infarction, deep vein thrombosis, cerebrovascular disorders, pulmonary embolism (now or in history);
- Conditions preceding thrombosis, including transient ischemic attacks and angina pectoris (currently or in history);
- Diabetes mellitus with vascular complications;
- Migraine with focal neurological signs (if available and in history);
- Uncontrolled arterial hypertension;
- The presence of multiple or pronounced risk factors for venous or arterial thrombosis, including cardiac arrhythmias, cardiac valve apparatus, diseases of the coronary arteries of the heart or cerebral vessels;
- Severe liver disease and liver failure (taking Mikroginona possible after the normalization of liver tests);
- Pancreatitis, with severe hypertriglyceridemia (currently or in history);
- Vaginal bleeding of unknown origin;
- Malignant hormone-dependent diseases, including the mammary glands or genitals (diagnosed or suspected of them);
- Benign or malignant tumors of the liver (now or in history);
- Extensive injuries, prolonged immobilization, surgery on the legs, serious surgical interventions;
- Pregnancy or suspicion of it;
- Lactation period;
- Hypersensitivity to the drug.
Mikroginon should be taken with caution in the following diseases / conditions:
- Sickle cell anemia;
- Severe disorders of fat metabolism, including hyperlipidemia, obesity;
- Thrombophlebitis of the superficial veins;
- Arterial hypertension;
- Hemolytic uremic syndrome;
- Otosclerosis with hearing impairment, itching, or idiopathic jaundice during a previous pregnancy;
- Congenital hyperbilirubinemia (Dubin-Johnson, Gilbert and Rotor syndromes);
- Systemic lupus erythematosus;
- Crohn's disease.
Dosing and Administration
Mikroginon accept inside, washing down with a small amount of water.
Dragee should be taken daily for 21 days in the order indicated on the package, preferably at the same time of day. Before taking the drug from a new package, you should take a break of 7 days. As a rule, withdrawal bleeding occurs at this time (it may start a little earlier, while taking the last pills from the package, and not end before the drug is taken from the new package).
In the absence of receiving any hormonal contraceptive drugs in the previous month, Mikroginon should be started on the first day of the menstrual cycle. Also, the drug can begin to take 2-5 of the menstrual cycle, while during the first 7 days of administration, you must use an additional barrier contraceptive.
When switching from combined oral contraceptives, it is recommended that you take Mikroginona on the next day after taking the last active dragee, but no later than the next day after the usual seven-day break (for preparations containing 21 pills per pack) or after taking the last inactive pill (for drugs with 28 pills packaged).
You can go on the reception of Mikroginon with a mini-pill without a break on any day, from the intrauterine contraceptive containing the progestogen or implant - on the day of its removal, from the injection form of the contraceptive - from the day on which the next injection should be made. In all the cases described for 7 days, you must additionally use a barrier method of contraception.
After an abortion in the first trimester of pregnancy, Mikroginon can be started immediately, in this case there is no need for additional measures of protection.
After an abortion and childbirth in the second trimester of pregnancy, it is recommended to start the preparation on days 21-28. If therapy was started later, additional protective measures should be applied for 7 days. However, if sexual intercourse took place at this time, one should exclude pregnancy before waiting for the use of Mikroginon, or wait for the first menstruation.
The contraceptive protection of Mikroginona does not decrease when skipping pills until 12 hours. The missed dose should be taken as soon as the woman remembers her.
If you are late more than the specified time, you should follow the following basic rules:
- Drops should never be taken longer than 7 days;
- To achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation, 7 days of continuous use of the drug are necessary.
In accordance with these rules, when taking a break between the techniques of Mikroginona for longer than 36 hours, the following guidelines should be followed:
- 1-7 days of taking the drug: missed pills should be taken as soon as the woman remembers the missed dose (even in cases where you need to take 2 pills at the same time). In the future, the drug is taken as usual. Over the next 7 days barrier contraceptive methods should be used. If during the week before skipping the dragee sexual intercourse took place, you need to consider the possibility of pregnancy. The more pills are missed, and the closer they are to a break in taking the drug, the higher the probability of pregnancy;
- 8-14 days of taking the drug: missed pills should be taken as soon as the woman remembers the missed dose (even in cases when you need to take 2 pills at the same time). In the future, the drug is taken as usual. If a woman took the dragee correctly during the first week of taking Mikroginona, additional contraceptive measures should not be used. In other cases, as well as when skipping two or more dragees, barrier contraceptive methods should be additionally used within 7 days;
- 15-21 days of taking the drug: during this period, the risk of reducing the reliability of Mikroginona is inevitable due to the upcoming break in taking pills. If during the 7 days preceding the first missed pills, the drug was taken correctly, no additional protective measures should be taken. In other cases, you should follow one of 2 methods: stop taking the drug for 7 days, then start a new package or continue taking it from the current package, taking the missed dose as soon as possible (2 tablets can be taken). In this case, the seven-day break between taking the drug should not be done. The occurrence of withdrawal bleeding until the end of the second package is unlikely in this case, however, the appearance of spotting and breakthrough bleeding is possible. If a woman misses Mikroginona, and then during a break in taking the drug, she has no withdrawal bleeding, it is necessary to exclude pregnancy.
With the development of diarrhea or vomiting within 4 hours after taking active dragee, absorption may be incomplete (you should be guided by the recommendations for skipping the drug).
To delay the onset of menstruation, Mikroginona reception should be continued without interruption. During the taking of the drug from the new package may be spotting or breakthrough uterine bleeding. It is necessary to resume taking pills from the new package after the usual seven-day break.
During the use of Mikroginona the following side effects may occur:
- Soreness and tension of the mammary glands, their increase, discharge from the nipples;
- Breakthrough uterine bleeding and spotting;
- Mood changes / decrease;
- Change in libido;
- Cholestatic jaundice;
- Blurred vision;
- Poor tolerance of contact lenses;
- Vaginal secretion changes;
- Nausea, abdominal pain, vomiting;
- Erythema nodosum, skin rash, generalized pruritus, erythema multiforme;
- Change in body weight;
- Fluid retention;
- Allergic reactions.
Sometimes chloasma is observed while taking pills (especially in women with a history of chloasma in pregnant women), rarely - diarrhea, fatigue, development of thromboembolism and thrombosis.
When planning surgical operations, the administration of Mikroginon should be interrupted at least 4 weeks prior to its implementation and should not be resumed after the end of immobilization for 2 weeks.
During medication, affecting microsomal enzymes, as well as within 28 days after their withdrawal, it is necessary to additionally use barrier methods of contraception.
During the use of antibiotic drugs (such as tetracyclines and ampicillins), as well as another 7 days after the end of therapy, it is necessary to additionally use barrier methods of contraception.
If any of the following risk factors or conditions are present, there is a need to carefully compare the potential risk with the expected benefits from its use before starting to take Mikroginona:
- Diseases of the cardiovascular system. Symptoms of arterial or venous thrombosis or cerebrovascular disorders include: unilateral pain in the leg and / or edema; sudden severe chest pain, with or without irradiation to the left hand; sudden shortness of breath; sudden coughing attack; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; weakness or a very significant loss of sensation, suddenly appearing on one side or in one part of the body; aphasia or inarticulate speech; movement disorders; dizziness; loss of consciousness with or without convulsive seizures; sharp belly;
- Tumors. In rare cases, the use of combined oral contraceptives observed the development of liver tumors. If you experience severe pain in the abdomen, signs of intra-abdominal bleeding, or an enlarged liver during a differential diagnosis, this should be taken into account;
- Hypertriglyceridemia (in women, as well as in the presence of this condition in the family history). The risk of developing pancreatitis increases.
When weighting, aggravation or appearance of the first symptoms of any of these conditions or risk factors, the patient should consult a doctor.
It is necessary to take into account that the risk of thrombosis (venous and / or arterial) and thromboembolism increases with age, in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases in the future, especially in women over 35) and in the presence of the following diseases / states:
- Obesity (with a body mass index greater than 30 kg / m²);
- Arterial hypertension;
- Atrial fibrillation;
- Valvular disease;
- Prolonged immobilization, serious surgery, any surgery on the legs or extensive injuries;
- Indications for venous or arterial thromboembolism have ever been with close relatives or parents at a relatively young age in the family history.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Also, circulatory disorders can occur in women with diabetes, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
The reason for the immediate cessation of Mikroginona can be an increase in the severity and frequency of migraine (may precede the development of cerebrovascular disorders).
Clinically significant increases in blood pressure during the use of the drug were rarely observed. With the development of a persistent, clinically significant increase in blood pressure should be abolished Mikroginon and begin treatment of hypertension. The use of combined oral contraceptives can be continued if normal blood pressure values are reached.
Also during the reception of Mikroginona the following conditions may develop or worsen: porphyria; cholestasis pruritus and / or jaundice; the formation of gallstones; herpes pregnant; hemolytic uremic syndrome; systemic lupus erythematosus; chorea; Otosclerosis-related hearing loss. Also described are cases of Crohn's disease and ulcerative colitis.
Acute or chronic functional disorders of the liver may require discontinuation of Mikroginon taking until the liver function returns to normal. In case of recurrent cholestatic jaundice, which first developed during pregnancy or during previous use of sex hormones, the drug should be discontinued.
For women with diabetes, taking Mikroginon, requires careful medical supervision. Patients with a tendency to chloasma are advised to avoid prolonged exposure to the sun and other exposure to ultraviolet radiation.
During the reception of Mikroginona irregular bleeding may occur, especially during the first months of its use. Therefore, an assessment of any irregular bleeding is necessary only after the end of the adaptation period, which is approximately three cycles.
If irregular bleeding recurs or occurs after previous regular cycles, a thorough examination is necessary to rule out malignant neoplasms or pregnancies.
In some cases, during a break in the reception of Mikroginona, the withdrawal bleeding may not develop. If the drug was taken according to the instructions, the probability of pregnancy is low. However, if the contraceptive was taken irregularly or in the absence of two bleeding withdrawals in a row, pregnancy should be excluded before continuing with Mikroginon.
Before starting the drug, a woman is recommended to undergo a thorough examination (general medical and gynecological) and to exclude violations of the blood coagulation system and pregnancy.
In the case of prolonged use of Mikroginona every 6 months it is necessary to carry out control tests.
It must be borne in mind that the drug does not protect against HIV infection and other sexually transmitted diseases.
With the simultaneous use of Mikroginona with certain drugs, the following undesirable effects may occur:
- Sulfonamides, pyrazolone derivatives: increased metabolism of steroid hormones that are part of Mikolinon;
- Antibiotic drugs (tetracyclines, ampicillins): decrease in contraceptive protection;
- Phenytoin, primidone, barbiturates, carbamazepine and rifampicin (drugs that induce liver enzymes): the development of breakthrough bleeding and / or a decrease in the contraceptive effectiveness of Mikroginon (possibly, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and containing zyrone, Zyroxazole, topiramate, felbamate, containing ritonavir, zirefulvin, and containing zirconavir, and containing zyrophaemone, and containing zyrophaemone, containing zyrophaemone, and topiramate, felbamate, ritonavir, and greeofulvin, and containing zirconavir, and zirama, and topiramate, felbamate, ritonavir, and greeofulvin, and containing zyrophaemone, containing zyrophaemone, and topiramate, felbamate, ritonavir, and greeofulvin and containing zyrone, have the same effect.
Mikroginon can influence the metabolism of other drugs, including cyclosporine, which causes a change in their concentration in tissues and plasma.
When you receive Mikroginona may require correction dosing regimen of indirect anticoagulants and hypoglycemic drugs.
Terms and conditions of storage
Keep out of the reach of children in normal conditions.
Shelf life - 5 years.