Marvelone is a monophasic oral contraceptive.
Release form and composition
Marvelon is produced in the form of tablets: white, round, biconvex, on one side - the inscription "TR" above the number "5", on the other - the image of a five-pointed star with the inscription "ORGANON" (21 pieces in blisters, 1, 3 , 6 blisters in a carton box).
The composition of 1 tablet contains the active substances:
- Desogestrel - 0.15 mg;
- Ethinyl estradiol - 0.03 mg.
Auxiliary components: potato starch, stearic acid, povidone, alpha-tocopherol, colloidal silicon dioxide, lactose monohydrate.
Indications for use
Marvelon is used for contraception.
- Precursors of thrombosis (including transient attack of coronary heart disease, angina);
- Venous or arterial thrombosis / thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);
- Diabetes mellitus with vascular lesions;
- Migraine with focal neurological symptoms in history;
- The presence of multiple or severe risk factors for arterial or venous thrombosis (including arterial hypertension with arterial pressure of 160/100 mm Hg and above);
- Pancreatitis, incl. a history of, accompanied by severe hypertriglyceridemia;
- Liver tumors (malignant and benign), incl. in the anamnesis;
- Severe liver disease, incl. history (to normalize the performance of the liver);
- Hormone-dependent malignant neoplasms of the mammary glands or genitals, incl. suspects;
- Vaginal bleeding of unknown etiology;
- Smoking over the age of 35 (more than 15 cigarettes per day);
- Rare hereditary diseases: glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
- Pregnancy (including intended) and the period of breastfeeding (lactation);
- Hypersensitivity to the drug.
If any of the above conditions / diseases occur while taking Marvelon, the drug should be stopped immediately.
Care must be taken when applying Marvelon under the following conditions / diseases:
- Age over 35 years;
- The presence of thromboembolic diseases in the family history (arterial or venous thrombosis / thromboembolism in close relatives - sisters, brothers or parents at a relatively early age);
- Obesity (with a body mass index of more than 30 kg / m2);
- Valvular heart disease;
- Arterial hypertension;
- Atrial fibrillation;
- Severe injuries, extensive surgical interventions, prolonged immobilization, surgical interventions carried out on the lower limbs (with prolonged immobilization and the above surgical interventions, it is recommended to interrupt the use of the drug (with planned surgical interventions no later than 1 month before the operation) and not to resume 14 days after complete remobilization);
- Postpartum period;
- Superficial thrombophlebitis, varicose veins;
- Sickle cell anemia;
- Changes of biochemical indicators that may be acquired or congenital markers of predisposition to venous or arterial thrombosis (including hyperhomocysteinemia, resistance to activated protein C, protein C deficiency, protein S and antithrombin III, antiphospholipid antibodies, including antibodies against cardiolipin, lupus anticoagulant);
- Hemolytic uremic syndrome;
- Systemic lupus erythematosus;
- Chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease);
- Acute and chronic liver diseases, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson syndrome, Rotor).
- Hypertriglyceridemia (including in family history).
Dosing and Administration
Marvelon is taken internally on 1 tablet, washing down if necessary with a small amount of water. Tablets need to be taken for 21 days approximately at the same time, following the order indicated on the package. After the end of the package, you need to take a break for 7 days, during which menstrual-like bleeding should occur (as a rule, it starts 2-3 days after taking the last pill and can continue even after you start taking the pills from the next package).
In cases where hormonal contraceptives have not been used during the last month, Marvelon should be taken on the first day of the menstrual cycle. It is also possible to start therapy later on - 2-5 days after the start of the menstrual cycle, however in these cases additional (non-hormonal) methods of contraception are recommended in the first 7 days of taking the pills.
When switching from combined hormonal contraceptives, it is advisable to start taking Marvelon the next day after taking the last active tablet of the previously used drug (the last tablet with the content of active substances). If for any reason this is not possible, taking Marvelon should begin no later than the next day after taking the last pill that does not contain hormones, or the next day after the end of the usual break in taking the pills. When using a transdermal patch or vaginal ring, Marvelon is recommended to start on the day of their removal, but not later than the day when the next patch application was to be made or a new ring was inserted.
The transition to Marvelon after applying the “mini-pili” can be started any day; after using the drug in the form of injections - on the day of the next injection; after the implant or progestogen-releasing intrauterine system (IUD) - on the day of their removal. In all cases, additional contraceptive methods should be used during the first 7 days of taking Marvelon.
After an abortion in the first trimester, you can start taking the drug immediately without using any additional methods of contraception.
After an abortion or childbirth in the second trimester, Marvelon is recommended to begin to apply no earlier than 21-28 days after an abortion or childbirth. In cases where a woman began taking the drug later, during the first 7 days it is recommended to use barrier methods of contraception. If a woman has already had sexual intercourse before starting to take Marvelon after childbirth or abortion, pregnancy should be excluded or you should wait until the first menstruation.
With a delay in taking the next pill for less than 12 hours, the reliability of contraception is not reduced. A woman needs to take the missed pill as soon as she remembers, and take the next one at the usual time.
The reliability of contraception can be reduced by delaying the next pill intake for more than 12 hours. In such a situation it is recommended to follow the following rules:
- Marvelon's reception should never be interrupted for longer than 7 days;
- Tablets must be taken 7 days in a row to adequately suppress the hypothalamic-pituitary-ovarian system.
In the presence of severe gastrointestinal disorders, Marvelon absorption may be incomplete, therefore additional contraceptive measures are recommended. With the development of vomiting within 3-4 hours after taking the drug, you should use the recommendations that relate to skipping the next dose of the drug. If one does not want to change the usual regimen of Marvelon, a woman can take additional pill (s) from another package (the number of additional pills is determined by an obstetrician-gynecologist).
Taking the drug without interruption allows you to delay menstruation. To offset the day of the onset of menstruation, you can reduce the usual break in reception for the required period. It is necessary to resume reception according to the usual scheme after observance of a break in 7 days.
During therapy, the following side effects may develop:
- Cardiovascular system: increased blood pressure, thromboembolism or thrombosis (including pulmonary embolism, myocardial infarction, deep vein thrombosis, stroke) thromboembolism of retinal arteries, as well as renal, mesenteric, hepatic veins and arteries);
- Reproductive system: acyclic bleeding (most often develop in the first months of taking the drug);
- Digestive system: ulcerative colitis and Crohn's disease, cholelithiasis, jaundice and / or itching associated with cholestasis (occurrence or exacerbation);
- Skin: chloasma (especially if there is a history of chloasma during pregnancy);
- Other: allergic reactions, systemic lupus erythematosus, porphyria, hemolytic-uremic syndrome, herpes of pregnant women, small chorea, hearing loss due to otosclerosis.
Also, when Marvelon was used, the development of side effects was noted, the connection of which with its intake was not proven (in more than 1/1000 cases - often / infrequently; in less than 1/1000 cases - rarely):
- Nervous system: often - migraine, headache, depression, decreased libido, mood changes; rarely - increased libido;
- Immune system: rarely - hypersensitivity;
- The digestive system: often - nausea, abdominal pain, vomiting, diarrhea;
- Reproductive system: often - an increase in the mammary glands, breast tenderness, chest pain; rarely, discharge from the mammary glands and vagina;
- Body of vision: rarely - intolerance to contact lenses;
- Skin and subcutaneous tissue: often - urticaria, skin rash; rarely, erythema multiforme or knobby;
- Metabolism and nutrition: often - fluid retention, weight gain; rarely - weight loss.
If any of the following risk factors or conditions are present, you must carefully weigh the benefits of taking Marvelon and the possible risks:
- Vascular diseases: there may be a link between taking Marvelon and increasing the risk of developing venous and arterial thrombotic and thromboembolic diseases (myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism). The increase in the intensity and frequency of migraines may serve as a basis for immediate discontinuation of the drug;
- Tumors: Some studies have noted an increase in the risk of developing cervical cancer in women who have been receiving Marvelon for a long time, and there has been a slight increase in the relative risk of developing breast cancer. Cases of the development of liver tumors were observed extremely rarely (in the differential diagnosis of diseases, symptoms such as acute pain in the upper abdomen, signs of intra-abdominal bleeding, or enlargement of the liver should be considered);
- Hypertriglyceridemia: in diagnosing the disease in a woman or her family members, an increase in the risk of pancreatitis is possible;
- Persistent, clinically significant arterial hypertension: Marvelon should be abolished and therapy for hypertension should be prescribed. Resumption of the drug is possible after reaching normal blood pressure values;
- Functional disorders of the liver (acute or chronic): it is possible to cancel Marvelon before normalization of liver function indicators (relapse of cholestatic jaundice previously observed during pregnancy or when using sex steroids requires discontinuation of the drug);
When exacerbation of the disease, deterioration of the condition or the development of the first symptoms of these risk factors or conditions, a woman is recommended to consult a doctor. The doctor decides on canceling the drug individually.
Before taking and resuming use of Marvelon, it is necessary to conduct a thorough examination (including contraindications and cautions) and to collect a detailed medical history. Periodically, medical examinations should be repeated, which will allow time to identify the development of diseases that are contraindications to the drug. The doctor determines the frequency and list of examinations individually (but not less than once every six months). Particular attention should be paid to blood pressure measurement, examination of the mammary glands, pelvic organs (including cervical cytology) and the abdominal cavity.
It must be borne in mind that Marvelon does not protect against HIV (AIDS) and other sexually transmitted infections.
Marvelone can influence the metabolism of other drugs and, accordingly, change their concentration in plasma and tissues (for example, cyclosporine, salicylic acid, morphine).
With simultaneous use with other drugs to determine the possible interaction is recommended to consult with your doctor or use the instructions for their use.
Terms and conditions of storage
Store in a dark, dry, out of reach of children at a temperature of 2-30 ° C.
Shelf life - 3 years.