Expiration date: 12/2025
Structure and Composition:
Tablets, film-coated. 1 tablet contains:
2 mg chlormadinone acetate
ethinyl estradiol 30 mcg
excipients: Povidone magnesium stearate, corn starch, lactose monohydrate
in blisters Table 21. a stack of cardboard 1, 3 or 6 packages.
Pharmachologic effect:
It has estrogen-progestogen action, anti-androgenic properties.
Pharmacokinetics:
When administered components of the drug is rapidly and completely absorbed from the gastrointestinal tract. Chlormadinone acetate Cmax achieved within 1-2 hours, T1 / 2 - 34 hours, metabolites are excreted in urine and bile in a ratio of 4: 6.. Ethinyl estradiol (T1 / 2 is about 25 h) biotransformed to form sulfates and glucuronides, which are excreted in the urine and bile in a ratio of 4: 6.
Description of the pharmacological actions:
With long-term (over 21 days) application reduces the secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH), a hormone suppresses ovulation, endometrial proliferation and secretory transformation. It changes the properties of cervical mucus, difficult passage of sperm through the cervical canal and impairs their mobility. Chlormadinone replaces androgens on specific receptors. Ethinyl estradiol production increases binding globulin sex hormones, and reduce the level of free testosterone. It helps normalize the menstrual cycle, reduce the amount of menstrual blood, reduce the intensity of premenstrual pain and the incidence of iron deficiency anemia, dysmenorrhea, functional ovarian cysts, ectopic pregnancy, malignancy endometrial and ovarian, some forms of benign breast diseases and inflammatory diseases of the pelvic organs. Ethinylestradiol skin inhibits secretion of sweat glands.
Testimony: Contraception.
Contraindications:
Hypersensitivity, arterial thrombosis and venous (including history), severe or multiple risk factors for thrombosis, diabetes with angiopathy, severe liver disease (including history) to the normalization of liver function tests, Dubina syndrome - Johnson syndrome, Rotor syndrome, benign or malignant liver tumors (including in history), sickle-cell anemia, porphyria, the expressed disturbances of lipid metabolism, severe arterial hypertension, atherosclerosis, migraine, epilepsy, hormone-dependent malignant diseases of the genital organs or the breasts (including suspects), pelvic inflammatory disease, vaginal bleeding of unknown etiology, idiopathic jaundice or itching, or otosclerosis with hearing loss during the previous pregnancy, pregnancy (including suspected), breastfeeding.
Application of pregnancy and breastfeeding:
Contraindicated. When the diagnosis of pregnancy, the drug should be discontinued immediately. At the time of treatment should stop breastfeeding because the drug reduces the amount of milk produced and changes its consistency. Minor amounts of hormones and / or their metabolites may be excreted into breast milk.
Side effect:
Cardio-vascular system and blood (blood, hemostasis): increased blood pressure, increased risk of thromboembolic disorders of arteries and veins.
From the digestive tract: nausea, vomiting, gastrointestinal disorders, biliary tract lesions, liver tumors (benign or malignant).
From the nervous system and sensory organs: depression, irritability, headache, blurred vision, tinnitus.
From the urogenital system: breast tenderness, vaginal discharge, dysmenorrhea.
For the skin: chloasma, dry skin, rash, itching, acne, seborrhea.
Other: back pain, allergic reactions.
Drug Interactions:
Contraceptive effectiveness is reduced when taken with phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, griseofulvin, phenylbutazone, rifampicin, ampicillin, tetracycline.
Dosage and administration:
Inside.
The tablets should be swallowed whole, choosing the one that is marked with the corresponding day of the week. The choice is determined by the direction of the arrows on the packaging.
Reception begin at the 1st day of the menstrual cycle and continuing daily (preferably at the same time) for 21 days. This is followed by a 7-day break, during which menstrualnopodobnoe bleeding should begin. After a 7-day interval should resume reception of the next blister whether menstrualnopodobnoe bleeding stopped or not.
If not used hormonal contraceptives during the preceding menstrual cycle, the pills should be started in the 1 st day of a normal menstrual cycle. The contraceptive effect begins with the 1st day of the reception. If menstruation lasts more than one day, the first pill to be taken on the 5th day of menstruation, irrespective of whether the bleeding stopped. In this case, the use of additional, non-hormonal methods of contraception during the first 7 days. If the start of menstruation took longer than 5 days, it is recommended to take the drug with the next menstrual cycle.
When changing from another hormonal contraceptive containing 21 active pill intake should finish all the pills the old packaging. Belarus first tablet should be taken the next day. Tablet-free interval should not be should not wait until the next menstrual cycle.
When switching from other hormonal contraceptive containing 28 tablets, the first tablet to be taken Belarus the next day after the last active tablet from the packaging prior contraceptive product (i.e. active after receiving 21 tablets). There should be no tablet-free interval (do not wait until the next menstrual cycle).
Go with contraceptives containing only progestogen (mini-pill), it is possible any day (without a break) in the transition from the use of an implant containing a progestogen - the day of its removal when changing from progestogen in injectable form - from the date when should be the next injection . In all cases, you must use an additional barrier method of contraception during the first 7 days of receipt of Belarus.
After the abortion I trimester of pregnancy should start taking the drug immediately after abortion. Additional methods of contraception are not required.
After delivery, women who are not breastfeeding can begin receiving Belarus for 21 -28 th day postpartum period (additional contraceptive measures are not needed). If use of the drug in the postpartum period started 28 days after birth, it is necessary to take additional measures of contraception for 7 days. If a woman has had sexual contact, before the use of the drug is necessary to exclude pregnancy or wait until the next menstrual cycle.
If necessary, the use of phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, griseofulvin, phenylbutazone, rifampicin, ampicillin, tetracycline should take extra non-hormonal contraceptive measures (except for the "temperature method" and the calendar method Knaus-Ogino) throughout the treatment period and 7 days after its termination. When receiving rafampitsina and within 28 days after it is recommended to use another method of contraception in addition to oral contraceptives.
Overdose:
Symptoms: Accidental receiving a large number of pills - nausea, vomiting, vaginal bleeding (in girls).
Treatment: symptomatic. No specific antidote. In rare cases, requires monitoring indicators of water and electrolyte metabolism and liver function.
Precautionary measures:
If the patient has not taken medication in the usual time, and after the set time has passed less than 12 hours, the contraceptive effect of the drug is maintained, and should be as soon as possible to take the missed pill. The next tablet should be taken at a set time.
If after the set time has been more than 12 hours, may reduce the contraceptive action of the drug. In this case, take the missed pill and then continue taking the usual time. Thus it is necessary to use an additional barrier method of contraception for the next 7 days. If within 7 days of pills in a package finished, the pills of the next pack should be started immediately after the completion of the tablets in the previous package, ie do not pause between taking tablets from a variety of packages. If there was no menstrualnopodobnoe bleeding after taking the second pack, pregnancy should be ruled.
If you have vomiting or diarrhea while taking Belarus, it is recommended to use additional methods of contraception, because contraceptive effect may be reduced due to incomplete absorption of active substances in the intestine.
Be wary of a convulsive syndrome, chorea minor, liver, lipid metabolism disorders, autoimmune diseases (including systemic lupus erythematosus), obesity, hypertension, endometriosis, varicose disease, inflammatory diseases of the veins, bleeding disorders, mastitis, uterine myoma. Patients with a tendency to develop chloasma should avoid exposure to the sun and UV radiation during use of the drug. Use of the drug in early pregnancy is not an indication for therapeutic abortion. On a background of reception of Belarus may experience irregular vaginal bleeding (spotting or heavy), especially during the first months of the drug that is not an indication for further examination, and the application can be extended. If the bleeding resumes after a few cycles, it is necessary to conduct a survey to exclude organic pathology. Intermenstrual bleeding may indicate a lack of contraceptive effect. In the first months of the drug may not occur menstrualnopodobnoe bleeding that is not a measure reducing the contraceptive effect. If the bleeding does not occur after the cycle in which not missed any tablet, 7-day interval is not exceeded, at the same time not taken other drugs were not recorded episodes of vomiting or diarrhea, intake of pills can be extended, as Pregnancy is unlikely. Pregnancy must be excluded for the first 10 days of the new cycle. If menstrual bleeding occurred in two successive cycles, perform a check-up on the pregnancy.
Special instructions:
Against the background of the drug may vary some laboratory parameters of liver function, adrenal and thyroid glands.
