Ethinylestradiol, drospirenone (Midiana) 30 mcg + 3 mg – [63 tablets]

Description

Midiana Pharmacodynamics
A combined oral contraceptive drug containing ethinylestradiol and drospirenone. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation and endometrial changes.
In a therapeutic dose drospirenone also has antiandrogenic and weak anti-mineralocorticoid properties. It has no estrogenic, glucocorticoid and antiglucocorticoid activity. This provides drospirenone with a pharmacological profile similar to that of natural progesterone.
There is evidence of a reduced risk of endometrial and ovarian cancer with combined oral contraceptives.

Indications
contraception.

Contraindications
Midiana® should not be prescribed if any of the conditions listed below are present. If any of these conditions develops for the first time while taking this medicine, it should be stopped immediately.
– Current or past history of venous thrombosis (deep vein thrombosis, pulmonary embolism);
– current or history of arterial thrombosis (e.g., myocardial infarction) or preexisting conditions (e.g., angina and transient ischemic attack);
– Complicated cardiac valvular disease, atrial fibrillation, and uncontrolled arterial hypertension;
– serious surgical intervention with prolonged immobilization;
– Smoking over the age of 35 years;
– hepatic insufficiency;
– current or past history of cerebrovascular disease;
– Presence of severe or multiple risk factors for arterial thrombosis;

Dosage and administration

• Tablets should be taken at approximately the same time each day, if necessary with a small amount of liquid, in the sequence indicated on the blister pack. It is necessary to take 1 tablet per day for 21 consecutive days. Taking pills from each subsequent package should begin after a 7-day interval in the intake of pills, during which time menstrual bleeding usually occurs. It usually begins 2-3 days after taking the last pill and may not end by the time the next package begins.
• If previously hormonal contraceptives were not used (in the last month) the intake of combined oral contraceptives starts on day 1 of a natural menstrual cycle of a woman (i.e. on day 1 of a menstrual bleeding).
• If another combined oral contraceptive, vaginal ring, or transdermal patch is replaced, it is preferable to start Midiana® the day after taking the last active pill of the previous combined oral contraceptive; in such cases, Midiana® should not be started later than the day after a normal pill interruption or taking inactive pills of her previous combined oral contraceptive. If the vaginal ring or transdermal patch is replaced, the Midiana® oral contraceptive should preferably be started on the day of removal of the previous product; in such cases, the Midiana® should be started no later than the day of the intended replacement procedure.
• In case of progestin-only replacement method (mini-pills, injectable forms, implants) or intrauterine contraceptives with progestin release: a woman can switch from mini-pills on any day (from an implant or intrauterine contraceptive – on the day of its removal, from an injectable form – from the day when the next injection was to be made). However, in all these cases, it is advisable to use an additional barrier method of contraception during the first 7 days of taking the pills.
• After a pregnancy termination in the first trimester, the woman can start taking the pills immediately. If this condition is met, no additional contraceptive measures are necessary.
• After delivery or termination of pregnancy in the second trimester, it is preferable for the woman to start taking Midiana® on day 21-28 after delivery or termination of pregnancy in the second trimester. If administration is started later, barrier contraception should be used additionally during the first 7 days of taking the pills. If you have sexual intercourse before taking the drug, pregnancy must be excluded or you must wait for your first menstrual period.
• Taking missed pills
  If the pill is taken less than 12 hours late, contraceptive protection is not reduced. The woman should take the pill as soon as possible, the next pills are taken at the usual time.