Midiana pills 3 mg + 0.03 mg №21

Coated tablets

Active ingredient

In 1 tablet, film coated, contains:

- Active substances
- Ethinyl estradiol 0.03 mg.
- Drospirenone 3 mg.

- Excipients Lactose monohydrate, corn starch, pregelatinized corn starch, Povidone C25, Magnesium stearate.

- Opadry II white shell 85G18490 (polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, soy lecithin).

Packing

In the blister 21 tablets. In packing 1 blister.

Mechanism of action

Midiana - the contraceptive effect of the drug is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the endometrium.

Combined oral contraceptive preparation containing ethinyl estradiol and drospirenone. At a therapeutic dose, drospirenone also has anti-androgen and weak anti-mineralocorticoid properties. It does not have estrogenic, glucocorticoid and antiglucocorticoid activity. This provides drospirenone with a pharmacological profile similar to natural Progesterone.

There is evidence of a reduction in the risk of endometrial and ovarian cancer with combined oral contraceptives.

- Contraception.

Contraindications

The drug Midiana should not be appointed in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, its immediate cancellation is required.

- Presence of vein thrombosis at present or in history:
- Deep vein thrombosis.
- Pulmonary embolism.

- Angina pectoris.
- Transient ischemic attack.

- Resistance to APS (activated protein C).
- Antithrombin III deficiency.
- Protein C deficiency.
- The lack of protein S.
- Hyperhomocysteinemia.
- The presence of antiphospholipid antibodies:
- Antibodies to cardiolipin.
- Lupus anticoagulant.

- Risk factors for thrombosis and thromboembolism:
- Smoking at the age of 35 years.
- Obesity.

Pregnancy and Breastfeeding

During pregnancy and lactation the use of the drug Midiana is contraindicated. If the pregnancy occurred on the background of hormonal contraception, immediate withdrawal of the drug is necessary.

The few data available on the unintentional use of combined oral contraceptives indicate a lack of teratogenic effect and an increased risk for children and women during labor.

Combined oral contraceptives affect lactation, can reduce the amount and change the composition of breast milk. Small amounts of hormonal contraceptives or their metabolites are found in milk during hormonal contraception and can affect the baby.The use of combined oral contraceptives is possible after complete cessation of breastfeeding.

Dosage and administration

Tablets should be taken every day at about the same time, if necessary, with a small amount of liquid, in the order indicated on the blister pack. It is necessary to take 1 pill per day for 21 days in a row. Acceptance of pills from each subsequent package should begin after a 7-day interval in the intake of tablets, during which, usually, menstrual-like bleeding occurs. It usually begins 2-3 days after taking the last pill and may not end by the time the next pack starts.

- If previously hormonal contraceptives were not used (in the last month) Reception of combined oral contraceptives begins on the 1st day of a woman’s natural menstrual cycle (that is, on the 1st day of menstrual bleeding).

- In case of replacement of another combined oral contraceptive, vaginal ring or transdermal patch. It is preferable to start taking the drug Midiana the next day after taking the last active pill of the previous combined oral contraceptive; in such cases, Median should not be taken later than the next day after the usual interruption in taking the pills or taking the inactive pills of her previous combined oral contraceptive.When replacing the vaginal ring or transdermal patch, taking the oral contraceptive Midiana is advisable to begin on the day the previous remedy is removed; in such cases, taking Median should begin no later than the day of the scheduled replacement procedure.

- In case of replacement of the method with the use of progestins only (mini-pilli, injection forms, implants) or intrauterine contraceptives with the release of progestins. - from the day when the next injection was to be given). However, in all these cases, it is desirable to use an additional barrier method of contraception during the first 7 days of taking the pills.

- After termination of pregnancy in the first trimester. A woman can start taking immediately. Under this condition, there is no need for additional contraceptive measures.

- After childbirth or termination of pregnancy in the second trimester. It is desirable for a woman to start taking the drug Midiana on the 21-28th day after giving birth or terminating a pregnancy in the second trimester. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. In the case of sexual contact, pregnancy should be excluded or the first menstruation should be avoided before taking the drug.

- Acceptance of missed pills If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. A woman needs to take a pill as soon as possible, the following pills are taken at the usual time.If the delay in taking the pills is more than 12 hours, contraceptive protection can be reduced. Tactics for skipping the drug is based on the following two rules:
- Do not stop taking pills for more than 7 days.
- To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary 7 days of continuous administration of tablets.

- Week 1 You need to take the last missed pill as soon as possible, even if it means taking two pills at the same time. The next pill is taken at the usual time. Additionally, a barrier method of contraception should be used over the next 7 days. If sexual intercourse took place within 7 days before the pill is missed, the likelihood of pregnancy should be considered. The more pills missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.

- Week 2 You need to take the last missed pill as soon as possible, even if it means taking two pills at the same time. The next pill is taken at the usual time. If a woman has taken the pills correctly for the previous 7 days, there is no need to use additional contraceptives. However, if she missed more than 1 pill, additional contraceptive measures should be used in the next 7 days.

- Week 3 The probability of reducing the contraceptive effect is significant due to the upcoming 7-day break in the pill. However, by adjusting the schedule for taking the pills, it is possible to prevent a decrease in contraceptive protection.If you follow any of the following two tips, you will not need additional contraceptive methods if a woman has taken all of the pills correctly during the previous 7 days before skipping the pill. If this is not the case, she should follow the first of the two methods and also use additional contraceptive measures for the next 7 days.
- You must take the last missed pill as soon as possible, even if it means taking two pills at the same time. The next pill is taken at the usual time. Taking the pills from the new package should be started as soon as the current package is finished, that is, without a break between taking two packages. Most likely, the withdrawal bleeding will not be until the end of the second package, but there may be spotting or breakthrough uterine bleeding on the days of taking the pills.
- A woman may be recommended to stop taking pills from this package. Then you must stop taking the pills for 7 days, including the days when she forgot to take the pills, and then start taking the pills from the new package.

In case of missing a pill and the absence of the withdrawal bleeding interval from the first drug free, it is necessary to exclude pregnancy.

- Gastrointestinal Disorders In the event of severe reactions from the gastrointestinal tract (such as vomiting or diarrhea), absorption may be incomplete and additional contraceptive measures must be taken.In case of vomiting within 3-4 hours after taking the pill, it is necessary to take a new replacement pill as soon as possible. A new pill, if possible, must be taken within 12 hours after the usual time taken. If you miss more than 12 hours, if possible, you must follow the rules of taking the drug.

- Taking the missed pills If the patient does not want to change the normal mode of taking the drug, she must take an additional pill (or several pills) from another package.

- How to delay bleeding "cancellation" To postpone the start of withdrawal bleeding, you must continue taking the drug Midiana from the new package without interruption in the reception. Delay is possible until the end of the pills in the second package. Slow bleeding from the vagina or breakthrough uterine bleeding may occur during the lengthening cycle. Resume taking the drug Midiana from a new pack should be after the usual 7-day break. To transfer the day of the onset of withdrawal bleeding to another day of the week on a regular schedule, shorten the next break in taking the pills by as many days as necessary. The shorter the interval, the higher the risk that there will be no bleeding, and while taking the pills from the second package, there will be spotting bleeding and breakthrough uterine bleeding (as well as in the case of delaying the onset of "withdrawal" bleeding).

Side effects during the simultaneous use of drospirenone and ethinyl estradiol were reported with the following frequency:

- Often (? 1/100,