Instruction for use: Diane-35

Active substance: Cyproterone + Ethinylestradiol

ATX code G03HB01 Cyproterone and estrogen

Pharmacological group

Contraceptive agent (estrogen + antiandrogen) [Estrogens, gestagens; Their homologues and antagonists in combinations]

Contraceptive agent (estrogen + antiandrogen) [Androgens, antiandrogens in combinations]

Nosological classification (ICD-10)

L21 Seborrheic dermatitis

Dermatitis seborrheic, Increased sebum separation, Seborrheic Eczema, Seborrheic dermatitis of the scalp, Seborrheic pyodermatitis, Seborrhea, Eczema seborrheic

L64 Androgenic alopecia

Alopecia androgenic, Androgenetic alopecia, Androgenic alopecia of moderate severity, Severe Androgen-Dependent Alopecia, Male pattern hair loss

L68.0 Hirsutism

Pathological hair body and body

L70 Acne

Acne nodulocystica, Acne, Comedone acne, Acne Treatment, Papulous pustular acne, Papulopustulicular acne, Papulo-pustular acne, Acne, Acne Disease, Acne, Acne vulgaris, Nodular-cystic acne, Nodular-cystic acne

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition

Dragee 1 dragee

active substance:

Cyproterone acetate 2 mg

Ethinylestradiol 0.035 mg

Auxiliary substances: lactose monohydrate - 31,115 mg; Corn starch - 18 mg; Povidone - 2,1 mg; Magnesium hydrosilicate (talc) - 1.65 mg; Magnesium stearate 0.1 mg

Shell: sucrose - 19.371 mg; Povidone 700,000 - 0.189 mg; Macrogol 6000 - 2,148 mg; Calcium carbonate - 8.606 mg; Magnesium hydrosilicate (talc) - 4.198 mg; Titanium dioxide - 0.274 mg; Glycerol 0.137 mg; Wax mountain glycolic - 0.05 mg; Iron (II) oxide - 0.027 mg

pharmachologic effect

Pharmacological action - contraceptive, gestagenic, antiandrogenic, estrogenic.

Dosing and Administration

Inside.

When and how to take pills

To achieve therapeutic effect and ensure the necessary contraception should take the drug Diane-35® on a regular basis. If any other hormonal contraceptive was used before the Diane-35® drug was taken, its reception should be discontinued. The dosing regimen of Diane-35® coincides with the dosage regimen of most oral contraceptives. Thus, the administration of Diane-35® is subject to the rules for taking other oral contraceptive drugs (CPC). Irregular intake of the drug Diane-35® can lead to acyclic bleeding, a decrease in the therapeutic effect and contraceptive effectiveness. When used correctly, Perl's index (an indicator that reflects the frequency of pregnancy in 100 women during the year of contraceptive use) is approximately 1.

The calendar pack of Diane-35® contains 21 tablets. In the package, each dragee is marked with the day of the week in which it should be taken. You should take the pills at the same time every day, washing down with a small amount of water. It is necessary to follow the direction of the arrow until all the pills are taken. During the next 7 days the patient does not take the drug. The withdrawal bleeding should begin within these 7 days. Usually it starts on the 2nd-3rd day after the last drug of Diane-35®. After a 7-day break, you must start taking the dragee from the next package, even if the bleeding has not stopped. This means that the patient will always start a new package on the same day of the week, and that every month the withdrawal bleeding will occur approximately on the same day of the week.

Initiation of Diane-35®:

- when no hormonal contraceptive was used in the previous month.

Diane-35® begins on the first day of the menstrual cycle (ie on the first day of menstrual bleeding). You should take a pills, which is marked with the corresponding day of the week. For example, if the menstrual cycle started on Friday, you should take a tablet with the Fri mark. Then the dragees should be taken in order. The effect of the drug Diane-35® will begin immediately after the first pills are taken, without the need for additional contraceptive methods;

It is allowed to start taking the menstrual cycle on the 2nd-5th day, but in this case it is recommended to additionally use the barrier method of contraception during the first 7 days of taking the pills from the first package

- when switching from PDA, vaginal ring or contraceptive patch. It is preferable to start taking the drug Diane-35® the day after the last active pills were taken from the previous package, but in no case later than the day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive dragee For preparations containing 28 dragees in a package). Diane-35® should be taken on the day of removal of the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is stuck;

- when switching from contraceptives containing only gestagens (mini-pili, injection molds, implant). A woman can switch from a mini-drink to a Diane-35® drug on any day (without a break), from the implant - on the day of its removal, from the injection form - from the day that the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills;

- when switching from an injectable contraceptive, an implant or with a progestogen releasing intrauterine therapeutic system (Mirena). Start the Diane-35® on the same day that the next injection is to be made, or the day the implant or intrauterine contraceptive is removed. During the first 7 days of taking the pills, it is also necessary to use the barrier method of contraception.

- After abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection;

- after a spontaneous abortion or abortion. You should consult your doctor.

- after childbirth or abortion in the second trimester of pregnancy. A woman should be recommended to begin taking the drug on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. If the woman has already lived a sexual life, before the start of taking the drug Diane-35® pregnancy should be excluded or it is necessary to wait for the first menstruation.

Acceptance of missed dragees. If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. A woman should take the pills as soon as possible, the next one is taken at the usual time.

If the delay in taking the dragee is more than 12 hours, the contraceptive protection can be reduced. The more pills are missed, and the closer the pass to the 7-day break in taking the pills, the greater the probability of pregnancy. In this case, you can follow the following two basic rules:

- taking the drug should never be interrupted for more than 7 days;

- 7 days of continuous reception of dragees are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

If the delay in taking the dragees was more than 12 hours (the interval from the moment of reception of the last dragee is more than 36 hours), the following tips can be given.

The first and second week of taking the drug

The woman should take the last missed pills as soon as possible (even if it means taking two pills at the same time). The next dragee is taken at the usual time. In addition, a barrier method of contraception (eg a condom) should be used for the next 7 days. If sexual intercourse took place during the week before skipping the dragees, the probability of pregnancy should be taken into account. The more pills are missed, and the closer this pass to the 7-day break in taking the pills, the higher the risk of pregnancy.

The third week of taking the drug

The risk of pregnancy is increased due to the upcoming interruption in taking the pills, however if within 7 days preceding the first missed pellet, all pills were taken correctly, there is no need to use additional contraceptive methods.

1. A woman should take the last missed pills as soon as possible (even if this means taking two pills simultaneously). The next dragee is taken at the usual time. In addition, a barrier method of contraception (eg a condom) should be used for the next 7 days. In addition, the reception of a dragee from a new package should be started as soon as the current packaging is finished, i. E. nonstop. Most likely, a woman will not have withdrawal bleeding until the end of the second package, but she may have spotting spotting or breakthrough uterine bleeding on the days of taking the pills.

2. A woman can also interrupt the reception of pills from the current package. Then she should take a break for 7 days, including the day of skipping the dragees and then start accepting the new package.

If the woman missed taking the pills, and then in the first normal interval from the intake of the drug interval, she does not have a withdrawal bleeding, it is necessary to exclude pregnancy.

Recommendations for gastrointestinal disorders

If a woman has vomiting or diarrhea within 3 to 4 hours after taking the pills, the absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on recommendations when skipping the dragees.

Postponement of menstrual bleeding

In order to delay the onset of menstruation, a woman should continue taking the pills from a new package of Diane-35® immediately after taking all the pills from the previous one without taking a break. Dragee from this new package can be taken for as long as the woman wishes (until the package is finished). Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Renewal of Diane-35® from the new package follows the usual 7-day break.

Change in the day of menstrual bleeding

In order to postpone the day of the onset of menstruation on the next day of the week, the woman should be recommended to shorten the nearest break in taking the dragees for as many days as she wants. The shorter the interval, the higher the risk that there will be no withdrawal bleeding and thereafter there will be spotting and breakthrough bleeding during the reception of the second package (as well as in case she would like to delay the onset of menstruation).

Duration of application

The duration of taking the pills depends on the severity of the symptoms of androgenation and the response to treatment. Basically, the treatment is carried out for several months. The answer to the treatment of acne and seborrhea usually occurs faster than the response to the treatment of hirsutism or alopecia. It is recommended to take the drug at least 3-4 courses after the disappearance of signs of the disease. In case of recurrence of the disease in a few weeks or months after stopping the taking of the pellet, treatment with Diane-35® can be resumed. If the drug is resumed (after a 4-week break or more), an increased risk of VTE should be considered.

Additional information for some patient groups

Children and teenagers. The drug Diane-35® is shown only after the onset of menarche.

Patients of advanced age. Not applicable. The drug Diane-35® is not indicated after the onset of menopause.

Patients with impaired liver function. The drug Diane-35® is contraindicated in women with severe liver diseases until the liver function test results are normal.

Patients with impaired renal function. The drug Diane-35® was not specifically studied in patients with impaired renal function. The available data do not imply a change in treatment in such patients.

Form of issue

Dragee. For 21 dragees in a blister of PVC and aluminum foil. The blister is placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

storage conditions

At a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.