Diane 35

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cyproterone (cyproterone acetate), ethinylestradiol

Available from:

Bayer Pharma AG

INN (International Name):

cyproterone (cyproterone acetate), ethinylestradiol

Dosage:

2mg+0,035mg

Pharmaceutical form:

dragee

Prescription type:

Prescription

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Diane-35, 0.035 mg/2 mg dragee
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: ethinylestradiol/cyproterone acetate
Each coated tablet contains 0.035 mg of ethinylestradiol and 2 mg of
cyproterone acetate.
Excipients:
Lactose monohydrate 31 mg, sucrose 19 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dragee
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe acne due to androgen sensitivity (with
or without seborrhoea) and/or
hirsutism in women of childbearing age.
Diane-35 should be used only after the failure of topical therapy or
systemic antibiotic treatments for
acne therapy.
As Diane-35 is also a hormonal contraceptive, it must not be used in
combination with other hormonal
contraceptives (see section 4.3).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Diane-35 inhibits ovulation and thereby has a contraceptive effect.
Patients who are using Diane-35
should, therefore, not use an additional hormonal contraceptive, since
this leads to an overdose of
hormones and is not necessary for effective contraceptive protection.
For the same reason, women who desire to become pregnant should not
use Diane-35. Diane-35 must
be taken regularly in order to develop an adequate therapeutic
efficacy and effective contraceptive
protection.
Method of administration
Oral use
2
Posology
Tablets must be taken in the order directed on the package every day
at about the same time with some
liquid as needed. One tablet is to be taken daily for 21 consecutive
days. Each subsequent pack is
started after a 7-day tablet-free interval, during which withdrawal
bleeding usually occurs, which often
starts on the 2nd-3rd day after taking the last tab