Diane-35 tablets coated

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

cyproterone (cyproterone acetate), ethinylestradiol

Disponible desde:

Bayer Weimar GmbH & Co. KG

Código ATC:

G03HB01

Designación común internacional (DCI):

cyproterone (cyproterone acetate), ethinylestradiol

Dosis:

2mg+ 0,035mg

formulario farmacéutico:

tablets coated

Unidades en paquete:

(21/1x21/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2019-09-23

Ficha técnica

1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diane-35, 0.035 mg/2 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: ethinylestradiol/cyproterone acetate
Each coated tablet contains 0.035 mg of ethinyl estradiol 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
Coated tablet, beige
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
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 tablet and can
continue until the next pack is started.
2
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Contraceptive protection starts on the first day the tablets are taken
and also continues during the 7
tablet-free days. The simultaneous use of hormonal con