ANDROCUR 50MG TABLET

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

CYPROTERONE ACETATE

Verfügbar ab:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

CYPROTERONE ACETATE

Einheiten im Paket:

50Tablet Tablets

Hergestellt von:

Bayer Weimar GmbH und Co. KG

Fachinformation

Androcur ®
50mg
Tablets 1. NAME OF THE MEDICINAL PRODUCT
Androcur 50
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyproterone acetate.
For full list of excipients, see section ‘List of excipients’.
3. PHARMACEUTICAL FORM
Tablet.
White to faintly yellowish tablets, scored on one side, with an embossed "BV" in a regular hexagon on the other side. The
tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 Indication(s)
► Indications in the woman
Severe signs of androgenization, e.g. very severe hirsutism, severe androgenetic alopecia, often attended by severe forms
of acne and/or seborrhoea.
► Indications in the man
Reduction of drive in sexual deviations in men.
Antiandrogen treatment in inoperable carcinoma of the prostate.
4.2 Dosage and method of administration
Method of administration
Oral use
Dosage regimen
The tablets are to be taken with some liquid after meals.
The maximum daily dose is 300 mg.
► Dosage in the women
Pregnant women must not take Androcur 50. Therefore, pregnancy must be excluded before the start of therapy.
In women of childbearing age, the treatment is commenced on the 1st day of the cycle (= 1st day of bleeding).
Two Androcur 50 tablets are to be taken daily from the 1st to the 10th day of the cycle. In addition, these women receive a
progestogen-estrogen-containing preparation, e.g. from the 1st to the 21st day of the cycle 1 tablet Diane-35 daily, to
provide the necessary contraceptive protection and to stabilize the cycle.
Women receiving the cyclical combined therapy should keep to a particular time of the day for tablet-taking.
A 7-day tablet-free interval is observed after 21 days, during which time a withdrawal bleeding occurs. Exactly 4 weeks after
the first course of treatment was started, i. e. on the same day of the week, the next cyclical course of combined treatment is
started, regardless of whether bleeding has stopped or not.
Reference : Androcur 50 / 50 mg Tablets (for use in men) / CCDS / Version 13 / 13 Jun 2017