Androcur 10mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cyproterone (cyproterone acetate)

Available from:

Bayer Weimer GmbH und Co.KG

ATC code:

G03HA01

INN (International Name):

cyproterone (cyproterone acetate)

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(15/1x15/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-04-14

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Androcur
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Cyproterone acetate
One tablet contains 10 mg cyproterone acetate (CPA).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to pale yellow tablets with a breaking score line on one side
and embossed with ‘BW’ in a
regular hexagon on the other. The score line is to break the tablet
for ease of swallowing; not to
divide the tablet into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of pronounced signs of virilisation in women, which make
hormone therapy necessary:
-
severe forms of acne, when it is accompanied by inflammation and the
formation of nodes (Acne
papulopustulosa, Acne nodulocystica) or if there is a risk of
scarring,
-
moderate to severe forms of hirsutism,
-
moderate to severe forms of androgenic alopecia,
when CPA has not proved to be effective from a medical point of view
at a lower dose as part of a
low-dose cyproterone acetate-oestrogen combination 2 mg/0.030 mg or 2
mg/0.035 mg (combined
oral contraceptive ‘pill’) or when another anti-androgen therapy
has not been effective. When
treating acne, hormone treatment should be weighed against systemic
antibiotic treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _
Oral administration
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_Dosage _
Pregnant women may not take Androcur. Consequently, pregnancy has to
be excluded prior to the
start of therapy (see section 4.4). Androcur 10 mg has to be used in
combination with a suitable
oestrogen or a suitable progestogen-oestrogen combination (combined
oral contraceptive ‘pill’), in
order to ensure necessary contraceptive protection and to avoid
irregular bleeding.
This combination therapy shall be carried out as follows:
Both products have to be started on day 1 of the cycle (day 1 of
menstruatio