ANDROCUR 10 mg TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CYPROTERONE ACETATE 10 mg

Authorization status:

Registered

Authorization date:

1990-07-04

Patient Information leaflet

APPLICANT: BAYER (PTY) LTD
PRODUCT NAME: Androcur 10 mg
DOSAGE FORM: Tablet
STRENGTHS: 10, 0 mg
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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
ANDROCUR 10 MG TABLETS
cyproterone acetate
Contains sugar – 59,9 mg lactose per tablet
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ANDROCUR 10 MG.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
ANDROCUR 10 mg has been prescribed for you personally and you should
not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What ANDROCUR 10 mg is and what it is used for
2.
What you need to know before you take Androcur 10mg
3.
How to take ANDROCUR 10 mg
4.
Possible side effects
5.
Contents of the pack and other information
1.
WHAT ANDROCUR 10 MG IS AND WHAT IT IS USED FOR:
ANDROCUR 10 mg is a hormone preparation that blocks the effect of
androgens, which are sex hormones
produced mainly in males but also – to a lesser extent – in
females. The active substance is cyproterone
acetate.
In addition to ANDROCUR 10 mg, your doctor will prescribe a
progestogen-oestrogen contraceptive to
provide contraceptive protection and cycle stabilisation. For the
duration of ANDROCUR therapy women
of child-bearing age must also receive a combination oral
contraceptive. During combined treatment
ovarian function is blocked. These changes are reversible after
stopping treatment.
ANDROCUR 10 mg tablets are used for moderately severe signs of
androgenisation, such as:
•
moderately severe hirsutism (increased facial and body hair)
•
moderately
severe
androgen-dependent
loss
of
scalp
hair
(moderately
severe
androgenetic
alopecia),
•
severe and moderately severe forms of acne and/or seborrhoea.
APPLICANT: BAYER (PTY) LTD
PRODUCT NAME: Androcur 10 mg
DOSAGE FORM: Tablet
STRENGTHS: 10, 0 mg
CCPI 10 /14.02.12/SA 2/12.2021 Page
2
of
8
variation 3082; 4801
2.
W

Summary of Product characteristics

APPLICANT: BAYER (PTY) LTD
PRODUCT NAME: ANDROCUR 10 mg
DOSAGE FORM: Tablet
STRENGTHS: 10,0 mg
CCDS10 /14.02.12/SA3 /12.2021 Page
1
of
9
variation 3082/4801
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1 NAME OF MEDICINE
ANDROCUR 10 mg
Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each ANDROCUR 10 mg tablet contains cyproterone acetate 10 mg.
Contains 59,9 mg lactose per tablet (see section 4.4).
For full list of excipients see “section 6.1”
3 PHARMACEUTICAL FORM
White to faintly yellowish tablets, scored on one side, with an
embossed "BW" in a regular hexagon on the
other side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal
doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderately severe signs of androgenisation in women of child-bearing
age, e.g.:
•
moderately severe forms of hirsutism.
•
moderately severe androgen-dependent loss of scalp hair (moderately
severe androgenetic alopecia).
•
severe and moderately severe forms of acne and seborrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Pregnant women must not take ANDROCUR, pregnancy must be excluded.
For the duration of ANDROCUR therapy women of child-bearing age must
also receive a combination oral
contraceptive. This will provide the necessary contraceptive
protection and will stabilise the menstrual
cycle. Dosage and directions for use as per the package insert of that
product should be strictly adhered to.
APPLICANT: BAYER (PTY) LTD
PRODUCT NAME: ANDROCUR 10 mg
DOSAGE FORM: Tablet
STRENGTHS: 10,0 mg
CCDS10 /14.02.12/SA3 /12.2021 Page
2
of
9
variation 3082/4801
Prior to commencing ANDROCUR treatment it is always necessary for the
patient to receive one complete
cycle of a combination oral contraceptive.
Extra non-hormonal methods (with the exception of the rhythm and
temperature methods) should be
employed during the first 3 weeks of the first cycle, which may be
shorter than 4 weeks. Subsequent cycles
should then be regular.
In the subsequent cycle of the combin