Androcur 50mg Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CYPROTERONE ACETATE

Inapatikana kutoka:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC kanuni:

G03HA01

INN (Jina la Kimataifa):

CYPROTERONE ACETATE 50 mg

Dawa fomu:

TABLET

Tungo:

CYPROTERONE ACETATE 50 mg

Dawa ya aina:

POM

Eneo la matibabu:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2007-02-06

Taarifa za kipeperushi

PACKAGING TECHNOLOGY BERLIN SGQWX
page 1
Bayer AG
client: JS86
material-no.: 85993399
PZ: 2599F-4A
code-no.: 228
name: LF-ANDROCUR 50MG TAB GB
country: GB/-/BAG
colors: BLACK
version: 21.07.2017/01
Restricted Document
dimension: 160 X 594 MM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
RKeep this leaflet. You may need to read it
again.
RIf you have any further questions, ask your
doctor or pharmacist.
RThis medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
RIf you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT ANDROCUR IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ANDROCUR
3. HOW TO TAKE ANDROCUR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ANDROCUR
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT ANDROCUR IS AND WHAT
IT IS USED FOR
WHAT IS ANDROCUR?
Androcur is a medicine containing cyproterone
acetate. It is an anti-androgen therapy. It
blocks the actions of male sex hormones
(androgens) and reduces the amount of male
sex hormones produced by the body.
WHAT IS ANDROCUR USED FOR?
Androcur is used to control sexual desire in
men who have an increased sex drive
(hypersexuality) and/or sexual deviation.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ANDROCUR
RYour doctor may ask you to sign a witnessed
agreement to treatment before prescribing
Androcur. You may also have a test to check
the number and function of your sperm
before you start treatment as Androcur can
affect this. The overall number of sperm you
produce will be reduced and more sperm
than usual will be abnormal in shape.
DO NOT TAKE ANDROCUR
If you have:
Rliver diseases (including previous or existing
liver tumours, Dubin-Johnson syndrome or
Rotor syndrome)
Rany type of cancer (other than cancer of the
prostate gland)
Rever been diagnosed wi

Tabia za bidhaa

V017_0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Androcur 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyproterone acetate.
Excipient with known effect: lactose 108.75 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round tablet, scored on one side and embossed with the letters
“BV” in a regular
hexagon on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Control of libido in severe hypersexuality and/or sexual deviation in
the adult male.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Generally, treatment is started with 1 tablet Androcur 50 mg twice
daily, after the morning and
evening meals. When a satisfactory result has been achieved, one
should try to maintain the
therapeutic effect with the lowest possible dose. When establishing
the maintenance dose or
when discontinuing the preparation, it is recommended to reduce the
dose gradually.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS
_Paediatric population_
Androcur is not recommended for use in male children and adolescents
below 18 years of age
due to a lack of data on safety and efficacy.
Androcur must not be given before the conclusion of puberty since an
unfavourable influence
on longitudinal growth and the still unstabilised axes of endocrine
function cannot be ruled out.
_Older people_
There are no data suggesting the need for a dosage adjustment in
elderly patients.
_Patients with hepatic impairment:_
The use of Androcur is contraindicated in patients with liver diseases
(see section 4.4 and 4.8).
_Patients with renal impairment:_
The use of Androcur in patients with renal impairment has not been
investigated. There are no
data suggesting the need for dosage adjustment in patients with renal
impairment (see section
5.2).
V017_0
2
Method of administration
The tablets are to be taken with some liquid after meals.
For oral administration.
4.3
CONTRAINDICATIONS
Androcur must not be used in patients with:
Hypers