Androcur 50mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Cyproterone acetate

Tilgængelig fra:

Bayer Plc

ATC-kode:

G03HA01

INN (International Name):

Cyproterone acetate

Dosering:

50mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 08030402; GTIN: 5016703002956 5010605333156

Indlægsseddel

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.
For reduction of drive in sexual deviations, you
should only take cyproterone acetate 50 mg, if
your doctor considers that other interventions
are inappropriate.
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 with a meningioma (a
generally benign tumour of the tissue layer
between the brain

Produktets egenskaber

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.
For reduction of drive in sexual deviations in men, cyproterone
acetate 50 mg can be
used when other interventions are considered inappropriate.
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. The duration of cyproterone acetate
treatment should be
defined on an individual basis. When a satisfactory result has been
achieved, the
therapeutic effect should be maintained with the lowest possible dose.
When changing
the dose or when discontinuing cyproterone acetate, this should be
done 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 sec