Cyproterone 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

Stragen UK Ltd

ATC code:

G03HA01

INN (International Name):

Cyproterone acetate

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402; GTIN: 5060098730000 5060098730017

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CYPROTERONE ACETATE 50 MG TABLETS
(cyproterone acetate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others; it may harm them, even if their symptoms are
the same as yours.
• If 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 Cyproterone Acetate tablets are and what they are
used for
2. What you need to know before you take Cyproterone
Acetate tablets
3. How to take Cyproterone Acetate tablets
4. Possible side effects
5. How to store Cyproterone Acetate tablets
6. Contents of the pack and other information
1. WHAT CYPROTERONE ACETATE TABLETS ARE AND
WHAT THEY ARE USED FOR
Cyproterone
Acetate
tablets
are
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.
Cyproterone Acetate tablets are used in men to treat prostate
cancer and to control sexual desire in men who have an
increased sex drive (hypersexuality) and/or sexual deviation.
THIS MEDICINE IS USED:
1. to reduce the possible worsening of the disease which may
occur when you start other treatments used for prostate
cancer.
2. for long term treatment of prostate cancer when surgery or
other medicines are not suitable.
3.
to treat hot flushes which may occur during treatments with
other medicines used for prostate cancer or following
surgery.
4. 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
CYPROTERONE ACETATE TABLETS
Your doctor may ask you to sign a witnessed agreement to
treatme

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cyproterone Acetate 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyproterone acetate.
Excipient with known effect
lactose 104.447 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
The tablets are white, round, scored on one side and embossed “50”
on the reverse
side
4.1
THERAPEUTIC INDICATIONS
For control of libido in severe hypersexuality and/or sexual deviation
in the
adult male.
Management of patients with prostatic cancer (1) to suppress "flare"
with
initial LHRH analogue therapy,(2) in long-term palliative treatment
where
LHRH analogues or surgery are contraindicated, not tolerated, or where
oral
therapy is preferred, and (3) in the treatment of hot flushes in
patients under
treatment with LHRH analogues or who have had orchidectomy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Control of libido in severe hypersexuality and/or sexual deviation.
_Adults and the elderly:_
The usual dose is started with 1 tablet Cyproterone Acetate 50 mg
twice daily.
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. The daily dose should be divided and taken
after
the morning and evening meals.
The management of patients with prostatic cancer
The maximum daily dose is 300mg
_ADULTS AND THE ELDERLY:_
To suppress "flare" with initial LHRH Analogue therapy: Initially 2
tablets of
Cyproterone Acetate 50 mg twice daily (200 mg) alone for 5-7 days,
followed
by 2 tablets of Cyproterone Acetate 50 mg twice daily (200 mg) for 3-4
weeks
together with the LHRH analogue therapy in the dosage recommended by
the
marketing authorization holder (see SmPC of LHRH analogue)..
In
long
term
palliative
treatment
where
LHRH
analogues
or
surgery
are
contraindicated, not tolerated, or w