Cyproterone 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

Phoenix Healthcare Distribution 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CYPROTERONE ACETATE 50 MG & 100 MG TABLETS
(cyproterone acetate)
The name of this medicine is Cyproterone Acetate 50 mg and 100 mg
Tablets, which will
be referred to as Cyproterone Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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 any of the side effects gets serious, or if you notice any side
effects not listed in the leaflet
please tell your doctor or pharmacist. See section 4
IN THIS LEAFLET
1. What Cyproterone Tablets are and what they are used for
2. Before you take Cyproterone Tablets
3. How to take Cyproterone Tablets
4. Possible side effects
5. How to store Cyproterone Tablets
6. Further Information 1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is cyproterone acetate, which
belongs to a group of medicines
called anti-androgens. These work by blocking the actions of male sex
hormones (androgens) which
are released naturally in your body. They also reduce the production
of androgens.
It has been shown that the growth of tumours of the prostate gland may
be dependent on male
hormones. Since cyproterone acetate blocks the action of androgens and
reduces the amount of
androgens produced by the body, it can be used to help relieve the
symptoms of a tumour of the
prostate gland.
It can also be taken by males to control an over active sex drive. 2. BEFORE YOU TAKE CYPROTERONE TABLETS
DO NOT TAKE CYPROTERONE TABLETS IF YOU:
• ARE ALLERGIC (HYPERSENSITIVE) to cyproterone acetate, or any of
the OTHER INGREDIENTS in
Cyproterone Tablets (these are listed in section 6, Further
Information)
• ARE UNDER 18 YEARS OF AGE
• HAVE EVER BEEN DIAGNOSED WITH A MENINGIOMA (a generally benign
tumor of the tissue
layer be

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: Lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Uncoated tablet.
White, circular shaped tablet with a central breakline on one side and
plain on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For control of libido in severe hypersexuality and/or sexual deviation
adult
male.
For the 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 oral
therapy is preferred, and (3) in the treatment of hot flushes in
patients under
treatment with LHRH analogues or who have had an 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
cont