Cyproterone 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

Kent Pharma (UK) Ltd

ATC code:

G03HA01

INN (International Name):

Cyproterone acetate

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402; GTIN: 5015201009016

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 100 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg cyproterone acetate.
Excipient: Lactose monohydrate.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Uncoated tablet.
White, capsule shaped tablet with a breakline on one side and ‘CPA
100’
marked on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 where 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.
_Adults and the elderly: _
The maximum daily dose is 300mg
To suppress "flare" with initial LHRH Analogue therapy: : Initially 1
tablet of
Cyproterone Acetate 100 mg twice daily (200 mg) alone for 5-7 days,
followed by 1
tablet of Cyproterone acetate 100 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 when oral therapy is preferred: 200
- 300 mg/day.
For the above two indications the dosage should be divided into 2-3
doses per day
and taken after meals.
In the treatment of hot flushes in patients under treatment with LHRH
analogues or
who have had an orchidectomy: 50 mg starting dose with upward
titration if
necessary within the range 50-150mg/day. For this indication the
dosage should be
divided into 1-3 doses per day and taken after meals
_Children: _
Its use is not recommended in children and adolescents (under 18
years).
Additional information on special population (applies to all
indicat