Cyproterone 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

DE Pharmaceuticals

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYPROTERONE ACETATE 100 MG TABLETS
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 pharmacist.
• This 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.
• 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 100mg tablets is and what it is used for
2. What you need to know before you take Cyproterone Acetate 100mg
tablets
3. How to take Cyproterone Acetate 100mg tablets
4. Possible side effects
5. How to store Cyproterone Acetate 100mg tablets
6. Contents of the pack and other information
1. WHAT CYPROTERONE ACETATE TABLETS IS AND WHAT IT IS USED FOR
WHAT IS CYPROTERONE ACETATE TABLETS?
Cyproterone Acetate tablets 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 CYPROTERONE ACETATE TABLETS USED FOR?
Cyproterone Acetate tablets is used in men to treat prostate cancer.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYPROTERONE ACETATE TABLETS
DO NOT TAKE CYPROTERONE ACETATE TABLETS:
• If you have liver diseases (including previous or existing liver
tumours (unless these are due to secondary cancers
caused by prostate cancer), Dubin-Johnson

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