Cyproterone 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

A A H Pharmaceuticals 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: 5025903006039

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 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg cyproterone acetate.
Excipient with known effect : lactose 208.894mg.
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White oblong tablets, with a break bar on both sides, embossed
“C1” on one
side..
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
_Posology : _
_Adults_
The maximum daily
dose is 300 mg.
For long-term palliative treatment where LHRH analogues or surgery are
contraindicated, not tolerated, or where oral therapy is preferred the
dosage is 200-300 mg/day.
Dosage for suppression of "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 authorisation holder (see
SmPC of LHRH analogue).
For the above two indications the dosage should be divided into 2 - 3
doses
per day and taken with some liquid after meals.
For the treatment of hot flushes in patients under treatment with LHRH
analogues
or
who have had orchidectomy a 50 mg starting dose, with
upward
titration
if
necessary
within
the
range
50-150
mg/day,
is
recommended. For this indication the dosage should be divided into
1 - 3 doses per day and taken with some liquid after meals.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS
_Paediatric population: _Cyproterone Acetate is not recommended for
use i