Cyprostat 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate

Available from:

Bayer Plc

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: 5012670300293 5010605333170

Patient Information leaflet

v023
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYPROSTAT® 50 MG TABLET
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 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 Cyprostat is and what it is used for
2.
What you need to know before you take Cyprostat
3.
How to take Cyprostat
4.
Possible side effects
5.
How to store Cyprostat
6.
Contents of the pack and other information
1.
WHAT CYPROSTAT IS AND WHAT IT IS USED FOR
WHAT IS CYPROSTAT?
Cyprostat 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 CYPROSTAT USED FOR?
Cyprostat 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 CYPROSTAT
DO NOT TAKE CYPROSTAT:
•
If you have liver diseases (including previous or existing liver
tumours (unless these are due to
secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome
or Rotor Syndrome)
•
If you have any type of cancer (except for cancer of the prostate
gland)
•
If you have ever been diagnosed with a meningioma (a generally benign
tumour of the tissue
laye

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cyprostat® 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white, scored tablet contains 50 mg cyproterone acetate.
Excipient with known effect
lactose 108.75 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round tablet, scored on one side and embossed with the letters
“BV” in a
regular hexagon on the other 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 2 tablets of Cyprostat 50 mg twice daily (200 mg) alone for
5 - 7 days,
followed by 2 tablets of Cyprostat 50 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: _Cyprostat is not recommended for use