Cyproterone Acetate

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

CYPROTERONE ACETATE

זמין מ:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

קוד ATC:

G03HA01

INN (שם בינלאומי):

CYPROTERONE ACETATE 50 mg

טופס פרצבטיות:

TABLET

הרכב:

CYPROTERONE ACETATE 50 mg

סוג מרשם:

POM

איזור תרפויטי:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

מצב אישור:

Withdrawn

תאריך אישור:

2006-08-23

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER 
CYPROTERONE ACETATE 50MG TABLETS 
CYPROTERONE ACETATE 100MG TABLETS 
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 further questions, please ask your doctor or your
pharmacist. 
- This medicine has been prescribed for you personally and you
should 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. 

IN THIS LEAFLET: 
1. What Cyproterone Tablets are and what they are used for 
2. What you need to know before you take Cyproterone Tablets 
3. How to take Cyproterone Tablets 
4. Possible side effects 
5. How to store Cyproterone Tablets 
6. Contents of the pack and other information 

1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY ARE USED FOR 

Cyproterone acetate belongs to a group of medicines called
anti-androgens. These medicines 
work by blocking the actions of male sex hormones (androgens)
and reducing the amount of 
male sex hormones produced by the body. 

Cyproterone Tablets are used either on
their own or in conjunction with other hormone 
treatments to treat patients with certain prostate gland
problems. 

2. WHAT YOU NEED TO
KNOW BEFORE YOU TAKE CYPROTERONE TABLETS 

DO NOT TAKE CYPROTERONE TABLETS: 
• if you have ever been diagnosed with meningioma
(a generally benign tumour of the tissue 
layer between the brain and the skull). You should ask your
physician if you are in doubt. 
• if you are allergic to cyproterone acetate or any of the
other ingredients of this medicines 
(listed in section 6)  
• suffer from

מאפייני מוצר

 
1 

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Cyproterone acetate 50mg tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION

Cyproterone acetate 50mg 

For excipients, see 6.1. 

3 
PHARMACEUTICAL FORM

Tablet  

For oral administration 

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 

(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 

For use only in the adult male. 

(1) 
To suppress “flare” with initial LHRH analogue therapy: 

300 mg/day which may be reduced to 200 mg if the higher dose is
not 
tolerated 

(2) 
In long-term palliative treatment where LHRH analogues or
surgery are 

contraindicated, not tolerated, or where oral therapy is
preferred: 

200-300 mg/day 

(3) 
In the treatment of hot flushes in patients under treatment
with LHRH 
analogues or who have had orchidectomy: 

2 

50 mg starting dose with upward titration if necessary within the
range 
50-150 mg/day 

_Elderly men: _The dosage is dependent on the clinical indication
and not the age 
of the patient, although greater monitoring for
possible adverse effects may be 
necessary in the elderly. 
_ _
4.3 
CONTRAINDICATIONS 
_ _
Must not be used in patients with meningioma or
a history of meningioma. 
Hypersensitivity to the active substance or to any of the
excipients listed in 
section 6.1. 
Liver disease (including Dubin-Johnson syndrome and Rotor
syndrome) 
Malignant or wasting diseases (except
for prost