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CYPROTERONE ACETATE TABLETS 50MG

Active substance(s): CYPROTERONE ACETATE

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Patient Information Leaflet for
Cyproterone Acetate 50mg Tablets
KEEP ALL MEDICATION OUT OF THE REACH AND SIGHT OF CHILDREN.
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET
CAREFULLY. This leaflet contains a summary of the information about your medicine,
Cyproterone Acetate Tablets 50 mg.
YOUR MEDICINE
Your medicine is in the form of a tablet. Each tablet contains 50 mg of the active ingredient,
Cyproterone Acetate. The tablet also contains lactose, maize starch, povidone, silicon dioxide
and magnesium stearate.
Cyproterone Acetate Tablets are available in blister packs containing 56 & 168 tablets. Your
pharmacist will dispense the number of tablets prescribed by your doctor.
HOW DOES YOUR MEDICINE WORK
Cyproterone acetate is a synthetic steroid which blocks the action of hormones called
androgens which are released naturally in your body. Cyproterone also reduces the production
of these hormones. Increased levels of androgens may cause or worsen several medical
conditions.
Product Licence Holder and Manufacturer: Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL.
WHY DO YOU NEED TO TAKE YOUR MEDICINE?
As Cyproterone Acetate Tablets can reduce the amount of androgens in the body, it can be
taken by males to control an overactive sex drive. Depending on the dose prescribed by your
doctor, it can also be used to help relieve the symptoms of a tumour in the prostate gland.
These symptoms may be as a result of the tumour itself or as a result of other medicines or
surgery used to treat the tumour.
WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?
Do not take this medicine and tell your doctor if:
• you are younger than 18 years
• you have liver disease
• you know you have tumours or have had tumours, other than in your prostate gland
• you have a wasting disease
• you have or have ever had a blood clot in a blood vessel (heart attack, stroke, deep venous
thrombosis, pulmonary embolism), or if anyone in your family has suffered from one of
these conditions at an early age
• you suffer from diabetes
• you have or someone in your family has sickle-cell anaemia




you suffer from, or have suffered from depression
you have taken Cyproterone, a similar medicine or any of the tablet ingredients before,
and suffered an unusual or allergic reaction to it
• you have an intolerance to some sugars, as this medicine contains lactose
Do not use Cyproterone Acetate if you have ever been diagnosed with a meningioma (a
generally benign tumor of the tissue layer between the brain and the skull). You should ask
your physician if you are in doubt.
Take special care if:
• you are planning a family or,
• you are an alcoholic
Tell your doctor or pharmacist if either of the above apply to you.
DO NOT drink alcohol whilst taking Cyproterone Acetate Tablets. DO NOT drive or operate
machinery if after taking the tablets you feel tired or weak.
WHILST TAKING YOUR TABLETS
Your doctor will give you regular blood tests to check your liver function while you are on
Cyproterone Acetate Tablets. Cyproterone Acetate Tablets may reduce the production of
sperm in males, but should not be used instead of contraception. Your doctor may check your
sperm count before and during treatment.
Tell your doctor immediately, if you suffer from severe pains in the chest or stomach.
HOW SHOULD YOU TAKE YOUR TABLETS?
Your doctor can only prescribe these tablets for you once he has explained what they do and
you have agreed to take them. Cyproterone Acetate Tablets should be taken after meals.
Adults including the Elderly – if you are taking Cyproterone Acetate Tablets for an
overactive sex drive, the usual dose is 50 mg (one tablet) twice a day.
If you are taking Cyproterone Acetate tablets to help relieve the symptoms of a prostatic
tumour the following doses may be given: To reduce the likelihood of a flare-up of a
prostatic tumour which sometimes occurs in the first few weeks of starting LHRH treatment
(eg. Buserelin Injection). The usual dose of Cyproterone Acetate is 300 mg (6 tablets) a day,
in two or three divided doses. If you suffer from side effects your doctor may reduce this dose
to 200 mg (4 tablets) a day.
For patients where LHRH treatment or surgery is unsuitable, the usual total dose of
Cyproterone Acetate is 200 mg to 300 mg (4 to 6 tablets) given in two or three divided doses.
To treat the side effects caused by either LHRH therapy or following removal of the
testes, the usual starting dose is 50 mg daily. If necessary, your doctor may increase this dose
to 150 mg (3 tablets) daily of Cyproterone Acetate.
Children
Cyproterone Acetate Tablets are not recommended for children.

If you forget to take a dose take it as soon as you remember. If it is almost time for your next
dose though, do not double the dose, just carry on as before.
IF YOU TAKE TOO MUCH OF YOUR MEDICATION CONTACT YOUR DOCTOR
IMMEDIATELY.
CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?
The most common side effects are feeling unusually tired or weak. These side effects may
occur in the first few weeks of treatment but usually go away as your body adjusts to your
medicine.
Other side effects include:


yellowing of the whites of the eyes or skin (jaundice), inflammation of the liver (hepatitis)
with swelling and severe pain in the upper part of the abdomen. (Liver function tests
should be performed regularly by your doctor whilst you are taking Cyproterone).



change in sex drive and reduction in the male sperm count and volume of ejaculate



breathlessness or pain on breathing



breast tenderness or swelling of the breasts



changes in body weight



drying of the skin and scalp



lightening of hair colour, increased growth of scalp hair but a loss in body hair. Female
type of pubic hair growth



and rarely milk secretion from the breasts or brittle bones

The occurrence of meningiomas has been reported in association with longer term use (years)
of Cyproterone Acetate at doses of 25mg/day and above.
If you should suffer from any of these undesired effects or any other undesired effect
please tell your pharmacist or doctor.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE
CARTON.
REMEMBER this medicine was prescribed by your doctor for you.
DO NOT give it to others. It may harm them.

Store at a temperature not exceeding 25°C and protect from light.

Date of revision: February 2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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