Patient Leaflet Updated 15-Jun-2020 | Fannin UK/Kent Pharma UK Limited
Cyproterone Acetate 50 & 100mg Tablets
PATIENT INFORMATION LEAFLET
CYPROTERONE ACETATE 50 mg & 100 mg TABLETS
The name of this medicine is Cyproterone Acetate 50 mg and 100 mg Tablets, which will be referred to as Cyproterone Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet
1. What Cyproterone Tablets are and what they are used for
2. Before you take Cyproterone Tablets
3. How to take Cyproterone Tablets
4. Possible side effects
5. How to store Cyproterone Tablets
6. Further Information
1. WHAT CYPROTERONE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is cyproterone acetate, which belongs to a group of medicines called anti-androgens. These work by blocking the actions of male sex hormones (androgens) which are released naturally in your body. They also reduce the production of androgens.
It has been shown that the growth of tumours of the prostate gland may be dependent on male hormones. Since cyproterone acetate blocks the action of androgens and reduces the amount of androgens produced by the body, it can be used to help relieve the symptoms of a tumour of the prostate gland.
It can also be taken by males to control an over active sex drive.
2. BEFORE YOU TAKE CYPROTERONE TABLETS
Do not take Cyproterone Tablets if you:
If you are being treated for an overactive sex drive you should not take this medicine if you:
Take special care with Cyproterone Tablets
Before you take Cyproterone Tablets you should tell your doctor if you:
If you are a diabetic and your doctor decides that it is still alright for you to take Cyproterone Tablets, the dose of your medicine used to treat your diabetes (oral diabetic treatments or insulin), may be altered.
It is likely that your doctor will arrange regular blood tests whilst you are taking Cyproterone Tablets.
If you are being treated for an overactive sex drive, your doctor may check your sperm count before and during treatment. Whilst Cyproterone Tablets may reduce the production of sperm, the medicine must not be used instead of contraception.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell your doctor or pharmacist before taking this medicine if you are also on:
Taking your medicine with food and drink
Cyproterone Tablets should be taken after meals. You should avoid drinking alcohol whilst taking these tablets.
Pregnancy and breast-feeding
This medicine is not for use in women.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate tools or machines because this medicine may make you feel tired or weak particularly within the first few weeks of taking it.
Important information about some of the ingredients of Cyproterone Tablets
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
3. HOW TO TAKE CYPROTERONE TABLETS
Always take Cyproterone Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.
For adults and the elderly, the dose for Cyproterone Tablets is dependent on the condition for which your doctor has prescribed them.
For the control of an overactive sex drive the usual dose is 50 mg twice a day.
Your doctor can only prescribe this medicine once he has explained what the tablets will do and you have agreed to take them.
To help relieve the symptoms of a prostate cancer the usual doses are as follows:
Method of administration
Cyproterone Tablets should be taken by mouth after meals.
If you take more Cyproterone Tablets than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
If you forget to take Cyproterone Tablets
If you miss a dose do not worry. Take another as soon as you remember and then go on as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cyproterone Tablets can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately:
The following side effects have been reported
Very common (probably affecting more than 1 in 10 people)
Common (probably affecting more than 1 in 100 people)
Uncommon (probably affecting fewer than 1 in 10 people)
Rare side effects (probably affecting fewer than 1 in 1000 people):
Very rare (probably affecting fewer than 1 in 10,000 people)
The following side effects with unknown frequency have also been reported:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CYPROTERONE TABLETS
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of that month.
Do not store your tablets above 25˚C. Store your tablets in the original package. Keep blisters in the outer carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cyproterone Tablets contain:
Cyproterone Tablets contains 50 mg or 100 mg of the active ingredient cyproterone acetate.
The other ingredients are lactose monohydrate, maize starch, pregelatinised maize starch, povidone, magnesium stearate and colloidal anhydrous silica.
What Cyproterone Tablets looks like and the contents of the pack:
Cyproterone Acetate 50 mg Tablets are white, circular tablets with a central break line on one side and plain on the other. Cyproterone Acetate 50 mg Tablets are available in a pack size of 56 tablets.
Cyproterone Acetate 100 mg Tablets are white capsule shaped tablets with a breakline on one side and CPA 100 marked on the other. Cyproterone Acetate 100 mg Tablets are available in a pack size of 84 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer responsible for batch release:
This leaflet was last revised in December 2019
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