CYPROTERONE ACETATE 100 MG TABLETS - patient leaflet, side effects, dosage

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 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 liver disease
• suffer from liver tumours (now or in the past) that are not due to prostate cancer
• have cancer (other than prostate cancer)
• suffer from a wasting disease (one which has caused you to lose muscle mass)
• have a tendency for your blood to clot too easily, are suffering from thrombosis (a clot in a blood vessel) or have had a thrombosis in the past.
• are a woman
• are a young male who is not fully developed as an adult, usually under 18 years of age
• drink large amounts of alcohol

Warnings and precautions:

Talk to your doctor or pharmacist before taking Cyproterone Tablets if you:

• are suffering from diabetes mellitus (blood sugar levels should be monitored initially and at regular intervals)
• are severely depressed
• suffer from sickle cell anaemia (a disease of the blood)
• shortness of breath has been reported in patients taking this medicine at high doses (300mg daily)
• Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Cyproterone Tablets.

Prior to taking these tablets you must have blood tests to check that your blood count and liver function are healthy.

You may need to have periodic blood tests to check your blood count and the function of your liver and adrenal glands.

Other medicines and Cyproterone Tablets

Taking another medicine while you are taking Cyproterone Tablets can affect how it or the other medicine works.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications. Please check with your doctor if you are taking any of the following:

• Ketroconazole, intraconazole, clotimazole, or other medicines for the treatment of fungal conditions
• Ritonavir or other medicines used to treat HIV infections
• Rifampicin, or any other medicines used for the treatment of tuberculosis
• Phenytoin, or any other medicine used to treat epilepsy or other illness
• St. John's wort
• Statins
• other sex hormones
• oral antidiabetic medicines such as thiazolidinediones or insulin.

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

Cyproterone Tablets with food and drink

You should avoid drinking alcohol because it reduces the effect of Cyproterone Tablets Cyproterone Tablets should be taken with water unless otherwise directed.

Driving and using machines

Cyproterone Tablets may cause fatigue or weakness especially when treatment is first started.

If affected, you should not drive or operate machinery.

Cyproterone Tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take cyproterone tablets

Always take Cyproterone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For adults, including older people, the dose for Cyproterone Tablets is dependent upon the condition for which your doctor has prescribed them.

Treatment in conjunction with other hormone treatment

When treatment in conjunction with other hormone treatment is first started, the recommended dose is 300mg daily (may be reduced to 200mg).

Long term treatment

For long term treatment with Cyproterone Tablets alone, the recommended dose is 200 –300mg daily.

Treatment of hot flushes in patients who have had orchidectomy (removal of the testes) For the treatment of hot flushes which may arise in patients who are being treated with other hormones or those who have had orchidectomy (removal of the testes), the recommended starting dose is 50mg daily, increasing if necessary up to 150mg daily.

If you take more Cyproterone Tablets than you should

If you or anybody else takes too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.

If you forget to take Cyproterone Tablets:

If you forget to take a dose do not worry, just take the next dose when it is due. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Cyproterone Tablets

Do not stop taking the medicine without talking to your doctor first. When it is time to stop taking Cyproterone

Tablets the dose should be reduced gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have trouble breathing or swallowing,

The occurrence of meningiomas has been reported in association with longer term use (years) of cyproterone at doses of 25mg/day and above.

Common (may affect up to 1 in every 10 people)

The most common side effects are impotence (erectile dysfunction) and a reduction in sexual desire (libido), sperm production, resulting in infertility (this is reversible, but should NOT be used as a male contraceptive). You may still produce some sperm but more of them than usual will be abnormal, with a possible increased risk of abnormal babies. Your doctor will advise you further if you are thinking of having children.

Other side effects

Side effects that some other patients have had with Cyproterone Tablets include:

• stroke
• heart attack
• raised blood pressure
• hot flushes
• swelling of the ankles
• thrombosis (a clot in a blood vessel)
• anaemia,
• suppression of adrenal gland function
• temporary restless ness
• development of breasts (which usually lessen as treatment continues however, this enlargement may also remain permanent), sometimes combined with nipple tenderness
• discharge from the nipples
• breast lumps
• impotence
• fatigue or sleepiness (usually lessening as treatment continues)
• headache (also lessening as treatment continues)
• feeling sick
• jaundice (yellowing of the skin) and liver problems including tumours (benign and malignant)
• bleeding inside the abdomen causing pain and loss of blood pressure with possible fainting or collapse.
• tumours of the lining of the brain (meningiomas)
• rash, sweating
• depression
• restlessness
• breathing problems
• loss of hair or an increase in body hair and scalp hair
• lightening of hair colour
• Change in shape of pubic hair
• dry skin
• possible improvement of acne
• weight changes (chiefly weight gain due to fluid retention)
• thinning of the bones (osteoporosis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cyproterone tablets

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use this medicine if you notice they are discoloured (they should be white).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

What Cyproterone Tablets contain

The active substance in the Cyproterone Tablets is cyproterone acetate.

The other ingredients are lactose, maize starch, povidone, colloidal silicon dioxide and magnesium stearate.

What Cyproterone Tablets look like and contents of the pack

Cyproterone acetate 50mg tablets are round white tablets marked CPA, breakline and 50 on one face and CP on the reverse.

Cyproterone acetate 100mg tablets are round white tablets marked CPA, breakline and 100 on one face and CP on the reverse.

Cyproterone acetate 50mg tablets are available in blister packs of PVC film and aluminium foil containing 56 or 168 tablets.

Cyproterone acetate 100mg tablets are available in blister packs of PVC film and aluminium foil containing 84 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Kensington Pharma Limited, Unit A Newlands House, 60 Chain House Lane, Whitestake Preston, Lancashire, PR4 4LG, United Kingdom.

Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

Date of leaflet preparation: August 2020