Informations for option: Cyproterone Acetate 50mg Tablets, show other option

Select option:

1. Cyproterone Acetate 50mg Tablets
2. Cyproterone Acetate 50mg Tablets

Document: leaflet MAH GENERIC_PL 21844-0001 change

• leaflet MAH GENERIC_PL 20417-0032
• leaflet MAH GENERIC_PL 21844-0001

---

CYPROTERONE ACETATE 50 mg tablets ^-

PACKAGE LEAFLET: INFORMATION FORTHE USER

In this leaflet:

1.    What Cyproterone Acetate Tablets are and what they are used for

2.    Before you use Cyproterone Acetate Tablets

3.    How to take Cyproterone Acetate Tablets

4.    Possible side effects

5.    How to store Cyproterone Acetate Tablets

6.    Further information

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

Cyproterone Acetate works by blocking the action of hormones called androgens which occur naturally in your body. Cyproterone Acetate also lowers the production of these hormones. Increased levels of androgens may cause or worsen several medical conditions.

Cyproterone Acetate Tablets 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. Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect

2. BEFORE YOU USE CYPROTERONE ACETATE TABLETS

Do not take Cyproterone Acetate Tablets

•    if you thinkyou may be allergic to any of the ingredients

•    if you have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt

Do not take Cyproterone Acetate Tablets if your doctor has prescribed the tablets for an overactive sex drive, and:

•    you are under the age of 18 years •you are planning a family

•you have a disease of the liver

•you have or have had a tumour, other than in your prostate gland •you have a wasting disease •you are diabetic

•you suffer from, or have suffered from severe, longstanding depression

•you have or have ever had a blood clot in a blood vessel (heart attack, stroke, deep venous thrombosis, pulmonary embolus), or if anyone in your family has suffered from one of these conditions at an early age •you, or someone in your family, has sickle-cell anaemia

•you have taken Cyproterone Acetate or a similar medicine before and suffered an unpleasant or allergic reaction to it

Take Special Care with Cyproterone Acetate Tablets

•    if you are an alcoholic (consultyour doctor before taking Cyproterone Acetate Tablets)

Taking Cyproterone Acetate Tablets with Food and Drink

Do not drink alcohol whilst taking Cyproterone Acetate Tablets.

Taking or using other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Some medicines may stop Cyproterone Acetate Tablets from working properly. Also Cyproterone Acetate Tablets may change the way other medicines you are taking are broken down in your body.

Tell your doctor if you take any other medicines regularly, especially:

•    medicines such as rifampicin for the treatment of tuberculosis

•    medicines such as phenytoin used to treat epilepsy or other illnesses

•    products containing the herbal remedy commonly known as St John's wort (Hypericum perforatum)

•    medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions

•    medicines such as ritonavir used to treat HIV infections

•    cholesterol-lowering drugs such as statins. Cyproterone Acetate Tablets may make the side effects of statins worse, for example the breakdown of muscle

•    medicines such as glitazones used to treat diabetes.

If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes.

See also Section 2 'Take Special Care with Cyproterone Acetate Tablets'.

Pregnancy and breast-feeding:

This medicine is not intended for use by women, or usually prescribed for women. If you are a woman, and your doctor has prescribed this medicine for you, please tell your doctor if you are pregnant, likely to become pregnant, or if you are breast-feeding a child.

Driving and using machines

Do not drive or operate machinery if after taking the tablets you feel weak or tired.

Important information about some of the ingredients of Cyproterone Acetate Tablets

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

Your doctor can only prescribe these tablets for you, once he has explained what they do and you have agreed to take them.

3. HOW TO TAKE CYPROTERONE ACETATE TABLETS

Take your tablets after meals.

Overactive Sex Drive

Usual dose for adults including the elderly -if you are taking Cyproterone Acetate Tablets for an overactive sex drive, the usual dose is 50mg (onetablet) twice a day.

Prostate Tumour

If you are taking Cyproterone Acetate Tablets to help relieve the symptoms of a tumour in the prostate gland, the following doses may be given:

To reduce the likelihood of a flare-up of the tumour which sometimes occurs in the first few weeks of starting LHRH treatment (e.g. Buserelin injection), the usual dose of Cyproterone Acetate is 300mg (6 tablets) a day. If you suffer from

side effects your doctor may reduce this dose to 200mg (4 tablets) a day For patients where LHRH treatment or surgery is unsuitable, the usual total dose of Cyproterone Acetate is 200mg to 300mg (4-6 tablets) a day.

To treat the side effects caused by either LHRH therapy or following removal of the testicles, the usual starting dose is 50mg daily. If necessary, your doctor may increase this dose to 150mg (3 tablets) daily of Cyproterone Acetate.

Your doctor will take regular blood tests to check your liver function while you are on Cyproterone Acetate Tablets. This medicine 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 while taking Cyproterone Acetate Tablets.

Children - Cyproterone Acetate Tablets are not recommended for children.

If you forget to take Cyproterone Acetate Tablets

If you forget to take a dose take it as soon as you remember. If it is almost time for your next dose, do not double the dose, just carry on as before.

If you take more Cyproterone Acetate than you should

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cyproterone Acetate Tablets can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience yellowing of the skin (jaundice) or inflammation of the liver with swelling and severe pain in the upper part of the abdomen (hepatitis).

If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction - contact your doctor or go to a hospital straight away.

These are the possible side effects of Cyproterone Acetate Tablets, starting with the more common ones:

Very common (more than 1 in 10 people may get these)

•    decreased sex drive

•    impotence

•    reduced sperm count

•    reduced volume of ejaculate

Common (up to 1 in every 10 people may get these)

•weight decrease or increase, which can be associated with fluid retention

•    depressed mood

•    restlessness

•    breast swelling sometimes with tenderness •tiredness

Uncommon (up to 1 in every 100 people may get this)

•    rash

Rare (up to 1 in every 1000 people may get these)

•    allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contactyour doctor or go to a hospital straight away)

•    effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine.

Your doctor may arrange for you to have regular blood tests during treatment to monitor this

•    benign (non-malignant) liver tumours, see also section 2 'Take Special Care with Cyproterone Acetate Tablets' •tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if

treatment is stopped or if the dose of Cyproterone Acetate Tablets is reduced Very rare (less than 1 in every 10,000 people may get these)

•thinning of the bones (osteoporosis)

•    some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway

Effects of Cyproterone Acetate Tablets on sperm

After you have been taking this medicine for some months, you may not have any sperm in your ejaculate.

You will probably be unable to make anyone pregnant, but note that this does nothappen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.

Other changes that have been reported include:

•    liver problems, some of them severe or even fatal, have been reported with high-dose cyproterone acetate treatment (300mg daily). Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary

•    blood clots have been reported in patients taking this medicine but they have not definitely been linked to Cyproterone Acetate Tablets. See also section 2 'Take Special Care with Cyproterone Acetate Tablets'

•    the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Cyproterone Acetate Tablets at doses of 25 mg per day and above

•    hot flushes, sweating, shortness of breath •dry skin and improvement in acne

•temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth.

After stopping treatment

After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal.

If any of the 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 ACETATE TABLETS

Keep out of the reach and sight of children.

Store your medicine in the original package.

On the label you will find the letters "EXP" followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacisthowto dispose of medicines which you no longer require. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Cyproterone Acetate contains

Each tabletcontains 50 mg of the active ingredient cyproterone acetate.

The tablet also contains lactose, maize starch, povidone, colloidal anhydrous silica and magnesium stearate. What Cyproterone Acetate Tablets look like and contents of the pack Your medicine is a white tablet marked "50" on one side.

Cyproterone Acetate tablets are available in packs containing 56 and 168 tablets.

Marketing Authorisation Holder

Stragen UK Limited, Castle Court, 41 London Road, Reigate, Surrey, RH2 9RJ, United Kingdom Manufacturer:

Haupt Pharma GmbH, Schleebruggenkamp 15, Munster, D-48159 Germany.

This leaflet was last approved in February 2010