Stromba

PATIENT INFORMATION LEAFLET

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

The name of this medicine is Stromba tablets. Its active ingredient is stanozolol.

What is in this medicine? Each Stromba tablet contains 5 mg Stanozolol BP.

Each Stromba tablet also contains calcium phosphate, lactose, maize starch, purified talc and magnesium stearate.

Stromba tablets are gluten free.

Stromba tablets are white round tablets with Stromba stamped on one side and the other side marked into quarters. They are supplied in packs of 56 tablets.

Stromba is an anabolic steroid.

The Product Licence holder is:

Sanofi Winthrop Ltd

One Onslow Street

Guildford

Surrey GU 1 4YS

The manufacturer is:

Sanofi Winthrop Ltd

Edgefield Avenue

Fawdon

Newcastle upon Tyne NE3 3TT

What is this medicine for ? Stromba is used to treat some features of Behcet's disease (e.g. blood clots in veins) and for the prevention of attacks of hereditary angioedema (a severe allergic type reaction).

Before taking this medicine Stromba is not intended to treat loss of appetite, unexplained weight loss or failure to thrive in children.

You should not take Stromba if you:

• are pregnant or trying to become pregnant.

• are breast feeding.

• have liver disease.

• have cancer of the prostate.

• have porphyria or a history of it.

• have diabetes and use insulin.

• have liver, kidney or heart problems. . have had jaundice.

• have breast cancer.

• are female and have not yet gone through the

menopause.

Special care is also needed in children (Stromba may affect bone growth). Stromba tablets are not suitable for use in children under one year old.

If taken with some other medicines the effect of Stromba or the effects of the other medicine may be changed. Please check with your doctor if you are taking any of the following:

• anticoagulant therapy - used to thin the blood (e.g.

warfarin).

• tablets to control diabetes.

Taking this medicine

The usual adultdose of Stromba in patients with Behtet's disease is 10 mg a day.

The adult dose to treat hereditary angioedema usually starts between 2.5 mg and 10 mg a day. Once a patient's condition has been stabilised dosages as low as 2.5 mg three times a week have been effective. The usual dose for children between 1 and 6 years is 2.5 mg a day. The usual dose for children aged 6 to 12 years is 2.5 to 5 mg a day. The correct dose for you will have been decided by your doctor. Check the label and if you are not sure ask your doctor or pharmacist.

Swallow the tablets with a drink of water.

Keep taking your medicine until your doctor tells you to stop.

As with all medicines an overdose could be dangerous. If you have taken an overdose tell your doctor or go to the nearest hospital casualty department immediately.

Whilst taking this medicine

Stromba may cause problems in some people. These include acne, increased growth of hair on the face or body, changes in women's periods, headache, muscle cramp, skin rash, hair loss, indigestion, and changes in mood. If you experience any of these effects you need not worry but you should discuss with your doctor any which become troublesome.

Rarely Stromba can cause voice changes or liver problems (e.g. jaundice). If you experience these or if you get any unusual symptoms tell your doctor immediately as it may be necessary for you to stop taking Stromba.

Stromba may also cause changes in the amount of lipid (fat), thyroid hormone and some other enzymes present in your blood. Your doctor may ask you to have periodic blood tests to check this.

Very rarely, in patients taking long term treatment, Stromba has caused liver tumours.

Do not take this medicine after the expiry date which you will find on the pack.

Date of last revision April 1994.

This leaflet does not contain all the information about your medicine. Pharmaceutical companies are not able to discuss your personal medical case. If you have any questions or are not sure about anything ask your doctor or pharmacist.