itraconazole

Before you start to take your medicine, please read this leaflet carefully all the way through as it contains important information. The leaflet does not contain the complete information about the medicine. If there is anything that you do not understand or if you need further information or advice, you should ask your pharmacist or doctor who will have more details.

This leaflet applies only to Sporanox capsules. Please do not throw it away until you have finished taking the full course of your medicine. You may need to refer to it again.

Each pink and blue capsule contains 100 mg of itraconazole. The capsules also contain the following inactive ingredients - sucrose. maize starch, starch syrup, hypromellose and macrogol. The capsule itself is made up of gelatin and the colours titanium dioxide, indigo carmine and erythrosine.

Sporanox is one of a group of medicines called "antifungals" which are used to treat infections caused by fungi including yeasts.

Sporanox capsules are supplied in blister packs of 4, 15 or 60 capsules.

The UK Product Licence for this medicine (PL number 0242/0142) is held by Janssen-Cilag Ltd, Saunderton High Wycombe, Bucks HP14 4HJ. Sporanox capsules are manufactured by Janssen Pharmaceutica nv, Turnhoutseweg 30, B-2340 Beerse, Belgium.

affecting your vagina or mouth, causing "thrush", or the skin. Sporanox can also be used to either prevent or treat fungal infections affecting other parts of the body.

Doctors sometimes prescribe this medicine for other purposes. If this applies to you talk to your doctor

REMEMBER - This medicine has been prescribed for you only. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

BEFORE TAKING ANY MEDICINE - always inform your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant.

Inform your doctor before taking the medicine if any of the above applies to you. Your doctor will then decide whether Sporanox is suitable for you.

Sporanox is not normally prescribed for use in children under the age of 12 or for the elderly. However, your doctor may use his judgement to prescribe it in special cases.

Tell your doctor if you have, or have had a liver problem such as jaundice.

See your doctor immediately if any of the following appear during your course of treatment with Sporanox: severe lack of appetite, feeling sick, being sick, unusual tiredness, stomach pain, unusually dark urine, or pale stools

If you have taken Sporanox continuously for more than one month, your doctor may want to check your liver by testing your blood.

Tell your doctor if you have a kidney problem as the dose of Sporanox may have to be changed.

You should also tell your doctor immediately if you have any unusual feelings of tingling, numbness or weakness, in your hands or feet whilst taking Sporanox

contraceptive precautions to make sure that you do not become pregnant while you are taking your medicine. As Sporanox remains in the body for some time after you stop taking it, you should continue to use some form of contraception for one month after your treatment with Sporanox is finished.

If you do find that you are pregnant after starting a course of Sporanox capsules, stop taking them and tell your doctor straight away.

doctor for advice.

harmful.

For example, you should not take Sporanox if you are taking an antihistamine containing terfenadine or astemizole for hay fever or allergy. You should not take Sporanox if you are taking cisapride (a drug used for certain digestive problems) or midazolam or triazolam (drugs used as sleeping pills). Your doctor will need to know if you are using the antibiotic rifampicin or anti-epileptics such as phenytoin, as they may stop Sporanox from working properly.

Your doctor may need to alter the dose of certain other medicines before you begin your course of Sporanox. These include blood thinning agents, the heart drug digoxin, medicines known as cyclosporin A and tacrolimus which are usually given after an organ transplant. Special care is required if the tranquilliser midazolam is given intravenously during treatment with Sporanox. Sporanox can make the side effects of a medicine known as vincristine more severe and your doctor may need to change the dose of either or both of these medicines.

There must be sufficient stomach acid to ensure that Sporanox is properly absorbed by the body. Therefore, medicines that neutralise stomach acid such as medicines for indigestion, stomach ulcers or heartburn, should not be taken sooner than 2 hours after Sporanox.

Swallow the correct number of capsules whole with some liquid.

Your doctor will tell you how many Sporanox capsules to take and for how long you should continue to take them. Always read the label on your medicine and follow your doctor's instructions carefully. Ask your pharmacist if you are not sure about anything.

Your doctor will probably have recommended one of the following treatment courses with Sporanox:

• Yeast infection of the vagina (thrush) capsules for one day always taken as: two capsules, followed by another two capsules ideally 12 hours later (e.g. 2 capsules in the morning and 2 in the evening).

• Yeast infection of the mouth (oral thrush) 1 capsule each day for 15 days

• For fungal infections of the skin the dosage depends on your condition. It is likely to be either:

2 capsules each day for 7 days

or 1 capsule each day for 15 days

• or 1 capsule each day for 30 days
• For treatment or prevention of fungal infections of other parts of the body the dosage and length of treatment varies depending on the type of infection. Your doctor may sometimes prescribe Sporanox at different dosages or for different lengths of time. Talk to your doctor if this applies to you.

It is important that you carry on taking your medicine for as long as your doctor has told you to. Do not stop your treatment just because you feel better

With skin infections, the patches on your skin may only disappear completely a few weeks after you have finished your treatment with Sporanox. This is because your skin will only appear normal once new skin has grown, even though Sporanox has already killed the fungus causing the infection.

If you miss any capsules, take the next dose as usual and continue your course until the capsules are finished.

upset stomach, constipation or changes in menstrual bleeding. It is unusual for people to have an allergic reaction to Sporanox. However, if you experience a skin rash, itching, shortness of breath and/or a swollen face, stop taking Sporanox and contact your doctor immediately.

In patients taking Sporanox for long periods, occasionally swelling, muscle weakness, jaundice, very dark urine, pale stools, tingling sensation in the limbs and rarely hair loss have occurred. In such cases, stop taking the medication and see your doctor immediately.

If your medicine affects you in any other way, you should tell your doctor or pharmacist.

See also Special Precautions section, above.

capsules in their carton at room temperature (15°C-30°C) in a dry place and out of strong sun light. Do not use the capsules after the expiry date printed on the packaging. Always return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.

This leaflet was prepared in October 1995.