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-Pulse 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 of gelatin and the colours titanium dioxide, indigo carmine and erythrosine.

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

Sporanox-Pulse capsules are supplied in blister packs of 28 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-Pulse capsules are manufactured by Janssen Pharmaceutica N.V, Beerse, Belgium.

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.

pregnant (e.g. by not using contraception)

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

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

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

take adequate contraceptive precautions to make sure that you do not become pregnant while you are taking your medicine. As Sporanox-Pulse 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-Pulse is finished.

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

Ask your doctor for advice.

can be harmful.

For example, you should not take Sporanox-Pulse if you are taking an antihistamine containing terfenadine or astemizole for hay fever or allergy. You should not take Sporanox-Pulse 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 antiepileptics such as phenytoin, as they may stop Sporanox-Pulse from working properly.

Your doctor may need to alter the dose of certain other medicines before you begin your course of Sporanox-Pulse. These include blood thinning agents, the heart drug digoxin and 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-Pulse. Sporanox-Pulse 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-Pulse 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-Pulse.

Always take Sporanox-Pulse immediately after a meal as this helps the body absorb the medicine.

Swallow the correct number of capsules whole with some liquid.

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 the following treatment course with Sporanox-Pulse.

One pulse means 2 capsules of Sporanox-Pulse twice daily for 1 week. After this pulse you should stop taking Sporanox-Pulse for 3 weeks. Then the cycle is repeated, once for fingernail infections and twice for toenail infections. For toenail infections, wait 3 weeks after the second pulse before taking Sporanox-Pulse again.

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 your condition appears to have improved.

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

without delay.

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

In patients taking Sporanox-Pulse 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.

the 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 January 1996.

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