Sporanox 100 mg Capsules

SPORANOX contains a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’. SPORANOX is used for treating fungal infections of the vagina, skin, nails or internal organs.

Do not take SPORANOX

• If you are hypersensitive (allergic) to itraconazole or any of the other ingredients of SPORANOX (listed in section 6).
• if you are pregnant. If you are of childbearing age and could become pregnant, you should take adequate contraceptive precautions to make sure that you do not become pregnant while you are taking SPORANOX. As SPORANOX remains in the body for some time after you stop taking it, you should continue to use contraception until your next period after your treatment with SPORANOX capsules is finished.
• if you have a condition called heart failure (also called congestive heart failure or CHF), SPORANOX could make it worse. If your doctor decides that you need to take SPORANOX even if you have this condition, be sure to get immediate medical help if you have shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue, or begin to wake up at night.

Also, do not use certain medicines if you are on SPORANOX capsules. There are many medications that interact with SPORANOX capsules. Please refer to the section “Other medicines and SPORANOX”.

Do not share medicines prescribed for you with any other person. Always take SPORANOX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

How much SPORANOX you will need to take and how long will depend on the type of fungus and the place of infection. Your doctor or pharmacist will tell you exactly how to use SPORANOX.

Skin infections: With skin infections, the lesions will disappear a few weeks after the end of the treatment with SPORANOX capsules. This is typical of fungal patches: the medicine kills the fungus itself, but the lesion disappears together with regrowth of healthy skin.

Nail infections: Nail lesions disappear only 6 to 9 months after the end of treatment with SPORANOX capsules since SPORANOX kills only the fungus. That nail still needs to grow back after this and regrowth takes many months. So do not worry if you notice no improvement during your treatment. SPORANOX will remain in your nail for several months to kill the fungus. You should therefore only stop treatment as prescribed by your doctor, even though you do not see any improvement.

If you take more SPORANOX than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take SPORANOX: Do not take a double dose to make up for forgotten individual doses.

SPORANOX can have side effects. If any of the following happens, stop taking SPORANOX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity to SPORANOX capsules can occur. It can be recognised, for instance, by skin rash, itching, hives, shortness of breath or difficulty breathing, and/ or swollen face. Uncommonly, diminished sensation in the limbs, a tingling sensation in the limbs, or other problems with the nerves in the arms or legs can occur. Very rarely, an oversensitivity to sunlight or a severe skin disorder (widespread rash with peeling skin and blisters in the mouth, eyes and genitals, or rash with small pustules or blisters) can occur.
• You may experience one or more of the following symptoms that may be related to heart failure: shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue, or begin to wake up at night.
• One or more of the following symptoms that may be related to liver disorders may appear: lack of appetite, nausea, vomiting, tiredness, abdominal pain, jaundice, very dark urine, and pale stools.
• Your vision could get blurry or you could see double. You could hear a ringing in your ears. You could lose the ability to control your urine or urinate much more than usual. You may experience temporary or permanent hearing loss.

These are all very serious side effects. If you have them, you may have had a serious reaction to SPORANOX. You may need urgent medical attention or hospitalisation.

• Store in a dry place at or below 25° C. Protect from light.

• Do not use SPORANOX after the expiry date which is stated on the blisters and the carton. The expiry date refers to the last day of the month.

• Store all medicines out of reach of children.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).