Consumer Medicine Information

SPORANOX^®

itraconazole
100 mg capsule

What is in this leaflet

This leaflet answers some of the common questions about SPORANOX capsules. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPORANOX capsules against the benefits this medicine is expected to have for you.

If you have any concerns about taking SPORANOX capsules, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What SPORANOX capsules are used for

SPORANOX capsules are used to treat certain fungal infections which include the following:

• persistent infections of the nails, skin, hands, feet or groin;
• persistent candida (yeast) infections of the vagina;
• eye infections which have not responded to other treatment or which may be affecting vision;
• candida (yeast) infections of the mouth or throat in patients with lower resistance to disease;
• generalised infections.

SPORANOX works by killing or stopping the growth of the fungus that causes the infection.

Your doctor may have prescribed SPORANOX capsules for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take SPORANOX capsules

When you must not take it

Do not take SPORANOX capsules if:

• you are pregnant or may become pregnant.
• you have an allergy to SPORANOX capsules or any of the ingredients. See Product Description at the end of this leaflet.

Do not take SPORANOX capsules with any of the following:

• certain medicines for allergy or hay fever (terfenadine, astemizole or mizolastine);
• cisapride (used for certain digestive problems);
• certain medicines used to produce calmness or to help you sleep (midazolam or triazolam);
• certain HMG-CoA reductase inhibitors, such as simvastatin or lovastatin (used to lower your cholesterol);
• pimozide or sertindole (used to treat mental disorders);
• quinidine or dofetilide (used to treat irregular heart beats);
• levacetylmethadol (used to treat opoid-dependency);
• dihyroergotamine and ergotamine (used to treat migraine);
• ergometrine or methylergometrine (used to control bleeding and maintain uterine contraction after child birth).

Do not take SPORANOX capsules if the packaging is torn or shows signs of tampering. Do not take SPORANOX capsules beyond the expiry date (month and year) printed on the pack.

Before you start to take it

You must tell your doctor if:

• you are breast feeding or wish to breastfeed;
• you have had an allergic reaction to other medicines used to treat fungal infections;
• you have or have had any liver problems;
• you have or have had any kidney problems;
• you have heart problems
• you are a neutropenic, AIDS or an organ transplant patient.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given SPORANOX capsules.

Your doctor will advise whether or not to take SPORANOX or if you need to adjust the dose or adapt your treatment.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

In particular, SPORANOX capsules must not be taken with some medicines. Examples are:

• certain medicines for allergy or hay fever (terfenadine, astemizole or mizolastine);
• cisapride (used for certain digestive problems);
• certain medicines used to produce calmness or to help you sleep (midazolam or triazolam);
• certain HMG-CoA reductase inhibitors, such as simvastatin or lovastatin (used to lower your cholesterol);
• pimozide or sertindole (used to treat mental disorders);
• quinidine or dofetilide (used to treat irregular heart beats);
• levacetylmethadol (used to treat opoid-dependency);
• dihyroergotamine and ergotamine (used to treat migraine);
• ergometrine or methylergometrine (used to control bleeding and maintain uterine contraction after child birth).

Certain medicines may be affected by SPORANOX capsules or may affect how well SPORANOX capsules work. Your doctor may need to adjust the dose or adapt your treatment. Examples of these medicines are:

• anticoagulants (used to slow blood clotting);
• rifampicin, rifabutin or isoniazid (used to treat tuberculosis);
• phenytoin, phenobarbital or carbamazepine (used to treat fits);
• clarithromycin, erythromycin ( antibiotics);
• certain medicines used to treat AIDS, such as indinavir, saquinavir and ritonavir;
• certain calcium channel blockers (used to treat heart or blood pressure problems);
• digoxin (used to treat heart failure);
• ciclosporin, sirolimus, tacrolimus (used to help prevent organ transplant rejection or to treat certain problems with the immune system);
• some contraceptive pills (birth control pills);
• busulphan, vinca alkaloids, docetaxel (used to treat some cancers);
• methylprednisolone, budesonide and dexamethasone (often used to reducefor conditions such as inflammations, asthma and allergies);
• trimetrexate (used to treat certain type of pneumonia);
• alfentanil (used in surgery for pain relief and to help anaesthesia);
• buspirone, alprazolam, brotizolam (used to treat anxiety or help you sleep);
• ebastine (used to treat allergies);
• raboxetine (used to treat depression);
• atorvastin (used to lower cholesterol);
• eletriptan (used to treat migraine);
• medicines taken for diabetes (in particular repaglinide);
• halofantrine (used to treat malaria);
• medicines which neutralize stomach acid or suppress the production of stomach acid (such as antacids, cimetidine, ranitidine, omeprazole).

Taking SPORANOX capsules

How much to take

Adults

The usual doses are shown below, but your doctor may decide to adjust them for your individual needs.

Tinea of body & groin:

1 capsule (100 mg) daily for 2 weeks.

Tinea of hands & feet:

1 capsule (100 mg) daily for 2 or 4 weeks.

Other skin infections:

2 capsules (200 mg) daily for 1 week.

Eye infections:

2 capsules (200 mg) daily for 3 weeks.

Vaginal infections:

2 capsules (200 mg) morning & evening for 1 day, or 2 capsules (200 mg) daily for 3 days.

Mouth infections:

1 capsule (100 mg) daily for 4 weeks or 2 capsules (200 mg) daily for 4 weeks.

Systemic infections:

1 to 2 capsules (100 mg to 200 mg) once or twice daily for 3 weeks to 8 months, depending on the condition.

Nail infections:

Continuous nail therapy: 2 capsules (200 mg) once daily for 3 months.

Cyclic (pulse) nail therapy: 2 capsules (200 mg) twice daily for 1 week. After that, stop taking SPORANOX for 3 weeks. Then the cycle is repeated, once for fingernails and twice for toenail infections (with or without fingernail infections). (See below).

Fingernails only

Week 1: Take 2 capsules twice daily.

Week 2, 3, 4: No SPORANOX.

Week 5: Take 2 capsules twice daily.

Week 6: Stop.

Toenails with or without fingernails

Week 1: Take 2 capsules twice daily.

Week 2, 3, 4: No SPORANOX.

Week 5: Take 2 capsules twice daily.

Week 6, 7, 8: No SPORANOX.

Week 9: Take 2 capsules twice daily.

Week 10: Stop.

Children and Elderly

SPORANOX capsules are not recommended for use in children and in the elderly.

How to take it

• Always take SPORANOX capsules after a meal.
• Do not take medicines that neutralise stomach acid within 2 hours of taking SPORANOX capsules. This is because sufficient stomach acid is required to ensure that SPORANOX capsule is properly absorbed by the body. If you take medicines that suppress the production of stomach acid, you should take your SPORANOX capsules with an acidic drink, such as a cola beverage.

If you forget to take it

• Take the dose you missed as soon as you remember, and then continue to take it as you would normally.
• If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
• Do not take a double dose to make up for the one you missed.

If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you have taken too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Poisons Information Centre telephone numbers:

• Australia: 13 11 26
• New Zealand: 0800 POISON or 0800 764 766

Keep these telephone numbers handy.

While you are taking SPORANOX capsules

Things you must do

• Always follow your doctor's instructions carefully.
• If you have to take SPORANOX capsules continuously for more than 1 month, your doctor may ask you to have your blood checked regularly. This is to make sure that your liver is not affected.
• If there is any chance of you becoming pregnant, talk to your doctor about the need for an adequate contraception. Once you have finished taking SPORANOX, you should continue using adequate contraception until you have had your next period. Tell your doctor immediately if you do become pregnant while taking SPORANOX.
• If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking SPORANOX capsules.
• Always complete the treatment as directed by your doctor, even if the signs of infection have gone.

Things you must not do

• Do not take SPORANOX capsules to treat any other complaint unless your doctor says so.
• Do not give this medicine to anyone else, even if his or her symptoms seem similar to yours.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you experience any of the following:

• upset stomach, stomach cramps, nausea, vomiting, diarrhoea or constipation.
• headache, dizziness.
• a change in menstrual pattern.
• unusual hair loss or thinning.

Tell your doctor immediately if you notice any of the following as you may need urgent medical care:

• tingling, numbness or weakness in the hands or feet.
• swelling of hands ankles, feet, legs or abdomen.
• shortness of breath, unexpected weight gain, or begin to wake up at night.
• oversensitivity to sunlight.

STOP taking SPORANOX capsules and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

• abnormal tiredness, loss of appetite, nausea, vomiting, dark urine, pale stools, yellowing of the skin or eyes.
• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

After using SPORANOX capsules

Storage

• Keep SPORANOX capsules in the pack until it is time to take them.
• Keep SPORANOX capsules in a cool dry place where the temperature is below 25°C.
• Keep your medicines where young children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is good place to store medicines.
• Do not store SPORANOX capsules, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking SPORANOX capsules or your medicines has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.

Product Description

What it looks like

SPORANOX capsules are pink and blue. They are supplied in a blister pack, containing:

• 15 capsules.

Ingredients

The active ingredient in each SPORANOX capsule is 100 milligrams of itraconazole. Other ingredients include sucrose, starch, macrogol, and hypromellose. The capsule is made of gelatin and also contains titanium dioxide, indigo carmine and erythrosine.

SPORANOX capsules do not contain lactose or gluten.

Sponsor

Janssen-Cilag Pty Ltd
1-5 Khartoum Road
North Ryde NSW 2113 Australia
Telephone: (02) 8875 3333

NZ Office: Auckland New Zealand
Telephone: 0800 800 806

Australian Registration Number: AUST R 47012

This leaflet was prepared in February 2004.

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