Consumer Medicine Information

SPORANOX^®

itraconazole
10 mg/mL oral solution

What is in this leaflet

This leaflet answers some of the common questions about SPORANOX Oral Solution. 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 Oral Solution against the benefits this medicine is expected to have for you.

If you have any concerns about using SPORANOX Oral Solution, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your SPORANOX Oral Solution. You may need to read it again.

What SPORANOX Oral Solution is used for

SPORANOX Oral Solution is a medicine used for:

• the treatment of candida (yeast) infections of the mouth, throat and/or gullet in patients who have a lowered resistance to disease.
• the prevention of fungal infections in certain patients who may have a lowered resistance.

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

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

Before you take SPORANOX Oral Solution

When you must not take it

Do not take SPORANOX Oral Solution if

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

Do not take SPORANOX Oral Solution 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 and 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 Oral Solution if the packaging is torn or shows signs of tampering. Do not take SPORANOX Oral Solution 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 a heart problem;
• you suffer from cystic fibrosis.

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

Your doctor will advise you whether or not to take SPORANOX Oral Solution 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 oral Solution 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 Oral Solution or may affect how well SPORANOX Oral Solution works. 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 or 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 for 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 to help you sleep);
• ebastine (used to treat allergies);
• reboxetine (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).

Taking SPORANOX Oral Solution

How much to take

Adults

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

Treatment of yeast infections in the mouth, throat or gullet

• two measuring cups (200 mg or 20 mL) once a day or
• one measuring cup (100 mg or 10 mL) twice a day (morning and afternoon).
• a measuring cup is supplied with the product.
• SPORANOX Oral Solution is usually taken for one to four weeks.

Prevention of fungal infection

• the dose will depend on your body weight. Your doctor will tell you how much and how often you should take SPORANOX Oral Solution.
• SPORANOX Oral Solution is usually taken up to 8 weeks.

Children and the elderly

SPORANOX Oral Solution is not recommended for use in children or in the elderly.

How to take it

• You should always take SPORANOX Oral Solution on an empty stomach, at least one hour before a meal.
• If you are taking SPORANOX Oral Solution for the treatment of yeast infections in the mouth or throat you should swish the solution around your mouth for approximately 20 seconds before swallowing it. DO NOT RINSE your mouth after swallowing.

Directions for opening the bottle

The bottle comes with a child-resistant cap, and should be opened by pushing the plastic screw cap down while turning it anti-clockwise.

If you forget to take it

• Take the dose you missed as soon as you remember, and then continue taking 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 the 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 Oral Solution

Things you must do

• Always follow your doctor's instructions carefully.
• If you have to take SPORANOX Oral Solution continuously for more than 1 month, your doctor may ask you to have your blood checked regularly. This is to make sure 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 Oral Solution, you should continue using adequate contraception until you have your next period. Tell your doctor immediately if you do become pregnant while taking SPORANOX Oral Solution.
• If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking SPORANOX Oral Solution.
• 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 Oral Solution 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 notice 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, the legs or the abdomen.
• shortness of breath, unexpected weight gain or begin to wake up at night.
• oversensitivity to sunlight.

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

• abnormal tiredness, lack 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 taking SPORANOX Oral Solution

Storage

• Keep SPORANOX Oral Solution in the bottle until it is time to take it.
• Keep your SPORANOX Oral Solution in a cool, dry place where the temperature is below 25°C.
• Keep your medicines where children cannot reach it. A locked cupboard at least one-and-a-half metres (1.5m) above the ground is a good place to store medicines.
• Do not store SPORANOX Oral Solution, or any 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 Oral Solution, or your medicine 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 Oral Solution is a yellow to slightly amber clear solution.

It is supplied in 150 mL amber glass bottle with a child-resistant screw cap. A 10 mL measuring cup is provided in the pack.

Ingredients

The active ingredient in SPORANOX Oral Solution is 100 mg/10 mL of itraconazole.

Other ingredients include hydroxypropyl-beta-cyclodextrin, sorbitol, propylene glycol, hydrochloric acid, cherry flavour 1, cherry flavour 2, caramel flavour, saccharin sodium, sodium hydroxide and purified water.

SPORAONX Oral Solution does 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 62008

This leaflet was prepared in February 2004.

SPORANOXoralsoln(040210)ANZ