Itraconazole

• For fungal and yeast infections
• In capsule form or oral solution
• Not to be used while pregnant or breastfeeding

Itraconazole kills certain fungi and yeasts. This medicine is available in capsule form and as oral solution (suspension). Itraconazole capsules are used to treat:

• Yeast infection of the vagina (thrush, candidiasis).
• Fungal infections of the skin and nails.
• Fungal infections affecting internal organs.
• Yeast infections of the mouth or throat (oral thrush).

Itraconazole oral solution is used for:

• Fungal infections in the mouth, throat or food pipe (oesophagus).
• The oral solution is prescribed in patients who are unable to swallow the capsules.

Always use this medicine as directed by a doctor. The general guidelines for use are as follows.

Itraconazole capsules:

• Always take Itraconazole capsules with or straight after a meal.
• The capsules should not be chewed but swallowed whole. It is best to swallow the capsules with some liquid.
• There must be enough acid in your stomach to make sure that your body can absorb the active ingredient. Some medicines and health conditions can affect the stomach producing acid. For this reason, you should wait two hours after taking Itraconazole capsules before taking any of these other medicines. If you do take medicines that stop the production of stomach acid, you should take Itraconazole capsules with a fizzy drink, such as cola.

Itraconazole oral solution:

• Take the oral solution on an empty stomach, at least one hour before eating or drinking.
• Swish the solution around in your mouth for 20 seconds, before swallowing. Do not rinse your mouth after swallowing the oral solution. Do not drink or eat anything for one hour after taking Itraconazole. This way, the mucous membranes in your mouth, throat or food pipe can absorb the medicine.

Dosage

The dosage is determined by a doctor based on the symptoms. The general recommended dose in adults is:

Itraconazole capsules (100 mg):

Yeast infection of the vagina and/or skin around the vagina (thrush)

Two options:

• One-day course: two capsules, followed by another two capsules after 10-12 hours.
• Three-day course: two capsules once a day for three days.

Yeast infection of the mouth (oral thrush)

• One capsule a day for two weeks.

Fungal infections of the skin

The dosage depends on the site of infection and the type of fungus.

• One capsule a day for two to four weeks.
• Two capsules a day for one week.

Itraconazole takes around two to four weeks after treatment to reach the best results. Patches of skin need time to completely clear up after the medicine has killed the fungus that caused the infection.

Fungal infections of the nails

Two options:

• Course consisting of three pulses: A pulse is defined as a cycle of two capsules of Itraconazole taken twice daily for one week (two capsules in the morning and two capsules in the evening), followed by three weeks without taking Itraconazole. Repeat until three cycles (pulses) have been completed.

• Continuous course: two capsules once a day for three months.

Itraconazole takes around six to nine months after treatment to reach the best results. This is because your nail will only look normal after a new nail has grown, even though the medicine has killed the fungus that caused the infection.

Fungal infections affecting internal organs

• The dosage depends on the site of infection and the type of fungus. This can vary from one capsule a day to two capsules three times a day. Your doctor will tell you how many Itraconazole capsules to take and for how many months.

Itraconazole solution (10 mg/ml)

Yeast infections of the mouth, throat or food pipe (oesophagus)

• The usual dose is 20 ml (two measuring cups) per day for one week. This may be taken either all at once or in two divided doses during the day.

If after one week of using the oral solution, your infection has not cleared, your doctor may decide to continue your treatment for one more week.

There are other guidelines for the treatment of yeast infections of the mouth, throat or food pipe (oesophagus) that have already been treated with another antifungal but have still not cleared (see the package leaflet). This also applies to the prevention of yeast infections of the mouth, throat or food pipe (see the package leaflet).

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

If you use more than you should/miss a dose/stop using Itraconazole

Consult a doctor if you have taken too much of Itraconazole.

If you miss a dose, you may take it as soon as you remember unless it is almost time for your next scheduled dose. Never take a double dose to make up for the forgotten one.

Do not stop your treatment without consulting a doctor first.

Itraconazole is not suitable for everyone. Do not take this medicine if:

• You are allergicto itraconazole or any of the other ingredients in the capsules or oral solution (see section 'What Itraconazole contains’).
• You are pregnant, may be pregnantor trying to conceive (see section 'Pregnancy and breastfeeding’).
• You are taking certain medicines (see the package leaflet).

When should this medicine be used with caution?

In some cases, special care should be taken with this medicine. Talk to your doctor before using Itraconazole if:

• You have a heart condition.
• You have a liver or kidney disease.
• You have had an allergic reaction to another antifungal product in the past.

For more information, see the package leaflet.

Pregnancy and breastfeeding

Do not use Itraconazole if you are pregnant or breastfeeding.

Other medicines and Itraconazole

Itraconazole may interact with some medicines. For a complete list of these medicines, see the package leaflet. Consult your doctor or pharmacist if you are taking any of these medicines.

In particular, do NOT take Itraconazole and tell your doctor if you are taking any of the following:

• Terfenadine, astemizole or mizolastine (antihistamines).
• Bepridil (for angina).
• Nisoldipine (for high blood pressure).
• Cisapride (for digestive problems).
• Midazolam (by mouth) or triazolam (for anxiety or to help you sleep).
• Lovastatin, simvastatin, atorvastatin (used to lower blood cholesterol).
• Pimozide and sertindole (for conditions affecting thoughts, feelings and behaviour).
• Levacetylmethadol (for the treatment of drug abuse).
• Dihydroergotamine, ergotamine and eletriptan (for migraine headaches).
• Ergometrine (ergonovine) and methylergometrine (methylergonovine) (used after giving birth).
• Quinidine and dofetilide (for an irregular heartbeat).

For more information, see the package leaflet.

Itraconazole may cause side effects. The following list includes some of the side effects of Itraconazole.

• Headache.
• Gastrointestinal problems.
• Liver problems.
• Skin rash.

See the package leaflet for a complete list of side effects. If you get any severe side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

What Itraconazole capsules contain:

• Each capsule contains 100 mg itraconazole.

• The other ingredients are: sucrose, maize starch, hypromellose (E464), macrogol, gelatin (E485), titanium dioxide (E171), indigo carmine (E132), erythrosine (E127).

What Itraconazole oral solution contains:

• The active substance is itraconazole (10 mg itraconazole per ml).

• The other ingredients are: hydroxypropyl-β-cyclodextrin, sorbitol (E420), propylene glycol (E490), hydrochloric acid, cherry flavour, caramel flavour, sodium saccharin dihydrate, sodium hydroxide, purified water.

Read the package leaflet before use.