PACKAGE LEAFLET: INFORMATION FOR THE USER

ITRACONAZOLE 100 mg CAPSULES

(itraconazole)

Read all of this leaflet carefully

before you start taking this medicine.

*    Keep this leaflet. You may need to read it again.

*    If you have further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

*    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Itraconazole is and what it is used for.

2.    Before you take Itraconazole.

3.    How to take Itraconazole.

4.    Possible side effects.

5.    How to store Itraconazole.

6.    Further information.

1.    WHAT ITRACONAZOLE IS AND WHAT IT IS USED FOR

Itraconazole belongs to a group of medicines called 'antifungals' used to treat fungal and yeast infections. It can be taken to treat any of the following infections:

•    'thrush' (yeast infection) in the mouth, throat or vagina

•    fungal infections of the nails or skin (e.g. athlete's foot, ringworm and the skin infection called pityriasis versicolor)

•    fungal infections affecting other parts of the body (e.g. systemic fungal infections, histoplasmosis, cryptococcal meningitis)

•    Itraconazole can also be taken if you have a weak immune system to stop you getting a fungal infection.

2.    BEFORE YOU TAKE ITRACONAZOLE

Do not take Itraconazole if you:

•    are allergic (hypersensitive) to itraconazole or any of the other ingredients of this medicine

•    are pregnant or could become pregnant (e.g. you are not using contraception)

•    suffer from heart failure

•    are already taking any of the following medicines:

*    antihistamines such as terfenadine, astemizole, mizolastine

*    cisapride, used for stomach problems

*    midazolam or triazolam, to treat anxiety or help you sleep

*    dofetilide or quinidine, to treat an irregular heart rhythm

*    bepridil or nisoldipine, for angina or high blood pressure

*    pimozide, for mental illness

*    cholesterol lowering medicine such as atorvastatin, simvastatin or lovastatin

*    levacetylmethadol, to treat drug abuse (opoid-dependency)

*    ergometrine (ergonovine) or methylergometrine

(methylergonovine), used after giving birth

*    eletriptan, dihydroergotamine or ergotamine, to treat migraine headaches.

Take special care with Itraconazole -You should tell your doctor before taking this medicine if you:

•    have ever had a heart problem, including heart failure (also referred to as congestive heart failure or CHF). Itraconazole could make your condition worse. If after taking this medicine you suffer from any of the following, stop taking Itraconazole and tell your doctor immediately: breathlessness, fatigue, swollen feet, legs or stomach.

•    have ever had liver problems such as yellowing of the skin (jaundice). Your doctor may need to change your dose.

If after taking this medicine you suffer from any of the following, stop taking Itraconazole and tell your doctor immediately: yellowing of the skin or whites of the eyes, dark urine or pale stools, loss of appetite, feeling or being sick, fatigue or stomach pain.

•    have ever had kidney problems, as your doctor may need to change your dose

•    have taken other antifungal medicine before and suffered an allergic reaction

•    have Acquired Immunodeficiency Syndrome (AIDS) or your immune system is not working as well as it should.

Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following:

•    antibiotic to treat tuberculosis (such as rifampicin, rifabutin, isoniazid) or antiepileptic medicine (such as phenytoin, carbamazepine, phenobarbital), as they may stop itraconazole working properly: If you have stopped taking any of these medicines within the last two weeks, tell your doctor

•    calcium channel blockers, used to treat angina or high blood pressure

e.g. dihydropyridines (such as nisoldipine) or verapamil

•    digoxin or disopyramide, to treat a heart condition

•    anticoagulants e.g. warfarin, used to thin the blood

•    clarithromycin, erythromycin (antibiotics)

•    ritonavir, indinavir, saquinavir (antivirals)

•    anticancer medicine such as busulphan, docetaxel, trimetrexate, vinca alkaloids

•    ciclosporin, rapamycin or sirolimus, tacrolimus (immunosuppressants)

•    buspirone, alprazolam, brotizolam, to treat anxiety

•    midazolam (given by injection), a sedative

•    reboxetine, to treat depression

•    ebastine, to treat allergy

•    alfentanil or fentanyl, a painkiller

•    methylprednisolone, budesonide, dexamethasone or fluticasone, anti-inflammatory medicines

•    cilostazol, to improve blood circulation

•    halofantrine, to treat malaria

•    repaglinide, for diabetes

•    the herbal remedy, St John's wort; or you have stopped taking this remedy within the last 2 weeks.

Do not take medicines to treat heartburn, stomach ulcers or indigestion, within 2 hours of your Itraconazole dose as it can affect absorption of itraconazole. If you have low acid levels in your stomach (e.g. if you take anti-ulcer medicine such as esomeprazole), take Itraconazole with a cola drink.

Pregnancy and breast-feeding -

Do not take Itraconazole if you are pregnant or plan to become pregnant. Take adequate contraceptive precautions during and after Itraconazole treatment (until your next period). Breast-feeding is not recommended whilst using Itraconazole. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines -

Itraconazole should not affect your driving ability, but if you do suffer from side effects such as dizziness, visual disturbances or hearing loss, do not drive or use machines.

Important information about some of the ingredients of Itraconazole - This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.

3. HOW TO TAKE ITRACONAZOLE

Always take Itraconazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the capsules with a glass of water. Do not chew the Capsules. Take straight after a meal.

Adults - The usual dose is one or two capsules daily. If you suffer from a weak immune system, your doctor may need to increase this dose. The dose and length

of treatment will depend on the type of yeast or fungal infection you have. To treat the following infections:

Vaginal thrush (yeast infection) -

the usual dose is 200 mg (2 capsules) followed by another 200 mg (2 capsules) 12 hours later.

Thrush in the mouth, throat or oesophagus (gullet) - the usual dose is 1 capsule once daily for 15 days. Fungal infections of the skin - the

dose can range from 2 capsules once daily for 7 days to 1 capsule once daily for 15 or 30 days.

Fungal nail infections - the usual dose is 2 capsules once daily for 3 months. Infections affecting other parts of the body - your daily dose and length of treatment will depend on the type of infection you have.

The elderly and children (under 12 years) - Itraconazole is not recommended unless it is considered really necessary to treat with it.

Patients with liver or kidney problems - Your doctor will advise you on the right dose for you (which may be lower than stated above).

Patients with a weak immune system (including HIV/AIDs patients) - Your doctor may need to give you blood tests to monitor the amount of Itraconazole in your body. In some cases, your doctor may increase your dose to 200 mg twice a day.

If you take more Itraconazole than you should - Contact your doctor or nearest casualty department immediately. Take the container and any remaining capsules with you.

If you forget to take Itraconazole -

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Itraconazole -

Even when you start to fell better it is important for you to keep on taking your capsules for as long as your doctor tells you. If you stop too soon, the infection may start up again. Sometimes your doctor may want you to continue taking your capsules to prevent your infection from coming back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, itraconazole can cause side effects, although not everybody gets them. If the treatment lasts for one month or longer, side effects become more likely.

If you suffer from any of the following, stop taking Itraconazole and tell your doctor immediately or go to your nearest hospital emergency department:

•    an allergic reaction causing swelling of the lips, tongue or face or have difficulty breathing

•    heart failure reactions such as breathlessness and swollen ankles

•    severe skin reactions including blistering of the skin, mouth, eyes and genitals

or flaking or peeling of the skin

•    liver problems causing yellowing of the skin or whites of the eyes, dark urine or pale stools, loss of appetite, feeling or being sick, fatigue or stomach pain

•    numbness or tingling in the fingers and toes.

These are very rare but serious side effects. You may need medical attention.

Common side effects (affecting fewer than 1 in 10 people):

•    stomach pain

•    feeling sick

•    skin rash.

Uncommon side effects (affecting fewer than 1 in 100 people):

•    headache

•    dizziness

•    being sick

•    diarrhoea, constipation or wind

•    indigestion

•    taste disturbance or loss of taste

•    changes in liver enzymes (shown by blood tests)

•    skin problems such as a nettle-like rash, hives or itching

•    hair loss

•    change in the menstrual cycle

•    swelling due to excessive fluid in the body.

Rare side effects (affecting fewer than 1 in 1,000 people):

•    reduction in white blood cells causing frequent infections such as fever, chills, sore throat or mouth ulcers

•    decreased feeling or sensitivity, especially in the skin

•    visual disturbance such as blurred or double vision

•    ringing in the ears

•    inflammation of the pancreas which causes severe pain in the abdomen and back

•    increased frequency of urination.

Other side effects (frequency not known):

•    reduction in blood platelets which increase risk of bleeding or bruising

•    low levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm

•    high levels of triglycerides in the blood (shown by blood tests)

•    loss of hearing (may be permanent)

•    sensitivity of the skin to light

•    muscle pain or painful, swollen joints

•    accidential leakage of urine

•    erection difficulties.

If any side effect gets serious, or if you notice any side effects not mentioned in the leaflet, please tell your pharmacist or doctor.

5.    HOW TO STORE ITRACONAZOLE

Keep out of the reach and sight of children. Do not take itraconazole after the expiry date which is stated on the carton or label after 'EXP'. The expiry date refers to the last day of that month. Do not store the carton above 25°C.

Keep your medicine in the original package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Itraconazole contains - The

active substance is 100 mg of itraconazole. The other ingredients are sugar spheres (with maize starch), hypromellose (E464), sorbitan stearate and colloidal hydrated silica. The capsule shell is made of gelatin, titanium dioxide (E171) and red iron oxide (E172).

Contents of the pack - This medicine comes in blister packs of 4, 6, 7, 8, 14, 15, 18, 28, 30, 50, 60, 84, 100, 140, 150, 280 and 300 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer -

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.

This leaflet was last approved in: 12/2011