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 any 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:

j What Itraconazole capsules are and what they are used for Before you take How to take 4 Possible side effects How to store 6| Further information

called bepridil and nisoldipine

•    Medicines for migraine headaches called eletriptan, hydroergotamine and ergotamine

•    Cisapride - for digestive problems

•    Ergometrine (ergonovine) and methylergometrine (methylergonovine)

- used after giving birth

•    Levacetylmethadol - for treatment of drug abuse (opioid-dependency)

•    Midazolam (by mouth) or triazolam - for anxiety or to help you sleep

•    Pimozide and sertindole - for conditions affecting thoughts, feelings and behaviour

Do not start taking itraconazole capsules and tell your doctor if you are taking any of the above.

Tell your doctor before taking, or if you are already taking, any of the following medicines. They may stop itraconazole capsules from working properly:

•    Medicines for tuberculosis called rifampicin, rifabutin or isoniazid

•    Medicines for epilepsy called phenytoin, carbamazepine or phenobarbital

•    St. John's Wort (a herbal medicine)

Do not use itraconazole capsules within 2 weeks of taking these medicines.

•    Medicines for indigestion, stomach ulcers or heartburn can affect the stomach producing acid. There must be enough acid in your stomach to make sure that your body can use the medicine. For this reason you should wait two hours after taking itraconazole capsules before taking any of these other medicines. If you take medicines that stop the production of stomach acid, you should take itraconazole capsules with a drink of cola

Tell your doctor before taking, or if you are already taking any of the above. They may stop itraconazole capsules from working properly.

Tell your doctor before taking, or if you are already taking any of the following medicines. They may need to alter the dose of itraconazole capsules or your other medicine:

•    Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam

•    Medicines used in the treatment of cancer such as busulphan, docetaxel, trimetrexate and a group of medicines known as 'vinca alkaloids'

•    Medicines to thin the blood (anticoagulants) such as warfarin

•    Medicines for HIV infection such as ritonavir, indinavir and saquinivir. They are called 'antiviral protease inhibitors'

•    Medicines for bacterial infections called clarithromycin or erythromycin

•    Medicines that act on the heart and blood vessels called digoxin and disopyramide, cilostazol or 'calcium channel-blockers' such as dihydropyridines and verapamil

•    Medicines for inflammation, asthma or allergies (given by mouth or injection) called methylprednisolone, fluticasone, budesonide or dexamethasone

•    Medicines that are usually given after an organ transplant called ciclosporin, tacrolimus or rapamycin. Another name for rapamycin is sirolimus

•    Alfentanil and fentanyl - for pain

•    Ebastine - for allergy

•    Halofantrine - for malaria

•    Reboxetine - for depression

•    Repaglinide - for diabetes

•    Midazolam - to help you relax or sleep when given into a vein

Tell your doctor before taking, or if you are already taking any of the above. They may need to alter the dose of itraconazole capsules or your other medicine.

Taking Itraconazole capsules with food and drink:

Always take itraconazole capsules straight after a meal as this helps your body to use the medicine.

Pregnancy and breast-feeding:

•    Do not take itraconazole capsules if you are pregnant unless your doctor has told you to. You should use contraception

to make sure that you do not become pregnant when taking this medicine

•    The medicine in itraconazole capsules stays in your body for some time after you have stopped taking them. After your treatment has finished, you must use contraception up until your next period (menstrual bleed). Ask your doctor for advice on what type of contraception to use

•    If you become pregnant after starting a course of itraconazole capsules, stop taking them and tell your doctor straight away

•    Do not breast-feed if you are taking itraconazole capsules, as small amounts of the medicine could pass into your milk. Ask your doctor for advice

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines:

Itraconazole capsules can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms do not drive or use machines.

Important information about one of the ingredients of Itraconazole capsules

This medicine contains the sugar sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take

Always take Itraconazole capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method and route of administration

Itraconazole must be taken immediately following a meal for optimum absorption. Capsules should be swallowed with a small amount of water.

Frequency and duration of treatment The number of capsules and the duration of treatment will depend on the fungus and on the location of infection. Your doctor will tell you exactly what dose to take.

The following table lists some of the more frequent dosages:

For nail infections, depending on your specific requirements, your doctor may opt for continuous or pulse treatment:

When you should expect the results

Drug effects are not immediate.

•    Severe skin disorders with peeling and/ or rashes with small pustules (with a fever) or blistering of the skin, mouth, eyes and genitals, with fever, chills, aching muscles and generally feeling unwell. (the precise frequency of how often these may occur is not known)

•    A tingling sensation, numbness or weakness in your limbs (the precise frequency of how often this may occur is not known)

•    Severe lack of appetite, feeling sick (nausea), being sick (vomiting), unusual tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of your eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a liver problem. This only happens in a small number of people

•    Shortness of breath, unexpected weight gain, swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night. These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs (this only happens in a small number of people).

Tell your doctor or pharmacist if you notice any of the following side effects:

Common (affects less than 1 in 10 people)

• Stomach ache, feeling sick (nausea)

Uncommon (affects less than 1 in 100 people)

•    Problems with periods

•    Headache, dizziness

•    Constipation, diarrhoea, wind, being sick (vomiting), indigestion, change in taste

•    Swelling due to fluid under the skin

•    Unusual hair loss or thinning (alopecia)

Rare (affects less than 1 in 1000 people)

•    Increases in liver function tests (shown by blood tests)

•    Unexpected passing of urine or need to urinate (pass water) more often

•    Problems with sight including blurred vision and double vision

•    Certain blood disorders which may increase the risk of bleeding, bruising or infections

•    Ringing in your ears

•    Severe upper stomach pain, often with nausea and vomiting

•    Fever or high temperature

The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they occur is classed as unknown:

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

•    Muscle pain, painful joints

•    Red, itchy, flaking or peeling skin

•    Erection difficulties

•    Sensitivity of the skin to light

•    Hearing loss (may be permanent)

•    Lower levels of potassium in your blood (shown by blood tests)

If you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

In skin infections, lesions normally disappear a few weeks after treatment is suspended. This is characteristic of fungus lesions as the drug will eliminate the fungus but the lesions will remain until new skin grows.

Nail lesions will disappear six to nine months after treatment, as the drug will eliminate the fungus but new nail growth takes several months.

Do not worry if you see no improvement during the treatment.

The drug will remain in your nails for several months and is doing its job. Suspend treatment as soon as your doctor tells you to, even if you see no visible signs of improvement.

For infections of internal organs higher doses and longer treatment times may be required.

Do not forget to take your medication. Follow these instructions unless your doctor tells you otherwise.

Your doctor will tell you how long you should take Itraconazole capsules.

Do not interrupt treatment before being advised to do so by your doctor or cure may not be complete.

If you take more Itraconazole capsules than you should

Immediately consult your doctor or pharmacist if you take more Itraconazole capsules than you should.

If you forget to take Itraconazole capsules

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

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

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Itraconazole capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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.

What Itraconazole capsules contain

Itraconazole capsules is presented in the form of hard gelatin capsules containing micro-granules.

The active substance is itraconazole. Each capsule contains 100mg of itraconazole (I.N.N.).

The other ingredients are:

Capsule contents: sugar spheres (maize starch and sucrose), poloxamer 188 and hypromellose.

Capsule shell: indigo carmine (E 132), quinoline yellow (E 104), titanium dioxide (E 171) and gelatin.

What Itraconazole capsules look like and contents of the pack

Itraconazole Capsules are opaque green and are available in blister packs of 15 and 60s.

Marketing authorisation holder:

Actavis Group PTC ehf.

Reykjavikurvegur 76-78, 220 HafnarfjorSur Iceland

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), SPAIN

Stop taking itraconazole capsules and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

• Sudden signs of allergy such as rash, hives (also known as nettle rash or urticaria), severe irritation of your skin, swelling of the face, lips, tongue or other parts of the body. These may be signs of a severe allergic reaction. This only happens in a small number of people

This leaflet was last revised in: January 2015

If you would like a leaflet with larger text, please contact 01271 311257.

^actavis

Actavis, Barnstaple, EX32 8NS, UK

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