Tracon capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’.

Tracon capsules are used for infections caused by fungi or yeasts. They are used for:

• Infections of the mouth or vagina causing ‘thrush’.
• Skin infections.
• Infections affecting other parts of the body.

Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Tracon capsules. Finger and toenails may take several months to completely clear up. This is because your skin or nail will only look normal after new skin or nail has grown, even though the medicine has killed the fungus that caused the infection.

Do not use Tracon capsules if:

• You are allergic to anything in Tracon capsules (listed in section 6 below).
• You are pregnant or could become pregnant unless your doctor has told you to (see ‘Pregnancy and breast-feeding below).
• You are taking oral midazolam, nisoldipine, felodipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine, and methylergometrine (methylergonovine) or methadone.

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Tracon capsules.

Take special care with Tracon capsules

Check with your doctor or pharmacist before using this medicine if:

• You have ever had kidney problems. Your dose of Tracon capsules may have to be changed
• You have ever had liver problems such as yellow skin (jaundice). Your dose of Tracon capsules may have to be changed. If after taking this medicine you have a severe lack of appetite, feel sick (nausea), are sick (vomiting), feel unusually tired, get stomach pain, muscle weakness, yellowing of the skin or whites of the eyes, unusually dark urine, pale stools or hair loss, stop taking Tracon capsules and tell your doctor straight away.
• You have ever had a heart problem including heart failure (also called congestive heart failure or CHF). Tracon capsules could make it worse. If after taking this medicine you get any of the following:

-          Shortness of breath.

-          Unexpected weight gain.

-          Swelling of your legs or tummy.

-          Feel unusually tired.

-          Wake up short of breath at night.

  Stop taking Tracon capsules and tell your doctor straight away. These may be signs of heart failure

• You have Acquired Immunodeficiency Syndrome (AIDS) or your immune system is not working as well as it should.
• You have had an allergic reaction to another antifungal product in the past.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tracon capsules.

Children and the elderly

Tracon capsules are not normally given to children under the age of 12 or the elderly. However, your doctor may prescribe them in special cases.

Blood tests

If your Tracon capsules course is for more than one month, your doctor may want to check your liver by testing your blood.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular, do not take this medicine and tell your doctor if you are taking any of the following:

• Medicines for hay fever or allergy called terfenadine, astemizole, or mizolastine.
• Medicines to lower cholesterol called atorvastatin, lovastatin, or simvastatin.
• Medicines for an irregular heartbeat called quinidine or dofetilide.
• Medicines used to treat angina (crushing chest pain) and high blood pressure called bepridil and nisoldipine.
• Medicines for migraine headaches called eletriptan, dihydroergotamine,  ergometrine (ergonovine), ergotamine, and methylergometrine (methylergonovine).
• 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.
• Methadone as life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using methadone.
• Calcium channel blockers: as ( felodipine).                                                                                      A clinical study showed that felodipine exposure was increased by coadministration of itraconazole, resulting in approximately a 6-fold increase in the AUC and an 8-fold increase in Cmax.The concomitant use of Tracon and felodipine is contraindicated.
• Pimozide and sertindole - for conditions affecting thoughts, feelings, and behavior.

Do not start taking Tracon 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 Tracon 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 Tracon 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 Tracon capsules before taking any of these other medicines. If you take medicines that stop the production of stomach acid, you should take Tracon capsules with a drink of cola

Tell your doctor before taking, or if you are already taking any of the above. They may stop Tracon 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 Tracon capsules or your other medicine:

• Medicines used for anxiety or to help you sleep (tranquilizers), 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 saquinavir. 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 Tracon capsules or your other medicine.

Taking Tracon capsules with food and drink

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

Pregnancy and breast-feeding

Do not take Tracon 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 Tracon 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 Tracon capsules, stop taking them and tell your doctor straight away

Do not breastfeed if you are taking Tracon 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 breastfeeding.

Driving and using machines

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

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking Tracon capsules

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

Swallow the capsules whole with some liquid.

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

How much to take

Your doctor will tell you how many Tracon capsules to take and for how long. They may recommend the following treatment courses.

Yeast infection of the vagina (thrush)

Take 2 capsules in the morning and two capsules 12 hours later for one day only.

Yeast infection of the mouth (oral thrush)

Take 1 capsule each day for 15 days.

Fungal infections of the skin

The dosage depends on your infection. Your doctor might tell you to take:

2 capsules each day for 7 days, or

1 capsule each day for 15 days, or

1 capsule each day for 30 days.

Fungal infections in other parts of the body

Your doctor will tell you how many Tracon capsules to take and for how long depending on your infection.

If you take too much of your medicine

If you take more Tracon capsules than you were told to, talk to your doctor or go to the nearest hospital casualty department straight away.

If you forget to take Tracon capsules

If you forget to take your capsules, take them as soon as you remember. However, if it is nearly time for the next capsules, skip the missed capsules.

Do not take a double dose to make up for a forgotten dose.

When to stop using Tracon capsules

Keep taking Tracon capsules for as long as your doctor has told you. Do not stop your treatment just because you feel better.

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

Like all medicines, Tracon capsules can cause side effects, although not everybody gets them.

Stop using Tracon 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 to a small number of people.

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 to 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, diarrhea, 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 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 (maybe permanent).
• Lower levels of potassium in your blood (shown by blood tests).
• Dyspnea and acute generalized exanthematous pustulosis (AGEP).

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

Keep out of the reach and sight of children.

Store the capsules in their carton to protect from light

Store below 30°C.