Indication

• Short term treatment: Itraconazole is used to treat vulvovaginal candidiasis, pityriasis versicolor, dermatomycoses unresponsive to topical treatment, fungal keratitis and oral candidiasis.
• Long term treatment: Itraconazole is used to treat onychomycoses caused by dermatophytes and/or yeasts, aspergillosis and systemic candidiasis, cryptococcal infections (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycoses.

Therapeutic levels of Itrasix remain in the skin for two to four weeks following the end of treatment, depending on its duration. In vaginal tissue, Itrasix can be found for a period of two to three days, again depending on the duration of treatment.

Posology and method of administration
Itrasixmust be taken immediately following a meal for optimum absorption. should be swallowed with a
small amount of water. 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, you doctor may opt for continuous or pulse
treatment:

When you should expect the results:
Drug effects are not immediate.
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 Itrasix. Do not interrupt treatment before being advised to
do so by your doctor or cure may not be complete.

If you take more Itrasix than you should:
Immediately consult your doctor or pharmacist if you take more Itrasix than you should.

If you forget to take Itrasix:
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.

POSSIBLE SIDE EFFECTS

During treatment with Itrasix the following symptoms may appear: dyspepsia, nausea, abdominal pain and constipation. Patients may also suffer headaches, menstrual disorders or dizziness. Hypersensitivity to Itrasix is very rare and manifests itself as a skin rash, pruritus, difficulty breathing and/or inflammation of the face. Should any of these symptoms appear stop taking the drug and inform your doctor. In very rare situations patients have presented tingling of the extremities or important skin conditions. Should this happen stop taking Itrasix and consult your doctor.

Although very infrequent, one or more of the following symptoms may appear during long term Itrasix treatment: muscle weakness, jaundice, dark urine, pale feces, fluid accumulation or hair loss. If any of these symptoms appear stop taking the drug and inform your doctor immediately.
There have been occasional reports of edema, congestive heart failure and pulmonary edema.

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.

Contraindication

• If you are pregnant (only your doctor is in a position to decide if you need this drug).
• If you are breastfeeding.
• If you are hypersensitive to the active ingredient or any of the other ingredients of the formulation.
• If you suffer from congestive heart failure

Children should not be given Itrasix, except for exceptional situations as assessed by the doctor.

Take special care with Itrasix:

- Please inform your doctor:

• if you have any type of liver disease. The dose may have to be adjusted.
• if you have any type of kidney disease. The dose may have to be adjusted
• if you have a history of any reaction to antifungal medication.
• if you suffer from decreased stomach acid
• if you have been informed that you have any type of sugar intolerance (this drug contains sucrose)

Take special care with Itrasix:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Examples of drugs that should never be taken with Itrasix include:
- Certain allergy medications, especially terfenadine, astemizole and mizolastine
- Cisapride, a drug used to treat certain digestive problems
- Certain cholesterol lowering drugs such as, for example, simvastatin and lovastatin:
- Sleep inducing drugs midazolam and triazolam
- Pimozide, a drug to treat psychotic conditions
- Cardiac arrhythmia drugs quinidine and dofetilide

Certain drugs can drastically decrease the action of Itrasix. This is particularly true of certain drugs used to
treat epilepsy (carbamazepine, phenytoin and phenobarbital) and tuberculosis (rifampicin, riphabutin and
isoniazid). Inform your doctor if you are taking any of these drugs so that proper measures may be taken.

Examples of drug combinations that may require adjusting the dose of Itrasix or of the other drugs.:
- Antibiotics clarithromycin and erythromycin
- Antineoplastic agents
- Certain drugs that act on the heart and blood vessels (digoxin and some calcium channel blockers)
- Certain drugs used to regulate blood circulation
- Methylprednisolone, an oral or injectable anti-inflammatory
- Cyclosporin A, tracolimus and rapamycin, normally used following organ transplantation
- Certain HIV Protease inhibitors (ritonavir, indinavir, saquinavir)
- Carbamazepine, rapamycin, alfentanil, alprazolam.
- Certain drugs used to treat cancer
- Certain anti-anxiety drugs, especially buspirone and alprazolam.

Proper absorption of Itrasix by the human body requires an adequate level of acidity. Therefore, drugs that
inhibit stomach acid must not be taken for a period of two hours preceding Itrasix. For the same reason, if
you are taking medication to decrease the formation of stomach acids, take Itrasix with a cola drink.

Bear in mind that these instructions may also apply to medication you took before or may take after.

 

Pregnancy:

Do not take Itrasix if you are pregnant. Women of childbearing age who may become pregnant must use
proper contraception to ensure they do not get pregnant while under treatment with Itrasix. Contraception
should be used through the first normal menstrual cycle following termination of Itrasix treatment, as the drug
can remain in the system for some time.

Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor if you are breast-feeding and are prescribed Itrasix, as small amounts of the drug may be
present in milk.

Driving and using machines:

Itrasix will not affect you ability to drive or operate machinery unless you suffer from dizziness.

Storage condition

Keep out of the reach and sight of children.
Do not store above 25ºC.

 

Manufacturer: Laboratorios Liconsa, S.A.Guadalajara, SPAIN
Imported by : Sinensix Pharma (Thailand) Co., Ltd. Bangkok, Thailand