SPORANOX CAPSULE (ITRACONAZOLE) 100MG
Why do you need to give this medicine?
Sporanox is an antifungal medication that fights infections caused by fungus.
Sporanox is used to treat infections in adults caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

ACTIVE INGREDIENT
Itraconazole 100mg

THERAPEUTIC CATEGORY
Anti-fungal

ADDED INFORMATION
It contains these excipients: Sugar spheres, Hypromellose 2910 5mPa.s, Macrogol 20000, Capsule shell: Titanium dioxide, Indigo carmine, Gelatin, Erythrosine

INDICATION
1. Vulvovaginal candidosis.
2. Pityriasis versicolor.
3. Dermatophytoses caused by organisms susceptible to itraconazole (Trichophyton spp., Microsporum spp., Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum.
4. Oropharyngeal candidosis.
5. Onychomycosis caused by dermatophytes and/or yeasts.
6. The treatment of histoplasmosis.
7. Sporanox is indicated in the following systemic fungal conditions when first-line systemic anti-fungal therapy is inappropriate or has proved ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.
– Treatment of aspergillosis and candidosis
– Treatment of cryptococcosis (including cryptococcal meningitis): in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system.
– Maintenance therapy for penicilliosis and histoplasmosis only in AIDS patients.
– Maintenance therapy of cryptococcal meninigitis only in AIDS patients when standard therapy is considered inappropriate.
Sporanox is also indicated for prophylaxis of fungal infections in immunocompromised patients with severe neutropenia when standard therapy is considered inappropriate.
CONTRAINDICATION
Sporanox Capsules are contra-indicated in patients with known hypersensitivity to itraconazole or to any of the excipients.
Coadministration of a number of CYP3A4 substrates is contraindicated with Sporanox Capsules
Sporanox Capsules should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections.
Sporanox Capsules must not be used during pregnancy except for life-threatening cases.

DOSAGE
Adult dose is usually 100 – 200mg one to two times daily.

POSSIBLE SIDE EFFECT
headache, dizziness, drowsiness, tiredness;
increased blood pressure;
rash, itching;
nausea, vomiting, stomach pain, diarrhea, constipation;
swelling;
abnormal liver function or blood tests;
fever, muscle or joint pain;
unusual or unpleasant taste in your mouth;
hair loss;
impotence, erection problems; or
changes in your menstrual periods.

CAUTION
Caution should be used in prescribing Sporanox Capsules to patients with hypersensitivity to other azoles.
caution should be exercised when co-administering itraconazole and calcium channel blockers.
Cautioned in hepatic impairment patients.
Cautioned in the paediatric and the elderly.

STORAGE
Do not store above 30°C.
Store in the original container

PRODUCT SUBSTITUTE
Itraconazole cap UK

MANUFACTURER/MARKETER
Janssen-Cilag

COUNTRY OF ORIGIN
Belgium