Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Itraconazole 100mg;
Janssen-Cilag (New Zealand) Ltd
Itraconazole 100 mg
100 mg
Capsule
Active: Itraconazole 100mg Excipient: Erythrosine Gelatin Hypromellose Indigo carmine Macrogol 20000 Sugar spheres Titanium dioxide
Blister pack, 15 capsules
Prescription
Prescription
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
SPORANOX capsules are indicated for the following conditions: - Treatment of vulvovaginal candidiasis. - Treatment of pityriasis versicolor. - Treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - Treatment of fungal keratitis. - Treatment of oral candidiasis. - Treatment of onychomycosis caused by dermatophytes and/or yeasts. - Systemic mycoses, only in the following fungal infections: o Treatment of systemic aspergillosis and candidiasis, o Treatment of histoplasmosis, o Histoplasmosis, maintenance therapy only in AIDS patients. o Treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o Treatment of paracoccidioidomycosis, o Treatment of chromomycosis, o Treatment of blastomycosis.
Package - Contents - Shelf Life: Blister pack, - 15 capsules - 36 months from date of manufacture stored at or below 30°C
1989-08-28
SPORANOX ® CAPSULES 1 SPORANOX ® CAPSULES _Itraconazole _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPORANOX capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPORANOX capsules against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING SPORANOX CAPSULES, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT SPORANOX CAPSULES ARE USED FOR SPORANOX capsules are used to treat certain fungal infections which include the following: • persistent infections of the nails, skin, hands, feet or groin; • persistent candida (yeast) infections of the vagina; • eye infections which have not responded to other treatment or which may be affecting vision; • candida (yeast) infections of the mouth or throat • generalised infections. SPORANOX works by killing or stopping the growth of the fungus that causes the infection. Your doctor may have prescribed SPORANOX capsules for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE SPORANOX CAPSULES _WHEN YOU MUST NOT TAKE IT _ Do not take SPORANOX capsules if: • you have an allergy to SPORANOX capsules or any of the ingredients. See Product Description at the end of this leaflet. Signs of allergy may include skin rash, itching, shortness of breath, and/or swollen face or tongue. • you are pregnant or planning to become pregnant. If there is any chance of you becoming pregnant, talk to your doctor about the need for highly effective contraception. Once you have finished taking SPORANOX, you should continue using highly effective contraception until you have had your next period. Tell your doctor immediately if you do become pregnant while taking SPORANOX. • you have a condition cal Read the complete document
CCDS180629v014 1 SPORANOXcaps(180928)ADS SPORANOX ® ITRACONAZOLE DATA SHEET 1. PRODUCT NAME SPORANOX™ itraconazole 100 mg capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains itraconazole 100mg. For a full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Capsule Blue opaque cap and pink transparent body containing beads. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPORANOX capsules are indicated for the following conditions: - Treatment of vulvovaginal candidiasis. - Treatment of pityriasis versicolor. - Treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - Treatment of fungal keratitis. - Treatment of oral candidiasis. - Treatment of onychomycosis caused by dermatophytes and/or yeasts. - Systemic mycoses, only in the following fungal infections: o Treatment of systemic aspergillosis and candidiasis, o Treatment of histoplasmosis, o Histoplasmosis, maintenance therapy only in AIDS patients. o Treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o Treatment of paracoccidioidomycosis, o Treatment of chromomycosis, o Treatment of blastomycosis. CCDS180629v014 2 SPORANOXcaps(180928)ADS 4.2 DOSE AND METHOD OF ADMINISTRATION For optimal absorption, it is essential to administer SPORANOX capsules immediately after a full meal. The capsules must be swallowed whole. Treatment schedules are as follows: INDICATION DOSE DURATION Treatment of vulvovaginal candidiasis 200 mg twice daily or 200 mg once daily 1 day 3 days Treatment of pityriasis versicolor 100 mg twice daily or 200 mg once daily 5 - 7 days Treatment of dermatomycosis 100 mg once daily or 200 mg once daily 15 days or 7 days Treatment of dermatomycosis in highly keratinised regions as in plantar tinea pedis and palmar tinea manus 200 mg twice daily or 100 mg once daily 7 days or 30 days Treatment of oral candidiasis 100 mg once daily 15 days Treatment of fungal keratitis 200 mg once daily 21 days The duration of treatment s Read the complete document