Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ITRACONAZOLE
JOHNSON & JOHNSON SDN BHD
ITRACONAZOLE
4Capsule Capsules; 14Capsule Capsules; 28Capsule Capsules
JANSSEN CILAG SPA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SPORANOX ® CAPSULES Itraconazole (100mg) 1 WHAT IS IN THIS LEAFLET 1. What SPORANOX ® is used for 2. How SPORANOX ® works 3. Before you use SPORANOX ® 4. How to use SPORANOX ® 5. While you are using it 6. Side effects 7. Storage and disposal of SPORANOX ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial number WHAT SPORANOX ® IS 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 in patients with lower resistance to disease; • generalised infections. 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. HOW SPORANOX ® WORKS SPORANOX works by killing or stopping the growth of the fungus that causes the infection. BEFORE YOU USE SPORANOX ® - _When you must not use it _ Do not use SPORANOX: - if you know you are hypersensitive (allergic) to it; - if you are pregnant (unless your doctor knows you are pregnant and decides you need SPORANOX); - if you are of child bearing age and could become pregnant, you should take adequate contraceptive precautions to make sure that you do not become pregnant while you are taking your medicine. As SPORANOX remains in the body for some time after you stop taking it, you should continue to use contraception until your next period after your treatment with SPORANOX capsules is finished. If you are breast-feeding, tell your doctor before taking SPORANOX. - if you have a condition called heart failure (also called congestive heart failure or CHF), SPORANOX could make it worse. If your doctor decides that you need to take SPORANOX even if you have Baca dokumen lengkap
1 PRODUCT NAME SPORANOX ® Capsule 100mg GENERIC NAME/INTERNATIONAL NON-PROPRIETARY NAME Itraconazole DOSAGE FORMS AND STRENGTHS Each capsule, for oral administration, contains 100 mg itraconazole in a pellet formulation, and is available as a blue opaque cap and pink transparent body. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS SPORANOX capsules are indicated for the following conditions: • Gynecological indications: - Treatment of vulvovaginal candidosis. • Dermatological/mucosal/ophthalmological indications: - Treatment of dermatomycosis, including highly keratinized regions as in plantar tinea pedis and palmar tinea manus; - Treatment of pityriasis versicolor; - Treatment of oral candidosis; • Treatment of onychomycosis, caused by dermatophytes and/or yeasts. • Systemic mycoses, only in the following fungal infections: - Treatment of systemic aspergillosis and candidosis; - Cryptococcosis (including cryptococcal meningitis): - Treatment of immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system, only when first line treatment is considered inappropriate or has proven ineffective; - For maintenance therapy of cryptococcal meningitis in AIDS patients, only when first line treatment is considered inappropriate or has proven ineffective. - Treatment of histoplasmosis; - Histoplasmosis, maintenance therapy only in AIDS patients; - Treatment of blastomycosis; - Treatment of sporotrichosis, including lymphocutaneous/cutaneous and extracutaneous; - Treatment of paracoccidioidomycosis; - Treatment of chromomycosis. DOSAGE AND ADMINISTRATION For optimal absorption, administer SPORANOX capsules immediately after a full meal. The capsules must be swallowed whole. GYNECOLOGICAL INDICATION INDICATION DOSE TREATMENT DURATION 2 Treatment of vulvovaginal candidosis 200 mg twice daily or 200 mg once daily 1 day or 3 days DERMATOLOGICAL/MUCOSAL/OPHTHALMOLOGICAL INDICATIONS INDICATION DOSE TREATMENT DURATION Treatment of dermatom Baca dokumen lengkap