1- NAME OF THE MEDICINAL PRODUCT Ultrafulvin 125 mg Tablets. 2- QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active ingredient: Griseofulvin (micronized) 125 mg 3-PHARMACEUTICAL FORM: White rounded beveled flat tablet with break line on one side. The scoring is non functional (not for dose division). 4. CLINICAL PARTICULARS 4.1. Therapeutic Indications The treatment of fungal infections of the skin, scalp, hair or nails where topical therapy is considered inappropriate or has failed. When Griseofulvin is given orally for systemic treatment of fungal infections, it enables newly-formed keratin of the skin, hair and nails to resist attack by the fungi. As the new keratin extends, the old infected keratin is shed. Griseofulvin is effective against the dermatophytes causing ringworm (tinea), including: Microsporum canis and T. Verrucosum. Griseofulvin is not effective in infections caused by Candida albicans(monilia), Aspergilli, Malassezia furfur (Pityriasis versicolor) and Nocardia species. 4.2 Posology and method of administration Posology Adults Normally 500 to 1000 mg daily, but not less than 10 mg/kg bodyweight daily. A single dose daily is often satisfactory, but divided doses may be more effective in patients who respond poorly. Paediatric population Usually 10 mg/kg (5 mg/lb) body weight daily in divided doses. Duration of Treatment This depends upon the thickness of keratin at the site of infection. For hair or skin at least four weeks treatment is required, whereas toe or fingernails may need six to twelve months treatment. Therapy should be continued for at least two weeks after all signs of infection have disappeared. Method of administration: For oral administration. Doses should be taken after meals, otherwise absorption is likely to be inadequate. 4.3 Contraindications Porphyria or severe liver disease. Griseofulvin may cause liver disease to deteriorate, and liver function should be monitored in such conditions. Systemic Lupus Erythematosus: Griseofulvin has been reported to exacerbate the condition. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. There is no evidence of the safety of Griseofulvin in human pregnancy. Griseofulvin is teratogenic in animals and some case reports of human foetal abnormalities have been observed. Therefore, Griseofulvin should not be used in pregnancy, or in women intending to become pregnant within one month following cessation of treatment. Males should not father children within six months of treatment with Griseofulvin. Long term administration of high doses of Griseofulvin with food has been reported to induce hepatomas in mice and thyroid tumours in rats but not hamsters. The clinical
