מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Griseofulvin
Alliance Healthcare (Distribution) Ltd
D01BA01
Griseofulvin
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020500
FRONT BACK _Continued over page_ 82-83/L/e/6 82-83/L/e/6 WHAT IS IN THIS LEAFLET 1. WHAT GRISEOFULVIN TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRISEOFULVIN TABLETS 3. HOW TO TAKE GRISEOFULVIN TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE GRISEOFULVIN TABLETS 6. FURTHER INFORMATION 1. WHAT GRISEOFULVIN TABLETS ARE AND WHAT THEY ARE USED FOR Griseofulvin Tablets contain griseofulvin which is an antifungal antibiotic. Griseofulvin kills the fungi that cause infections of: the skin, scalp, hair or nails. It works by helping the newly formed skin, hair and nails to resist attack by fungi. As the new tissue grows, the old and infected is cast off. It is important to continue treatment until all the old infected tissue is gone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRISEOFULVIN TABLETS DO NOT TAKE GRISEOFULVIN TABLETS if you are allergic to griseofulvin or to any of the other ingredients of this medicine (listed in section 6). if you are pregnant or intending to become pregnant within 1 month of stopping treatment. if you are planning to father children within 6 months of treatment with these tablets. if you have severe liver disease. if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder). if you have systemic lupus erythematosus (a disorder which causes the immune system to attack the body). Griseofulvin Tablets must NOT be taken if your skin, hair or nails are healthy, as a precaution to prevent a long-past infection returning. If any of the above apply to you, speak to your doctor or pharmacist. OTHER MEDICINES AND GRISEOFULVIN TABLETS Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may be affected by Griseofulvin Tablets or they may affect how well Griseofulvin Tablets will work. Tell your doctor or pharmacist if you are taking: oral contraceptives (the pill). You will need an additional method of contraception, such as condoms wh קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Griseofulvin 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Griseofulvin BP 500.0 mg Excipient(s) with known effect: Each tablet contains 1.55 mg propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 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 r קרא את המסמך השלם