País: Israel
Idioma: anglès
Font: Ministry of Health
BENZOYL PEROXIDE AS HYDROUS; CLINDAMYCIN AS PHOSPHATE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
D10AF01
GEL
CLINDAMYCIN AS PHOSPHATE 1 %W/W; BENZOYL PEROXIDE AS HYDROUS 5 %W/W
TOPICAL
Required
GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)
CLINDAMYCIN
CLINDAMYCIN
Mild to moderate acne vulgaris, particulary inflammatory lesions.
2014-05-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duac Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains: 10 mg clindamycin as clindamycin phosphate 50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel White to slightly yellow homogeneous gel 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate acne vulgaris, particularly inflammatory lesions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use only. Posology _Adults and Adolescents (aged 12 years and above) _ Duac gel should be applied once daily in the evening, to the entire affected area. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted (see section 4.4). An effect on inflammatory and non-inflammatory lesions may be seen as early as week 2-5 of treatment (see section 5.1). The safety and efficacy of Duac Gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with Duac Gel should not exceed more than 12 weeks of continuous use. _Pediatric population _ The safety and efficacy of Duacgel has not been established in children under 12 years of age, therefore Duac gel is not recommended for use in this population. _Elderly patients _ No specific recommendations. _Method of administration _ Duac Gel should be applied in a thin film after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied. Hands should be washed after application 4.3 CONTRAINDICATIONS Duac Gel must not be administered to patients with known hypersensitivity to: - clindamycin - lincomycin - benzoyl peroxide - any of the excipients in the formulation, listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact with the mouth, eyes, lips and mucous Llegiu el document complet