Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE HYDROUS ERYTHROMYCIN
SCHWARZ PHARMA Limited
3/5 %w/w
Gel
2001-09-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benzamycin 3% / 5% w/w Gel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of reconstituted gel contains 75 mg benzoyl peroxide, hydrous equivalent to 5% w/w benzoyl peroxide, anhydrous and 30 mg erythromycin equivalent to 3% w/w erythromycin. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM The product is a three component system: o White, viscous gel. o White to off-white erythromycin powder. o Clear, colourless diluent. After reconstitution, the final product is a white, viscous gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Benzamycin Gel should be applied twice daily, morning and evening, to areas usually affected by acne or as directed by the physician. These areas should first be gently washed, rinsed with lukewarm water, and gently patted dry. Benzamycin should be applied in a thin layer with the fingertips until dry and the hands washed after application. It is not recommended for children under 12 years of age. 4.3 CONTRAINDICATIONS Benzamycin is contraindicated in persons who have shown hypersensitivity to benzoyl peroxide hydrous, erythromycin or any of the other ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep away from the eyes, nose, mouth and other mucous membranes. Very fair skinned individuals should begin with a single application at bedtime allowing overnight medication. May bleach hair or dyed fabrics. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/09/2007_ _CRN 2041418_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTH Read the complete document