Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
MEPYRAMINE MALEATE
G & A Licensing Limited
MEPYRAMINE MALEATE
2 %w/w
Cream
Product not subject to medical prescription
Withdrawn
2013-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anthisan 2% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mepyramine maleate 2% w/w Excipients: includes methyl parahydroxybenzoate (E218), cetostearyl alcohol and benzyl benzoate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from the UK_ Smooth homogenous cream of fairly firm consistency, off-white to pale in colour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anthisan has analgesic, anti-histaminic and anti-pruritic properties. Symptomatic relief in insect bites, stings and nettle rash. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of administration is topical. Recommended Dosage Apply to affected area 2 to 3 times daily for up to 3 days or as directed by the physician. 4.3 CONTRAINDICATIONS Acute vesicular and exudative dermatoses. Use on broken skin. Use with occlusive dressings. Use in patients hypersensitive to mepyramine maleate or any of the excipients of Anthisan Cream. Use in premature infants and neonates. Pregnancy and lactaction. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist, consult a doctor. Contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed). Contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Contains benzyl benzoate : mildly irritant to the skin, eyes and mucous membrane IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2011_ _CRN 2107054_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION There is no evidence of the safety of Mepyramine Maleate in human pregnancy. Izlasiet visu dokumentu