Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Cetrimide; Chlorocresol; Dimeticone; Urea
Actavis Group PTC ehf
D08AJ; D08AJ04
Cetrimide; Chlorocresol; Dimeticone; Urea
Per Cent
Cream
Product not subject to medical prescription
Quaternary ammonium compounds; cetrimide
Marketed
1997-04-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cymex Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Cream Smooth white cream with characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the application to cold sores and cracked lips. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology There are no special hazards associated with the use of cetrimide in specific patient groups. No special precautions or modified dosage requirements are, therefore, indicated for its use in infants, the elderly or during pregnancy or lactation. No hazardous drug interactions are considered likely. Adults, elderly and children: apply sparingly every hour for the relief of cold sores and cracked lips. Method of administration Topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep out of the reach and sight of children. For external use only. If symptoms persist consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. Urea 1.0 % w/w Cetrimide 0.5 % w/w Dimeticone 350 9.0 % w/w Chlorocresol 0.1 % w/w H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _6_ _4_ _4_ _8_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 FERTILITY, PREGNANCY AND Read the complete document