Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE ZINC OXIDE BISMUTH OXIDE BENZOIC ACID CINNAMIC ACID
Eastern Pharmaceuticals Limited
25 Grams
Cream
1995-03-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hemocane Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM A smooth white odourless cream intended for external use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of haemorrhoids and allied ano-rectal conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults - apply morning and night and after bowel movements until the condition is controlled. Not recommended for children. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Untreated infectious conditions, of bacterial, viral, tuberculous or fungal orgin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or worsen, or if an allergic reaction occurs, discontinue use immediately and consult your doctor. Persons who suffer from haemorrhoids are advised to consult their doctor. Keep out of reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND LACTATION Not to be used in pregnancy unless considered essential by the physician. Lignocaine Hydrochloride Ph. Eur 0.65 % w/w Zinc Oxide Ph. Eur 10.00 % w/w Bismuth Oxide 2.00 % w/w Cinnamic Acid B.P 0.45 % w/w Benzoic Acid Ph. Eur 0.40 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/04/2010_ _CRN 2080946_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS None. 4.9 OVERDOSE Overdose is unlikely to occur with the cream. Symptoms would be associated with high plasma levels of lignocaine hydrochloride. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Lignocaine has local anaesthetic properties. Zinc oxide and bismuth oxide, when applied lo Read the complete document