Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
MAGNESIUM OXIDUM LEVE ALUMINIUM HYDROXIDE DIMETHICONE 350
Seton Products Ltd
Oral Suspension
2002-10-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asilone Antacid Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Light magnesium oxide 70 mg/5ml Dried aluminium hydroxide 420 mg/5 ml Activated dimeticone 135 mg/5 ml _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Oral suspension. A smooth white free-flowing suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiflatulent and antacid; for the relief of dyspeptic symptoms of functional or organic origin, including flatulence and associated abdominal distension, heartburn, hiatus hernia, and oesophagitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults including the Elderly One or two 5ml spoonfuls after meals and at bedtime or when required, up to a maximum of four times daily. Children The suspension formulation is not recommended for children under 12 years of age. 4.3 CONTRAINDICATIONS Antacid preparations should not be administered in severe debilitation or renal impairment. Do not use during the first trimester of pregnancy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Asilone is not recommended in flatulent abdominal distention possibly related to intestinal obstruction. The label states: If symptoms persist consult your doctor. Not suitable for children under 12 years of age. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2010_ _CRN 2079002_ _page number: 1_ Keep all medicines out of reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Antacids may interfere with the absorption of tetracyclines, rifampicin, warfarin and digoxin if given concomitantly. Antacids should preferably not be taken at the same time as other drugs since they m Aqra d-dokument sħiħ