Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MAGNESIUM ALGINATE ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL MAGNESIUM CARBONATE POTASSIUM BICARBONATE CALCIUM CARBONATE
Rorer Pharmaceuticals Limited
MAGNESIUM ALGINATE ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL MAGNESIUM CARBONATE POTASSIUM BICARBONATE CALCIUM CARBONATE
%v/v
Oral Suspension
Withdrawn
2006-04-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Algicon Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension. A yellow suspension with the odour and taste of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of heartburn associated with gastric reflux, oesophagitis, hiatus hernia, pregnancy and hyperacidity. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION 4.3 CONTRAINDICATIONS None specified. w/v Magnesium alginate 5.00% Aluminium hydroxide/Magnesium carbonate coprecipitated dry gel 2.80% Magnesium Carbonate 3.50% Potassium Hydrogen Carbonate 1.00% Precipitated Calcium Carbonate 1.50% For excipients, see section 6.1 To be taken orally. Adults: 10 to 20 ml or 1 to 2 sachets four times a day or as directed by a physician. The suspension should be taken after meals and at bedtime or as needed. Children: Not recommended. Elderly: No specific precautions are necessary in normal use. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 10/08/2005_ _CRN 2013441_ _page number: 1_ 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Aluminium hydroxide may form complexes with certain drugs e.g. tetracyclines, digoxin, and vitamins, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered. 4.6 PREGNANCY AND LACTATION This product should not be used in pregnancy unless considered essential by the physician. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS Aluminium hydroxide may cause constipation due to its astringent action. This effect may be balanced by the cathartic effect of the magnesium salts. 4.9 OVERDOSE In overdose, abdominal dis Přečtěte si celý dokument