Land: Malta
Tungumál: enska
Heimild: Malta Medicines Authority
MAGNESIUM HYDROXIDE
Aldox Limited School Street Tarxien, Malta
A02AA04
MAGNESIUM HYDROXIDE 63 g
POWDER FOR ORAL SUSPENSION
MAGNESIUM HYDROXIDE 63 g
OTC
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2006-10-31
1 501740 06904/05 Please follow the dosage mentioned in this leaflet or prescribed by your physician. If you feel that the medicine’s efficacy is too low or on the contrary to high, please consult your physician or your pharma- cist. WHAT KIND OF ADVERSE EFFECTS MIGHT MAGNESIA SAN PELLEGRINO HAVE? In sensitive patients or if proper dosage is not fol- lowed, diarrhoea may occur with water loss and electrolytic troubles (especially potassium loss). In this case, the treatment should be stopped. WHAT SHOULD ALSO BE TAKEN IN ACCOUNT? Keep the medicine out of children’s reach as they could be tempted by the refreshing flavour and the pleasant taste. It is recommended to drink a full glass of water after the intake of Magnesia San Pellegrino, to ensure an optimal action. Magnesia San Pellegrino contains sugar. It is there- fore recommended to observe an appropriate mouth care after use. Keep bottle well closed in a dry place. This medicine must not be used beyond the expiry date mentioned by «EXP.» on the box and on the bottle’s label. For further information, please consult your physi- cian or your pharmacist who hold complete medical information. WHAT IS THE FORMULA OF MAGNESIA SAN PELLEGRINO? NORMAL POWDER Magnesium hydroxide 63.00 g / 70 g (90%) Sucrose 6.86 g / 70 g (9.8%) Anise flavour 0.14 g / 70 g (0.2%) EFFERVESCENT POWDER Magnesium hydroxide 56.25 g / 125 g (45%) Sucrose 21.00 g / 125 g (16.8%) Tartaric acid 25.00 g / 125 g (20%) Sodium hydrogen carbonate 22.50 g / 125 g (18%) Lemon flavour 0.25 g / 125 g (0.2%) WHERE IS MAGNESIA SAN PELLEGRINO AVAILABLE AND WHAT ARE THE PHARMACEUTICAL FORMS? In pharmacies, without medical prescription. The normal type of powder (anise flavour) is available in bottles of 70 g and the effervescent type of powder (lemon flavour) in bottles of 125 g. MARKETING AUTHORISATION (MA) HOLDER: Aldox Limited, School Street, Tarxien, Malta MARKETING AUTHORISATION NUMBER: MA 186/00101 Magnesia San Pellegrino Lemon Flavour MA 186/00102 Magnesia San Pellegrino Anise MANUFACTURER: EU Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Magnesia San Pellegrino® anise flavour 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Magnesium hydroxide 63.00g/ 70g (90%) 3. PHARMACEUTICAL FORM White, normal powder for oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of constipation and of digestive troubles caused by gastric acidity and dyspepsia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NORMAL TYPE: Adults: _As a laxative_ - ½-1 measuring spoon in a glass of water preferably in the morning _Gastric acidity and dyspepsia_ – ¼-½ measuring spoon in half a glass of water after meals or when symptoms occur Children U/12 years: Half adult dose 4.3 CONTRA-INDICATIONS This product should not be taken by patients suffering from kidney disease, in case of severe renal or heart insufficiency, in case of nausea or in case of abdominal pain from unknown origin. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Medicinal treatment of constipation is only additive to management of this disease by hygienic and dietetic measures: - Alimentation enriched with vegetal fibres, sufficient liquid supply - Sufficient physical activity Wait for two hours between intake of a dose of Magnesia San Pellegrino® anise flavour and intake of another drug. Magnesia San Pellegrino® anise flavour contains sugar. It is therefore recommended to observe an appropriate mouth care after use. As for all laxatives, long-term use (beyond 1 to 2 week Lestu allt skjalið