Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALGINIC ACID CALCIUM CARBONATE MAGNESIUM CARBONATE
Bayer PLC
300/1250/147 %v/v
Tablets Chewable
2006-04-28
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rennie Duo Chewable Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of 3,486 mg contains the following active substances: alginic acid 300 mg, calcium carbonate 1,250 mg and heavy magnesium carbonate 147 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet White tablet with bevelled edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of complaints resulting from gastro-oesophageal reflux and hyperacidity, such as regurgitation and heartburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual dose is 1 tablet to be chewed. It should preferably be taken one hour after meals and before going to bed. An additional dose of 1 tablet can also be taken in between in the case of heartburn. Do not take more than 8 tablets in any 24-hour period. Only for use by adults (over 12 years of age). 4.3 CONTRAINDICATIONS Severe renal insufficiency, hypercalcaemia and pre-existing hypophosphataemia. Nephrolithiasis due to calculi containing calcium deposits. Hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use should be avoided. If the symptoms persist or only partly disappear, further medical advice should be sought. As with other antacids, Rennie Duo chewable tablet may mask a malignancy in the stomach. In general, caution should be exercised in patients with impaired renal function. If Rennie Duo chewable tablet is used in such patients, plasma concentrations of calcium and magnesium should be monitored regularly. Prolonged use of high doses may result in undesirable side-effects such as hypercalcaemia, magnesaemia and the milk alkali syndrome, particularly in patients suffering fr Read the complete document