Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium carbonate
SSL International Plc
A02AC01
Calcium carbonate
800mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201; GTIN: 5038483000267 5038483000229 5038483000243
OBJECT 1 REMEGEL Summary of Product Characteristics Updated 15-May-2013 | SSL International plc 1. Name of the medicinal product Remegel 2. Qualitative and quantitative composition Each Remegel tablet contains 800 mg calcium carbonate Also contains glucose syrup, sucrose, glycerol and sorbitol (E420). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Soft, light-green, mint flavoured, chewable square tablet 4. Clinical particulars 4.1 Therapeutic indications Remegel tablets are indicated for the relief of acid indigestion and heartburn, and associated stomach upsets (dyspepsia) 4.2 Posology and method of administration Oral. Tablets to be chewed and swallowed. ADULTS AND CHILDREN 12 YEARS AND OVER: One or two tablets of Remegel to be chewed as a single dose, when symptoms occur. Repeat as necessary. Maximum dose: 12 tablets in 24 hours. CHILDREN UNDER 12 YEARS OF AGE: Not recommended. THE ELDERLY: As for adults, see above. HEPATIC DYSFUNCTION There is no specific information relating to the use of Remegel in hepatic impairment. Normal adult dosage is appropriate. RENAL DYSFUNCTION Remegel should be used with caution in subjects with mild to moderate renal impairment. Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia. 4.3 Contraindications Hypersensitivity to the active ingredient or any of the excipients, refer to section 6.1 Hypercalcaemia Nephrocalcinosis Patients with renal calculi, or with a history of renal calculi Severe renal function impairment (creatinine clearance below 30ml/min) Hypophosphatemia 4.4 Special warnings and precautions for use This product should be used with caution in renal dysfunction (see Posology and Method of Administration). Long term uses at high doses can result in undesirable effects such as hypercalcaemia and milk-alkali syndrome, especially in patients with renal insufficiency. Prolonged use possibly enhances the risk for the development of renal calculi. Calcium carbonate should be used with cau Lugege kogu dokumenti