1. Name Of The Medicinal Product
Remegel Summer Fruit.
2. Qualitative And Quantitative Composition
Each tablet contains 800mg Calcium Carbonate USP.
3. Pharmaceutical Form
Soft, pink, raspberry-flavoured, chewable square tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Remegel Summer Fruit are indicated for the relief of acid indigestion, heartburn and associated stomach upsets (dyspepsia).
4.2 Posology And Method Of Administration
Route of administration: oral
Adults and children 12 years and over: One or two tablets of Remegel Summer Fruit to be chewed as symptoms occur. Repeat hourly 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 Summer Fruit in hepatic impairment. Normal adult dosage is appropriate.
Renal Dysfunction: Remegel Summer Fruit should be used with caution in subjects with moderate to severe renal impairment. Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia.
4.3 Contraindications
Hypersensitivity to any of the components. Hypercalcaemia.
4.4 Special Warnings And Precautions For Use
This product should be taken with care by subjects on a low phosphate diet (e.g. the malnourished), as it may lead to a phosphate depletion syndrome, (see Undesirable Effects).
This product should be used with caution in renal dysfunction, (see Posology and Method of Administration).
This product contains sucrose and glucose syrup and as such, care is required in patients with diabetes mellitus.
If symptoms persist, a pharmacist or doctor should be consulted.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In common with other antacids, calcium carbonate may form complexes with certain drugs such as tetracyclines and digoxin, leading to their reduced absorption. This should be taken into account when concomitant administration is considered.
4.6 Pregnancy And Lactation
There is no information relating to the use of Remegel Summer Fruit in pregnancy.
Calcium carbonate antacids have been used during pregnancy for many years without apparent ill consequence, although as with other antacids, this product should be administered with care in the first trimester.
There is no information relating to the excretion of Remegel Summer Fruit in breast milk. However, no problems would be anticipated from the use of this product during lactation.
4.7 Effects On Ability To Drive And Use Machines
No special comment – unlikely to produce an effect.
4.8 Undesirable Effects
Calcium carbonate may cause constipation. Eructation (due to carbon dioxide production in the stomach) may occur in come patients.
4.9 Overdose
Excessive ingestion of calcium carbonate can lead to hypercalcaemia (characterised by gastro-intestinal pain, nausea and vomiting), metabolic alkalosis and reversible renal failure, sometimes presenting as the milk-alkali syndrome. Treatment should be symptomatic and supportive. Haemodialysis and other therapeutic measures, such as saline diuresis, have been used to successfully treat excessive ingestion of calcium carbonate antacid.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Calcium carbonate is a potent antacid, neutralising gastric acid when taken orally.
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn.
5.2 Pharmacokinetic Properties
Absorption: Calcium carbonate is converted to calcium chloride by gastric acid (hydrochloric acid) in the stomach, with the resulting formation of carbon dioxide and water. Some of the calcium is absorbed from the intestines but the majority is reconverted into insoluble calcium salts such as carbonate and stearate, which is excreted in the faeces.
Distribution, Metabolism and Elimination: Once absorbed from the stomach, physiological concentrations of calcium are tightly controlled, principally through the effects of parathyroid hormone, vitamin D and its metabolites, and calcitonin. These control mechanisms are well documented in standard texts.
5.3 Preclinical Safety Data
Pre-clinical safety data does not add anything of further significance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sugar solution; Glucose syrup (41o baume); Purified water; Hyfoama DS (hydrolysed milk protein); Gelatin 200 Bloom; Cornflour Starch; Sorbitol (crystalline); Glycerol; Titanium dioxide (E171); Allure Red (E129); Paramount C (hydrogenated vegetable fat); Amerfond Fondant Sugar; Raspberry flavour; Butylated hydroxyanisole; Talc
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
Each tablet in stickpacks is wrapped in printed silicone paper and overwrapped in hermetically sealed aluminium foil stickpack. 8 piece stickpack
6.6 Special Precautions For Disposal And Other Handling
None applicable.
7. Marketing Authorisation Holder
Seton Products Limited, Tubiton House, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 11314/0131.
9. Date Of First Authorisation/Renewal Of The Authorisation
03/01/2006
10. Date Of Revision Of The Text
03/01/2006
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