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REMEGEL SUMMER FRUIT

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Remegel Summer Fruit

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800mg Calcium Carbonate

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PHARMACEUTICAL FORM
Soft, pink, raspberry-flavoured, chewable square tablets

4
4.1

CLINICAL PARTICULARS
Therapeutic indications Remegel Summer Fruit are indicated for the relief of due to 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 For Remegel Summer Fruit no clinical data on exposed pregnancies are available. Studies in animals have not been done.

Calcium containing drugs are used widely in pregnancy by way of oral calcium supplements or antacid therapy. No relationship between malformations in general and calcium exposure has been noted. Although a weak association with CNS malformations and exposure in the first 4 months of pregnancy has been detected in one large study. Caution should be exercised when taken by pregnant women. 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 None known.

4.8

Undesirable effects Calcium carbonate may cause constipation. Eructation (due to carbon dioxide production in the stomach) may occur in some patients.

4.9

Overdose Excessive ingestion of calcium carbonate can lead to hypercalcaemia (characterised by gastro-intestinal pain, nausea, 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 diurersis have been used to successfully treat excessive ingestion of calcium carbonate antacid.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Calcium carbonate is a potent antacid, neutralising gastric acid when taken orally. Calcium carbonate neutralizes 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.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients sucrose solution glucose syrup purified water Hyfoama DS (hydrolysed milk protein) gelatin 200 Bloom maize starch sorbitol (E420) glycerol (E422) titanium dioxide (E171) allure red (E129) paramount C (hydrogenated vegetable fat) amerfond fondant sugar raspberry flavour butyl hydroxyanisole (E320) talc (used as a processing aid)

6.2

Incompatibilities None known.

6.3

Shelf life 24 months, unopened.

6.4

Special precautions for storage Do not store above 25 C.

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. a) b) c) d) e) 5 piece stickpack 8 piece stickpack 8 piece stickpack, three stickpacks per carton 8 piece stickpack, six stickpacks per carton 8 piece stickpack, five stickpacks per carton

6.6

Special precautions for disposal None applicable.

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MARKETING AUTHORISATION HOLDER
SSL International PLC. Venus, 1 Old Park Lane, Trafford Park,

Manchester, M41 7HA, UK

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MARKETING AUTHORISATION NUMBER(S)
PL 17905/0086

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/07/1999

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DATE OF REVISION OF THE TEXT
May 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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