This information is intended for use by health professionals

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 caution in patients with hypercalciuria.

This product contains sucrose and glucose syrup and as such, care is required in patients with diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The elderly should take care to observe warnings and contraindications, due to increased susceptibility to adverse drug reactions, by means of age-related changes and polypharmacy.

Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist, despite 7 days of continuous therapy, the clinical situation should be reviewed by a medical professional. Diagnostic measures are recommended in order to rule out a more serious disease.

Keep out of the sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed. It is recommended that antacids are not taken simultaneously with other medications, but spaced at least 2 hours apart.

In common with other antacids, calcium carbonate may form complexes with certain drugs e.g., antibiotics (such as tetracyclines and quinolones) and cardiac glycosides (digoxin), H2-antihistaminics, fluoroquinolone, iron containing drugs, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates leading to their reduced absorption. This should be taken into account when concomitant administration is considered.

Thiazide diuretics reduce the urinary excretion of calcium and increase the serum calcium.

4.6 Pregnancy and lactation

Pregnancy:

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 prescribing to pregnant women.

Lactation:

There is no information relating to the excretion of Remegel in breast milk. Calcium carbonate can be used during lactation if taken as instructed. However, no problems would be anticipated from the use of this product during lactation, if taken in accordance with the posology.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Immune System Disorders:

Hypersensitivity, anaphylactic reaction.

Metabolism and Nutrition Disorders:

Hypercalcaemia, alkalosis.

Gastrointestinal Disorders:

Eructation, constipation, nausea, vomiting, abdominal discomfort, diarrhoea.

Musculoskeletal and Connective Tissue Disorders:

Muscular weakness.

Skin and Subcutaneous Disorders:

Rash, urticaria, angioedema.

4.9 Overdose

Excessive ingestion of calcium carbonate, especially in patients with impaired renal function can lead to hypercalcaemia, renal insufficiency and alkalosis, characterised by gastro-intestinal symptoms (pain, nausea, vomiting, constipation) and muscular weakness. In these cases, the intake of the product should be stopped and adequate isotonic fluid intake encouraged. In severe cases of overdosage, milk-alkali syndrome may occur.

Treatment should be symptomatic and supportive. Haemodialysis and other therapeutic measures such as saline diuresis have been used to treat successfully the excessive ingestion of calcium carbonate antacid.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Classification: Antacids

ATC Code: Calcium carbonate: A02AC01

Calcium carbonate is a potent antacid, neutralising gastric acid when taken by the oral route.

Calcium carbonate neutralises gastric acid to provide fast relief for 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

Sucrose

Glucose syrup

Purified water

Hyfoama DS (hydrolysed milk protein)

Gelatin

Comfiour starch

Sorbitol (crystalline) (E420)

Glycerol (E422)

Titanium dioxide (E171)

Patent Blue V (E131)

Quinoline yellow (E104)

Paramount C (hydrogenated vegetable fat)

Amerfond Fondant Sugar

Peppermint Oil

Menthol

Butylated 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 waxed paper and overwrapped in hermetically sealed aluminium foil stickpack.

a) 5 piece stickpack

b) 8 piece stickpack

c) 8 piece stickpack, two stickpacks per clear plastic sleeve

d) 8 piece stickpack, three stickpacks per carton

e) 8 piece stickpack, six stickpacks per carton

f) 8 piece stickpack, five stickpacks per carton

6.6 Special precautions for disposal and other handling

None applicable

7. Marketing authorisation holder

SSL International plc

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

8. Marketing authorisation number(s)

PL 17905/0084

9. Date of first authorisation/renewal of the authorisation

30/7/99

10. Date of revision of the text

13th December 2012