CALCIUM CARBONATE

Tablets to be taken orally, sucked or chewed.

Adults and children over 12 years:

Two tablets to be sucked or chewed as a single dose, preferably to be taken one hour after meals and before going to bed but also in between in case of heartburn or gastric pain. A maximum daily dose of 8 g calcium carbonate, corresponding to 16 tablets, a day must not be exceeded.

Children:

Not recommended for children under 12 years. As with all antacids, if symptoms persist despite 14 days of continuous therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease.

The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories of frequency is not possible.

Immune System Disorders:

Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, urticaria, pruritus, angioedema, difficulty in breathing and anaphylaxis.

Metabolism and Nutrition Disorders:

Especially in patients with impaired renal function, prolonged use of high doses can result in hypercalcaemia and alkalosis.

Gastrointestinal Disorders:

Nausea, vomiting, stomach discomfort, constipation and diarrhoea may occur.

Musculoskeletal and Connective Tissue Disorders:

Muscular weakness may occur. 9): Gastrointestinal Disorders: Ageusia may occur in the context of milk-alkali syndrome.

General Disorders and Administration Site Conditions:

Calcinosis and asthenia may occur in the context of milk-alkali syndrome.

Nervous System Disorders:

Headache may occur in the context of milk-alkali syndrome.

Renal and Urinary Disorders:

Azotemia may occur in the context of milk-alkali syndrome. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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• Prolonged use should be avoided. • The stated dose should not be exceeded. If, after 14 days of treatment, symptoms persist or only partly disappear, the patient should consult a doctor. 3 – contraindication in severe renal insufficiency).

If this tablet is used in such patients, plasma calcium and phosphate levels should be regularly monitored. • Long term use at high doses can result in undesirable effects such as hypercalcaemia and milk-alkali syndrome, especially in patients with renal insufficiency.

3). Prolonged uses increases the risk of formation of renal calculi. • This product should not be taken with large amounts of milk or dairy products. • Patients with rare hereditary problems of sucrose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• Colour- Lake of Sunset Yellow may cause allergic reactions.

This tablet should not be administered to patients with: • Hypersensitivity to any of the ingredients of the product • Hypercalcaemia and/or conditions resulting in hypercalcaemia • Nephrolithiasis due to calculi containing calcium deposits • Severe renal insufficiency • Hypophosphataemia