RENNIE GUM

Adults and children over 12 years:

One or two pieces of gum to be chewed as a single dose as required, usually after meals and before going to bed but also in between in case of heartburn or gastric pain. The recommended time for chewing is 15 minutes and the remaining gum should not be swallowed.

A maximum daily dose of 8 g calcium carbonate, corresponding to 10 gums 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. As with other antacids, calcium carbonate may mask a malignancy in the stomach.

3 – contraindication in severe renal insufficiency). If this product is used in such patients, plasma calcium and phosphate levels should be regularly monitored. • Long term uses at high doses can result in undesirable effects such as hypercalcaemia resulting in kidney damage or milk syndrome subsequent renal damage or milk-alkali syndrome, especially in patients with renal insufficiency.

3). Prolonged use increases the risk of formation of renal calculi. • This product should not be taken with large amounts of milk or dairy products. • Due to the sorbitol and isomalt content, patients with rare hereditary fructose intolerance (HFI) should not take this medicine.

This product 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