RENNIE SOFT CHEWS

Posology:

Tablets to be taken orally, sucked or chewed.

Adults and children over 12 years:

One or 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 10 tablets a day must not be exceeded.

Elderly:

No special dosage regimen is required, but care should be taken to observe the contraindications and warnings.

Children under 12 years:

Not recommended. 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 including anaphylaxis have been reported.

Metabolism and Nutrition Disorders:

Especially in patients with impaired renal function, prolonged use of high doses can result in hypercalcaemia and alkalosis which may give rise to gastric symptoms and muscular weakness (see below).

Gastrointestinal Disorders:

Nausea, vomiting, stomach discomfort and diarrhoea may occur.

Musculoskeletal and Connective Tissue Disorders:

Muscular weakness may occur.

Skin and Subcutaneous Disorders:

Rash, urticaria, and angioedema in context of hypersensitive reactions. 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.

• Prolonged use should be avoided. • Do not exceed the stated dose and if symptoms persist consult your doctor. • Caution should generally be exercised in the case of patients with impaired renal function. If Rennie 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 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 • Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Diabetic patients should note that the product contains 1724 mg sucrose. It also contains glucose syrup which contains the equivalent of not more than 1829 mg glucose per tablet.

1.  Hypercalcaemia