GATTART

Posology:

Adults and adolescents (> 12 years): One to 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 11 tablets a day, must not be exceeded.

Paediatric population Not recommended for children under 12 years of age. Duration of treatment If symptoms persist despite 7 days continuous treatment or only partly disappear, the patient should seek medical advice. If symptoms occur from time to time and there is a need for frequent administration of the drug, the patient should consult a doctor.

Method of administration Tablets to be taken orally, sucked or chewed.

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, angioedema and anaphylaxis.

Metabolism and nutrition disorders:

Especially in patients with impaired renal function, prolonged use of high doses can result in hypermagnesaemia or 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. 9): Nervous system disorders: Headache may occur in the context of milk-alkali syndrome.

Gastrointestinal disorders:

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

Renal and urinary disorders:

Azotemia 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. 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. The stated dose should not be exceeded. If, after 7 days of treatment, symptoms persist or only partly disappear the patient should consult a doctor. As with other antacids, Gattart tablets may mask a malignancy in the stomach.

3 – contraindication in severe renal insufficiency). If Gattart is used in such patients, plasma calcium, phosphate and magnesium levels should be regularly monitored. Long term uses at high doses can result in undesirable effects such as hypercalcaemia, hypermagnesaemia and 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.

1 - Hypercalcaemia and/or conditions resulting in hypercalcaemia - Nephrolithiasis due to calculi containing calcium deposits - Severe renal insufficiency - Hypophosphataemia