RENACET Film-coated tablet Ref.[49790] Active ingredients: Calcium acetate

Treatment with Renacet 475 mg film-coated tablets requires regular measurement of the serum calcium and serum phosphate levels. Under no circumstances should the calcium concentration multiplied by the phosphate concentration exceed 5.3 mmol/l since the frequency of extraosseous calcification increases if this value is exceeded.

To avoid an increase in serum calcium level beyond the normal range the intake of Renacet 475 mg film-coated tablets should be monitored regularly when patients are already on preparations which contain calcium.

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

Concomitant intake of Renacet 475 mg film-coated tablets with other medicinal products may impair their absorption.

For numerous anionic medicinal agents, e.g. tetracyclines and doxycycline, quinolones (gyrase inhibitors), biphosphonates, fluorides and anticholinergics changes in absorption may occur. Interaction may also occur with vitamin D preparations.Therefore it is recommended that there should be an interval of 1-2 hours between the intake of Renacet 475 mg film-coated tablets and other medicinal products.

An increased effect may occur with cardiac glycosides, a reduced effect may occur with calcium antagonists.

Concomitant administration of thiazides results in an increased risk of hypercalcemia. If the calcium level is increased, use of adrenaline may lead to severe cardiac arrhythmia.

Intake of larger quantities of calcium salts may cause a precipitation of fatty or bile acids as calcium soaps. This may impair the absorption of ursodeoxycholic acid and chenodeoxycholic acid as well as fats and fat soluble vitamins.

Harmful effects on humans due to calcium taken during pregnancy and lactation have not been reported.

However, the likelihood of hypercalcaemia is increased in pregnant women in whom calcium and vitamin D are co-administered.

Renacet 475 mg has no effect on the ability to drive or use machines.

The following definitions apply to the incidence of undesirable effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

General disorders

Uncommon: Soft tissue calcification (e.g in the fatty tissue under the skin) usually occurring only after many years of intake and frequently associated with increased blood calcium levels.

Cardiac/vascular disorders

Uncommon: Hypercalcemia, especially following overdosage.

Gastrointestinal disorders

Rare: Gastrointestinal disorders such as nausea and constipation, especially in case of too high dosages.

If gastrointestinal side effects occur, treatment should be changed to calcium carbonate as appropriate.

Not applicable.