CALCI-D

Posology Adults and elderly: 1 tablet/day for oral use The tablets may be chewed or sucked, they should not be swallowed whole. It is advisable to take the preparation during the evening meal.

Paediatric population:

There is no relevant use of CALCI-D chewable tablets in the paediatric population. 6).

Patients with hepatic dysfunction:

No dosage adjustment is required.

Patients with renal dysfunction:

CALCI-D should not be used in patients with severe renal dysfunction.

Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders:

Not known (cannot be estimated from the available data): Serious allergic (hypersensitivity) reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria Not known (cannot be estimated from the available data): Hyperphosphatemia Very rare: Milk-alkali syndrome (also called Burnett’s syndrome and usually only seen when excessive amounts of calcium have been ingested), symptoms are frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment).

9).

Gastrointestinal disorders Rare:

Constipation, flatulence, nausea, stomach pain and diarrhoea Skin and subcutaneous disorders Very rare: Pruritus, rash and urticaria Renal and urinary disorders: Not known (cannot be estimated from the available data): Nephrolithiasis 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. uk/yellowcard.

During long-term treatment it is advisable to monitor the serum and urinary calcium levels and to monitor the kidney function through measurement of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics.

In case of hypercalcaemia or signs of impaired renal function the dose must be reduced or the treatment interrupted. 5 mmol/24 h (300 mg/24 h). g. g. hypercalciuria, nephrocalcinosis, nephrolithiasis) is increased due to accumulation of active vitamin D.

Idiopathic infantile hypercalcaemia may be asymptomatic and undiagnosed at the beginning of vitamin D therapy and may be unmasked and become clinically apparent after vitamin D supplementation. Initial symptoms of hypercalcaemia are anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness and fatigue.

9). When these symptoms occur in a patient being treated with CALCI- D, the treatment should be discontinued and the patient should be referred to a physician for evaluation and advice. ) when prescribing other drugs containing vitamin D or food supplemented with vitamin D.

- Additional administration of vitamin D or calcium should be given under medical supervision. In such cases the plasma and urinary levels of calcium must be regularly monitored. g. leukaemia, lymphoma, sarcoidosis). CALCI-D should be prescribed with caution in these patients and urine and serum calcium should be monitored.

- Patients with renal insufficiency have disturbed metabolism of vitamin D and if treated with Colecalciferol, the effect on calcium and phosphate homeostasis should be monitored. The risk of soft tissue calcification should be taken into account.

- Patients with malabsorption may not adequately absorb vitamin D - The product should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia. Treatment with CALCI-D could be stopped in case of prolonged immobilisation and should only be restarted after the patients has regained mobility.

- CALCI-D contains contains sucrose and isomalt (isomaltitol , E953), therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

May be harmful to the teeth. - CALCI-D contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. - During concomitant treatment with other sources of vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with subsequent kidney function impairment.

In these patients serum calcium levels should be followed and renal function should be monitored.

1. 5 mmol/24 hours), severe renal insufficiency, nephrolithiasis, nephrocalcinosus, calcification of tissues, diseases and/or conditions resulting in hypercalciurea and/or hypercalcaemia. - Hypervitaminosis D.