KALCIPOS-D

Posology Adults and older people One chewable tablet (500 mg/800 IU) daily. The amount of calcium in Kalcipos-D is less than the usually recommended daily intake. Kalcipos-D is therefore primarily to be used by patients with need of D- vitamin substitution but with a dietary intake of calcium of 500 mg-1000 mg per day.

The patients dietary intake of calcium should be estimated by the prescriber. 4). Paediatric population There is no relevant use of Kalcipos-D chewable tablets in children or adolescents. Method of administration Tablet can be chewed or slowly melted in the mouth.

Adverse reactions frequencies are defined as: 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) or not known (cannot be estimated from the available data) Immune system disorders Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria.

Very rare:

Milk-alkali syndrome, seen usually only in overdose.

Gastrointestinal disorders Rare:

Constipation, flatulence, nausea, abdominal pain, and diarrhoea.

Skin and subcutaneous tissue disorders Rare:

Pruritus, rash and urticaria. Special Populations Patients with renal impairment are at potential risk of hyperphosphataemia, nephrolithiasis and nephrocalcinosis. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sarcoidosis Calcium/cholecalciferol chewable tablets should be prescribed with caution to patients suffering from sarcoidosis due to risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Monitoring of calcium levels During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. 5) and in patients with a high tendency to calculus formation.

If signs of hypercalcaemia and/or hypercalciuria occur treatment must be discontinued. 5mmol/24 h (300 mg/24 h) in adults. Renal impairment This product should be used with caution in patients with renal impairment and the effect on calcium and phosphate levels should be monitored.

The risk of soft tissue calcification should be taken into account. In patients with severe renal impairment, vitamin D in the form of cholecalciferol might not be activated normally. 2). Osteoporosis Calcium/cholecalciferol chewable tablets should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

Vitamin D therapy The content of vitamin D (800 IU) in calcium/cholecalciferol chewable tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision.

In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. e. hypercalcaemia, alkalosis and renal impairment, can develop when large amounts of calcium are ingested with absorbable alkali.

5). Kalcipos-D chewable tablets contain glucose and sucrose. 8 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The content of glucose and sucrose may be harmful to the teeth. Sodium content This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. g. myeloma, bone metastases, primary hyperparathyroidism). • Nephrolithiasis. • Nephrocalcinosis • Hypervitaminosis D. • Renal failure.