Document: Kalcipos film-coated tablet ENG SmPC change

• Kalcipos 500 mg film-coated tablet SmPC
• Kalcipos film-coated tablet ENG SmPC

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summary of the product characteristics

Kalcipos 500 mg film-coated tablet (Finland and Sweden)

Each film-coated tablet contains 500 mg calcium (as calcium carbonate).

For the full list of excipients, see section 6.1.

Tablets, film-coated

White, oval, engraved with R 103

Prevention and treatment of calcium deficiency. Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis. Phosphate binder in hyperphosphataemia.

To be swallowed whole, divided or crushed before intake.

Prevention and treatment of calcium deficiency

Adults: 500-1500 mg per day

Children: 500-1000 mg per day

Adjunctive therapy in osteoporosis

Adults: 500-1500 mg per day.

Hyperphosphataemia

Individual dosage. 2-8 g calcium daily is often required divided into 2-4 doses. The tablets should be taken with meals in order to bind phosphate in the food.

Diseases and /or conditions resulting in hypercalcaemia and/or hypercalciuria. Nephrolithiasis.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia.

Caution should be exercised in patients with a history of renal calculi.

During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored.

Milk-alkali syndrome (Burnett´s syndrome) i.e. hypercalceamia, alkalosis and renal impairment, can develop when large amounts of calcium are ingested with absorbable alkali.

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Kalcipos.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Kalcipos since gastrointestinal absorption may be reduced.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-13000 mg calcium. During pregnancy, the daily intake of calcium should not exceed 15000 mg. Significant amounts of calcium are secreted in milk during lactation. Kalcipos can be used during pregnancy in case of a calcium deficiency.

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1,000, <1/100) or rare (>1/10,000, <1/1,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose (see section 4.9) Milk-alkali syndrome.

Gastrointestinal disorders

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

Skin and subcutaneous disorders

Rare: Pruritus: rash and urticaria.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Medical Product Agency

Box 26

751 03 Uppsala

www.mpa.se

Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification. Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

Pharmacotherapeutic group: Calcium

ATC-code: A12AA04

An adequate intake of calcium is of importance during growth, pregnancy and breast feeding.

Calcium

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.

Core: maltodextrin, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Film-coating: hypromellose, macrogol, paraffin.

Not applicable.

3 years.

No special precautions for storage.

60 and 180 tablets in plastic containers made of polyethylene. The 180 tablets package is an especially adjusted packaging with an accessibility cap for people with reduced function in the hands.

No special requirements.

Recip AB, Box 906, SE-170 09 Solna, Sweden

130 76 (SE), 13093(FI)

Date of first authorisation: 1996-08-30 (SE)

Date of last renewal: 2006-08-30

2014-11-28