| Composition |
| Each film-coated tablet contains 600 mg calcium (as calcium carbonate 1500 mg) and 10 micrograms of colecalciferol(equivalent to 400 IU vitamin D3) |
| Pharmacodynamic properties |
Calcium, combination with Vitamin D increases the intestinal absorption of calcium.
Administration of this supplement counteracts the increase of parathyreoid hormone (PTH), which is caused by calcium deficiency and which causes increased bone resorption.
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| INDICATIONS |
Prevention of vitamin D and calcium deficiency.
Vitamin D and calcium supplement as an adjunct to specific osteoporosis to support patients who are at risk of vitamin D and calcium deficiency.
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| Contraindications |
• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases,primary hyperparathyroidism).
• Nephrolithiasis / nephrocalcinosis
• Renal failure
• Hypervitaminosis D
• Hypersensitivity to the active substances or to any of the excipients.
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| WARNINGS & PRECAUTIONS |
Long-term in take of this Food supplements, serum and urinary calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant in take with cardiac glycosides or diuretics and in patients with a high tendency to calculus formation.
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| Undesirable effects |
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.
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| Interactions |
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.
Hypercalcaemia must be avoided in digitalised patients.
Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcium D3 film-coated tablets.
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.
Rifampicin, phenytoin or barbiturates may reduce the activity of vitamin D3, since they increase the rate of its metabolism.
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| Pregnancy and lactation |
Pregnancy
Calcidal film-coated tablets may be given during pregnancy in cases of calcium and vitamin D3 deficiency.
Breast-feeding
Calcidal film-coated tablets can be used during breast-feeding.
Calcium and vitamin D3 pass into breast milk.
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| Dosage & administration |
Adults and the elderly: One tablet a day.
Calcidal film-coated tablets should not be used for longer than one month without medical advice.
Dosage in hepatic impairment
No dose adjustment is required.
Dosage in renal impairment
Calcidal should not be used in patients with severe renal impairment.
Children and adolescents
Calcidal are not intended for use in children and adolescents.
It is recommended to take within one hour and an hour and a half after meals with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed.
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| Overdose |
Overdose can lead to hypervitaminosis D and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia.
Treatment of hypercalcaemia: The adminsration of calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Gastric lavage in patients with impaired consciousness.Rehydration, and according to severity, isolated or combined treatment with loop diuretics,bisphosphonates, calcitonin and corticosteroids.
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| Presentation |
| Calcidal: Pack of 30 film coated tablets. |
| Storage |
| Store at temperature below 25o C, Protect from moisture, and store away from reach of children. |
