Calcichew D3 Forte Chewable Tablet Per tablet: Calcium carbonate 1250 mg
(equivalent to 500 mg of elemental calcium)
Colecalciferol 400 IU
(equivalent to 10 micrograms vitamin D3)
Contains sorbitol, 390mg; isomalt, 49.90mg; aspartame, 1mg; sucrose, 1.52mg; and soya bean oil, hydrogenated, 0.30mg. For a full list of excipients, see Section
Form: Round, white, uncoated and convex tablets.
Therapeutic indications: The treatment and prevention of vitamin D/calcium deficiency (characterised by raised serum alkaline phosphatase levels associated with increased bone loss, raised levels of serum PTH and lowered 25-hydroxyvitamin D) particularly in the housebound and institutionalised elderly subjects.
The supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia, and in other situations requiring therapeutic supplementation of malnutrition.
Adults and elderly: 2 chewable tablets per day, preferably one tablet morning and evening.
The tablet may be chewed or sucked.
Dosage in hepatic impairment:
No dose adjustment is required.
Dosage in renal impairment:
Calcichew-D3 Forte Chewable Tablets should not be used in patients with severe renal impairment.
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
Hypersensitivity to soya or peanut
Hypersensitivity to the active substances or to any of the excipients
Special warnings and precautions for use
During long-term treatment, serum 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 treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.
Vitamin D should be used with caution in patients with impairment of renal function 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 insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3, contraindications).
Calcichew-D3 Forte Chewable Tablets should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Calcichew-D3 Forte Chewable Tablets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.
The content of colecalciferol (400 IU) in Calcichew-D3 Forte 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.
CalcichewD3 ForteChewable Tablets contain aspartame (a source of phenylalanine) which may be harmful for people with phenylketonuria.
CalcichewD3 ForteChewable Tablets contain sorbitol (E420), isomalt and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
CalcichewD3 ForteChewable Tablets are not intended for use in children.
Interaction with other medicinal products and other forms of interaction
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 Calcichew-D3 Forte Chewable Tablets.
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
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 and vitamin D. 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 Calcichew-D3 Forte Chewable Tablets 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 calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU colecalciferol (15µg vitamin D). Studies in animals have shown reproductive toxicity with high doses of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Calcichew-D3 Forte Chewable Tablets can be used during pregnancy, in case of a calcium and vitamin D deficiency.
Calcichew-D3 Forte Chewable Tablets can be used during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.
Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis 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.
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. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.
List of excipients
Fatty acid mono- and diglycerides
Soya bean oil, hydrogenated
Do not store above 30°C. Keep the container tightly closed.
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