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Drug Details

Calcichew-D3 500 mg/400IU Caplets

• Drug Class Description
  Calcium, combination with other drugs ATC code: A12AX
• Generic Name
  calcium carbonate, colecalciferol
• Presentation
  Film-coated tablet Oval, white/off white, film-coated tablets. May have hardly visible grey spots.
• Description
  One tablet contains: Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram ) cholecalciferol (vitamin D3) Excipient(s): Sorbitol E420 Sucrose Soya-bean oil, hydrogenated
• Indications
  

  Prevention and treatment of vitamin D and calcium deficiency in the elderly.

  Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.

• Adult Dosage
  

  One film-coated tablet twice daily. The tablet may be swallowed or chewed.

  Dosage in hepatic impairment

  No dose adjustment is required

  Dosage in renal impairment

  Calcichew-D₃ 500 mg/400 IU Caplets should not be used in patients with severe renal impairment.

• Child Dosage
  

  Calcichew-D₃ 500 mg/400 IU Caplets are not intended for use in children.

• Elderly Dosage
  

  One film-coated tablet twice daily. The tablet may be swallowed or chewed.

• Contra Indications
  

  Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria

  Nephrolithiasis

  Hypervitaminosis D

  Hypersensitivity to soya or peanut

  Hypersensitivity to the active substances or to any of the excipients.

• Special Precautions
  

  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 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 cholecalciferol is not metabolised normally and other forms of vitamin D should be used.

  Calcichew-D₃ 500 mg/400 IU Caplets should be prescribed with caution to patients suffering from sarcoidosis, due to the 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.

  Calcichew-D₃ 500 mg/400 IU Caplets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

  The content of vitamin D (400 IU) in Calcichew-D₃ 500 mg/400 IU Caplets 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.

  Co-administration with tetracyclines or quinolones is usually not recommended, or must be done with precaution.

  Calcichew-D₃ 500 mg/400 IU Caplets contains sorbitol (E420) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine

• 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.

  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 is used concomitantly, this preparation should be administered at least one hour before the intake of Calcichew-D₃ 500 mg/400 IU Caplets since gastrointestinal absorption may be reduced.

  The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

  The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.

• Adverse Drug Reactions
  

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

  Metabolism and nutrition disorders

  Uncommon: Hypercalcaemia and hypercalciuria.

  Gastrointestinal disorders

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

  Skin and subcutaneous tissue disorders

  Very rare: Pruritus, rash and urticaria.