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Metocal Vit D3Metocal VIT D3
Calcium carbonate 1500 mg (equivalent to 600 mg of elemental calcium) + Cholecalciferol 400 I.U.
Chewable tablets


COMPOSITION
One chewable tablet contains:
Active substances:

1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 4 mg of cholecalciferol concentrate (equivalent to 400 U.I. of vitamin D,).


Excipients:
Xylitol, mannitol, magnesium stearate, silica colloidal anhydrous, pregelatinised starch, butylated hydroxytoluene (E321), medium-chain triglycerides, sucrose, gelatin, modified starch, sodium aluminium silicate, flavouring agents.


PHARMACEUTICAL FORM
Chewable tablets.
White biplane tablets with a snap grove and the letter C/D.


THERAPEUTIC CATEGORY (ATC CODE)

A12AX: Vitamin-mineral combinations.


PHARMACODYNAMIC PROPERTIES
METOCAL VIT D, chewable tablets are a vitamin-mineral combination.


Vitamin D supplementation corrects an insufficient vitamin D intake. It increases the intestinal absorption of calcium. The optimal vitamin D dose in elderly subjects is 500 - 1000 I.U. per day. Calcium supplementation balances a dietary calcium deficiency. The usual calcium requirement of the elderly is 1500 mg/day. Vitamin D and calcium supplementation correct secondary senile hyperparathyroidism.


In a double-blind placebo controlled study of 18 months, including 3270 women aged 846 and living in nursing homes, supplemented with cholecalciferol (800 I.U./day) + calcium (1.2 g/day), a significant decrease in PTH secretion has been observed. After 18 months, the results of the intent to treat analysis showed 80 hip fractures (5.7%) in the calcium vitamin D group and 110 hip fractures (7.9%) in the placebo group (p=0.004). So in the conditions of this study, the treatment of 1387 women prevented 30 hip fractures.


After 36 months of follow-up, 137 women presented at least one hip fracture (11.6%) in the calcium vitamin D3 group (n=1176) and 178 (15.8%) in the placebo group (n=1127) (p≤0.02).


PHARMACOKINETIC PROPERTIES
Calcium carbonate
Calcium carbonate releases, pH-dependently, calcium ions in the stomach. Calcium administered as calcium carbonate is absorbed from 20 to 30%. The uptake takes place mainly in the duodenum through a vitamin D-dependent, saturable, active transport. Calcium is excreted with the urine, faeces and perspiration. The excretion of calcium in the urine depends on the glomerular filtration and tubular reabsorption of calcium.


Vitamin D
Vitamin D is absorbed in the small intestine and bound to specific alpha globulins, and is transported to the liver where it is metabolised into 25-hydroxy-cholecalciferol. A second hydroxylation to 1,25-dihydroxy-cholecalciferol takes place in the kidneys. This metabolite is responsible for the effect of vitamin D, i.e. increase of calcium absorption. Non-metabolised vitamin D is stored in tissues, e.g. in fat and muscle. Vitamin D is excreted by the faeces.


INDICATIONS
Correction of combined Vitamin D and calcium deficiencies in the elderly.


Vitamin D and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients, where combined vitamin D and calcium deficiencies have been diagnosed or at a high risk of such deficiencies.


CONTRAINDICATIONS
  - Hypercalcaemia, hypercalciuria

  - Kidney stones
  - Long-term immobilisation in combination with hypercalciuria and/or hypercalcaemia
  - Nephrocalcinosis
  - Primary hyperparathyroidism

  - Vitamin D overdose

  - Myeloma
  - Bone metastases
  - Hypersensitivity to the active substances or to any of the excipients


PRECAUTIONS FOR USE
During prolonged treatment with METOCAL VIT D, chewable tablets the calcium levels in serum and urine should be monitored, and the renal function should be controlled by measuring serum creatinine. This control is particularly important in elderly patients and during concomitant treatment with cardiac glycosides and diuretics. In the event of hypercalcaemia or signs of impaired renal function the dose must be reduced or the treatment interrupted. It is advisable to reduce the dose or interrupt the treatment if urinary calcium level exceeds 7.5 mmol/24 hours (300 mg/24 hours). Special care is required on concurrent treatment with bisphosphonates, sodium fluoride or tetracycline (see 4.5 Interactions).


Take into account the vitamin D dose when prescribing other medicinal products containing vitamin D. An additional administration of vitamin D or calcium should take place under medical supervision. In such cases the calcium levels in plasma and urine must be monitored.


METOCAL VIT D3 chewable tablets should be prescribed with caution in patients with sarcoidosis, since there is the risk of increased conversion of vitamin D into its active metabolite. In these patients the calcium levels in plasma and in urine should be monitored.
 

Patients with renal insufficiency have an altered vitamin D metabolism. If they are treated with cholecalciferol the effects on calcium and phosphate turnover should be monitored.


METOCAL VIT D, chewable tablets contain Sucrose and therefore should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

 

Note for diabetics:
The proportion of digestible carbohydrate in METOCAL VIT D, chewable tablets is 0.47 g per tablet. The daily dose of 2 tablets corresponds to 0.08 carbohydrate units (CU).

1    2

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