CALCIDOSE oral suspension powder in sachet 60Sachet

Powder for oral suspension.

Calcium carbonate .......................................................................................................................1 250,00 mg

Quantity corresponding to calcium element ......................................................................................500,00 mg

Per sachet.

Excipients:

• Calcium deficiencies during growth, pregnancy, and breastfeeding.
• Adjunctive treatment of osteoporosis: senile, post-menopausal, under corticosteroid therapy, immobilisation osteoporosis upon resumption of mobility.

Dosage

Adults:

Calcium deficiencies in general and adjunctive treatment of osteoporosis: 1 g to 1,5 g of calcium element per day, i.e. two to three dose sachets per day to be dissolved in a glass of water.

Children:

Calcium deficiencies during growth periods:

• child up to 10 years: 0,5 g of calcium element per day, i.e. one dose sachet per day to be dissolved in a glass of water.
• child over 10 years: 1 g of calcium element per day, i.e. two sachets per day to be dissolved in a glass of water.

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

Hypercalcaemia, hypercalciuria, calcium lithiasis, tissue calcifications.

Prolonged immobilisation accompanied by hypercalcaemia and/or hypercalciuria: calcium treatment should only be used upon resumption of mobilisation.

Concomitant administration of calcium and vitamin D must be carried out under monitoring of calcaemia and calciuria.

In case of renal insufficiency, regularly monitor calcaemia and calciuria, and avoid administration of high doses.

In case of long-term treatment and/or renal insufficiency, it is necessary to monitor calciuria and to reduce or temporarily interrupt treatment if it exceeds 7,5 mmol/24 h (300 mg/24 h) in adults; 0,12 to 0,15 mmol/kg/24 h (5 to 6 mg/kg/24 h) in children.

In case of diabetes or a low-carbohydrate diet, take into account the sucrose content = 1,25 g per dose unit, in the daily ration.

Associations subject to Precautions for use

+ BISPHOSPHONATES:

Decreased digestive absorption of bisphosphonates.

Take calcium salts apart from bisphosphonates (at least 30 minutes to more than 2 hours, if possible, depending on the bisphosphonate).

 

+ CYCLINES:

Decreased digestive absorption of cyclines.

Take calcium salts apart from cyclines (more than two hours, if possible).

 

+ DIGITALIS:

Risk of serious, even fatal, rhythm disorders with calcium salts administered intravenously.

Clinical monitoring and, if appropriate, ECG and serum calcium monitoring.

 

+ ESTRAMUSTINE:

Decreased digestive absorption of estramustine.

Take calcium salts apart from estramustine (more than 2 hours, if possible).

 

+ IRON (salts) (oral route):

Decreased digestive absorption of iron salts.

Take iron salts apart from meals and in the absence of calcium.

 

+ THYROID HORMONES:

Decreased absorption of thyroid hormones.

Take calcium salts apart from thyroid hormones (more than 2 hours, if possible).

 

+ STRONTIUM:

Decreased digestive absorption of strontium.

Take strontium apart from calcium salts (more than two hours, if possible).

 

+ ZINC:

Decreased digestive absorption of zinc by calcium.

Take calcium salts apart from zinc (more than 2 hours, if possible).

Associations to be taken into account

+ THIAZIDE DIURETICS AND RELATED DRUGS:

Risk of hypercalcemia due to decreased urinary elimination of calcium.

This medicine may be used during pregnancy and breastfeeding. However, the daily dose must not exceed 1500 mg of calcium.

• A sensation of dry mouth may be observed.
• Hypercalciuria with prolonged treatment at high doses; exceptionally, hypercalcemia.
• Risk of hypophosphatemia.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.ansm.sante.fr.

Symptoms: Thirst, polyuria, polydipsia, nausea, vomiting, dehydration, arterial hypertension, vasomotor disorders, constipation. In children, cessation of staturo-ponderal growth may precede all signs.

Treatment: Cessation of all calcium and vitamin D intake, rehydration and, depending on the severity of the intoxication, use, alone or in combination, of diuretics, corticosteroids, calcitonin, peritoneal dialysis.

Pharmacotherapeutic class: Calcium/Mineral supplement, ATC code: A12AA04.

One sachet provides 500 mg of elemental calcium.

Absorption

In the gastric environment, calcium carbonate releases the calcium ion depending on the pH. Calcium is essentially absorbed in the upper part of the small intestine by a saturable active transfer mechanism dependent on vitamin D. The absorption rate of calcium in this form is of the order of 30 % of the ingested dose.

Elimination

Calcium is eliminated by sweat and digestive secretions. Urinary calcium depends on glomerular filtration and the rate of tubular reabsorption of calcium.

2 years

No special precautions for storage.

Dilute the powder in a glass of water, then swallow immediately.

Marketing authorisation (AMM)

CIP 3400933922368 (60 sachets).

Price:

5,29 euros (60 sachets).

Social Security reimbursement at 65%.
Collection.