CALCIUM COOPER 500 mg chewable/dissolving tablet Bottle/60

Dissolvable or chewable tablet.

Calcium carbonate.........................................................................................................................1237,50 mg

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

For one sucking or chewable tablet.

Excipients with known effect: aspartame, sorbitol.

Excipients:

• Calcium deficiencies, particularly during growth, pregnancy, breastfeeding.

• Adjunctive treatment of osteoporosis: elderly subject, postmenopausal, under corticosteroid therapy, immobilization upon resumption of mobility.

Dosage

Adults

Calcium deficiencies in general and adjunctive treatment of osteoporosis: 2 to 3 tablets per day.

Paediatric population

Calcium deficiencies during periods of growth:

• child aged 6 to 10 years: 1 tablet per day;

• child aged 11 years and older: 2 tablets per day

Method of administration

Sucking or chewable tablet to be taken away from meals.

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

• Hypercalcemia, hypercalciuria, calcium lithiasis, tissue calcifications.

• Prolonged immobilization accompanied by hypercalcemia and/or hypercalciuria: calcium treatment should only be administered upon resumption of mobilization.

Special precautions for use

Calcemia and calciuria must be monitored and renal function must be monitored:

• in case of renal insufficiency;

• in case of administration of high doses and particularly in case of concomitant administration of calcium and vitamin D;

• in immobilized patients with osteoporosis.

There is a risk of hypercalcemia followed by worsening of renal function.

Treatment should be reduced or temporarily interrupted if calciuria 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.

CALCIUM COOPER 500 mg should be used with caution in elderly patients concomitantly treated with digitalis or thiazide diuretics (see section Interactions).

Children and adolescents

CALCIUM COOPER 500 mg may be administered to children and adolescents aged 6 years and over, but only to treat calcium deficiency, and not for preventive purposes.

Excipients

This medicine contains 426,25 mg of sorbitol per tablet. Patients with hereditary fructose intolerance (HFI) must not take/receive this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 15 mg of aspartame per tablet. Aspartame contains a source of phenylalanine. May be harmful for people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine that cannot be properly eliminated.

Associations requiring precautions for use

+ Tetracyclines

Decreased digestive absorption of tetracyclines.

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

+ Digitalis glycosides

Risk of rhythm disorders.

Clinical monitoring and, if necessary, monitoring of the ECG and serum calcium.

+ Bisphosphonates

Risk of decreased digestive absorption of bisphosphonates.

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

+ 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 away from meals and in the absence of calcium.

+ Levothyroxine

The efficacy of levothyroxine may be reduced by concomitant use of calcium, due to a decrease in levothyroxine absorption. Calcium and levothyroxine should be taken at least 4 hours apart.

Associations to be taken into account

+ Thiazide diuretics

Risk of hypercalcemia due to decreased urinary elimination of calcium.

+ Food

Oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grain cereals) may inhibit calcium absorption through the formation of insoluble compounds with calcium ions. The patient should not take calcium-containing products within 2 hours following ingestion of foods rich in oxalic acid and phytic acid.

Pregnancy

This product may be used during pregnancy in cases of calcium deficiency. However, the daily dose must not exceed 1500 mg of calcium.

Breast-feeding

This product may be used during breastfeeding in cases of calcium deficiency. However, the daily dose must not exceed 1500 mg of calcium.

Calcium passes into breast milk. This must be taken into account when administering calcium supplementation to an infant.

Fertility

Normal levels of endogenous calcium should not have a harmful effect on fertility.

• Digestive disorders such as constipation, flatulence, nausea.

• Hypercalciuria, hypercalcaemia (in case of prolonged treatment at high doses).

• Pruritus, skin rash, urticaria.

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: https://signalement.social-sante.gouv.fr

Symptoms: thirst, polyuria, polydipsia, nausea, vomiting, dehydration, arterial hypertension, vasomotor disorders, constipation.

In children, arrest of growth in height and weight may precede all these signs.

Treatment: discontinuation 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, possibly combined with peritoneal dialysis.

Pharmacotherapeutic class: mineral supplements / calcium (A: alimentary tract and metabolism), ATC code: A12AA04.

Calcium supplementation corrects dietary calcium deficiency.

The daily calcium requirements are on the order of 1000 to 1500 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.

3 years.

Store at a temperature not exceeding 25°C.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorisation (AMM)

CIP 3400933940119 (Fl/60).

Price:

5,29 euros (Fl/60).

Social Security reimbursement at 65%.
Collection.