CALCIUM ARROW 500 mg lozenge 2Tablet/30

Elemental calcium....................................................................................................................................500,00 mg

In the form of calcium carbonate...............................................................................................1250,00 mg

For one tablet.

• calcium deficiencies, particularly during periods of growth, pregnancy, and breastfeeding;
• adjunctive treatment of osteoporosis (senile, postmenopausal, under corticosteroid therapy, immobilisation-related upon resumption of mobility).

FOR ADULTS AND CHILDREN OVER 6 YEARS ONLY.

Method of administration

Oral use.

The tablets are to be sucked.

Dosage

In adults :

Calcium deficiencies and osteoporosis: 1 to 1,5 g of elemental calcium per day, i.e. 2 to 3 sucking tablets per day.

In children :

Calcium deficiencies during periods of growth:

• child aged 6 to 10 years: 500 mg of elemental calcium per day, i.e. 1 sucking tablet per day;
• child over 10 years: 1 g of elemental calcium per day, i.e. 2 sucking tablets per day.

This medicine is contraindicated in cases of:

• hypersensitivity to any of the constituents,
• hypercalcaemia, hypercalciuria, calcium urolithiasis, tissue calcifications,
• prolonged immobilisation accompanied by hypercalcaemia and/or hypercalciuria: calcium treatment should only be administered upon resumption of mobility,
• phenylketonuria (due to the presence of aspartame).

Concomitant administration of calcium and vitamin D must be carried out under strict monitoring of serum calcium and urinary calcium.

In cases of renal insufficiency, regularly monitor serum calcium and urinary calcium and avoid administering high doses.

In cases 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/24h (300 mg/24 h) in adults and 0,12 to 0,15 mmol/kg/24 h (5 to 6 mg/kg/24 h) in children.

Due to the presence of lactose, this medicine is contraindicated in cases of congenital galactosaemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Due to the presence of sorbitol, this medicine must not be used in cases of fructose intolerance.

In particular in case of association with vitamin D:

Associations requiring precautions for use

+ Cyclines:

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.

Associations to be taken into account

+ Thiazide diuretics:

Risk of hypercalcemia due to decreased urinary elimination of calcium.

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

• Digestive disorders such as constipation, flatulence, nausea.
• Hypercalciuria, hypercalcaemia (in case of prolonged treatment at high doses).

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

Stop all calcium intake and, where appropriate, vitamin D; rehydration and, depending on the severity of the poisoning: isolated use or in combination, of diuretics, corticosteroids, calcitonin, possibly combined with peritoneal dialysis.

CALCIUM / MINERAL ELEMENT

(A: alimentary tract and metabolism)

• 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 transport mechanism dependent on vitamin D. The absorption rate of calcium in this form is on 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.

No special precautions for storage.

No special requirements.