CALCIUM VITAMIN D3 BIOGARAN 500 mg/400 IU lozenge Bottle/60

Elemental calcium..........................................................................................................................................500 mg

(in the form of calcium carbonate..................................................................................................1250 mg)

Cholecalciferol* concentrate (vitamin D3)..........................................................................................400 IU

(*in powder form)

For one chewable tablet.

Excipients with known effect: each tablet contains 8 mg of aspartame, lactose, sorbitol and maltodextrin (source of glucose).

• Correction of associated vitamin D and calcium deficiencies in the elderly.

• Vitamin and calcium supplementation associated with specific osteoporosis treatments, in patients with deficiency or at high risk of vitamin D and calcium deficiency.

Dosage

The dosage is 1 tablet morning and evening, i.e. 2 tablets per day.

Method of administration

Oral use.

Chewable tablet, then drink a glass of water.

This medicine is contraindicated in cases of:

• hypersensitivity to the active substances or to any of the excipients mentioned in section Composition,

• hypercalcaemia, hypercalciuria, calcium lithiasis,

• prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia: vitamin and calcium treatment should only be used when mobilisation resumes,

• due to the presence of aspartame, this medicine is contraindicated in cases of phenylketonuria.

In case of long-term treatment, it is justified to monitor calciuria and to reduce or temporarily interrupt treatment if it exceeds 7,5 mmol/24 h (300 mg/24 h).

In case of combined treatment with digitalis derivatives, bisphosphonates, sodium fluorides, thiazide diuretics, tetracycline, iron salts, estramustine, thyroid hormones, strontium, zinc (see section Interactions).

Take into account the dose of vitamin D per intake unit (400 IU) and any other prescription of vitamin D. As this product already contains vitamin D, additional administration of vitamin D or calcium must be carried out under strict medical supervision, with weekly monitoring of serum calcium and urinary calcium.

The product should be prescribed with caution in patients with sarcoidosis due to a possible increase in the metabolism of vitamin D to its active form. In these patients, serum calcium and urinary calcium should be monitored.

The product must be used with caution in patients with renal insufficiency, with monitoring of the calcium-phosphorus balance.

This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) should not take it.  

This medicine contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).

This medicine contains 8 mg of aspartame per chewable tablet. Aspartame contains a source of phenylalanine and may be harmful to people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine that cannot be properly eliminated. There is no clinical or non-clinical data on the use of aspartame in children under 12 weeks of age.

This medicine contains a mint flavouring that contains maltodextrin, a source of glucose. Patients with glucose-galactose malabsorption syndrome (a rare hereditary disease) should not take this medicine.

Associations requiring precautions for use

+ Digitalis glycosides

Oral administration of calcium combined with vitamin D increases the toxicity of cardiac glycosides (risk of rhythm disturbances). Strict clinical monitoring and, if necessary, ECG and serum calcium checks are required.

+ Bisphosphonate, sodium fluoride

 It is advised to observe a minimum interval of two hours before taking calcium (risk of reduced digestive absorption of the bisphosphonate and sodium fluoride).

+ Thiazide diuretics

Monitoring of serum calcium is recommended (decreased urinary elimination of calcium).

+ Oral tetracyclines

It is recommended to separate calcium intake by at least three hours (possible decrease in tetracycline absorption).

+ In case of additional administration of high-dose vitamin D, weekly monitoring of urinary calcium and serum calcium is essential.

+ Phenytoin, barbiturates

Possible decrease in the effect of vitamin D3 due to inhibition of its metabolism.

+ Glucocorticoids

Possible decrease in the effect of vitamin D3.

+ Food

Possibility of interactions with foods (for example those containing oxalic acid, phosphates or phytic acid).

+ Iron (salts) (oral route)

Decreased digestive absorption of iron salts. Take iron away from meals and in the absence of calcium.

+ Strontium

Decreased digestive absorption of strontium. Take strontium apart from calcium salts (more than 2 hours if possible).

+ Thyroid hormones

Decreased digestive absorption of thyroid hormones. Take strontium apart from calcium salts (more than 2 hours if possible).

+ Estramustine

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

+ Zinc

Decreased digestive absorption of zinc by calcium. Take calcium salts apart from zinc (more than 2 hours, if possible).

This product may be used during pregnancy and breastfeeding. However, the daily dose must not exceed 1500 mg of calcium and 600 IU of vitamin D3.

Pregnancy

During pregnancy, overdosage of cholecalciferol must be avoided:

• overdoses of vitamin D during gestation have had teratogenic effects in animals,

• in pregnant women, vitamin D overdoses must be avoided because persistent hypercalcaemia may lead to physical and mental retardation, supravalvular aortic stenosis or retinopathy in the child. However, several children were born without malformation after administration of very high doses of vitamin D3 for hypoparathyroidism in the mother.

Breast-feeding

Vitamin D and its metabolites pass into breast milk.

CALCIUM VITAMIN D3 BIOGARAN has no known or expected effect on the ability to drive vehicles and use machines.

Immune system disorders

• Hypersensitivity reactions such as angioedema or laryngeal oedema.

Gastrointestinal disorders

• Constipation, flatulence, nausea, epigastric pain, diarrhoea.

Metabolism and nutrition disorders

• Hypercalciuria and, exceptionally, hypercalcaemia in case of prolonged treatment at high doses.

• In case of renal insufficiency there is a potential risk of hyperphosphataemia, nephrolithiasis and nephrocalcinosis.

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/.

• Overdose results in hypercalciuria and hypercalcaemia, the symptoms of which are: nausea, vomiting, polydipsia, polyuria, constipation.

Treatment:

Stop all calcium and vitamin D intake, rehydration.

Chronic overdose of vitamin D3 may cause vascular and tissue calcifications due to hypercalcaemia.

Pharmacotherapeutic class: vitamin D-calcium supplement, ATC code: A12AX

Vitamin D corrects vitamin D supply insufficiency.

It increases intestinal absorption of calcium and its fixation on osteoid tissue.

Calcium supplementation corrects dietary calcium deficiency.

Requirements in elderly people are estimated at 1500 mg/day of calcium and 500-1000 IU/day of vitamin D.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

Calcium carbonate

In the stomach, calcium carbonate releases calcium ion, depending on pH. Calcium is essentially absorbed in the upper part of the small intestine. The rate of gastrointestinal absorption is of the order of 30 percent of the ingested dose.

Calcium is eliminated in the urine, feces and sweat secretions.

Vitamin D3

Vitamin D3 is absorbed in the intestine and transported in the blood bound to proteins to the liver (first hydroxylation) and then to the kidney (second hydroxylation).

Non-hydroxylated vitamin D3 is stored in reserve compartments such as adipose and muscle tissues. Its plasma half-life is on the order of a few days. It is eliminated in the feces and urine.

18 months.

Store at a temperature not exceeding 25°C.

No special requirements.