FIXICAL VITAMIN D3 500 mg/400 IU Chewable/sucking tablet Pilulier/180

Calcium carbonate  .......................................................................................................................1248,75 mg

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

Cholecalciferol coated at 100 000 IU/g (VITAMIN D3 100 CWS)* ..................................................4,00 mg

Quantity corresponding to cholecalciferol................................................................................................ 400 IU

For one chewable or sucking tablet.

*Mixture of cholecalciferol, alphatocopherol, dietary fats, gelatin, sucrose and corn starch.

Excipients with known effect: aspartame, sorbitol, sucrose.

• Correction of vitamin and calcium deficiencies in elderly subjects.

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

This medicine is indicated in adults.

Dosage

Reserved for adults.

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

Method of administration

Oral use.

The tablets are to be chewed then swallowed with a large glass of water, or allowed to dissolve in the mouth.

• Hypercalcaemia, hypercalciuria, calcium lithiasis.

• Prolonged immobilizations accompanied by hypercalciuria and/or hypercalcemia: vitamin-calcium treatment should only be used when mobilization resumes.

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

• 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 case of renal insufficiency, regularly monitor serum calcium and urinary calcium and avoid administration of high doses.

In case of long-term treatment and/or renal insufficiency, it is necessary to monitor urinary calcium and to reduce or temporarily interrupt treatment if it exceeds 7,5 mmol/24 h (300 mg/24 h) in adults.

This medicine should be used 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.

This medicine contains 15 mg of aspartame per tablet. Aspartame contains a source of phenylalanine which may be harmful to people with phenylketonuria.

This medicine contains 413,5 mg of sorbitol per tablet. Patients with hereditary fructose intolerance (HFI) must not take this medicine.

• This medicine contains sucrose. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) must not take this medicine.

Associations requiring precautions for use

+ Digitalis glycosides

Oral administration of calcium combined with vitamin D increases the toxicity of digitalis glycosides (risk of rhythm disorders). Strict clinical monitoring and, where appropriate, ECG and serum calcium monitoring are necessary.

+ Bisphosphonates

 It is advised to observe a minimum interval of two hours before taking calcium (risk of reduced digestive absorption of bisphosphonates).

+ Oral cyclines

It is recommended to delay calcium intake by at least two hours (possible reduction in cycline absorption).

+ Oral iron salts

It is recommended to take iron away from meals and in the absence of calcium (reduced digestive absorption of iron salts).

+ Estramustine

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

+ Thyroid hormones

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

+ Strontium

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

+ Zinc

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

+ Enzyme-inducing anticonvulsants

Decrease in vitamin D concentrations greater than in the absence of an inducer.

Measurement of vitamin D concentrations and supplementation if necessary.

+ Rifampicin

Decrease in vitamin D concentrations greater than in the absence of treatment with rifampicin.

Measurement of vitamin D concentrations and supplementation if necessary.

Associations to be taken into account

+ Thiazide diuretics and related agents

Risk of hypercalcemia due to decreased urinary elimination of calcium.

+ Orlistat

Decrease in vitamin D absorption.

+ Food

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

Pregnancy

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

During pregnancy, overdosage of cholecalciferol must be avoided:

• vitamin D overdoses during pregnancy 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

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

Vitamin D and its metabolites pass into breast milk.

Fertility

Not applicable.

Undesirable effects are listed below, by System Organ Class and by frequency. Frequencies are defined as follows: uncommon (≥ 1/1 000; < 1/100), rare (≥ 1/10 000; < 1/1 000), frequency not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders:

Rare: Pruritus, skin rash, urticaria.

Immune system disorders:

Frequency not known: Angioedema or laryngeal oedema.

Gastrointestinal disorders:

Rare: Constipation, flatulence, nausea, epigastric pain, diarrhoea.

Metabolism and nutrition disorders:

Uncommon: Hypercalciuria and exceptionally hypercalcaemia in case of prolonged treatment at high doses.

Special populations :

In patients with a medical history of renal insufficiency: risk of occurrence of adverse effects such as hyperphosphataemia, nephrolithiasis, 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 as follows:

Nausea, vomiting, polydipsia, polyuria, constipation.

Treatment:

Stop all calcium and vitamin D intake, rehydration.

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

Pharmacotherapeutic class: VITAMIN D-CALCIUM SUPPLEMENT

(Drug active on calcium balance. A: Alimentary tract and Metabolism), 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.

Daily calcium requirements are in the order of 1000 to 1500 mg of elemental calcium and 500-1000 IU/day of vitamin D.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

Calcium carbonate

Absorption

In the gastric environment, calcium carbonate releases the calcium ion, depending on pH.

Calcium is mainly absorbed in the upper part of the small intestine.

The rate of absorption via the gastrointestinal route is of the order of 30 percent of the ingested dose.

Elimination

Calcium is eliminated through sweat and digestive secretions.

Urinary calcium depends on glomerular filtration and the rate of tubular calcium reabsorption.

Vitamin D3

Absorption

Vitamin D3 is absorbed in the intestine.

Distribution - Biotransformation

Vitamin D3 is transported by protein binding in the blood to the liver (first hydroxylation) and to the kidney (second hydroxylation).

Vitamin D3 non-hydroxylated is stored in reserve compartments such as adipose and muscle tissues.

Elimination

The plasma half-life of vitamin D3 is of the order of a few days. It is eliminated in the feces and urine.

2 years.

No special precautions for storage.

No special requirements for disposal.

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