CALCIPRAT VITAMIN D3 500 mg/400 IU Lozenges to suck Bottle/2x30 (60)

VIDAL
Medicines
Update of 03/12/2025

CALCIPRAT^® vitamin D3 500 mg/400 IU
calcium, cholecalciferol

Forms and presentations

Sucking tablet (white):  Bottle of 60.

Composition

	per tablet
Cholecalciferol* or vitamin D3	400 IU
Calcium	500 mg
(as calcium carbonate: 1250 mg/tab)

^*  Cholecalciferol concentrate in powder form.

Excipients: xylitol, povidone (K30), levomenthol, aspartame, mint flavouring (peppermint essential oil, gum arabic), talc, magnesium stearate, lactose monohydrate.

Indications

• Correction of associated vitamin D and calcium deficiencies in the elderly.
  
• Vitamin-calcium supplementation associated with specific osteoporosis treatments, in patients who are deficient or at high risk of vitamin D-calcium deficiency.
  

Dosage and administration

Dosage

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

Method of administration:

Suck one tablet, then drink a glass of water.

Contraindications

• Hypercalcaemia, hypercalciuria, calcium lithiasis.
  
• Prolonged immobilisation accompanied by hypercalciuria and/or hypercalcaemia: vitamin-calcium treatment should only be used when mobilisation resumes.
  
• Hypersensitivity to any of the constituents.
  
• Phenylketonuria (presence of aspartame).
  

Warnings and precautions

• During long-term treatment, it is justified to monitor urinary calcium excretion and to reduce or temporarily interrupt treatment if it exceeds 7,5 mmol/24 h (300 mg/24 h).
  
• In case of concomitant treatment with digitalis, bisphosphonate, sodium fluoride, thiazide diuretic, tetracycline: see Interactions.
  
• Take into account the dose of vitamin D per intake unit (400 IU) and any other prescription of vitamin D. As Calciprat vitamin D3 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 should be used with caution in patients with renal insufficiency, with monitoring of the calcium-phosphorus balance.
  

Interactions

Associations subject to precautions for use:

• Digitalis glycosides: oral administration of calcium combined with vitamin D increases the toxicity of digitalis glycosides (risk of arrhythmias). Strict clinical monitoring and, if necessary, ECG and serum calcium monitoring 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 calcium excretion).
  
• Oral tetracyclines: it is recommended to delay calcium intake by at least three hours (possible reduction in tetracycline absorption).
  
• High-dose vitamin D: if additional high-dose vitamin D is administered, weekly monitoring of urinary calcium and serum calcium is essential.
  
• Phenytoin, barbiturates: possible decrease in the effect of vitamin D3 through inhibition of its metabolism.
  
• Glucocorticoids: possible decrease in the effect of vitamin D3.
  
• Food: possible interactions with foods (for example those containing oxalic acid, phosphates or phytic acid).
  

Fertility, pregnancy and breastfeeding

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.

During pregnancy, overdosage with cholecalciferol should be avoided:

• vitamin D overdoses during gestation have had teratogenic effects in animals;
  
• in pregnant women, vitamin D overdoses should be avoided because persistent hypercalcemia may cause 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.
  

Vitamin D and its metabolites pass into breast milk.

Driving and using machines

No known or expected effects.

Adverse effects

• Constipation, flatulence, nausea, epigastric pain, diarrhea.
  
• Hypercalciuria and, exceptionally, hypercalcemia in cases 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 continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should 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 Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

• Overdose results in hypercalciuria and hypercalcemia, the symptoms of which are as follows: nausea, vomiting, polydipsia, polyuria, constipation.
  
• Chronic overdose of vitamin D3 may cause vascular and tissue calcifications due to hypercalcaemia.
  

Treatment:

Stop any intake of calcium and vitamin D, rehydration.

Pharmacodynamics

Vitamin D and calcium supplementation (A: digestive system and metabolism - Medicine active on calcium balance).

Vitamin D corrects inadequate vitamin D intake.

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

Calcium supplementation corrects dietary calcium deficiency.

The needs of elderly people are estimated at 1500 mg/day of calcium and 500 to 1000 IU/day of vitamin D.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

Pharmacokinetics

In the gastric environment, calcium carbonate releases the calcium ion, depending on the 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 % of the ingested dose. Calcium is eliminated in the urine, feces and sweat secretions.

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

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

Storage conditions

No special precautions for storage.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400934115608 (1996, SmPC rev 11.01.2024).

Price:	5,29 euros (60 tablets).
Reimbursed by Social Security at 65 %. Collective.

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Tel: 01 45 21 02 69. Fax: 01 41 90 69 76
E-mail: info.fr@alfasigma.com

www.alfasigma.fr