CALCIDOSE VITAMIN D3 500 mg/800 IU oral solution powder in sachet 30Sachet/2,6g

Powder for oral solution.

Concentrate of Cholecalciferol powder form................................................................................8,00 mg

Quantity corresponding to cholecalciferol (vitamin D3) of...................................................................800 IU

Calcium Carbonate ......................................................................................................................1 250,00 mg

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

Per sachet.

Excipient(s) with known effect: sorbitol.

Excipients:

• Correction of vitamin D-calcium deficiencies in elderly subjects with insufficient dietary intake.
• Vitamin D-calcium supplementation associated with specific treatments of osteoporosis, in patients with deficiency or at high risk of vitamin D-calcium deficiency with insufficient dietary intake.

CALCIDOSE VITAMIN D3, 500mg/800IU should be used mainly in patients requiring vitamin D supplementation but who have a dietary intake of calcium.

Dosage

1 sachet per day.

Paediatric population

CALCIDOSE VITAMIN D3, 500mg/800IU is not indicated in children or adolescents.

Hepatic impairment

No dosage adjustment is necessary.

Renal impairment

CALCIDOSE VITAMIN D3, 500mg/800IU must not be used in cases of severe renal insufficiency.

Method of administration

Oral use.

FOR ADULTS ONLY

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition ;
• Hypercalcaemia, hypercalciuria, calcium lithiasis;
• Prolonged immobilisation accompanied by hypercalcaemia and/or hypercalciuria: calcium treatment should only be used when mobilisation resumes;
• Severe renal impairment

• In the case of long-term treatment, it is justified to monitor calciuria and to reduce or temporarily interrupt treatment if it exceeds 7.5 mmol/24h (300 mg/24h).
• In the case of combined treatment with digitalis derivatives, bisphosphonates, sodium fluoride, thiazide diuretics, tetracyclines: see section Interactions.
• Take into account the vitamin D dose per intake unit (800 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 must 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.
• Due to the presence of sorbitol, this medicine is contraindicated in cases of fructose intolerance.

Associations subject to Precautions for use

Cyclines:

Decreased digestive absorption of tetracyclines.

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

Digitalis derivatives:

Risk of rhythm disorders.

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

Bisphosphonates:

Decreased digestive absorption of bisphosphonates.

Take calcium salts and antacids apart from bisphosphonates (at least 30 minutes to more than 2 hours apart, if possible, depending on the bisphosphonate).

Estramustine:

Decreased digestive absorption of estramustine.

Take calcium salts at a distance from estramustine (more than 2 hours, if possible).

Iron (salts) (oral route):

Decreased digestive absorption of iron salts.

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

Thyroid hormones:

Reduced absorption of thyroid hormones

Take calcium salts at a distance from thyroid hormones (more than 2 hours, if possible).

Strontium:

Decreased digestive absorption of strontium.

Take strontium at a distance from calcium salts (at least 2 hours, if possible).

Zinc:

Decreased digestive absorption of zinc by calcium.

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

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.

Associations to be taken into account

Thiazide diuretics:

Risk of hypercalcemia due to decreased urinary elimination of calcium.

Orlistat:

Decrease in vitamin D absorption.

Pregnancy

During pregnancy, overdosage of cholecalciferol must be avoided:

• vitamin D overdoses during gestation have had teratogenic effects in animals;
• in pregnant women, vitamin D overdoses must be avoided because permanent hypercalcemia may lead in the child to physical and mental retardation, supravalvular aortic stenosis or retinopathy. 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.

CALCIDOSE VITAMIN D3 500mg/800IU has no effect or only a negligible effect on the ability to drive vehicles and use machines.

The adverse effects are listed below, classified by organ system and frequency. Frequencies are defined as follows: uncommon (> 1/1.000, < 1/100) or rare (> 1/10.000, < 1/1.000).

Metabolism and nutrition disorders:

Uncommon: Hypercalciuria and, exceptionally, hypercalcemia with prolonged treatment at high doses.

Gastrointestinal disorders:

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

Immune system disorders

Undetermined: Hypersensitivity reactions such as angioedema or laryngeal edema.

In case of renal insufficiency, there is a risk of hyperphosphatemia, renal lithiasis 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: www.signalement-sante.gouv.fr.

Overdose results in hypercalciuria and hypercalcaemia, with the following symptoms: 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.

(Medicinal product active on calcium balance. A: alimentary tract and metabolism).

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.

A controlled, double-blind, placebo-controlled study of 18 months, involving 3270 elderly women aged 84 ± 6 years living in care centres, showed a significant decrease in plasma PTH levels. At 18 months, the results of the intention-to-treat analysis revealed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p= 0.004). Under the conditions of this study, treatment of 1387 women prevented 30 hip fractures. After extension up to 36 months, the following results were obtained: 137 hip fractures in the calcium-vitamin D group and 178 in the placebo group (p < 0,02).

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 absorption via the gastrointestinal route is of the order of 30% of the ingested dose.

Calcium is eliminated through sweat and digestive secretions.

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

Vitamin D3

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

Non-hydroxylated vitamin D3 is stored in reserve compartments such as adipose and muscle tissues.

Its plasma half-life is of the order of a few days. It is eliminated in faeces and urine.

Non-clinical studies in the literature with calcium and/or vitamin D do not reveal any particular risks for humans.

At doses far exceeding therapeutic doses for humans, calcium caused foetotoxic effects and vitamin D caused teratogenic effects in animal studies.

2 years.

No special precautions for storage.

No special requirements.

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

Marketing authorisation (AMM)

CIP 3400930087688 (30 sachets/2,6 g).

Price:

5,29 euros (30 sachets/2,6 g).

Social security reimbursement at 65% under the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree

Collection.