NATECAL VITAMIN D3 600 mg + 400 IU orodispersible tablet pilulier/60

Calcium................................................................................................................................................................600 mg

In the form of Calcium carbonate..................................................................................................1 500 mg

Cholecalciferol (Vitamin D3)..........................................................................................................................400 IU (equivalent to 0,01 mg)

For one orodispersible tablet

Excipients with known effect: aspartame (E 951), lactose, hydrogenated soybean oil, sucrose.

Correction of vitamin and calcium deficiencies in elderly people.

Additional supply of calcium and VITAMIN D3 as an adjunct to specific treatment of osteoporosis in patients at high risk of combined calcium and VITAMIN D deficiency or in whom this deficiency has been diagnosed.

Adults and elderly

One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening). A dose reduction should be considered based on levels observed during calcium monitoring, as indicated in the sections Warnings and precautions and Interactions.

The tablets may be sucked and must not be swallowed whole.

The tablets should preferably be taken after a meal.

Posology in pregnant women

One tablet per day (see section Fertility, pregnancy and breastfeeding).

Dosage in case of hepatic impairment

No dose adjustment is necessary.

• Hypersensitivity to calcium, cholecalciferol or to any of the excipients (in particular soybean oil) mentioned in section Composition ;

• Renal calculi (nephrolithiasis, nephrocalcinosis)

• Severe renal insufficiency and renal dysfunction

• Hypercalciuria and hypercalcaemia and conditions and/or disorders leading to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism)

• Hypervitaminosis D

• NATECAL VITAMINE D3 tablets are not indicated in children and adolescents

• During prolonged treatment, it is recommended to monitor blood and urinary calcium levels as well as renal function by measuring serum creatinine. Monitoring is particularly important in elderly patients receiving concomitant treatment with cardiac glycosides or diuretics. In case of hypercalcaemia or signs of renal dysfunction, the dose must be reduced or treatment discontinued. It is recommended to reduce the dose or temporarily discontinue treatment if urinary calcium excretion exceeds 7,5 mmol/24 h (300 mg/24 h).

• Take into account the VITAMIN D dose (400 IU) when other medicines containing VITAMIN D or dietary supplements containing VITAMIN D are prescribed.

• Additional administration of VITAMIN D or calcium must be carried out under medical supervision. In this case, plasma and urinary calcium levels must be monitored regularly.

• The risk of renal calculi increases when total calcium intake approaches 2 000 mg/day. Therefore, calcium intake from other sources must be carefully monitored.

• The results of clinical studies show that high patient compliance is decisive for the efficacy of supplementation.

• The product should be prescribed with caution to patients with sarcoidosis given the increased risk of conversion of VITAMIN D to its active metabolite. In these patients, serum and urinary calcium should be monitored.

• Vitamin D metabolism is impaired in patients with renal insufficiency; if they are treated with cholecalciferol, the effect on calcium and phosphate homeostasis must be monitored. The risk of soft tissue calcification must be taken into account (see section Adverse effects).

• The product should be used with caution in immobilised patients with osteoporosis, due to the increased risk of hypercalcaemia.

• Calcium and alkali intake from other sources (diet, dietary supplements and other medicines) must be taken into consideration when prescribing calcium supplements. If very high doses of calcium are taken in combination with absorbable alkaline agents (such as carbonates), this could lead to milk-alkali syndrome (Burnett syndrome), which consists of hypercalcaemia, metabolic alkalosis, renal insufficiency and soft tissue calcification. In this case, frequent monitoring of serum and urinary calcium may be necessary.

• The product contains aspartame, a source of phenylalanine. The latter may be harmful to people with phenylketonuria.

• The product contains hydrogenated soybean oil and is contraindicated in patients with hypersensitivity to peanut or soya (see section Contraindications).

• The product contains lactose. Consequently, patients with rare hereditary disorders such as lactose intolerance, lactase deficiency or glucose/galactose malabsorption syndrome must not take this medicine.

• The product contains sucrose. Consequently, patients with rare hereditary disorders such as fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase deficiency must not take this medicine. The product may be harmful to teeth.

• Concomitant use of phenytoin or barbiturates may reduce the effect of VITAMIN D3 due to increased its metabolism.

• Rifampicin may reduce the activity of vitamin D3 as it increases the rate of its metabolism.

• In case of concomitant use of bisphosphonates, sodium fluoride or fluoroquinolones, it is recommended to observe an interval of at least three hours before taking NATECAL VITAMINE D3 given the risk of reduced gastrointestinal absorption.

• In case of treatment with thiazide diuretics, which reduce renal calcium elimination, it is recommended to regularly monitor plasma calcium levels.

• Concomitant administration of glucocorticoids may reduce the effect of VITAMIN D3.

• Calcium carbonate may interfere with the absorption of tetracyclines administered at the same time. For this reason, tetracycline products should be administered at least two hours before or four to six hours after oral calcium intake.

• Hypercalcaemia may increase the toxicity of digoxin and other cardiac glycosides during treatment with calcium and VITAMIN D. Patients should be monitored by electrocardiogram (ECG) and measurement of serum calcium levels.

• Orlistat, combined treatment with ion-exchange resins such as cholestyramine, or laxatives such as liquid paraffin may reduce the gastrointestinal absorption of VITAMIN D3.

• Calcium salts may reduce the absorption of iron, zinc and strontium. Therefore, iron, zinc or strontium should be taken two hours before or after calcium.

• Calcium salts reduce the absorption of estramustine or thyroid hormones. It is recommended to space the intake of NATECAL VITAMIN D3 and these medicines by at least 2 hours.

• Oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grain cereals) may inhibit calcium absorption by forming insoluble compounds with calcium ions. The patient should not take calcium products within two hours of consuming foods with a high content of oxalic acid and phytic acid.

Pregnancy

During pregnancy, the daily intake should not exceed 1 500 mg of calcium and 600 IU of VITAMIN D. Animal studies carried out with high doses of VITAMIN D have shown reproductive toxicity.

In pregnant women, calcium and cholecalciferol overdose should be avoided, as persistent hypercalcaemia has been shown to cause adverse effects on fetal development. There is no information indicating that VITAMIN D at therapeutic doses is teratogenic in humans. NATECAL VITAMIN D3 may be used during pregnancy in cases of calcium and VITAMIN D deficiency.

Breast-feeding

NATECAL VITAMIN D3 may be used during breastfeeding. Calcium and VITAMIN D3 pass into breast milk. This factor should be taken into account when VITAMIN D is administered to the child.

The effects on the ability to drive vehicles and use machines have not been studied. However, an effect is unlikely.

Undesirable effects are listed below by system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria

Gastrointestinal disorders

Rare: Constipation, flatulence, nausea, stomach ache and diarrhoea

Skin and subcutaneous tissue disorders

Rare: Pruritus, rash and urticaria

Immune system disorders

Not known (cannot be estimated from the available data): Severe allergic reactions (hypersensitivity) such as angioedema or laryngeal oedema.

Other special population

Patients with renal impairment: potential risk of hyperphosphataemia, nephrolithiasis and nephrocalcinosis. See section Warnings and precautions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centres - Website https://signalement.social-sante.gouv.fr/.

Overdose may lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and, in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may lead to coma and death of the patient. Continuously elevated calcium levels may lead to irreversible renal damage and soft tissue calcification.

Treatment

Treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued.

Gastric lavage in patients who have lost consciousness. Rehydration and, depending on severity, treatment alone or combined with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, an ECG and CVP should be performed.

Pharmacotherapeutic class: calcium, combinations with other drugs, ATC code: A12AX

Vitamin D corrects an insufficient intake of vitamin D. It increases intestinal absorption of calcium. The optimal amount of vitamin D in elderly people is 500 to 1 000 IU/day.

Calcium supplementation compensates for insufficient dietary calcium intake.

The daily required dose of calcium in elderly people is 1 500 mg/day.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

Calcium carbonate

In the stomach, calcium carbonate releases calcium ions depending on the pH. Calcium administered as calcium carbonate is absorbed at a rate of 20-30 % and absorption occurs essentially in the duodenum via saturable, vitamin D-dependent active transport. Calcium is eliminated in the urine, feces and sweat. The excretion of calcium in the urine depends on glomerular filtration and tubular reabsorption of calcium.

Vitamin D

Vitamin D is absorbed in the small intestine, binds to specific alpha globulins, and is then transported to the liver where it is metabolized to 25-hydroxy-cholecalciferol. A second hydroxylation to 1,25-dehydroxy-cholecalciferol takes place in the kidneys. This metabolite is responsible for the increase in calcium absorption. Non-metabolized vitamin D is stored in tissues such as fat and muscle. Vitamin D is eliminated in the feces and urine.

At doses well above the human therapeutic range, teratogenicity was observed in animal experiments. There is no other relevant information from the safety evaluation, other than that mentioned in the other sections of the SmPC.

2 years.

After opening: 60 days.

Store at a temperature not exceeding 30°C.

Store in the original outer packaging, protected from moisture.

No special requirements.