Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets

Correction of vitamin D and calcium combined deficiency in elderly people.

Vitamin D and calcium supplementation as an adjunct to specific therapy for osteoporosis treatment, in patients with established, or at high risk of vitamin D and calcium combined deficiencies.

Posology

One or two sachets per day.

Method of administration

Oral.

Pour the contents of the sachet into a glass, add a large quantity of water, then drink immediately.

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria

• Nephrolithiasis

• Hypervitaminosis D

Calcium and alkali intake from other sources (food, enriched foods, or other medicinal products) should be monitored when calcium carbonate is prescribed. When high calcium doses are given together with alkaline substances such as carbonate, there is a risk of milk-alkali syndrome (see sections 4.8 and 4.9). Calcium levels in serum should be monitored when administering high doses of calcium carbonate.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, treatment with calcium/vitamin D₃ sachets should be discontinued.

Vitamin D₃ should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and another form of vitamin D should be used (see section 4.3)

Calcium/vitamin D3 sachets should be used with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite. In these patients, serum calcium levels and urinary calcium excretion must be monitored.

Calcium/vitamin D3 sachets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

The dose of vitamin D3 in the sachets should be considered when prescribing other drugs containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

Cacit D3 sachets are not intended for use in children.

Cacit D3 contains sorbitol, sucrose, potassium and sodium.

This medicinal product contains 0.6 mg sorbitol in each sachet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicial product. May be harmful to the teeth.

This medicinal product contains 2.1 mmol potassium (81.6 mg) in each sachet. This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet.

This medicinal product contains less than 1 mmol of sodium (23 mg) per sachet, that is to say essentially `sodium free´ .

Concomitant use requiring precautions:

- Digitalis and other cardiac glycosides: the oral administration of calcium combined with vitamin D increases the toxicity of digitalis (risk of dysrythmia). Strict medical supervision, and if necessary, monitoring ECG and calcaemia are necessary.

- Bisphosphonate, sodium fluoride: it is advisable to allow a minimum period of two hours before taking the calcium (risk of reduction of the gastrointestinal absorption of bisphosphonate and sodium fluoride).

- Thiazide diuretics: reduce urinary elimination of calcium therefore supervision of calcaemia is recommended.

- Phenytoin or barbiturates: can decrease the effect of vitamin D because of metabolic inactivation.

- Glucocorticosteroid: can decrease the effect of vitamin D.

- Tetracyclines by oral route: it is advisable to delay taking the calcium by at least three hours (calcium salts reduce the absorption of tetracyclines).

- Possible interactions with food (e.g. containing oxalic acid, phosphate or phytinic acid).

- Iron, zinc and strontium: Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken at least two hours before or after calcium/cholecalciferol.

The product may be used during pregnancy and lactation. However, the daily intake should not exceed 1500mg calcium and 600IU vitamin D.

In pregnancy overdoses of colecalciferol must be avoided

- Overdoses of vitamin D have shown teratogenic effects in pregnant animals.

- In humans overdoses of vitamin D must be avoided, as permanent hypercalcaemia can lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy in the child.

There are several case reports of administration of very high doses in hypoparathyroidism in the mother, where normal children were born.

Vitamin D and its metabolites pass into the breast milk.

No remarkable findings. No effect expected.

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

Immune system disorders

Not known: Hypersensitivity reactions such as angio-oedema or laryngeal oedema

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Not known: Milk-alkali syndrome associating hypercalcaemia, alkalosis and renal impairment. (see sections 4.4 and 4.9)

Gastrointestinal disorders

Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

Other special populations

Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis (see section 4.4).

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 reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Goggle play or Apple App store.

In case of overdose, there is a risk of Milk-alkali syndrome (see sections 4.4 and 4.8).

Consequence of overdose are hypercalciuria and hypercalcaemia. Symptoms include: nausea, vomiting, thirst, polydipsia, polyuria, constipation.

Chronic overdoses can lead to vascular and organ calcifications as a result of hypercalcaemia.

Treatment

Stop all intake of calcium and vitamin D, rehydration.

Pharmacotherapeutic group: Calcium, combinations with vitamin D and/or other drugs, ATC code: A12AX.

Vitamin D corrects an insufficient intake of vitamin D and increases intestinal absorption of calcium. Calcium corrects an insufficient intake of calcium in the diet.

The commonly accepted requirement of calcium in the elderly is 1500 mg/day. The optimal amount of vitamin D in the elderly is 500 – 1000 IU/day.

Vitamin D and calcium correct secondary senile hyperparathyroidism.

In a double blind placebo controlled study of 18 months, including 3270 women aged 84 ± 6 years with a low intake of calcium and living in nursing homes, had their diet supplemented with colecalciferol (800 UI/day) + Calcium (1.2 g/day). A significant decrease in PTH secretion has been observed.

After 18 months, results of the intend to treat analysis showed 80 hip fractures (5.7%) in the Calcium Vitamin D group and 110 hip fractures (7.9%) in the placebo group (p = 0.004). Therefore, in these study conditions, the treatment of 1387 women prevented 30 hip fractures. After 36 months of follow up, 137 women presented at least one hip fracture (11.6%) in the Calcium Vitamin D group (n = 1176) and 178 (15.8%) in the placebo group (n = 1127) (p ≤ 0.02).

During dissolution the calcium salt contained in Cacit D3 is transformed into calcium citrate. Calcium citrate is well absorbed,( approximately 30% to 40% of the ingested dose).

Calcium is eliminated in the urine and faeces and secreted in the sweat.

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

The non-hydroxylated vitamin D is stored in reserve compartments such as adipose and muscle tissue. Its plasma half-life is several days; it is eliminated in the faeces and the urine.

No remarkable findings.

Citric acid , malic acid, gluconolactone, maltodextrin, sodium cyclamate, saccharin sodium, lemon flavouring (containing: sorbitol), rice starch, potassium carbonate, sodium ascorbate, modified starch, all-rac-alpha-tocopherol, sucrose, triglicerides medium chain and silica colloidal anhydrous.

Not applicable.

3 years.

Do not store above 25° C.

4 g sachets (paper/aluminium/polyethylene); boxes of 20, 28, 30, 46, 50, 56, 60 or 100 sachets, sample pack of 10 sachets and multipacks containing 90 (3 packs of 30) sachets.

Not all pack sizes may be marketed.

Pour the contents of the sachet into a glass, add a large quantity of water then drink immediately.

Administrative Data