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Document: Recikalc-D film-coated tablet ENG SmPC change

• Recikalc-D film-coated tablet SmPC
• Recikalc-D film-coated tablet ENG SmPC

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summary of the product characteristics

Recikalc-D 500 mg/400 IU film-coated tablet

Each film-coated tablet contains 500 mg calcium (as calcium carbonate about 1300 mg) and 10 microgram cholecalciferol (equivalent to 400 IU vitamin D)_.

Excipients with known effect: sucrose 0.9 mg.

For a full list of excipients, see section 6.1.

Film-coated tablet

White, oval, 8,5x19 mm, engraved with R 104.

Prevention and treatment of calcium and vitamin D deficiency in elderly people.

Vitamin D and calcium supplement in addition to specific of osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.

Recikalc-D is indicated in adults.

Posology

Adults and elderly

One tablet twice daily.

Dosage in hepatic impairment

No dose adjustment is required

Dosage in renal impairment

Recikalc-D should not be used in patients with severe renal impairment.

Method of administration

To be swallowed whole, divided or crushed before intake.

• Diseases and/or conditions resulting in hypercalcemia and/or hypercalciuria.

• Nephrolithiasis.

• Hypervitaminosis D.

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

Recikalc-D should be prescribed with caution to patients suffering from sarcoidosis due to risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

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 a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Vitamin D 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 other forms of vitamin D should be used (see section 4.3, contraindications).

Recikalc-D should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

The content of vitamin D (400 IU) in Recikalc-D should be considered when prescribing other medicinal products 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. Milk-alkali syndrome (Burnett´s syndrome), i.e. hypercalcaemia, alkalosis and renal impairment, can develop when large amounts of calcium are ingested with absorbable alkali.

Recikalc-D contains 0.9 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Recikalc-D are not intended for use in children.

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Recikalc-D_.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Recikalc-D since gastrointestinal absorption may be reduced.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

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

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 Recikalc-D.

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g. vitamin D₃).

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

Pregnancy

During pregnancy the daily intake should not exceed 1,500 mg calcium and 600 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Recikalc-D can be used during pregnancy, in case of a calcium and vitamin D deficiency.

Breast-feeding

Recikalc-D can be used during breast-feeding. Calcium and vitamin D₃ pass into breast milk. This should be considered when giving additional vitamin D to the child.

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

Adverse reactions frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000) and not known (cannot be estimated from available data).

Immune system disorders

Not known (cannot be estimated from available data): Hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose (see section 4.9) Milk-alkali syndrome.

Gastrointestinal disorders

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

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

Patients with renal impairment are at potential risk of hyperfosfatemi, nephrolithiasis and nephrocalcinos. See section 4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allow continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

To be completed nationally.

Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification. Milk-alkali syndrome (Burnett´s syndrome), i.e. hypercalcaemia, alkalosis and renal impairment, can develop when large amounts of calcium are ingested with absorbable alkali.

Treatment of hypercalcaemia: The 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. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

Pharmacotherapeutic group: Mineral supplements

ATC-code: A12AX

Vitamin D increases the intestinal absorption of calcium.

Administration of calcium and vitamin D₃ counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency and which cause increased bone resoprtion.

A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of two tablets of calcium 500 mg/vitamin D 400 IU for six months normalised the value of the 25-hydroxylated metabolite of vitamin D3 and reduced secondary hyperparathyroidism and alkaline phosphatases.

An 18 month double-blind, placebo controlled study including 3270 institutionalised women aged 84 (± 6 years) who received supplementation of vitamin D (800 IU/day) and calcium phosphate (corresponding to 1200 mg/day of elemental calcium), showed a significant decrease of PTH secretion. After 18 months, an "intent-to treat" analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0.004). A follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176) and 178 in the placebo group (n=1127) (p<0.02).

Calcium

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Vitamin D

Absorption: Vitamin D is easily absorbed in the small intestine.

Distribution and metabolism: Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. Cholecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. It is then further converted in the kidneys to 1.25- hydroxycholecalciferol. 1.25-hydroxycholecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D which is not metabolised is stored in adipose and muscle tissues.

Elimination: Vitamin D is excreted in faeces and urine.

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is no further information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.

Core: maltodextrin, sucrose, sodium ascorbate, silicon, dioxide, medium chain triglycerides, starch sodium octenyl succinate (E1450), all-rac-alpha-tocopherol, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Film-coating: hypromellose, macrogol, paraffin

Not applicable.

2 years.

Do not store above 30 °C. Store in the original container in order to protect from light.

60, 90, 120 and 180 tablets in plastic containers made of polyethylene, especially adjusted packaging with an accessibility cap for people with reduced function in the hands.

Not all pack sizes may be marketed.

No special requirements.

To be completed nationally

To be completed nationally

To be completed nationally

2016-03-10