Sandocal^®+D 600 Effervescent tablets

Each effervescent tablet contains:

1358 mg of calcium lactate gluconate and 1050 mg of calcium carbonate (equivalent to 600 mg or 15 mmol of calcium).

4 mg of colecalciferol concentrate “powder form” equivalent to 400 I.U. or 10 µg colecalciferol (vitamin D₃).

Also contains: Sucrose, sorbitol, aspartame (E951), 3.6 mmol (corresponding to 82.14 mg) of sodium per tablet.

For full list of excipients, see section 6.1.

Effervescent tablets

White circular, flat faced, bevelled edge tablets with an orange odour.

- Prevention and treatment of calcium and vitamin D deficiency.

- Calcium and vitamin D supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis for patients who are at risk of calcium and vitamin D deficiency.

Children: take 1 effervescent tablet daily.

Adolescents and adults: take 1 - 2 effervescent tablets daily (equivalent to 600-1200 mg of calcium and 400-800 I.U. of vitamin D₃).

The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately. Sandocal+D 600 effervescent tablets may be taken at anytime with or without food.

Oral use.

• Hypersensitivity to the active substances or to any of the excipients of the effervescent tablet

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

• Nephrocalcinosis, nephrolithiasis

• Hypervitaminosis D

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 patients on concomitant treatment with cardiac glycosides or thiazide 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.

In patients with impaired renal function, vitamin D should be used with caution. Serum and urinary calcium together with phosphate levels should be monitored during treatment. The risk of soft tissue calcification should also be taken into account.

In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D might be suitable as thought appropriate by the health professionals.

In patients suffering from sarcoidosis, Sandocal+D 600 effervescent tablets should be prescribed with caution due to the risk of increased metabolism of vitamin D into its active form. Sarcoidosis patients should be monitored with regard to the calcium content in serum and urine if Sandocal+D 600 effervescent tablets are prescribed.

In immobilized patients with osteoporosis, Sandocal+D 600 effervescent tablets should be used cautiously due to increased risk of hypercalcaemia.

The content of vitamin D (400 IU) in Sandocal+D 600 effervescent tablets 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.

There have been literature reports alluding to possible increased absorption of aluminium with citrate salts. Sandocal+D 600 effervescent tablet (which contains citric acid) should be used with caution in patients with severely impaired renal function, especially those also receiving aluminium-containing preparations.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Each Sandocal+D 600 effervescent tablet contains aspartame, a source of phenylalanine equivalent to 15 mg/dose, and may be harmful for people with phenylketonuria.

Sandocal+D 600 effervescent tablets contain 3.6 mmol (corresponding to 82.14 mg) of sodium per tablet.

Information for diabetics:

Sandocal+D 600 effervescent tablets contain 0.003 Carbohydrate Units per tablet and are therefore suitable for diabetics.

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 Sandocal+D 600 effervescent tablets.

Ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. Therefore Sandocal+D 600 effervescent tablets are recommended to be taken at least one hour before or four to six hours after intake of these preparations.

Tetracycline preparations administered concomitantly with calcium preparations may not be well-absorbed. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.

Cardiac glycoside toxicity may increase with hypercalcaemia resulting from treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If an oral bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Sandocal+D 600 effervescent tablets since gastrointestinal absorption of either oral bisphosphonate or sodium fluoride may be reduced.

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:

Sandocal+D 600 effervescent tablets can be used during pregnancy, in case of a calcium and vitamin D deficiency. However, for supplementation starting during the third trimester of pregnancy, the daily intake should not exceed 1500 mg calcium and 1000 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.

Breast-feeding:

Sandocal+D 600 effervescent tablets 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.

Sandocal+D 600 effervescent tablets has no influence on the ability to drive and use machines.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1000, <1/100), rare (>1/10 000, <1/1000), or very rare (1<10 000), including isolated reports.

Immune system disorders

Very Rare (<1/10,000): Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders

Rare (>1/10,000, <1/1,000): hypercalcaemia, hypercalciuria.

Gastrointestinal disorders

Uncommon (>1/1,000, <1/100): nausea, diarrhoea, abdominal pain, constipation, flatulence, abdominal distension.

Skin and subcutaneous tissue disorders

Uncommon (>1/1,000, <1/100): rash, pruritus, urticaria.

Overdose leads to hypervitaminosis, hypercalciuria and hypercalcaemia. Symptoms of hypercalcaemia may include: nausea, vomiting, thirst, polydipsia, polyuria, dehydration and constipation. Chronic overdose with resulting hypercalcaemia can cause vascular and organ calcification.

The threshold for vitamin D intoxication is between 40,000 and 100,000 I.U per day and for calcium intoxication is from supplementation in excess of 2000 mg per day, taken for several months, in persons with normal parathyroid function.

Treatment of overdose:

In the case of an intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.

Where overdosage requires treatment it should be via hydration, including i.v. saline solution when needed. A loop diuretic (e.g., furosemide) may then be used to further increase calcium excretion and to prevent volume overload, but thiazide diuretics should be avoided. In patients with renal failure, hydration is ineffective and they should undergo dialysis. In the case of persistent hypercalcaemia, contributing factors should be excluded, e.g., vitamin A or D hypervitaminosis, primary hyperparathyroidism, malignancies, renal failure, or immobilisation.

Pharmacotherapeutic group:

- Minerals supplements

- Vitamins

ATC codes: Calcium carbonate (A 12 AA 04), Calcium lactate gluconate (A 12 AA 06) and Colecalciferol (A 11 CC 05)

Sandocal+D 600 effervescent tablets are a fixed combination of calcium and vitamin D₃. Vitamin D₃ increases the intestinal absorption of calcium. Administration of calcium and vitamin D₃ counteracts the increase of parathyroid hormone (PTH) which causes increased bone resorption and results from calcium deficiency.

Human vitamin-D status depends on the latitude, the time spent outdoors and diet (vitamin-D containing food, food supplements, fish, cod liver oil). Vitamin-D hypovitaminosis - especially at winter and early spring - is common in many countries, including those in Europe, and affects all segments of the population, including children, adolescents and elderly people, due to less effective UV-radiation. People living indoors and not spending enough time in sunlight are prone to vitamin-D hypovitaminosis.

In a double-blind placebo controlled study of 18 months, 3270 women aged 84 ± 6 living in nursing homes were supplemented with colecalciferol (800 IU/day) + calcium (1.2 g/day), resulting in a significant decrease in PTH secretion. After 18 months, the results of the intent to treat analysis showed 80 hip fractures in the calcium vitamin D group as compared to 110 hip fractures in the placebo-group (p=0.004). In the conditions of this study, calcium and vitamin D treatment of 1387 women thus prevented 30 hip fractures. After 36 months of follow-up, 137 women presented with at least one hip fracture in the calcium-vitamin D group (n=1176) as compared to 178 in the placebo group (n=1127) (p0.02).

Calcium:

Sandocal+D 600 effervescent tablets contains two calcium salts, calcium lactate gluconate and calcium carbonate, which readily dissolve in water to make the active ionised form of calcium freely usable.

Absorption:

Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine and delivered to the exchangeable calcium pool. Vitamin D is required for calcium absorption and increases the capability of the absorptive mechanisms.

Distribution and metabolism:

99% of the calcium in the body is concentrated in the mineral component 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 5% being complexed to citrate, phosphate or other anions. The remaining 45% being bound to proteins, principally albumin.

Elimination:

Calcium is excreted in the urine, faeces and sweat. Urinary excretion depends on glomerular filtration and tubular reabsorption.

Vitamin D₃:

Absorption:

Colecalciferol is absorbed in the intestine.

Distribution and metabolism:

Colecalciferol is transported by protein binding in the blood to the liver where it undergoes the first hydroxylation to 25-hydroxycolecalciferol. It is then further hydroxylated in the kidneys into 1,25-dihydroxycolecalciferol which is the actual active metabolite of vitamin D₃ responsible for increasing calcium absorption.

Non-hydroxylated vitamin D₃ is stored in muscle and adipose tissues.

Elimination:

The plasma half-life of vitamin D₃ is in the order of several days; elimination is through the faeces and urine.

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies.

There is further no information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.

Citric acid

Sodium hydrogen carbonate

Macrogol 6000

Aspartame (E951)

Orange flavour (contains: orange essential oils, maltodextrin, arabic gum, sorbitol (E 420), dextrose)

Sucrose

Bovine gelatin

Maize starch

Partially hydrogenated soya oil

Alpha-tocopherol

Not applicable.

24 months.

Do not store above 30°C.

Keep the tube tightly closed. Store in the original package.

The effervescent tablets are packed in polypropylene tubes and tamperproof polyethylene stoppers with desiccant, each containing 10 or 20 tablets.

The tubes are packed in boxes containing 10, 20, 40 (2 tubes of 20), 60 (3 tubes of 20), 80 (4 tubes of 20) and 100 (5 tubes of 20) tablets.

Not all pack sizes may be marketed.

No special requirements.

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as Novartis Consumer Health

PL 00030/216

5th June 2008

03 June 2011

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