Change to section

Details of change

6.3 Shelf life

Reduction in the shelf-life for the HDPE tablet container (bottle) presentation Calcichew Double Strength from 3 years to 30 months.

10.  Date of revision of the text

08 July 2016

Change to section

Details of change

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Changed / re-worded to:

One tablet contains 88.7 mg isomalt (E953) (contained in the flavour) and 3 mg sucrose.

4.2 Posology

Changed / re-worded to:

Posology

Adults and elderly

One tablet, once daily.

Special Patient Populations

Paediatric population:

Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets are not intended for use in children and adolescents.

Impaired renal function:

Calcichew-D3 Forte Double Strength 1000mg/800 IU Chewable Tablets should not be used in patients with severe renal impairment (see section 4.3).

Impaired hepatic function:

No dose adjustment is required.

Method of Administration

Oral. The tablet should be chewed or sucked.

4.3 Contraindications

Changed / re-worded to:

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

·    Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m²)

·    Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria

·    Renal calculi (nephrolithiasis)

·    Hypervitaminosis D

4.4 Special warnings and precautions for use

Changed / re-worded to:

Calcium carbonate with cholecalciferol tablets should be used with caution in patients with hypercalcaemia or signs of impaired 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.

During concomitant treatment with other sources of vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored.

Calcichew-D3 Forte Double Strength should be prescribed with caution to patients suffering from sarcoidosis, due to the 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. 

Calcichew-D3 Forte Double Strength should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

Calcichew-D3 Forte Double Strength contains isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.6       Fertility, pregnancy and lactation

Changed / re-worded to:

Pregnancy

Calcichew-D3 Forte Double Strength 1000mg/800IU can be used during pregnancy, in case of a calcium and vitamin D deficiency. During pregnancy the daily intake should not exceed 2500 mg calcium and 4000 IU vitamin D. Studies in animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). 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.

4.7          Effects on ability to drive and use machines

Changed / re-worded to:

Calcichew-D3 Forte Double Strength 1000mg/800IU has no known influence on ability to drive and use machines

4.8 Undesirable effects

Changed / re-worded in the following sections to:

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

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare:  Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia ,alkalosis and renal impairment). Seen usually only in overdose (see section 4.9).

Gastrointestinal disorders

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

4.9 Overdose

Changed / re-worded to:

Symptoms

Overdose can lead to hypercalcaemia and hypervitaminosis D. 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 may occur in patients who ingest large amounts of calcium and absorbable alkali. 

Treatment of hypercalcaemia

Treatment is essentially symptomatic and supportive. The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, and cardiac glycosides must also be discontinued (see section 4.5). Emptying of the stomach in patients with impaired consciousness. 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.

5.1    Pharmacodynamic properties

Changed / re-worded to:

Pharmacotherapeutic group:  Mineral supplements. Calcium, combinations with vitamin D and/or other drugs

5.2 Pharmacokinetic properties

Sub-heading and following line changed / re-worded to:

Cholecalciferol

Absorption: Vitamin D₃ is easily absorbed in the small intestine.

6.1 List of excipients

Updated to:

Xylitol (E967)

Povidone

Isomalt (E953)

Flavouring (lemon)

Magnesium stearate

Sucralose (E955)

Mono- and diglycerides of fatty acids

All-rac-alpha-tocopherol

Sucrose

Modified Maize starch

Triglycerides, medium-chain

Sodium ascorbate

Silica, colloidal anhydrous

Please note:

‘Soya-bean oil, hydrogenated’ and ‘gelatine’ have been deleted.

10. DATE OF REVISION OF THE TEXT

Changed to:

6^th November 2015