Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
In the event of prolonged treatment, checking calcaemia and renal function by assaying serum creatinine is justified. This monitoring is particularly important in older people, in cases of combined treatment with cardiac glycosides or diuretics (see section 4.5) and in patients who are frequently subject to the formation of kidney stones. In the presence of hypercalcaemia or signs of problems with renal function, the dose must be reduced or treatment interrupted.
Caltrate must be prescribed with caution to patients who are immobilized and suffering from osteoporosis, because of the increase in the risk of hypercalcaemia.
Take into account the intake of vitamin D and calcium from all other sources before prescribing Caltrate. As this product already contains vitamin D, the additional administration of vitamin D or calcium must be carried out under strict medical supervision with regular monitoring of calcaemia and calciuria. It is advisable to reduce or interrupt treatment temporarily if urine calcium exceeds 7.5 mmol/24 h (300 mg/24 h).
Caltrate must be used with caution in patients suffering from sarcoidosis because of a possible increase in vitamin D3 metabolism to its active form. In these patients, calcaemia and calciuria must be monitored.
Caltrate must be used with caution and phosphate-calcium levels monitored in patients presenting with a decrease in renal function. The risk of soft tissue calcification must be taken into account. In patients with severe renal insufficiency, vitamin D3 in the form of cholecalciferol is not metabolised in the normal way and other forms of vitamin D3 must be used (see section 4.3).
Post-marketing cases of asphyxiation due to tablet choking have been reported. It is always recommended to take tablets with a large glass of water (200 ml). In order to facilitate intake by patients, especially older people or patients with known difficulties in swallowing, the breakable tablet may be divided into two parts before taking them with a large glass of water. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free.
This product contains sucrose, therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains partially hydrogenated soya bean oil which can cause hypersensitivity reactions (urticaria, anaphylactic shock). It is therefore contraindicated for patients hypersensitive to peanut or soya (see section 4.3).
Caltrate is not intended for use in children and adolescents.
Thiazide diuretics reduce calcium excretion in the urine. Because of the increased risk of hypercalcaemia, calcium monitoring is recommended in cases when thiazide diuretics are given simultaneously.
Systemic corticosteroids reduce calcium absorption. In the case of concomitant administration of corticosteroids, it might be necessary to increase the dose of Caltrate.
Orlistat, combined ion-exchange resin treatment such as cholestyramine or laxatives such as paraffin oil can reduce the gastrointestinal absorption of vitamin D3.
Calcium carbonate can alter tetracycline absorption when given simultaneously. It is recommended that taking tetracycline be staggered by at least 2 hours before or 4 to 6 hours after taking calcium by mouth.
Hypercalcaemia can increase the toxicity of cardiac glycosides in the case of simultaneous administration with calcium and vitamin D. Consequently patients must be monitored regularly (ECG check and calcaemia).
Phenytoin or barbiturates may reduce the activity of vitamin D3, since they increase the rate of its metabolism.
Calcium salts may decrease the absorption of iron, zinc or strontium. Consequently, the iron, zinc or strontium preparation should be taken at a distance of two hours from the calcium preparation.
Calcium salts may reduce the absorption of the estramustin or thyroid hormones. It is recommended that taking Caltrate be spaced at least 2 hours from these medicines.
In the case of concomitant bisphosphonate, sodium fluoride or fluoroquinoloneadministration, it is recommended that taking Caltrate be spaced by at least 3 hours, as their absorption during digestion may be reduced.
Oxalic acid (found in spinach and rhubarb) and phytic acid (found in wholegrain cereals) can inhibit calcium absorption by forming insoluble compounds with calcium ions. Patients must not take calcium containing-products in the two hours after the consumption of foods rich in oxalic acid and phytic acid.
Caltrate may be given during pregnancy in cases of calcium and vitamin D3 deficiency.
During pregnancy the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D. Animal studies have shown toxic effects on reproduction at high doses of vitamin D. In pregnant women, all calcium or vitamin D overdoses must be avoided as prolonged hypercalcaemia in pregnancy may lead to retardation of physical and mental development, supravalvular aortic stenosis and retinopathy in the child. There are no indications that Vitamin D3 at therapeutic doses is teratogenic in man.
Caltrate can be used during breastfeeding. Calcium and vitamin D3 pass into maternal milk. This must be taken into consideration when vitamin D3 is given concomitantly to the child.
There are no data relating to the effect of this medicinal product on the ability to drive vehicles. However there is little likelihood of an effect.
Adverse effects are listed below, classified by system, organ, class and frequency. Frequencies are defined as follows: uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000).
Uncommon: hypercalcaemia and hypercalciuria.
Rare: constipation, flatulence, nausea, abdominal pain and diarrhoea.
Not known: vomiting (usually an overdose symptom see section 4.9 of the SmPC).
Rare: pruritis, rash and urticaria.
Not known: nephrolithiasis.
Not known: hypersensitivity reactions including angioedema and laryngeal oedema.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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