Full Prescribing Info
Contents
Calcium, Vitamin D3.
Description
Each soft gelatin capsule contains: Calcium Carbonate BP 1250 mg (equivalent to elemental calcium 500 mg), Vitamin D3 BP 500 IU.
Approved colours used in capsule shell.
Action
Pharmacology: Calcium plays a very important role in the body. It is necessary for normal functioning of nerves, cells, muscle and bone. If calcium in blood is deficient, then the body removes calcium from bones, thereby weakening bones. Prolonged bone resorption from chronic dietary deficiency results in osteoporosis either by inadequate accumulation of bone mass during growth or increased rate of bone loss at menopause.
Vitamin D3 is a fat soluble sterol essential for the proper regulation of calcium and phosphate homeostasis and bone mineralisation.
Indications/Uses
As an adjunct to specific therapy for osteoporosis and in situations requiring therapeutic supplementation such as in pregnancy and established vitamin D dependent osteomalacia.
Prevention and treatment of calcium deficiency/vitamin D deficiency especially in elderly subjects.
Dosage/Direction for Use
The usual recommended dose is 1 to 2 capsules daily, do not exceed recommended dose.
And as prescribed by the physician.
Contraindications
Hypercalcaemia, osteoporosis due to prolonged immobilisation, renal stones and severe hypercalciuria.
Special Precautions
Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary excretion.
In patients with history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.
Caution is required in patients receiving treatment for cardiovascular disease with thiazide diuretics or cardiac glycosides including digitalis.
Allowances should be made for calcium and vitamin D supplements from other sources.
Side Effects
The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen with long term treatment at high dosages.
Drug Interactions
The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion.
Certain foods (e.g. those containing oxalic acid, phosphate or phytanic acid) may reduce the absorption of calcium.
Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D.
Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolones, tetracyclines and iron. It is advisable to allow a minimum period of four hours before taking calcium preparations.
Symptoms of overdosage and antidote: The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of calcium and vitamin D and rehydration.
Storage
Store in a dry place below 30°C, do not freeze.
ATC Classification
A12AX - Calcium, combinations with vitamin D and/or other drugs ; Used as dietary supplements.
Presentation/Packing
Softgel cap 3 x 10's.
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