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2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate: 1500mg,
equivalent to 600mg of elemental calcium
Colecalciferol: 400iu,
equivalent to 10μg vitamin D3
This product also contains
sucrose (part of the vitamin D3 concentrate: approximately 1.5 micrograms per
tablet) and soya oil (also part of the vitamin D3 concentrate:
approximately 0.3 milligrams per tablet).
For full list of excipients
see 6.1
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2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate: 1500mg,
equivalent to 600mg of elemental calcium.
Colecalciferol: 400iu,
equivalent to 10μg vitamin D3.
This product also contains
sucrose (part of the vitamin D3 concentrate: approximately 1.7 milligrams per
tablet) and soya oil (also part of the vitamin D3 concentrate:
approximately 0.3 milligrams per tablet).
For full list of excipients
see 6.1.
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4.4.
Special warnings and precautions for use
Patients with mild to moderate
renal failure or mild hypercalciuria should be supervised carefully. Including
periodic checks of plasma calcium levels and urinary calcium excretion.
In patients with a history of
renal stones urinary calcium excretion should be measured to exclude
hypercalciuria.
With long-term treatment it is
advisable to monitor serum and urinary calcium levels and kidney function,
and reduce or stop treatment temporarily if urinary calcium exceeds
7.5mmol/24 hours (300mg/24 hours).
Caution is required in
patients receiving treatment for cardiovascular disease (see Section 4.5 –
thiazide diuretics and cardiac glycosides including digitalis).
Adcal-D3 Lemon
should also be used with caution in other patients with increased risk of hypercalcaemia
e.g. patients with sarcoidosis or those suffering from malignancies.
Patients with rare hereditary
problems of fructose intolerance, glucose – galactose malabsorption or sucrase – isomaltase insufficiency should
not take this medicine.
Allowances should be made for
calcium and vitamin D supplements from other sources.
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4.4.
Special warnings and precautions for use
Patients with mild to moderate
renal failure or mild hypercalciuria should be supervised carefully including
periodic checks of plasma calcium levels and urinary calcium excretion.
In patients with a history of
renal stones urinary calcium excretion should be measured to exclude
hypercalciuria.
With long-term treatment it is
advisable to monitor serum and urinary calcium levels and kidney function,
and reduce or stop treatment temporarily if urinary calcium exceeds
7.5mmol/24 hours (300mg/24 hours).
Caution is required in
patients receiving treatment for cardiovascular disease (see Section 4.5 –
thiazide diuretics and cardiac glycosides including digitalis).
Adcal-D3 Lemon
should also be used with caution in other patients with increased risk of
hypercalcaemia e.g. patients with sarcoidosis or those suffering from
malignancies.
Patients with rare hereditary
problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should
not take this medicine.
Each tablet contains a small amount of sugar (about 1.7
mg per tablet) and may be harmful to teeth if used for a prolonged period.
Allowances should be made for
calcium and vitamin D supplements from other sources.
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