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2.
Qualitative and Quantitative Composition
Per tablet:
Calcium carbonate: 1500mg equivalent to 600mg of elemental
calcium
Colecalciferol: 400iu equivalent to 10mg vitamin D3
For 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 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 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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