ADCAL Chewable Tablet (2016)
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Περιεχόμενα
Name of the medicinal product
Adcal 1500mg Chewable Tablets.
Qualitative and quantitative composition
<u>Per tablet:</u> Calcium carbonate: 1500mg equivalent to 600mg of elemental calcium.
Pharmaceutical form
Chewable Tablet.
Therapeutic indications
Adcal is a chewable tablet recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy ...
Posology and method of administration
Oral. Adults, elderly and children Dietary deficiency and as an adjunct in osteoporosis therapy; 2 chewable tablets per day, preferably one tablet each morning and evening. For use in binding phosphate ...
Contraindications
Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe ...
Special warnings and precautions for use
Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with ...
Interaction with other medicinal products and other forms of interaction
The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients. The ...
Pregnancy and lactation
During pregnancy and lactation treatment with Adcal should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Reporting of suspected adverse reactions ...
Overdose
Overdosage may cause gastro-intestinal disturbances but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering ...
Pharmacodynamic properties
Calcium carbonate is a well established medicinal material and is used extensively for supplementation in deficiency states. Calcium carbonate is also widely used as an antacid.
Pharmacokinetic properties
The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal ...
Preclinical safety data
Calcium carbonate is a well known and widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could ...
List of excipients
Xylitol Polydextrose Pre-gelatinised starch Sodium saccharin Magnesium stearate Fruit flavour (contains propylene glycol and maltodextrin)
Incompatibilities
Not applicable, oral preparation.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C. Store in the original package. Keep container in the outer carton.
Nature and contents of container
PVC/PVdC aluminium foil blister packs of 10 (Physicians sample), or 100 tablets in a cardboard carton.
Special precautions for disposal and other handling
No special conditions.
Marketing authorization holder
Kyowa Kirin Ltd., Galabank Business Park, Galashiels, Scotland, TD1 1QH
Marketing authorization number(s)
PL16508/0005
Date of first authorization / renewal of the authorization
04/10/2005
Date of revision of the text
05/2016
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