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ADCAL 1500MG CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CALCIUM CARBONATE / CALCIUM CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Adcal 1500mg Chewable Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate: 1500mg
equivalent to 600mg of elemental calcium

3

PHARMACEUTICAL FORM
Chewable Tablet

4

CLINICAL PARTICULARS

4.1

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 as an adjunct to more specific conventional
treatments. Adcal chewable tablets can be used as a phosphate binding agent in the
management of renal failure.

4.2

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 in the management of renal failure in patients on renal

dialysis, the dose should be adjusted for the individual patient and is dependent on the
serum phosphate level.
The tablets should be chewed, not swallowed whole and taken just prior to, during or
immediately following a meal.

4.3

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 renal failure untreated by
renal dialysis. Hypersensitivity to any of the tablet ingredients.
Relative contra-indications are osteoporosis due to prolonged immobilisation, renal
stones, severe hypercalciuria.

4.4

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 mild to moderate renal failure or mild
hypercalciuria.
Urinary calcium excretion should also be measured. 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.
Allowances should be made for calcium and vitamin D supplements from other
sources.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5

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 effects of digitalis and other cardiac glycosides may be accentuated with the oral
administration of calcium combined with Vitamin D. Strict medical supervision is
needed and, if necessary monitoring of ECG and calcium.
Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may
reduce the absorption of calcium
Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium
fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a
minimum period of four hours before taking the calcium.
Calcium absorption is reduced in patients receiving systemic corticosteroid therapy.
This should be taken in to account when patients are receiving concomitant therapy.

4.6

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 supplementation allowances should be made for
availability of these agents from other sources. If Adcal and iron supplements are
both required to be administered to the patient, they should be taken at different times
(see Section 4.5).

4.7

Effects on ability to drive and use machines
None known

4.8.

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
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 the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard

4.9

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 serum calcium levels through a high fluid
intake and low calcium diet.I In severe cases treatments with corticosteroid and other
specialist treatment may be necessary. Alkalosis is a potential but rare risk.

5

PHARMACOLOGICAL PROPERTIES

5.1

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.

5.2

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 tract while the remainder reverts to
insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

5.3

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 result.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Xylitol, polydextrose, pre-gelatinised starch, sodium saccharin, magnesium stearate,
fruit flavour (contains propylene glycol and maltodextrin).

6.2

Incompatibilities
Not applicable, oral preparation.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25°C.
Store in the original package. Keep container in the outer carton.

6.5

Nature and contents of container
PVC/PVdC aluminium foil blister packs of 10 (Physicians sample), or 100 tablets in a
cardboard carton.

6.6

Special precautions for disposal
No special conditions

7.

MARKETING AUTHORISATION HOLDER
Kyowa Kirin Limited
Galabank Business Park
Galashiels
TD1 1QH
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL16508/0005

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/10/2005

10

DATE OF REVISION OF THE TEXT
13/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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