Calcium 500
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium 500
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Prepared Chalk BP 1.25 g/tablet
3. PHARMACEUTICAL FORM
Film coated tablet
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
A supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are increased.
A phosphate binder for the control of plasma levels of organic phosphate (Pi) in haemodialysis and CAPD patients.
4.2 Posology and Method of Administration
As a supplemental source of calcium:
Adults and the elderly: 1 tablet 2 or 3 times a day
Children (over 12 years): 1 tablet 2 or 3 times a day
As a phosphate binder: Initially 1 tablet 3 times a day.
The dose is gradually adjusted until Pi is controlled (it is assumed that the regular monitoring of haemodialysis and CAPD patients includes Pi and plasma calcium).
4.3 Contra-Indications
The product should not be given to patients receiving digitalis glycosides because the toxic effects are increased by calcium. It should not be given in cases of hypercalcaemia, hypercalciuria or hyperparathyroidism and only given with caution in patients with impaired renal function or to those with a history of renal stones. Calcium carbonate should not be used in or during the treatment of Zollinger-Ellison Syndrome.
4.4 Special Warnings and Special Precautions for Use
High dosage of the product may cause acid rebound. Regular monitoring of plasma levels of inorganic phosphate (Pi) and plasma calcium are necessary if the product is to be effectively used as a phosphate binder, and hypercalcaemia or phosphate depletion syndrome are to be avoided.
In a proportion of patients, prolonged high dosage particularly in conjunction with high calcium containing foods may result in hypercalcaemia. The dosage of Calcium 500 should be reduced or if necessary withdrawn if hypercalcaemia occurs.
4.5 Interactions with other Medicinal and other Forms of Interaction
• Digitalis glycosides: Toxic effects are increased by calcium.
• Vitamin D. In chronic renal failure modification of
Vitamin
D therapy may be required to avoid hypocalcaemia when calcium carbonate is used as a phosphate binder.
• Ciprofloxacin: reduces
peak serum levels of ciprofloxacin.
Concurrent use of calcium carbonate the total absorption and
• Bran: Decreases the gastrointestinal
absorption of calcium and
therefore reduces the efficacy of calcium supplements.
• Thiazide
Diuretics: Thiazide diuretics may increase the risk
of
hypercalcaemia.
• Calcium salts reduce the absorption of a number of other drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines. Administration should be separated by at least 3 hours.
No Data Held
4.6 Pregnancy and Lactation
As with all drugs during pregnancy, care should be taken in assessing the potential risk to benefit ratio.
4.7 Effects on Ability to Drive and Use Machines
None stated.
4.8 Undesirable Effects
The product may cause constipation, flatulence and eructation. If larger doses than those quoted previously are taken acid rebound may occur.
Overdose
4.9
The symptoms are usually, headache, nausea, nocturia, irritability and weakness. Plasma levels of calcium are raised and there may be mild alkalosis. Plasma levels usually revert to normal soon after withdrawal of calcium containing foods.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Calcium is the fifth most abundant element found in the body and plays important physiological roles, this includes nerve, muscle and cardiac function, the maintenance of membranes and coagulation of the blood.
5.2 Pharmacokinetic Properties
Above 1/3 of ingested calcium is absorbed. Only the ionised form is absorbed. About 90% of the bodies calcium is contained in the skeleton. The plasma contains about 5 meq/L.
Calcium is secreted in the gastric juices, saliva, bile and sweet. Excretion by the kidney depends upon the degree of reabsorption. This is stimulated by parathyroid hormone and the active metabolites of vitamin D.
5.3 Pre-clinical Safety Data
None of relevance.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Tablet Core: Polyvinylpyrrolidone Film coating: Sepifilm 002
Microcrystalline cellulose Propylene glycol
Magnesium stearate Opalux white
6.2 Incompatibilities
None stated
6.3 Shelf-Life
3 years (36 months)
6.4 Special Precautions for Storage
Store below 25°C
6.5 Nature and Content of Container
Polypropylene containers with polyethylene tamper evident caps (Securitainers). Pack sizes of 100, 250, 500 and 1000 are registered.
The 100 tablet (Securitainer) pack is packaged in a cardboard carton along with a patient leaflet.
6.6 Instruction for Use, Handling and Disposal
None
7 MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd
Bampton Road
Romford
RM3 8UG
England
MARKETING AUTHORISATION NUMBER(S)
8.
PL 00156/0086
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22nd September 1997 / 9th July 2003
10. DATE OF (PARTIAL) REVISION OF THE TEXT
February 2003