SCHEDULING STATUS Not scheduled

PROPRIETARY NAME (AND DOSAGE FORM)

CALCIBON® (tablets)
COMPOSITION
Each tablet contains:
Calcium (Elemental) as Calcium carbonate 500 mg
Vitamin D3 250 IU
Magnesium (Elemental) as Magnesium Oxide 40 mg
Manganese (Elemental) as Manganese Sulphate 1.8 mg
Zinc (Elemental) as Zinc Sulphate 7.5 mg
Copper (Elemental) as Copper Sulphate 1 mg
Boron as Sodium Borate 250 mcg

PHARMACOLOGICAL CLASSIFICATION
A 22.1 Vitamins with minerals

PHARMACOLOGICAL ACTION
The minerals found in CALCIBON are essential for normal bone metabolism in disorders of
calcium deficiency and calcium metabolism.

INDICATIONS
CALCIBON tablets are indicated as a daily dietary supplement in conditions requiring additional
calcium, such as in pregnancy, lactation and the prevention and treatment of osteoporosis.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria. These include,
hyperparathyroidism, hypervitaminosis D, tumors such as plasmacytoma and bone metastasis.
Renal failure.
Nephrolithiasis.
Dehydration.
Conditions of sarcoidosis and milk-alkali syndrome.

WARNINGS
The need for calcium supplementation should be discussed with a healthcare professional.
Unless indicated, high doses of vitamin D and derivatives should be avoided during calcium
supplementation.
CALCIBON tablets can potentially form non-absorbable complexes with many substances. The
concomitant administration of such medications and CALCIBON should therefore be avoided.
(see “INTERACTIONS” and “DOSAGE AND DIRECTIONS FOR USE”).

INTERACTIONS
Calcium absorption from the gastrointestinal tract may be diminished by the concomitant intake
of foods rich in oxalic acid and phytic acid, e.g. bran, cereals, rhubarb and spinach. The patient
should not take CALCIBON within 2 hours of eating such foods.
The concomitant use of corticosteroids may reduce calcium absorption.
Due to the possible formation of non-absorbable complexes, CALCIBON may reduce the
absorption of estramustine, quinolones, phenytoin, tetracyclines and sodium fluoride. These
substances should be taken at least 2 hours before CALCIBON administration, or 6 hours
thereafter. CALCIBON also reduces the absorption of bisphosphonates. For the concomitant

use of CALCIBON and bisphosphonates, see “DOSAGE AND DIRECTIONS FOR USE”.
Administration of large doses of oral calcium may increase the risk of cardiac arrhythmias in
patients taking digitalis.
The renal reabsorption of calcium may be increased by thiazide diuretics leading to
hypercalcaemia.
Due to the possible formation of non-absorbable complexes, CALCIBON may reduce the
absorption of other medicines, not listed above.

DOSAGE AND DIRECTIONS FOR USE

The need for calcium supplementation should be discussed with a healthcare professional.
Take one or two tablets daily, depending on the recommended requirements. If an oral
bisphosphonate (alendronate or risedronate) has been prescribed, the bisphosphonate must
be taken in the morning, strictly according to the “DOSAGE AND DIRECTIONS FOR USE” of
the bisphosphonate. CALCIBON should be taken at least 30 minutes after taking the
bisphosphonate, or preferably at night.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Hypercalcaemia and alkalosis may follow the regular use of calcium supplements (see “KNOWN
SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT”). Therefore,
regular monitoring of plasma calcium levels is recommended. In the event of mild hypercalciuria
(calcium excretion exceeding 300mg in 24 hours), chronic renal failure or evidence of urinary
tract stone formation, urinary calcium excretion must be adequately monitored. Eructation,
resulting from the carbon dioxide released by calcium carbonate, may occur. Constipation may
occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

High doses of CALCIBON may result in nausea, renal dysfunction and metastatic calcification.
Symptoms of hypercalcaemia include: nausea, vomiting, anorexia, constipation, thirst and
polyuria, drowsiness, hot flushes, sweating, muscle weakness, abdominal pain, hypotension,
circulatory collapse, confusion, bone pain due to demineralisation, nephrocalcinosis, loss of
renal concentrating capacity, renal calculi and in severe cases cardiac arrhythmias, coma and
cardiac arrest. In the event of the above, withdraw calcium supplementation immediately. Maintain
adequate hydration and prevent renal deposition of calcium by giving appropriate amounts of
fluid. Further treatment is symptomatic and supportive.

IDENTIFICATION
Orange coloured, capsule shaped, biconvex film-coated tablets plain on both sides.

PRESENTATION
30 tablets per pack in blister strips of 15 tablets.

STORAGE INSTRUCTIONS
Keep containers tightly closed, in a dry place, below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.

ADDRESS OF MANUFACTURER
CIPLA MEDPRO (PTY) LTD.
Rosen Heights, Pasita Street;
Rosen Park, Bellville, 7530, R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT

March, 2006
C724 B