Cacit 500mg Effervescent Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cacit 500mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25g Calcium Carbonate which when dissolved in water provides 500mg of calcium as calcium citrate.
3 PHARMACEUTICAL FORM
Effervescent tablet
white-pink, round, biplane, faultless surface effervescent tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
1. Treatment of calcium deficiency states including osteomalacia, rickets and malabsorption syndromes affecting the upper gastrointestinal tract.
2. An adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis.
3. In the arrest or slowing down of bone demineralisation in osteoporosis, where other effective treatment is contra-indicated.
4. As a therapeutic supplement during times when intake may be inadequate, particularly those associated with the increased demand of childhood, old age, pregnancy and lactation.
4.2
Posology and method of administration
The tablets must be dissolved in a glass of water and the solution should then be drunk immediately after complete dissolution of the tablets.
Adults and the Elderly
For calcium deficiency states including malabsorption, the dosage should be tailored to the individual patient’s needs. A dose of 1.0 g to 2.5g per day is recommended.
For the treatment of osteoporosis a dose of up to 1.5g per day is normally required. In patients with adequate dietary calcium intake, 500mg daily may be sufficient.
Up to 1.5g of calcium per day is the recommended dosage for therapeutic supplementation.
Children
Children:
Calcium deficiency during the growth period:
• Children aged 6 to 10 years: 1 tablet daily (500 mg per day),
• Children aged over 10 years: 2 tablets daily (1 g per day).
4.3 Contraindications
Hypercalcaemia (eg. due to hyperparathyroidism, hypervitaminosis D, decalcifying tumours, severe renal failure, bone metastases), severe hypercalciuria, calci-lithiasis and renal calculi. Long term immobilisation accompanied by hypercalciuria and/or hypercalcaemia. Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
In mild hypercalciuria (exceeding 7.5 mmol/24 hours in adults or 0.12-0.15 mmol/kg/24 hours in children) or renal failure, or where there is evidence of stone formation in the urinary tract; adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. The product should be administered with caution in patients with sarcoidosis because of possible increased metabolism of vitamin D to its active form. These patients should be monitored for serum and urinary calcium.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant administration with vitamin D causes an increase in calcium absorption and plasma levels may continue to rise after stopping vitamin D therapy.
The effects of digoxin and other cardiac glycosides may be accentuated by calcium and toxicity may be produced, especially in combination with vitamin D.
Calcium salts reduce the absorption of some drugs, in particular tetracyclines. It is therefore recommended that administration of Cacit tablets be separated from these products by at least 3 hours.
Thiazide diuretics increase renal absorption of calcium, so the risk of hypercalcaemia should be considered.
Bisphosphonate, sodium fluoride: it is advisable to allow a two hour minimum period before taking Cacit (risk of reduction of the gastrointestinal absorption of bisphosphonate and sodium fluoride).
4.6 Pregnancy and lactation
Calcium supplements have been in wide use for many years without apparent ill consequence.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Mild gastrointestinal disturbances have occurred rarely (eg. nausea, abdominal pain, diarrhoea, constipation, flatulence and eructation). Hypercalciuria and, in rare cases, hypercalcaemia in cases of long-term treatment with high doses. Skin reactions, such as pruritis, rash, and urticaria (especially urticaria in patients with a past history of allergy) have been reported. The colouring agent E110 can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin
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 national reporting system:
Yellow Card Scheme
Website: www .mhra. gov .uk/yellowcard
4.9 Overdose
The amount of calcium absorbed will depend on the individuals calcium status. Deliberate overdosage is unlikely with effervescent preparations and acute overdosage has not been reported. It might cause gastrointestinal disturbance but would not be expected to cause hypercalcaemia, except in patients treated with excessive doses of vitamin D. Symptoms of overdose may include nausea, vomiting, polydipsia, polyuria and constipation. Treatment should be aimed at lowering serum calcium levels, eg. administration of oral phosphates and rehydration.
Chronic overdoses can lead to vascular and organ calcifications as a result of hypercalcaemia.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Calcium is an essential element of tissues and plasma.
5.2 Pharmacokinetic properties
When the tablets are added to water, insoluble calcium carbonate is converted into absorbable calcium citrate.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid,
Sodium saccharin Sodium cyclamate
Sunset Yellow FCF (E110) and flavour
6.2 Incompatibilities
None
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Keep the tube tightly closed in order to protect from moisture.
6.5 Nature and contents of container
Supplied in boxes of 76 tablets (4 polypropylene tubes with polyethylene stoppers each containing 19 tablets).
6.6 Special precautions for disposal
To be dissolved in water before administration as described in Section 4.2
7 MARKETING AUTHORISATION HOLDER
Warner Chilcott UK Limited Old Belfast Road,
Millbrook Road,
Larne,
County Antrim, BT40 2SH
8 MARKETING AUTHORISATION NUMBER(S)
PL 10947/0016
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/10/2005
10 DATE OF REVISION OF THE TEXT
10/12/2014