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.
In case of overdose, there is a risk of Milk-alkali syndrome.
Three years.
- 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.
-
None
Citric acid,
Sodium saccharin
Sodium cyclamate
Sunset Yellow FCF (E110) and flavour
Effervescent tablet
white-pink, round, biplane, faultless surface effervescent tablets
The frequencies of adverse events are ranked according to the following:
Very common (>1/10), Common (>1/100 to <1/10), Uncommon (>1/1,000 to <1/100), Rare (>1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
|
System organ class |
Frequency |
Adverse drug reactions |
|
Immune system disorders |
Not known |
Allergic-type reaction (including asthma) to the colouring agent E110. Allergy is more common in those people who are allergic to aspirin. Hypersensitivity reactions such as angio-oedema or laryngeal oedema |
|
Metabolism and nutrition disorders |
Rare |
Hypercalciuria and, in rare cases, hypercalcaemia in cases of long-term treatment with high doses. |
|
Not known |
Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment) Milk-alkali syndrome is usually reversible upon drug's discontinuation and specific treatment (saline diuresis, pamidronic acid).* | |
|
Gastrointestinal disorders |
Rare |
Mild gastrointestinal disturbances e.g nausea, abdominal pain, diarrhoea, constipation, flatulence and eructation |
|
Skin and subcutaneous tissue disorders |
Rare |
Skin reactions, such as pruritis, rash, and urticaria (especially urticaria in patients with a past history of allergy) |
*9.
Other special populations
Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable
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.
Pharmacotherapeutic group: Calcium, ATC code: A12A A04
Pharmacodynamic effects
Calcium is an essential element of tissues and plasma.
Absorption
When the tablets are added to water, insoluble calcium carbonate is converted into absorbable calcium citrate.
16/03/2018
Cacit 500mg Effervescent Tablets
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Keep the tube tightly closed in order to protect from moisture.
Supplied in boxes of 76 tablets (4 polypropylene tubes with polyethylene stoppers each containing 19 tablets).
PL 20075/0669
Calcium supplements have been in wide use for many years without apparent ill consequence.
Each tablet contains 1.25g Calcium Carbonate which when dissolved in water provides 500mg of calcium as calcium citrate.
Excipients with known effect
Cacit 500mg Effervescent Tablets contain sunset yellow FCF (E110)
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.
Calcium and alkali intake from other sources (food, enriched foods, or other medicinal products) should be monitored when calcium carbonate is prescribed.
When high calcium doses are given together with alkaline substances such as carbonate, there is a risk of milk-alkali syndrome. Calcium levels in serum should be monitored when administering high doses of calcium carbonate.
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics and in patients with high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, treatment with calcium should be discontinued.
Cacit Effervescent Tablets have no or negligible influence on ability to drive and use machines.
Posology
Adults
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.
Special populations
Elderly people
The dose for adults can be applied for elderly patients.
Paediatric population
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).
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.
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Date of first authorisation: 09 October 1989
Date of latest renewal: 28 October 2005
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).
Iron, zinc and strontium: Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken at least two hours before or after calcium.
