Calcichew Forte Chewable Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew Forte Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet of 1000 mg contains calcium carbonate equivalent to 1g of calcium.
Excipients with known effect:
Aspartame (E951)
Isomalt (E953)
Sorbitol (E420)
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Round, white, uncoated and convex tablets. May have small specks.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Calcichew Forte Chewable Tablets are to be chewed as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.
Calcichew Forte Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.
4.2 Posology and method of administration
Posology
Adults:
Adjunctive therapy to osteoporosis One tablet to be chewed daily.
Prevention and treatment of calcium deficiency One tablet to be chewed daily.
Phosphate binder: Dose as required by the
individual patient depending on serum phosphate level.
Special patient populations
Elderly patients:
Dosage as for adults.
Paediatric patients:
Prevention and treatment of calcium deficiency One tablet to be chewed daily.
Impaired renal function:
In patients with severe renal failure having a creatinine clearance of less than 30 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels. See section 4.4.
Impaired hepatic function:
No dose adjustment is required.
Method of administration
Oral.
The tablets may be chewed or sucked.
For phosphate binding, the tablets should be taken just before, during or just after each meal in order to bind phosphate in the food.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Diseases and/or conditions resulting in hypercalcaemia and hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases, in severe renal failure untreated by renal dialysis and in osteoporosis due to immobilisation.
• Renal calculi (nephrolithiasis)
4.4
Special warnings and precautions for use
In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi.
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 patients on concomitant treatment with cardiac glycosides or diuretics (see 4.5), in patients with a high tendency to calculus formation, in cases of hypercalcaemia, or signs of impaired renal function.
Calcium carbonate should be used with caution in patients with hypercalcaemia or signs of impaired renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.
During high dose therapy and especially during concomitant treatment with vitamin D or nutrients (such as milk), there is a risk of hypercalcaemia and milk-alkali syndrome (hypercalcaemia, alkalosis and renal impairment) with subsequent kidney function impairment. In these patients, serum calcium levels should be followed and renal function should be monitored.
Calcichew Forte Chewable Tablets contain aspartame (E951, a source of phenylalanine) and should be avoided by patients with phenylketonuria.
Calcichew Forte Chewable Tablets contain sorbitol (E420) and isomalt (E953).
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.
Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.
The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or after intake of calcium.
If a bisphosphonate is used concomitantly, this preparation should be administered at least three hours before the intake of Calcichew Forte Chewable Tablets since gastrointestinal absorption may be reduced.
Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken two hours before or after calcium carbonate.
4.6 Pregnancy and lactation
Pregnancy
Calcichew Forte Chewable Tablets can be used during pregnancy. Daily intake should not exceed 2500 mg of calcium as permanent hypercalcaemia has been related to adverse effects on the developing foetus.
Breastfeeding
Calcium carbonate can be used during breast-feeding. Calcium passes into breast milk but at therapeutic doses no effects on the breastfed new-born are anticipated.
4.7 Effects on ability to drive and use machines
Calcium carbonate has no known influence on ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, to <1/100); rare (>1/10,000,to <1/1,000) or very rare (<1/10,000).
Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria.
Very rare: 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). Seen usually only in overdose (see 4.9).
Gastrointestinal disorders
Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.
Skin and subcutaneous disorders Very rare: Pruritus, rash and urticaria.
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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.
Milk-alkali syndrome may still occur in patients who ingest large amounts of calcium and absorbable alkali. It is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium daily). Metastatic calcification can develop.
Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Calcium
ATC-code: A12A A04
An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.
5.2 Pharmacokinetic properties
Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.
Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.
Excretion and elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.
5.3 Preclinical safety data
There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitol (E420)
Povidone
Magnesium stearate Aspartame (E951)
Orange flavour:
Isomalt (E953)
Flavouring (orange)
Mono, di-fatty acid glycerides
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 30°C. Keep the container tightly closed to protect from moisture.
6.5 Nature and contents of container
WiMo Box of 28, 30, 56, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.
It is a high density polyethylene cylindrical bottle with high density polyethylene screw cap and medium density polyethylene tamper-evident liner.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Takeda UK Limited Building 3,
Glory Park,
Glory Park Avenue,
Wooburn Green,
BUCKS,
HP10 0DF
8 MARKETING AUTHORISATION NUMBER(S)
PL 16189/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/01/1992 / 26/04/2004
10 DATE OF REVISION OF THE TEXT
22/06/2016