Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Calcium carbonate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Calcichew Forte 1000 mg Chewable Tablets are orange flavoured chewable tabletscontaining the active ingredientcalcium.Calcium is found in the diet and is an important substance in bone formation. Calcichew Forte is used to treat and prevent calcium deficiency which may occur if your diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or during pregnancy. It may also be given to patients receiving renal dialysis to remove the phosphate from the blood that cannot be removed by dialysis. 2.
e Calcichew Forte
Do not take Calcichew Forte if you:
• • •
if you are on long term treatment, especially if you are taking medicines for a heart disorder (cardiac glycosides), or diuretics (used in the treatment of high blood pressure or oedema) if you have signs of impaired kidney function or a high tendency to kidney stone (calculus) formation if you have cancer or any other conditions that may have affected your bones.
Your serum calcium or phosphate levels, or urinary calcium excretion must be monitored if you have any of the following conditions.
For use as a phosphate binder, Calcichew Forte should be taken just before, during or just after each meal. Pregnancy, breastfeeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Calcichew Forte. During pregnancy the daily intake should not exceed 2500 mg calcium (including food and
supplementation). If you are pregnant, you may use Calcichew 500 mg in case of a calcium
deficiency.
Calcichew Forte can be used during breastfeeding. Calcium passes into breast milk. Driving and using machines Calcichew Forte has no known influence on the ability to drive or use machines. Calcichew Forte contains isomalt Calcichew Forte contains isomalt (E953): if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. May be harmful to teeth. 3.
Calcichew Forte
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dosage: The recommended dose is: For use as an additional osteoporosis therapy: One tablet daily. For calcium deficiency: One tablet daily. As a phosphate binder (for kidney failure patients on dialysis): Your doctor will decide how many Calcichew Forte Chewable Tablets you need. The label the
pharmacist puts on your medicine will tell you exactly how many tablets to take. Use in children The recommended dose for children is one tablet daily.
The tablets can be chewed or sucked. If you take more than you should If you have taken more Calcichew Forte than you should, talk to your doctor or pharmacist immediately. If you accidentally take more Calcichew Forte than you should, you may have an increase in your blood calcium levels. Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat. Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation. If you forget to take Calcichew Forte Chewable Tablets Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking your medicine and see a doctor immediately if you experience any of the following side effects. These side effects may be a sign of milk-alkali syndrome (also called Burnett's Syndrome) that is reported to occur very rarely (affects less than 1 in 10,000 people):
may include: Uncommon side effects (may affect up to 1 in 100 people):
5.
Calcichew Forte
Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
What Calcichew Forte Chewable Tablets contain The active ingredient in each tablet is:
The Royal Osteoporosis Society is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The Royal Osteoporosis Society offers support to people with osteoporosis and raises awareness of the importance of healthy bones. If you are concerned about osteoporosis, please contact the Royal Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel: 01761 471 771 or email: [email protected] *Registered Trademark
Calcichew Forte Chewable Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Calcichew Forte Chewable Tablets is calcium carbonate.
Medicines with the same active substance, strength and form include: Boots Indigestion Relief Tablets Peppermint, Setlers Antacid Chewable Tablets Peppermint Flavour, Setlers Antacid Chewable Tablets Spearmint Flavour. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Calcichew Forte Chewable Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
• 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)
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.
Monitoring is especially important in patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5).
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 monitored and renal function should be monitored.
Calcichew Forte Chewable Tablets contain isomalt (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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.
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.
Calcium carbonate has no known influence on ability to drive and use machines.
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 section 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.
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.
Ask anything about Calcichew Forte Chewable Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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