SUMMARY OF PRODUCT CHARACTERISTICS. One chewable tablet contains 1250 mg calcium carbonate (equivalent to 500 mg calcium).

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [XXX] 500 mg chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains 1250 mg calcium carbonate (equivalent to 500 mg calcium). Excipients with known effect: 1.00 mg Aspartame (E951), mg Sorbitol (E420). For the full list of excipients, see section PHARMACEUTICAL FORM Chewable tablet. Round, curved white uncoated tablets with embossing. Could have small spots. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Prevention and treatment of calcium deficiency - Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis - Hyperphosphataemia caused by chronic renal impairment in patients undergoing dialysis. 4.2 Posology and method of administration Posology Prevention and treatment of calcium deficiency Adults: mg per day Children and adolescents: mg per day Adjunctive therapy in osteoporosis Adults: mg per day Children and adolescents: mg per day Hyperphosphataemia The administered dosage should be based on the serum phosphate level and should be accompanied by close monitoring (see section 4.4). Adults: The recommended dose is one tablet 3 times a day (equivalent to 1500 mg elemental calcium). The total

2 dose of elemental calcium should not exceed 1500 mg/day. The dose may need to be adjusted depending on phosphate intake and elimination by dialysis. Children and adolescents: There is no sufficient information for the use of calciumcarbonat for children and adolescents with hyperphosphataemia. [XXX] is not recommended for these patient groups. To achieve the maximum phosphate binding effect, [XXX] tablets should be taken only together with the meal. Method of administration Oral use. The tablet should be chewed. 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/or hypercalciuria Nephrocalcinosis, nephrolithiasis. 4.4 Special warnings and precautions for use For patients with mild hypercalciuria (exceeding 300 mg/24 hours or 7.5 mmol/24 hours), or with a history of urinary calculi, monitoring of calcium excretion in the urine is required. If necessary, the calcium dose should be reduced or therapy should be discontinued. An increased fluid intake is recommended for patients prone to formation of calculi in the urinary tract. In patients with impaired renal function, calcium salts should be taken under medical supervision with monitoring of calcium and phosphate serum level as a risk minimisation measure for the risk of nephrocalcinosis and nephrolithiasis (see section 4.3). During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment. In these patients serum calcium levels should be followed and renal function should be monitored. Patients should be informed about the symptoms of hypercalcaemia (see section 4.8). The calcium and alkali intake from other sources (food, dietary supplements and other drugs) should be taken into consideration when prescribing Calcium 500 mg. If high doses of calcium are taken concomitantly with absorbable alkali agents (like carbonates) this could lead to milk-alkali syndrome (Burnett-Syndrome), i.e. hypercalcaemia, metabolic alkalosis, renal failure and soft tissue calcification. High doses of calcium should only be given under close medical supervision. In these cases, frequent monitoring of the calcium level in the serum and urine is necessary. To avoid an additional calcium load, patients should be advised to consult a doctor before taking calciumcontaining antacids. Phosphate binder in Hyperphosphataemia: The use of phosphate binders should be preceded by a dietary consultation with the patient concerning phosphate and calcium uptake and may depend on the kind of dialysis treatment the patient is receiving. The dose must be adjusted according to phosphate intake and its elimination via dialysis. Close monitoring of the patient s serum phosphate and serum calcium levels is necessary to determine the effectiveness of the treatment and to prevent hypercalcaemia.

3 The calcium phosphate product should not exceed 5.25 mmol 2 / l 2 (65 mg 2 / dl 2 ), since the incidence of soft tissue calcifications increases when exceeding this limit. Monthly monitoring is recommended. Prolonged exceeding of a calcium phosphate product of 65 mg 2 / dl 2 requires a change in therapy. The recommendations of current treatment guidelines regarding dosage / monitoring/ choice of phosphate binding agents should be followed. Patients being treated simultaneously with cardiac glycosides should be monitored by ECG and by additional checks on their serum calcium level (see section 4.5). Co-administration with tetracyclines, cardiac glycosides or quinolones is usually not recommended, or must be done with precaution (see section 4.5). [XXX] tablets contain aspartame (E951, a source of phenylalanine). May be harmful for people with phenylketonuria. [XXX] tablets contain sorbitol (E420). 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. Concurrent use of oestrogens (estradiol) or vitamin A-preparations with calcium salts may increase calcium absorption. Absorption, and therefore effectiveness of the following medicinal products is reduced when [XXX] is taken concurrently: bisphosphonates, fluorides,, some cephalosporins (cefpodoxime, cefuroxime), ketoconazole, estramustin-preparations and anticholinergics. There should be at least 3 hours in between taking any of these medicinal products and [XXX]. Tetracycline preparations administered concomitantly with calcium preparations may not be wellabsorbed. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium. Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of [XXX]. The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium. Calcium salts may decrease the absorption of iron, zinc or strontium. Consequently, the iron, zinc or strontium preparation should be taken at a distance of two hours from the calcium preparation. Cardiac glycoside toxicity may increase with hypercalcaemia resulting from 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.

4 Calcium can reduce the pharmacological effects of verapamil and probably of other calcium channel blockers. Simultaneous use of aluminium containing antacids can lead to an increase in aluminium absorption. Oxalic acid (found in spinach or rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid. 4.6 Fertility, pregnancy and lactation Pregnancy [XXX] can be used during pregnancy in case of a calcium deficiency. The adequate daily intake (including food and supplementation) for normal pregnant women is mg calcium. During pregnancy, the daily intake of calcium should not exceed 1500 mg. In case of hyperphosphataemia, [XXX] can be used during pregnancy and lactation provided that treatment is accompanied by regular checks of the serum calcium level. Breast-feeding [XXX] can be used during breast-feeding. Significant amounts of calcium are secreted in milk during lactation. The adequate daily intake (including food and supplementation) for normal lactating women is mg calcium. Fertility There are no data on the effects of calcium on fertility available. 4.7 Effects on ability to drive and use machines There are no data about the effect of this product on driving capacity. An effect is, however, unlikely. 4.8 Undesirable effects Organ class Immune system disorders Metabolism and nutrition disorders Gastrointestinal disorders Uncommon ( 1/1,000 to <1/100) Hypercalcaemia, hypercalciuria** Rare ( 1/10,000 to <1/1,000) Hypersensitivity, such as rash, pruritus, urticaria Constipation, flatulence, nausea, abdominal pain, and diarrhoea*** Very rare (<1/10,000) Isolated cases of systemic allergic reactions (anaphylactic reaction, face oedema, angioneurotic oedema) Milk-alkali syndrome* * seen usually only in overdose (see section 4.9)

5 ** in Hyperphosphataemia: mild hypercalcaemia (Ca < 3 mmol/l) frequency common, prolonged severe hypercalcaemia (> 3 mmol/l) frequency uncommon *** in Hyperphosphataemia: frequency common Clinical studies with calcium carbonate have shown that in patients suffering from kidney failure, longterm treatment with high doses of calcium carbonate can cause extraosseus calcification as well as hypercalcaemia. 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. 4.9 Overdose Overdose can lead to hypercalciuria and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia, polyuria, bone pain, nephrocalcinosis, renal calculi 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 occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment. Treatment: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, vitamin D and cardiac glycosides must also be discontinued. Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed. With dialysis patients, the calcium content of the dialysate can be reduced temporarily. (Please refer to section 4.4 and 4.5) 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Calcium ATC-code: A12AA04 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

6 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. 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 SPC. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sorbitol (E420) Povidone Croscarmellose Sodium Dextrate, hydrogenated Lemon flavour (Maize maltodextrin, Flavouring ingredients, All rac-α-tocopherol [E 307]) Magnesium stearate Aspartame (E951). 6.2 Incompatibilities Not applicable. 6.3 Shelf life 2 years Stability after first opening: 6 months 6.4 Special precautions for storage Do not store above 25 C. Keep the container tightly closed in order to protect from moisture. 6.5 Nature and content of container High Density Polyethylene tablet containers. Pack sizes: 20, 40, 100, 120 tablets Not all pack sizes may be marketed. 6.6 Special precautions for disposal No special requirements.

7 7. MARKETING AUTHORISATION HOLDER 8. MARKETING AUTHORISATION NUMBERS 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT