Calvidin fn2012/05/008

Calvidin FN2012/05/008 8/8/12 10:51 AM Page 1 CALVIDIN CHEWABLE TABLETS
Calvidin FN2012/05/008 8/8/12 10:51 AM Page 2 CALVIDIN CHEWABLE TABLETS
Indications: Correction of combined Vitamin D and
barbiturates may reduce the activity of vitamin D3.
calcium deficiencies in the elderly. Supply of Vitamin D Calcium salts may decrease the absorption of iron, and calcium as an adjunct to specific treatment for zinc or strontium and may reduce the absorption of the osteoporosis, in patients where combined vitamin D estramustin or thryroid hormones. In the case of and calcium deficiencies have been diagnosed or concomitant administration of bisphosphonate, those at a high risk of such deficiencies. Vitamin D sodium fluoride or fluoroquinolone it is recommended supplementation corrects and insufficient vitamin D that taking Calvidin chewable tablets be spaced by at intake. It increases the intestinal absorption of calcium.
least 3 hours, as their absorption during digestion may The optimal vitamin D dose in elderly is 500-100 I.U.
be reduced Oxalic acid (found in spinach and rhubarb) Dosage and Administration One chewable tablet
and phytic acid (found in wholegrain cereals) can twice a day. Dose reduction should be considered as inhibit calcium absorption by forming insoluble necessary following the monitoring of calcium levels.
compound with calcium ions. Pregnancy and
The tablets are chewed and then swallowed with a lactation The daily intake should not exceed 1,500 mg
little liquid. In exceptional cases the tablets can be of calcium and 600 I.U. of vitamin D3. Therefore the sucked. Contra-indications Hypersensitivity to the
daily dose must not exceed 1 tablet. Vitamin D and its active substances or to any of the excipients. metabolites pass into breast-milk. This should be Renal failure. Hypercalcaemia and hypercalciuria and considered when giving additional vitamin D to the hypercalcaemia and/or hypercalciuria (e.g. myeloma, In pregnant and lactating women, the calcium bone metastases, primary hyperparathyroidism). preparation should be taken at a distance of two hours Kidney stones (nephrolitiasis, nephrocalcinosis).
from a meal due to a possible decrease of iron Hypervitaminosis D. Precautions and warnings
absorption. Effects on the ability to drive and use
During prolonged treatment, check calcaemia and machines
renal function by assaying serum creatinine, No data related these activities this however it is particularly in the elderly, in cases of combined unlikely to have an effect. Undesirable effects
treatment with cardiac glycosides and diuretics and in (frequency) Occurrence of adverse reactions: very patients frequently subject to the formation of kidney common (≥1/10), common (≥1/100 to <1/10), stones. Prescribe with caution to patients who are uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to immobilized and suffering from osteoporosis. Take into <1/1,000), very rare (<1/10,000, not known).
account the intake of Vitamin D, calcium and alkali like Uncommon: hypercalcaemia, hypercalciuria Rare:
carbonate from all other sources before prescribing Puritus, rash and urticaria, constipation, flatulence, CALVIDIN®. Use with caution in patients suffering bloating, abdominal distension, nausea, abdominal from sarcoidosis and in patients with a decreased pain, diarrhoea Not known: Vomiting, hypersensitivity,
renal function. CALVIDIN® is not intended for use in reactions such as angiooedema or laryngeal oedema children or adolescents. This product contains Overdose: An overdose can lead to hypervitaminosis
sucrose, therefore patients with rare hereditary and hypercalcaemia. Symptoms: anorexia, thirst,
problems of fructose intolerance, glucose-galactose nausea, vomiting, constipation, dehydration, malabsorption or sucrase-isomaltase insufficiency abdominal pain, muscle weakness, fatigue, mental should not take this medicine. Note for diabetics: The
disturbances, polydipsia, polyuria, skeletal pain, renal proportion of digestible carbohydrate in CALVIDIN® calcinosis, kidney stones and in some cases severe chewable tablets is 0.47 g per tablet. The daily dose of cardiac arrhythmia, coma and death. See SmPC for
2 tablets corresponds to 0.08 carbohydrate units (CU).
treatment. Package Quantities: 60 Tablets P.A. No:
PA868/4/1 P.A. Holder: Rottapharm Ltd. Damastown,
excretion in the urine. Systemic corticosteroids reduce Mulhuddart, Dublin 15. Date of revision of text: May
calcium absorption. Orlistat, combined ion-exchange resin treatment (cholestyramine) or laxatives (paraffinoil) can reduce the gastrointestinal adsorption of Medical product not subject to medical
vitamin D3. Calcium carbonate can alter tetracycline prescription.
absorption The toxicity of cardiac glycosides mayincrease during treatment with calcium and vitamin D (risk of cardiac arrhythmia). Rifampicin, phenytoin or Full prescribing information available upon request from:Fannin House, South County Business Park, Leopardstown, Dublin 18Tel:01 290 7000 Fax:01 290 7111 Email: [email protected]


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