देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Calcium carbonate; Cholecalciferol concentrate
Pfizer Healthcare Ireland
A12AX
Calcium carbonate; Cholecalciferol concentrate
600 mg/400 international unit(s)
Film-coated tablet
Product not subject to medical prescription
Calcium, combinations with vitamin D and/or other drugs
Marketed
2009-04-24
(NON-PRESCRIPTION) PACKAGE LEAFLET: INFORMATION FOR THE USER CALTRATE 600MG/400 IU, FILM-COATED TABLETS CALCIUM (AS CARBONATE) AND CHOLECALCIFEROL (VITAMIN D 3 ) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Caltrate 600 mg/400 IU, film-coated tablets carefully to get the best results from it. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Caltrate is and what it is used for 2. What you need to know before you take Caltrate 3. How to take Caltrate 4. Possible side effects 5. How to store Caltrate 6. Contents of the pack and other information 1. WHAT CALTRATE IS AND WHAT IT IS USED FOR This medicine contains two active substances calcium and vitamin D 3 . Calcium is an important constituent of bone and vitamin D 3 helps the absorption of calcium by the intestine and its deposition in the bones. It is used: In the correction of calcium and vitamin D deficiencies in older people, In combination with osteoporosis treatments where calcium and vitamin D levels are too low or where there is a high risk of them being too low. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALTRATE DO NOT TAKE CALTRATE If you are allergic to calcium, vitamin D or any of the other ingredients in Caltrate in particular soya bean oil or peanut (listed in section 6). If you are suffering from kidney failure If you have an abnormally high level of calcium in the blood (hypercalcaemia) and/or excessive loss of calcium in the urine (hypercalci पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 05 November 2019 CRN009FS0 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caltrate 600 mg/400 IU, Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 600 mg of calcium (as calcium carbonate) 10 micrograms of cholecalciferol (equivalent to 400 I.U. vitamin D 3 ) Excipients with known effect: sucrose, partially hydrogenated soya bean oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Capsule-shaped grey/beige tablets. One side is scored and engraved with “D” on the left and “600” on the right of the score. The other side is engraved with “Caltrate”. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Correction of combined vitamin D and calcium deficiencies in older people. Supply of vitamin D and calcium as an adjunct to specific treatments for osteoporosis, in patients where combined vitamin D and calcium deficiencies have been diagnosed or those at high risk of such deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and Older People One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening). Dose reduction should be considered as necessary following the monitoring of calcium levels as indicated in section 4.4 and 4.5. Paediatric population No data are available Pregnant women One tablet a day (see section 4.6). Hepatic insufficiency The dose does not require adjustment. METHOD OF ADMINISTRATION The tablet should be swallowed with a large glass of water. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 05 November 2019 CRN009FS0 Page 2 of 6 - Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. - The product contains partially hydrogenated soya bean oil and is contraindicated for patients hypersensitive to peanut or soya. - Renal failure. - Hypercalciuria an पूरा दस्तावेज़ पढ़ें