Country: Sweden
Bahasa: Sweden
Sumber: Läkemedelsverket (Medical Products Agency)
kalciumkarbonat; kolekalciferol
Orifarm Healthcare A/S
A12AX
calcium carbonate; cholecalciferol
500 mg/400 IE
Tuggtablett
isomalt Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans; xylitol Hjälpämne; kolekalciferol 10 mikrog Aktiv substans; sackaros Hjälpämne
Apotek
Receptbelagt
kombinationer med vitamin D och/eller övriga läkemedel
Förpacknings: Burk, 30 tabletter; Burk, 20 tabletter; Burk, 50 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter; Burk, 168 tabletter; Burk, 180 tabletter
Godkänd
2015-05-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICHEW-D 3 MELON 500 MG/400 IU CHEWABLE TABLETS calcium/cholecalciferol (vitamin D 3 ) For medicines available only on prescription: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. For medicines available without a prescription: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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. [To be completed nationally] WHAT IS IN THIS LEAFLET 1. What Calcichew-D 3 Melon is and what it is used for 2. What you need to know before you take Calcichew-D 3 Melon 3. How to take Calcichew-D 3 Melon 4. Possible side effects 5. How to store Calcichew-D 3 Melon 6. Contents of the pack and other information 1. WHAT CALCICHEW-D 3 MELON IS AND WHAT IT IS USED FOR Calcichew-D 3 Melon are chewable tablets containing calcium and vitamin D 3 , which both are important substances in bone formation. Calcichew-D 3 Melon is used in the prevention and treatment of calcium and vitamin D deficiency, and as a supplement to specific treatment of osteoporosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D 3 MELON DO NOT TAKE CALCICHEW-D 3 MELON: - if you are allergic to calci Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Melon 500 mg/400 IU chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram) cholecalciferol (vitamin D 3 ) Excipient(s) with known effect: One tablet contains 0.8 mg sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Round, white, uncoated and convex tablets of 14 mm. May have small specks. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency. Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly_ One tablet twice daily. SPECIAL PATIENT POPULATIONS _PAEDIATRIC POPULATION:_ Calcichew-D 3 Melon is not intended for use in children. _Impaired renal function_ Calcichew-D 3 Melon should not be used in patients with severe renal impairment (see section 4.3). _Impaired hepatic function_ No dose adjustment is required Method of administration 2 Oral. The tablets should be chewed or sucked. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m 2 ) Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria Renal calculi (nephrolithiasis) Hypervitaminosis D 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE During long-term treatment, serum calcium levels should be monitored. Renal function should also be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalca Baca dokumen lengkap