Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
kalciumkarbonat; kolekalciferol
Orifarm Healthcare A/S
A12AX
calcium carbonate; cholecalciferol
500 mg/1000 IE
Tuggtablett
xylitol Hjälpämne; sackaros Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans; kolekalciferol 25 mikrog Aktiv substans
Apotek
Receptbelagt
kombinationer med vitamin D och/eller övriga läkemedel
Förpacknings: Burk, 30 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter
Godkänd
2015-05-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICHEW-D 3 CITRON 500 MG/1000 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 Citron is and what it is used for 2. What you need to know before you take Calcichew-D 3 Citron 3. How to take Calcichew-D 3 Citron 4. Possible side effects 5. How to store Calcichew-D 3 Citron 6. Contents of the pack and other information 1. WHAT CALCICHEW-D 3 CITRON IS AND WHAT IT IS USED FOR Calcichew-D 3 Citron are chewable tablets containing calcium and vitamin D 3 , which both are important substances in bone formation. Calcichew-D 3 Citron 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 CITRON DO NOT TAKE CALCICHEW-D 3 CITRON: - if you are allerg Leggi il documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Calcichew-D 3 Citron 500 mg/1000 IU chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 1000 IU (25 microgram) cholecalciferol (vitamin D 3 ) Excipient(s) with known effect: One tablet contains 1 mg aspartame (E951), 49.9 mg isomalt (E953) (contained in the flavour), 390 mg sorbitol (E420) and 1.75 mg sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Round, white, uncoated and convex tablets of 16 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 once daily. The amount of calcium in Calcichew-D 3 Citron is lower than the recommended daily intake. Calcichew-D 3 Citron is therefore primarily to be used by patients with need of D-vitamin supplementation, but who have some dietary intake of calcium. SPECIAL PATIENT POPULATIONS _PAEDIATRIC POPULATION:_ Calcichew-D 3 Citron tablets are not intended for use in children or adolescents. _Impaired renal function_ Calcichew-D 3 Citron should not be used in patients with severe renal impairment (see section 4.3). _Impaired hepatic function_ 2 No dose adjustment is required Method of administration 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, ser Leggi il documento completo