देश: स्वीडन
भाषा: स्वीडिश
स्रोत: Läkemedelsverket (Medical Products Agency)
kolekalciferol
Paranova Läkemedel AB
A11CC05
cholecalciferol
2000 IE
Tablett
kolekalciferol 50 mikrog Aktiv substans; sackaros Hjälpämne; isomalt Hjälpämne
Receptbelagt
Förpacknings: Blister, 90 tabletter
Avregistrerad
2019-11-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DIVISUN 2000 IU TABLETS Colecalciferol (Vitamin D 3 ) 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. WHAT IS IN THIS LEAFLET : 1. What Divisun is and what it is used for 2. What you need to know before you take Divisun 3. How to take Divisun 4. Possible side effects 5. How to store Divisun 6. Contents of the pack and other information 1. WHAT DIVISUN IS AND WHAT IT IS USED FOR Divisun contains vitamin D 3 which regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. Divisun is used to treat vitamin D 3 deficiency in adults and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIVISUN DO NOT TAKE DIVISUN - if you are allergic to colecalciferol or any of the other ingredients of this medicine (listed in section 6). - if you have hypercalcaemia (increased levels of calcium in the blood) or hypercalciuria (increased levels of calcium in the urine). - if you have hypervitaminosis D (increased levels of vitamin D in the blood). - if you have kidney stones. If any of the above applies to you, talk to your doctor or pharmacist before taking Divisun. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Divisun - if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints). - when using other drugs containing vitamin D. - if you have kidney problems or have had kidney stones. OTHER MEDICINES AND DIVISUN Tell your doctor if you are taking, have recently taken or might ta पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Divisun 2000 IU tablet 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each tablet contains colecalciferol (vitamin D 3 ) 2000 IU (equivalent to 50 microgram vitamin D 3 ). Excipients with known effect: Each tablet contains isomalt 227.5 mg and sucrose 4.2 mg. For the full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Tablet White to light yellow, oblong, 14 mm long. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of vitamin D deficiency in adults and adolescents. Vitamin D deficiency is defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended dose: One tablet per day. The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment. The daily dose should not exceed 4000 IU (two tablets per day). _Pediatric population_ The safety and efficacy of Divisun in children under 12 years have not been established. _Dosage in hepatic impairment_ No dose adjustment is required. _Dosage in renal impairment_ Divisun should be used with caution in patients with renal impairment (see section 4.4). Method of administration The tablets can be swallowed whole or crushed. The tablets can be taken with food. 4.3 CONTRAINDICATIONS • Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria • Nephrolithiasis • Nephrocalcinosis • Hypervitaminosis D • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Divisun should be prescribed with caution to patients suffering from sarcoidosis due to risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine. During long-term treatment, serum calcium levels should be followed and renal function should be monitored t पूरा दस्तावेज़ पढ़ें