Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Cholecalciferol concentrate
Jaba Recordati S.A.
A11CC05
Cholecalciferol concentrate
Film-coated tablet
colecalciferol
2022-04-08
PACKAGE LEAFLET: INFORMATION FOR THE USER EGOSTAR 22 400 IU FILM-COATED TABLETS Cholecalciferol (Vitamin D3) 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Egostar is and what it is used for 2. What you need to know before you take Egostar 3. How to take Egostar 4. Possible side effects 5. How to store Egostar 6. Contents of the pack and other information 1. WHAT EGOSTAR IS AND WHAT IT IS USED FOR Prevention of vitamin D deficiency in patients with an identified risk. Initial treatment of clinically relevant vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Egostar is indicated in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EGOSTAR DO NOT TAKE EGOSTAR if you are allergic (hypersensitive ) to cholecalciferol (vitamin D3), or any of the other ingredients of this medicine (listed in section 6); if you have hypervitaminosis D (high levels of vitamin D in your blood); if you have renal calculi (kidney stones) (nephrolithiasis); severe renal problems (severe renal impairment); if you have a disorder or condition resulting from high levels of calcium in your blood (hypercalcaemia) and/or urine (hypercalciuria). WARNINGS AND PRECAUTIONS Talk to your doctor, or pharmacist or nurse before taking Egostar: if you have high levels of calcium in your blood (hypercalcaemia); if you have renal impairment or renal calculi (kidney stones). Your doctor shall ask you to have regular blood Lees het volledige document
Health Products Regulatory Authority 08 April 2022 CRN009K3N Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Egostar 22400 IU film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of Egostar contains 560 micrograms (22 400 IU) of cholecalciferol (vitamin D3). Excipients with known effect: Each tablet contains 429.60 mg of lactose monohydrate and 175 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Egostar 22 400 IU tablets are white, convex oblong 18 mm x 8 mm, film coated and engraved with a "V3" mark on one of the sides of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of vitamin D deficiency in patients with an identified risk. Initial treatment of clinically relevant vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Egostar is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. The patient's dietary habits should be carefully evaluated and artificially added vitamin D content of certain food types should be taken into consideration. Prevention of Vitamin D deficiency: One tablet (22 400 IU) once every 28 days. Initial treatment of Vitamin D deficiency: One tablet (22 400 IU) once a week for four weeks. After four weeks, lower doses may be considered, dependent upon desirable serum levels of 25 hydroxycolecalciferol (25(OH)D), the severity of the disease and/or the patient´s response to treatment. As an adjunct to specific therapy for osteoporosis: One tablet (22 400 IU) once every 28 days. Medical supervision is necessary as dose requirements may vary dependent on patient response (see section 4.4). PAEDIATRIC POPULATION This medicinal product should not be given to children (see section 4.4). Health Products Regulatory A Lees het volledige document