Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
COLECALCIFEROL
Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom
A11CC05
COLECALCIFEROL 20,000 IU
HARD CAPSULE
COLECALCIFEROL 20,000 IU
POM
VITAMINS
Withdrawn
2014-11-19
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CHOLECALCIFEROL 20 000 IU CAPSULES CHOLECALCIFEROL 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What are Cholecalciferol Capsules and what are they used for? 2. What you need to know before you take Cholecalciferol Capsules 3. How to take Cholecalciferol Capsules 4. Possible side effects 5. How to store Cholecalciferol Capsules 6. Contents of the pack and other information 1. WHAT ARE CHOLECALCIFEROL CAPSULES AND WHAT THEY ARE USED FOR? Cholecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions. Cholecalciferol 20 000 IU is the equivalent of 500 micrograms vitamin D 3 which is involved in bone formation. The active ingredient cholecalciferol is identical to the cholecalciferol that is found in the human body. It is found in the diet and is also produced in the skin after exposure to the sun. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). IF YOU ARE PLANNING TO GET PREGNANT OR YOU ARE PREGNANT AND YOU REQUIRE EXTRA VITAMIN D DO NOT TAKE IT WITHOUT MEDICAL SUPERVISION. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL CAPSULES DO NOT TAKE CHOLECALCIFEROL • If you are ALLERGIC (hypersensitive) to cholecalciferol or any of the other ingredients in the capsules (these are listed in section 6, Contents of the pack and other information) • if y Přečtěte si celý dokument
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cholecalciferol 20 000 IU Capsules Aviticol 20 000 IU Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: 20 000 IU cholecalciferol (equivalent to 500 μg vitamin D 3 ) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 3. PHARMACEUTICAL FORM Capsule, Hard Ivory opaque, unprinted, hard gelatin capsule containing a clear, slightly yellow oily liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment and prevention of vitamin D deficiency. Cholecalciferol is indicated in adolescents and adults 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One capsule contains 20 000 IU cholecalciferol (vitamin D 3 ). • ADULT POSOLOGY - Treatment of vitamin D deficiency: 40 000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy of 2-3 capsules (equivalent to 1 400 - 2 000 IU/day) per month, as directed by your doctor. Follow-up serum 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. - Prevention of vitamin D deficiency: 20 000 IU every 4 weeks (1 capsule), higher doses may be required in certain populations, see below CERTAIN POPULATIONS are at high risk of vitamin D deficiency, and may require higher doses and monitoring of serum 25(OH)D: • Institutionalised or hospitalised individuals • Dark skinned individuals • Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens Page 2 of 7 • Patients being evaluated for osteoporosis • Obese individuals • Use of certain concomitant medications (e.g. anticonvulsant medications glucocorticoids, anti-retrovirals) • Those recently treated for vitamin D deficiency, and requiring maintenance therapy • Patients with liver or renal disease • Patients with malabsorption, including inflammatory bowel disease and coeliac disease • PAEDIATRIC POSOLOGY - Prevention of vit Přečtěte si celý dokument