Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
COLECALCIFEROL
Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland
A11CC05
COLECALCIFEROL 1000 IU/ml
ORAL SOLUTION
COLECALCIFEROL 1000 IU/ml
POM
VITAMINS
Authorised
2019-04-15
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL THAME 10000 IU/ML ORAL SOLUTION 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. The name of your medicine is Colecalciferol Thame 10000 IU/ml Oral Solution but it will be referred to as Colecalciferol throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Colecalciferol is and what it is used for 2. What you need to know before you take Colecalciferol 3. How to take Colecalciferol 4. Possible side effects 5. How to store Colecalciferol 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL IS AND WHAT IT IS USED FOR Colecalciferol oral solution contains the active substance called colecalciferol (vitamin D 3 ). Vitamin D 3 can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D 3 helps the kidneys and intestine absorb calcium and it helps build bones. Vitamin D 3 deficiency is the predominant cause of rickets (defective mineralisation of bones in children) and osteomalacia (inadequate mineralisation of bones in adults). Colecalciferol is used: ► to prevent and treat vitamin D 3 deficiency in adults, adolescents and children with an identified risk of vitamin D 3 deficiency ► as an adjunct to specific bone loss medication. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL DO NOT TAKE COLECALCIFEROL IF: ► You are allergic to colecalciferol (vitamin D 3 ) or any of the other ingredients of this medicine (listed in section 6) ► You have high levels Soma hati kamili
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Colecalciferol Thame 10000IU/ml Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Colecalciferol oral solution contains the active substance, colecalciferol. Each ml of oral solution contains 10000IU colecalciferol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution A clear, yellow coloured solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D deficiency in adults, adolescents and children with an identified risk. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults: _Prevention of vitamin D deficiency and osteoporosis:_ Recommended dose is 600 – 800 IU per day (0.06-0.08ml). _Treatment of vitamin D deficiency: _ 800 IU (0.08ml) per day. Higher doses 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 4,000 IU (0.4ml per day). Paediatric population _Prevention_ : For prevention in children (0 years to 11 years old) with an identified risk, the recommended dose is 400 IU (0.04ml) per day. Page 2 of 9 For prevention in adolescents (12 years to 18 years old) with an identified risk, the recommended dose is 600-800 IU (0.06-0.08ml) per day. _Treatment of deficiency in children and adolescents_ : 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 1000 IU (0.1ml) per day for infants <1 year, 2000 IU (0.2ml) per day for children 1-10 years and 4000 IU (0.4ml) per day for adolescents >11 years. Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed. Special Po Soma hati kamili