Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Colecalciferol
EQL Pharma AB
A11CC05
Colecalciferol
800 international unit(s)
Tablet
colecalciferol
Not marketed
2021-07-09
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL EQL PHARMA 800 IU TABLETS COLECALCIFEROL EQL PHARMA 2000 IU TABLETS colecalciferol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Colecalciferol EQL Pharma is and what it is used for 2. What you need to know before you use Colecalciferol EQL Pharma 3. How to use Colecalciferol EQL Pharma 4. Possible side effects 5. How to store Colecalciferol EQL Pharma 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL EQL PHARMA IS AND WHAT IT IS USED FOR Colecalciferol EQL Pharma contains the active substance colecalciferol (vitamin D 3 ). Vitamin D 3 regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. Colecalciferol EQL Pharma 800 IU is used to prevent and treat vitamin D 3 deficiency in adults, elderly and adolescents. Your doctor may prescribe Colecalciferol EQL Pharma 800 IU as an adjunct to specific bone loss medication in adult and elderly patients. Colecalciferol EQL Pharma 2000 IU is used to treat vitamin D 3 deficiency in adults, elderly and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLECALCIFEROL EQL PHARMA DO NOT USE COLECALCIFEROL EQL PHARMA: - 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 Прочитать полный документ
Health Products Regulatory Authority 09 July 2021 CRN009N98 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colecalciferol EQL Pharma 800 IU tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Colecalciferol EQL Pharma 800 IU tablet: Each tablet contains colecalciferol (vitamin D 3 ) 800 IU (equivalent to 20 microgram vitamin D 3 ). Excipient(s) with known effect Each tablet contains isomalt 91 mg and sucrose 2 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off white, biconvex, round, uncoated tablets plain on both sides, 7 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of vitamin D deficiency in adults, elderly and adolescents with an identified risk. Treatment of vitamin D deficiency in adults, elderly and adolescents. Vitamin D deficiency is defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l. In addition to specific osteoporosis treatment of adult and elderly patients who are at risk of vitamin D deficiency, preferably in combination with calcium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be established on an individual basis depending on the desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment. The dosage has to be established individually by a physician. The tablets cannot be divided for dosing and so the appropriate formulation should be used to achieve the recommended dose which is as follows: _Adults and elderly_ Prevention of vitamin D deficiency: 800 – 1600 IU per day. For patients with osteoporosis: 800 – 1600 IU per day. A maximum dose of 2000 IU per day is recommended. Treatment of vitamin D deficiency: 800 – 4000 IU per day. A lower maintenance dose of 800 – 1600 IU/day or weekly or monthly equivalent should be considered one month after loading dose _Paediatric population_ Adolescents aged 12 – 18 years: Prevention of vitamin D deficiency: 800 IU per day. T Прочитать полный документ