Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Cholecalciferol; Cholecalciferol concentrate (powder form)
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol; Cholecalciferol concentrate (powder form)
800 international unit(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; colecalciferol
Not marketed
2015-01-30
PACKAGE LEAFLET: INFORMATION FOR THE USER COLECALCIFEROL 800 IU FILM-COATED TABLETS COLECALCIFEROL 1000 IU FILM-COATED TABLETS COLECALCIFEROL 7000 IU FILM-COATED TABLETS COLECALCIFEROL 30000 IU FILM-COATED TABLETS 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. WHAT IS IN THIS LEAFLET 1. What Colecalciferol Film-coated Tablets are and what they are used for 2. What you need to know before you take Colecalciferol Film-coated Tablets 3. How to take Colecalciferol Film-coated Tablets 4. Possible side effects 5. How to store Colecalciferol Film-coated Tablets 6. Contents of the pack and other information 1. WHAT COLECALCIFEROL FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR The active substance of Colecalciferol Film-coated Tablets is vitamin D 3 . Vitamin D helps the body to absorb calcium and enhances bone formation and decreases the level of parathyroid hormone (PTH). This medicine is recommended in the following cases: • For certain bone conditions, such as thinning of the bone (osteoporosis), when it will be given to you with other medicines. • To prevent or treat vitamin D deficiency. Vitamin D deficiency may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (e.g. when you are pregnant). Colecalciferol Film-coated Tablets are used in adults, the elderly and adolescents 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL FILM-COATED TABLETS DO NOT TAKE COLECALCIFEROL FILM-COATED TABLETS IF: • if you are allergic to vitamin D or any of the other ingredients Prečítajte si celý dokument
Health Products Regulatory Authority 10 February 2020 CRN008XSF Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colecalciferol 800 IU film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 8 mg colecalciferol concentrate (powder form) (equivalent to 20 microgram colecalciferol = 800 IU vitamin D 3 ). Excipients with known effect: Each film-coated tablet contains 59.52 mg lactose monohydrate and 1.4 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Colecalciferol 800 IU: yellow coloured, round, 6 mm diameter film-coated tablet with smooth convex surface on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of Vitamin D deficiency (serum 25(OH)D < 25 nmol/l) - Prevention of vitamin D deficiency in high-risk patients - 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 Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. Colecalciferol 800 IU and 1000 IU Film-coated Tablets are suitable for daily vitamin D supplementation, while the 7000 IU and 30000 IU doses contain amounts equal to the weekly and monthly vitamin D doses respectively, which should be taken into consideration and dosage should be established by a physician. Please refer to the respective national guidelines. Posology Adults and elderly: - Prevention of vitamin D deficiency (maintenance): - for adults and elderly: 800-1600 IU/day or equivalent weekly or monthly dose. - for adults and elderly with osteoporosis: maximum 2000 IU/day or equivalent weekly or monthly dose. - Treatment of vitamin D deficiency (loading dose): - 800-4000 IU/daily or equivalent weekly or monthly dose. Patients should receive supplemental calcium if intake from diet is inadequate. _Hepatic impairment:_ no dose adjustment is necessary for patients with Prečítajte si celý dokument