Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Cholecalciferol (02)
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol (02)
800 international unit(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; colecalciferol
Not marketed
2016-03-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ALTAVITA D3 800 IU SOFT CAPSULES colecalciferol (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. - 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 altavitaD3 is and what it is used for 2. What you need to know before you take altavitaD3 3. How to take altavitaD3 4. Possible side effects 5. How to store altavitaD3 6. Contents of the pack and other information 1. WHAT ALTAVITAD3 IS AND WHAT IT IS USED FOR altavitaD3 contains vitamin D3 which regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. altavitaD3 is used to prevent and treat vitamin D3 deficiency in adults and adolescents. Your doctor may prescribe altavitaD3 as an adjunct to specific bone loss medication. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALTAVITAD3 DO NOT TAKE ALTAVITAD3: - 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 D in the blood). - if you have kidney stones. If any of the above applies to you, talk to your doctor or pharmacist before taking altavitaD3. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking altavitaD3: - if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints). - when using other drugs containing vitamin D. - if y Läs hela dokumentet
Health Products Regulatory Authority 25 October 2022 CRN00D0MC Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AltavitaD3 800IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachcapsule contains colecalciferol (vitamin D3) 800 IU (equivalent to 0.02 mg vitamin D3). Excipients with known effect: Each capsule contains 0.01 mg Allura Red AC (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Pink, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has “0.8” printed in white ink. Capsule dimensions are 10.5mm x 7mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of vitamin D deficiency in adults and adolescents with an identified risk. In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency, preferably in combination with calcium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended dose: One capsule per day. Higher doses can be necessary in treatment of vitamin D deficiency, where 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 4,000 IU (5 capsules per day). _Dosage in hepatic impairment _ No dose adjustment is required. _Dosage in renal impairment _ AltavitaD3 should not be used in patients with severe renal impairment (see section 4.3). _Paediatric population_ AltavitaD3 is not recommended in children under 12 years of age Method of administration The capsules should be swallowed whole with water. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 25 October 2022 CRN00D0MC Page 2 of 5 · Diseases and/orconditions resulting in hypercalcaemia or hypercalciuria. · Nephrolithiasis. · Nephrocalcinosis · Hypervitaminosis D. · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS Läs hela dokumentet