Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Cholecalciferol
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol
400 international unit(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; colecalciferol
Not marketed
2016-09-02
PACKAGE LEAFLET: INFORMATION FOR THE USER ALTAVITAD3 400 IU SOFT CAPSULES colecalciferol (vitamin D3) 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 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, 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 colecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones. altavitaD3 is used: to prevent vitamin D deficiency when there is a significant risk of deficiency or an increased demand for vitamin D with other medicine to treat certain bone conditions, such as thinning of the bone (osteoporosis). to treat vitamin D deficiency that has been confirmed by laboratory tests. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALTAVITAD3 DO NOT TAKE ALTAVITAD3: if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6); if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria); if you have kidney stones (renal calculi); if you have serious renal impairment if you have high levels of vitamin D in your blood (hypervitaminosis D) if you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism) Läs hela dokumentet
Health Products Regulatory Authority 16 May 2022 CRN00C48D Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT altavitaD3 400 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 IU colecalciferol (equivalent to 0.01 mg vitamin D3). For thefulllistofexcipients,see section6.1. 3 PHARMACEUTICAL FORM Soft capsule Clear, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has “0.4” 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 children and adolescents with an identified risk. Prophylaxis of Vitamin D deficiency in adults, pregnant and breast-feeding women with an identified risk. As an adjunct to specific therapy for osteoporosis in patients with Vitamin D deficiency or at risk of Vitamin D deficiency 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Paediatricposology - prevention ofdeficiency10-18years800 IU/day (2 capsules). - Doses of up to 1200 IU/day (3 capsules) may be required to prevent deficiency in some children. - treatment ofdeficiency 10-18years2000 IU/day (5 capsules) for 6 weeks,followed bymaintenancetherapyof 400-1200IU/day (1-3 capsules) Pregnancyand breastfeeding - Prevention of deficiency 400 IU/day (1 capsule) - Doses of up to 2000 IU/day (5 capsules) may be required to prevent deficiency in some women (see below). - Even higher doses may be required during breast-feeding if women choose not to give the infant a vitamin D3 supplement. Adults - prevention ofVitamin D deficiency800 IU/day (2 capsules). Higher doses may be required in certain situations, see below. - as anadjunct tospecifictherapyforosteoporosis:800 IU/day (2 capsules) Certainpopulationsareathigh riskof vitamin D3 deficiency, and may requirehigherdosesand monitoringof serum25(OH)D: - Institutionalisedor hospitalisedindividuals - Darkskinnedindividuals - Individualswithlimitedeffective sun exposureduetoprotec Läs hela dokumentet