Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Cholecalciferol
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol
1000 international unit(s)
Capsule, soft
Product subject to prescription which may be renewed (B)
Vitamin D and analogues; colecalciferol
Marketed
2016-09-02
PACKAGE LEAFLET: INFORMATION FOR THE USER ALTAVITAD3 1,000 IU SOFT CAPSULES ALTAVITAD3 7,000 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, 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 D 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 high levels of vitamin D in your blood (hypervitaminosis D) If any of the above applies to you, talk to your doctor or pharmacist before taking altavitaD Læs hele dokumentet
Health Products Regulatory Authority 07 September 2023 CRN00DS0S Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT altavitaD3 1,000 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1,000 IU colecalciferol (equivalent to 0.025 mg vitamin D3) Excipients with known effect: each 1,000 IU capsule contains 0.11mg Allura Red AC (E129) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Dark red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has “1” 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, adolescents and adults with an identified risk. Prophylaxis of vitamin D deficiency in 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 Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. altavitaD3 1,000 IU soft capsules are suitable for daily supplementation, while altavitaD3 7,000 IU soft capsules are suitable for weekly supplementation, which should be taken into consideration and dosage should be established by a physician. The dose of 1,000 IU/day is considered equivalent to 7,000 IU/week. Paediatric posology - Doses of up to 1,000 IU/day may be required to prevent deficiency in some children. - treatment of deficiency 1 0-18 years 2,000 IU/day for 6 weeks,followed by maintenance therapy of 400-1,000 IU/day (such as one 1,000 IU soft capsule per day or one 7,000 IU soft capsule per week). Pregnancy and breastfeeding - Doses of 1,000 – 2,000 IU/day 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 D Læs hele dokumentet