Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Cholecalciferol (02)
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol (02)
25,000 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 25,000 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, pharmacist or nurse. This includes any possible any 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 D3 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 D3 in your blood (hypervitaminosis D) • if you have pseudohypoparathyroidism (disturbed parathyroid hormone metaboli Soma hati kamili
Health Products Regulatory Authority 08 February 2024 CRN00F3LG Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT altavitaD3 25,000 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 25,000 IU colecalciferol (equivalent to 0.625 mg vitamin D3) Excipients with known effect: each capsule contains 0.069 mg Allura Red AC (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Light red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has “25” printed in white ink. Capsule dimensions 12.8mm x 8.5mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of Vitamin D deficiency in adolescents and adults with an identified risk. 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 Posology 1 capsule contains 25,000 IU Vitamin D3. Paediatric posology preventionof deficiency 10-18 years 25,000 IU (1 capsule) every 6 weeks treatmentof deficiency 10-18 years 25,000 IU (1 capsule) once every 2 weeks for 6 weeks (followed by maintenance therapy of 400-1000 IU/day, such as 1 capsule per month.) o Pregnancy and breastfeeding The high strength formulation is not recommended o Adults prevention of Vitamin D deficiency 25,000 IU/month (1 capsule).Higher doses may be required in certain situations, see below. as an adjunct to specific therapy for osteoporosis: 25,000 IU/month (1 capsule) Treatment of Vitamin D deficiency (<25 nmol/l) 50,000 IU/week (2 capsules) for 6-8 weeks, followed by maintenance therapy (1400-2000 IU/day may be required, such as 2 capsules per month; follow up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved.) Certain populations are at high risk of Vitamin D deficiency, and may require higher doses an Soma hati kamili