देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Cholecalciferol (02)
Consilient Health Limited
A11CC; A11CC05
Cholecalciferol (02)
50,000 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 50,000 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 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 metabolism) • if you are pregnant • if you are under 18 years of age 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 bef पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 08 February 2024 CRN00F3LG Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT altavitaD3 50,000 IU soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50,000 IU colecalciferol (equivalent to 1.25 mg vitamin D3) Excipients with known effect: each capsule contains 0.0082 mg Allura Red AC (E129). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Red, oval-shaped, soft capsule. It contains a slightly yellow oily liquid. Each capsule has “50” printed in white ink. Capsule dimensions are 12.8mm x 8.5mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of vitamin D3 deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 capsule contains 50,000 IU vitamin D3. Paediatric posology - Due to lack of clinical data, altavitaD3 is not recommended. Pregnancy and breastfeeding - Due to lack of clinical data, altavitaD3 is not recommended. AdultsHigher doses may be required in certain situations, see below. Treatment of vitamin D3 deficiency (<25 nmol/l) 50,000 IU/week (1 capsule) for 6-8 weeks, followed by maintenance therapy (1400-2000 IU/day may be required, such as 1 capsule 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 D3 deficiency, and may require higher doses and monitoring of serum 25(OH)D: o Institutionalised or hospitalised individuals o Dark skinned individuals o Individuals with limited effective sun exposure due to protective clothing or consistent use of sun screens o Obese individuals o Patients being evaluated for osteoporosis o Use of certain concomitant medications (eg, anticonvulsant medications, glucocorticoids) o Patients with malabsorption, including inflammatory bowel disease and coeliac disease o Those recently treated for Vitamin D3 deficiency, and re पूरा दस्तावेज़ पढ़ें