国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Colecalciferol
Pharmafile Limited
A11CC; A11CC05
Colecalciferol
1000 international unit(s)
Capsule, soft
Vitamin D and analogues; colecalciferol
Not marketed
2017-10-06
Vitamin D 800/1000/10000 IU Capsules IE/H/0444/002-004/IB/004 2 PACKAGE LEAFLET: INFORMATION FOR THE USER Vitamin D 3 800 IU Capsules, soft Vitamin D 3 1,000 IU Capsules, soft Vitamin D 3 10,000 IU Capsules, soft Colecalciferol 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vitamin D 3 Capsules are and what they are used for 2. What you need to know before you take Vitamin D 3 Capsules 3. How to take Vitamin D 3 Capsules 4. Possible side effects 5. How to store Vitamin D 3 Capsules 6. Contents of the pack and other information 1. WHAT VITAMIN D 3 CAPSULES ARE AND WHAT THEY ARE USED FOR The active substance of Vitamin D 3 Capsules is vitamin D3. Vitamin D helps the body to absorb calcium and enhances bone formation. This medicine is recommended in the following cases: For certain bone conditions, such as thinning of the bone (osteoporosis), when it will be given to you with other medicines. To prevent or treat vitamin D deficiency. Vitamin D deficiency may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D. Vitamin D 3 Capsules are used in adults, the elderly and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAMIN D 3 CAPSULES DO NOT TAKE VITAMIN D 3 CAPSULES: - 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 severe kidney problems (severe renal impairmen 完全なドキュメントを読む
Health Products Regulatory Authority 09 January 2020 CRN009750 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitamin D3 1,000 IU Capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: 1,000 IU Colecalciferol (equivalent to 25 micrograms Vitamin D3) Excipients with known effect: Each capsule also contains 16.5 milligrams of sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft (Capsule) Green coloured clear transparent round shaped gelatin capsule with a clear, colourless liquid fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Vitamin D deficiency Prevention of Vitamin D deficiency in high-risk patients. As an adjunct to specific therapy for osteoporosis in patients with Vitamin D deficiency or at risk of Vitamin D insufficiency. Vitamin D 3 Capsulesis indicated in adults, the elderly and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. Vitamin D 3 800 IU and 1,000 IU capsules are suitable for daily vitamin D supplementation, while the 10,000 IU dose is suitable for weekly vitamin D dosing (equivalent to 1, 400 IU/day) respectively, which should be taken into consideration and dosage should be established by a physician. _Osteoporosis: _For the adjunct therapy of osteoporosis a daily dose of 800-1,000 IU. A daily doses equivalent of 2,000 IU vitamin D should be considered in fragile elderly patients who are at particular risk of falls and fractures. Patients should receive supplemental calcium if intake from diet is inadequate. _Vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in adults and the elderly: _800 IU-4,000 IU daily for up to 12 weeks depending upon the severity of the disease and the patient`s response to treatment. _Vitamin D insufficiency (serum levels 25-50 nmol/l or 10-20 ng/ml) in adults and the elderly:_ _AND_ _Long term main 完全なドキュメントを読む