Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Consilient Health Ltd
A11CC05
Colecalciferol
800unit
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5391512453701
PACKAGE LEAFLET: INFORMATION FOR THE USER Colecalciferol 800 IU Film-coated Tablets Colecalciferol 1000 IU Film-coated Tablets Colecalciferol 7000 IU Film-coated Tablets Colecalciferol 30000 IU Film-coated Tablets 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. What is in this leaflet 1. What Colecalciferol Film-coated Tablets are and what they are used for 2. What you need to know before you take Colecalciferol Film- coated Tablets 3. How to take Colecalciferol Film-coated Tablets 4. Possible side effects 5. How to store Colecalciferol Film-coated Tablets 6. Contents of the pack and other information 1. WhaT ColeCalCIFerol FIlm-CoaTed TableTs are and WhaT They are Used For The active substance of Colecalciferol Film-coated Tablets is vitamin D 3 . Vitamin D helps the body to absorb calcium and enhances bone formation and decreases the level of parathyroid hormone (PTH). 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 (e.g. when you are pregnant). Colecalciferol Film-coated Tablets are used in adults, the elderly and adolescents. 2. WhaT yoU need To knoW beFore yoU Take ColeCalCIFerol FIlm-CoaTed TableTs Do not take Colecalciferol Film-coated Tablets if: • if you are allergic to vitamin D or any of the other ingredient Læs hele dokumentet
OBJECT 1 COLECALCIFEROL 800 IU FILM-COATED TABLETS Summary of Product Characteristics Updated 02-Feb-2017 | Consilient Health Ltd 1. Name of the medicinal product Colecalciferol 800 IU Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 8 mg colecalciferol concentrate (powder form) (equivalent to 20 µg colecalciferol = 800 IU vitamin D 3 ). Excipients with known effect: Each film-coated tablet contains 59.52 mg lactose monohydrate and 1.4 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Yellow coloured, round, 6 mm diameter film-coated tablet with smooth convex surface on both sides. 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 Colecalciferol 800 IU Film-coated Tablets are indicated in adults, the elderly and adolescents. 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. Colecalciferol 800 IU and 1000 IU Film-coated Tablets are suitable for daily vitamin D supplementation, while the 7000 IU and 30000 IU doses contain amounts equal to the weekly and monthly vitamin D doses 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 800-1000 IU, or a correspondent total weekly dose of 7000 IU, alternatively monthly dose of 30000 IU vitamin D is recommended. A daily dosis 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 Læs hele dokumentet