Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk
Pharmemma Limited Unit 2, Ashbourne Manufacturing Park A84 KH58 ASHBOURNE (IERLAND)
CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk
Capsule, zacht
GELATINE (E 441) ; GLYCEROL (E 422) ; SORBITOL VLOEIBAAR, GEDEELTELIJK GEDEHYDRATEERD ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD
Oraal gebruik
1900-01-01
NL/H/5338/001-003/IA/002/G 1 PACKAGE LEAFLET NL/H/5338/001-003/IA/002/G 2 PACKAGE LEAFLET: INFORMATION FOR THE USER Cholecalciferol Pharmemma 20.000 IE, zachte capsules Cholecalciferol 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 Cholecalciferol Pharmemma Capsules are and what they are used for 2. What you need to know before you take Cholecalciferol Pharmemma Capsules 3. How to take Cholecalciferol Pharmemma Capsules 4. Possible side effects 5. How to store Cholecalciferol Pharmemma Capsules 6. Contents of the pack and other information 1. WHAT CHOLECALCIFEROL PHARMEMMA CAPSULES ARE AND WHAT THEY ARE USED FOR The active substance of Cholecalciferol Pharmemma Capsules is vitamin D3. Vitamin D helps the body to absorb calcium and enhances bone formation. _ _ This medicine is recommended in the following cases: • To prevent vitamin D deficiency in adults. • To treat vitamin D deficiency in adults. 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. • For certain bone conditions, such as conditions that affect bone development (osteomalacia), thinning of the bone (osteoporosis), when it will be given to you with other medicines. Cholecalciferol Pharmemma Capsules are used in adults and the elderly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL PHARMEMMA CAPSULES DO NOT TAKE CHOLECALCIFEROL PHARMEMMA CAPSULES: - if you are allergic to cholecalciferol (vitamin D) or any of the other ingredients Διαβάστε το πλήρες έγγραφο
NL/H/5338/001-003/IB/005 1 SUMMARY OF PRODUCT CHARACTERISTICS NL/H/5338/001-003/IB/005 2 PRODUCT SUMMARY 1 N AME OF THE M EDICINAL P RODUCT Cholecalciferol Pharmemma 20.000 IE, zachte capsules 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each capsule contains: 500 micrograms Cholecalciferol (vitamin D3), equivalent to 20,000 IU Excipient(s) with known effect: Each 20,000 IU capsule also contain 16.5 milligrams of sorbitol. For the full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Soft capsule Light Yellow coloured clear transparent round shaped gelatin capsule with a clear, colourless liquid fill with approximate dimensions 7.36 mm x 6.27 mm. 4. C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Treatment of Vitamin D deficiency (serum 25(OH)D < 25 nmol/l). 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. Indicated for use in adults and the elderly. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined individually by the attending physician, depending on the amount of vitamin D supplementation required. Adults and elderly: • Prevention of vitamin D deficiency (maintenance dose): NL/H/5338/001-003/IB/005 3 - for adults and the elderly: 800-1600 IU / day or a corresponding weekly or monthly dose. Recommended dose Cholecalciferol Pharmemma 20,000 IU soft capsules: 1-2 capsules per month. - for adults and the elderly with osteoporosis: 800-1000 IU / day with a maximum of 2000 IU / day or corresponding weekly or monthly dose in the case of fragile elderly people with osteoporosis who are at high risk of falls and fractures. Recommended dose Cholecalciferol Pharmemma 20,000 IU soft capsules: (1 to max 3 capsules per month). • Treatment of vitamin D deficiency (loading dose): - 800-4000 IU / day or a corresponding weekly or monthly dose (max. cumulative dose of 120,000 IU / month). A lower dose may occur after the first month be co Διαβάστε το πλήρες έγγραφο