Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Internis Pharmaceuticals Ltd
A11CC05
Colecalciferol
800unit
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5060222940206 5060222940251
MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 30's/90's 25465502 210 x 297mm 1 14.11.2017 Fultium D3 800IU Capsules Internis Swisscaps Yes E EBR 904371 14455 Amend storage conditions and update Yellow Card Statement Rockwell Helvetica 10pt 8pt 11pt 8pt Process Black + 60% tint Keyline (Non-Printing) POINT SIZES USED MIN MAX READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. DO NOT PASS IT ON TO OTHERS. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. PREGNANCY AND BREAST-FEEDING If you are pregnant or think you may be pregnant or you are breast-feeding you should talk to your doctor or pharmacist before you take Fultium-D 3 . Fultium-D 3 should be used during pregnancy and breast-feeding only if recommended by your doctor. 25465502 MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 30's/90's 25465502 210 x 297mm 1 14.11.2017 Fultium D3 800IU Capsules Internis Swisscaps Yes E EBR 904371 14455 Amend storage conditions and update Yellow Card Statement Rockwell Helvetica 10pt 8pt 11pt 8pt Process Black + 60% tint Keyline (Non-Printing) POINT SIZES USED MIN MAX USE IN PREGNANCY AND BREAST-FEEDING TO TREAT VITAMIN D DEFICIENCY: Your doctor will usually prescribe 1 - 5 capsules daily for up to 12 weeks, followed by a long term maintenance dose. LONG TERM MAINTENANCE AND TO PREVENT VITAMIN D DEFICIENCY: Your Preberite celoten dokument
OBJECT 1 FULTIUM-D3 800IU CAPSULES Summary of Product Characteristics Updated 15-Jan-2018 | Internis Pharmaceuticals Ltd 1. Name of the medicinal product Fultium-D 3 800 IU Capsules 2. Qualitative and quantitative composition Each capsule contains: 800IU Colecalciferol (equivalent to 20 micrograms vitamin D3) For a full list of excipients see section 6.1 3. Pharmaceutical form Capsule, soft (Capsule) Blue translucent Capsule 4. Clinical particulars 4.1 Therapeutic indications The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Fultium-D 3 is indicated in adults, the elderly and adolescents. 4.2 Posology and method of administration Posology Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment. Vitamin D insufficiency in adults and the elderly (serum levels 25 – 50 nmol/l (10-20 ng/mL)) AND long term maintenance therapy following treatment of deficiency in adults and the elderly AND Prevention of vitamin D deficiency 1-2 Capsules (800-1600 IU) daily Vitamin D deficiency or insufficiency in children over 12 years – 1 capsule daily depending on the severity of the disease and the patient's response to treatment. Should only be given under medical supervision. As an adjunct to specific therapy for osteoporosis 1 capsule daily During pregnancy and breast-feeding Treatment of vitamin D deficiency 1 – 5 capsules (800 – 4000 IU) daily. Long term maintenance therapy following treatment of deficiency 1 – 2 capsules (800 – 1600 IU) daily. Fultium-D3 should not be used in children under 12 years Method of administration Oral The capsules should be swallowed whole (not chewed) with water 4.3 Contraindications Hypersensitivity to vitamin D or any of the excipients in the product Hypervitaminosis D Nephrolithiasis Diseases o Preberite celoten dokument