Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Internis Pharmaceuticals Ltd
A11CC05
Colecalciferol
3200unit
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5060222940268 5060222940329
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 25450703 210 x 297mm 1 14.11.2017 Fultium D3 3,200IU Capsules Internis (Swisscaps) Yes H EBR 904467 14455 Amend storage conditions and update Yellow Card Statement Helvetica Rockwell 8pt 8pt 8pt 12pt Process Black + 60% tint Keyline (Non-Printing) POINT SIZES USED MIN MAX 13313 13313 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. PACKAGE LEAFLET: INFORMATION FOR THE USER FULTIUM-D 3 3,200 IU CAPSULES (COLECALCIFEROL) GLUCOCORTICOIDS (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D LAXATIVES (such as paraffin oil) or a cholesterol lowering drug called COLESTYRAMINE may reduce the absorption of vitamin D ACTINOMYCIN (a medicine used to treat some forms of cancer) and IMIDAZOLE ANTIFUNGALS (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D. TAKING FULTIUM-D 3 WITH FOOD AND DRINK You can take Fultium-D 3 with or without food and drink. 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. DRIVING AND USING MACHINES Fultium-D 3 should not affect your ability to drive or operate machinery. Always take Ful Đọc toàn bộ tài liệu
OBJECT 1 FULTIUM-D3 3,200IU CAPSULES Summary of Product Characteristics Updated 15-Jan-2018 | Internis Pharmaceuticals Ltd 1. Name of the medicinal product Fultium-D 3 3,200 IU Capsules 2. Qualitative and quantitative composition Each capsule contains: 3,200 IU Colecalciferol (equivalent to 80 micrograms vitamin D3) For a full list of excipients see section 6.1. 3. Pharmaceutical form Capsule, soft (Capsule) Green coloured translucent soft gelatin capsule 4. Clinical particulars 4.1 Therapeutic indications The treatment of vitamin D deficiency. Fultium-D 3 is indicated in adolescents, adults and the elderly. 4.2 Posology and method of administration Posology Vitamin D deficiency in adolescents, adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1 capsule (3,200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment. During pregnancy and breast-feeding Treatment of vitamin D deficiency 1 capsule (3,200 IU) daily. Fultium-D3 should not be used in children under the age of 12. 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 or conditions resulting in hypercalcaemia and/or hypercalciuria Severe renal impairment 4.4 Special warnings and precautions for use Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3, contraindications). Caution is required in patients receiving treatment for cardiovascular disease (see Section 4.5 – cardiac glycosides including digitalis). Fultium-D3 should be prescribed with caution to patients suffering from sa Đọc toàn bộ tài liệu