国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metformin hydrochloride; Alogliptin benzoate
Takeda UK Ltd
A10BD13
Metformin hydrochloride; Alogliptin benzoate
1gram ; 12.5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010203; GTIN: 5035382011288
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIPDOMET 12.5 MG/850 MG FILM-COATED TABLETS VIPDOMET 12.5 MG/1000 MG FILM-COATED TABLETS alogliptin/metformin hydrochloride 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 Vipdomet is and what it is used for 2. What you need to know before you take Vipdomet 3. How to take Vipdomet 4. Possible side effects 5. How to store Vipdomet 6. Contents of the pack and other information 1. WHAT VIPDOMET IS AND WHAT IT IS USED FOR WHAT VIPDOMET IS Vipdomet contains two different medicines called alogliptin and metformin in one tablet: - alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body. - metformin belongs to a group of medicines called biguanides which also help to lower blood sugar by lowering the amount of sugar made in the liver and helping insulin to work more effectively. Both of these groups of medicines are “oral anti-diabetics”. WHAT VIPDOMET IS USED FOR Vipdomet is used to lower blood sugar levels in adults with type 2 diabetes. Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM. Vipdomet is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together. If you are already taking both alogliptin and metformin as single 完全なドキュメントを読む
OBJECT 1 VIPDOMET 12.5 MG/1000 MG FILM COATED TABLETS Summary of Product Characteristics Updated 12-Jan-2017 | Takeda UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1000 mg film-coated tablets 2. Qualitative and quantitative composition Vipdomet 12.5 mg/850 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride. Vipdomet 12.5 mg/1000 mg film coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1000 mg metformin hydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). Vipdomet 12.5 mg/850 mg film-coated tablets Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side. Vipdomet 12.5 mg/1000 mg film coated tablets Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side. 4. Clinical particulars 4.1 Therapeutic indications Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus: • as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin. • in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. • in combination w 完全なドキュメントを読む