Source: European Medicines Agency (EU) Revision Year: 2016 Publisher: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
AVANDAMET 1 mg/500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Yellow film-coated tablets marked “gsk” on one side and “1/500” on the other. |
Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Excipients: Each tablet contains lactose (approximately 6 mg).
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Rosiglitazone |
Combination of two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone, a member of the thiazolidinedione class and metformin, a member of the biguanide class. Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production. |
|
| Rosiglitazone |
Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents. It reduces glycaemia by reducing insulin resistance at adipose tissue, skeletal muscle and liver. |
| List of Excipients |
|---|
|
Tablet core: Sodium starch glycollate Film coat: Hypromellose (E464) |
Opaque blisters (PVC/PVdC/aluminium). Packs of 28, 56, 112, 336 (3x112) and 360 tablets.
Not all pack sizes may be marketed.
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EU/1/03/258/001-003
EU/1/03/258/015
EU/1/03/258/019
Date of first authorisation: 20 October 2003
Date of latest renewal: 20 October 2008
| Drug | Countries | |
|---|---|---|
| AVANDAMET | Lithuania |
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