PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Avaglim?
Avaglim is a medicine containing two active substances, rosiglitazone and glimepiride. It is available as triangular shaped tablets (pink: 4 mg of rosiglitazone and 4 mg of glimeperide; red: 8 mg of rosiglitazone and 4 mg of glimeperide.
What is Avaglim used for?
Avaglim is used to treat adult patients with type 2 diabetes (also known as non-insulin dependent diabetes). Avaglim is used in patients who cannot sufficiently control blood glucose (sugar) with an adequate dose of sulfonylurea (a type of anti-diabetes medicine) alone and for whom metformin (another type of anti-diabetes medicine) -diabetes) is not appropriate. The medicine can only be obtained with a prescription.
How is Avaglim used?
Avaglim is taken once daily immediately before or during a meal, usually the first
Breakfast. Doctors should be careful when prescribing Avaglim to patients at risk of hypoglycaemia (low blood sugar), such as elderly patients, patients with low body weight or patients who have taken other medications.
Therapy can be started with separate tablets containing only rosiglitazone or a sulphonylurea and then, when control is achieved, switched to the tablet containing the combination. The starting dose is one 4 mg / 4 mg tablet, which can be increased to 8 mg / 4 mg after eight weeks if needed, but this requires caution due to the risk of fluid retention. If symptoms of hypoglycaemia occur, return to the separate tablets so that the dose of glimepiride can be adjusted.
How does Avaglim work?
Type 2 diabetes is a disease where the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Avaglim contains two active substances that each have a different action. Rosiglitazone makes cells (in adipose tissue, muscles and liver) more sensitive to insulin, thus making the body use the insulin it produces better. . Glimepiride is a sulphonylurea, which stimulates the pancreas to produce more insulin. The result of the combined action of the two active substances is a reduction in blood glucose, which helps to control type 2 diabetes.
How has Avaglim been studied?
Since rosiglitazone has been authorized alone in the European Union (EU) since 2000 under the name Avandia, studies carried out on rosiglitazone alone have been adopted as the basis for Avaglim. Glimeperide has been available in the EU since 1995. For the glimepiride information from scientific publications was used. In addition, four studies were carried out to compare the combination of both active substances with each substance alone, in previously untreated patients and in patients whose treatment with only one of the substances failed to control the sugar level in the blood. These studies measured the level of a substance called glycosylated hemoglobin (HbA1c) in the blood, which gives an indication of how well the blood glucose is controlled.
What benefit has Avaglim shown during the studies?
In all four studies, the combination of rosiglitazone and glimepride was found to be more effective than either of the components used alone in lowering HbA1c levels.
What are the risks associated with Avaglim?
The most common side effects of Avaglim (seen in more than one in 10 patients) are hypoglycemia (low blood sugar levels) and edema (swelling). For the full list of side effects reported with Avaglim, see the Package Leaflet.
Avaglim should not be used in patients who are likely to be hypersensitive (allergic) to rosiglitazone, glimepiride or other ingredients of the medicine, nor in patients with heart failure, an "acute coronary syndrome" such as unstable angina (a severe type of pain chest variable in intensity) or certain types of heart failure, liver problems or severe kidney problems.
It should also not be prescribed to patients with insulin dependent diabetes or to patients who have diabetes complications (diabetic ketoacidosis or diabetic coma). For the full list of restrictions, see the Package Leaflet.
The strength of Avaglim may need to be changed if it is taken with some other medicines such as gemfibrozil or rifampicin: The full list is provided in the package leaflet.
Why has Avaglim been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of adding the
rosiglitazone to sulfonylureas, especially glimepiride, has been satisfactorily demonstrated; decided that the benefits of Avaglim are greater than its risks for the treatment of type 2 diabetes in patients who fail to achieve sufficient glycemic control on optimal doses of sulfonylurea monotherapy and for whom metformin is inadequate due to contraindications or intolerance. The committee therefore recommended the granting of a marketing authorization for Avaglim.
More information about Avaglim
On 27 June 2006, the European Commission granted SmithKline Beecham plc a "Marketing Authorization" for Avaglim, valid throughout the European Union.
For the full evaluation version (EPAR) of Avaglim click here.
Last update of this summary: 03-2008.
The information on Avaglim published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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