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Product Information
Vildagliptin tablets
What is Vildagliptin?
Generic Galvus is a medicine that contains the active substance vildagliptin. It is available as tablets (50 mg).
What is Vildagliptin used for?
Vildagliptin is used to treat type-2 diabetes mellitus. It can be used in the following ways:
- on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
- together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient’s diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
- together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
- together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
Therapeutic Indication
Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults:
- as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;
- as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
- as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance;
- as dual oral therapy in combination with a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate;
- as triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;
- vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
How is Vildagliptin used?
In adults, the recommended dose of Vildagliptin is:
- one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
one tablet in the morning (50 mg per day) when taken with a sulphonylurea. A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
The daily dose should not exceed two tablets (100 mg). In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.
How does Vildagliptin work?
Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Vildagliptin, vildagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
What is the risk associated with Vildagliptin?
The most common side effect with Vildagliptin (seen in between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Vildagliptin, including side effects occurring when Vildagliptin is taken with other antidiabetes medicines, see the package leaflet.
Contraindications
Vildagliptin must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients. Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Vildagliptin and at regular intervals during treatment.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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