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Forxiga is indicated in adults aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control as: monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Therefore, the use of Forxiga is not recommended in patients with moderately or severely reduced kidney function. For patients with severely reduced liver function a starting dose of 5 mg is recommended. How does Forxiga work? Type-2 diabetes is a disease in which 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. This leads to high levels of glucose in the blood.
What is the risk associated with Forxiga? The most common side effect with Forxiga (seen in more than 1 patient in 10) is hypoglycaemia when used with a sulphonylurea or insulin. For the full list of side effects reported with Forxiga, see the package leaflet. Forxiga must not be used in people who are hypersensitive (allergic) to dapagliflozin or any of the other ingredients.
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How has Forxiga been studied? The effects of Forxiga were first tested in experimental models before being studied in humans. Forxiga on its own has been compared with placebo (a dummy treatment) in two studies in 840 patients. A third study compared Forxiga with a sulphonylurea (glipizide), both taken in combination with metformin in 814 patients. Four other studies compared Forxiga with placebo, when used as an add-on to either metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2,370 patients.
Stop taking the medication and seek immediate medical attention if any of the following occur: fainting or lightheadedness when standing
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