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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.
Commonly seen side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary-tract infection (infection of the structures that carry urine), and are considered to be manageable. A small but higher number of bladder-, breast- and prostate-cancer cases were seen in patients who took Forxiga compared with patients who took placebo. However, there was no difference between the groups when cancer overall was considered and preclinical studies investigating the risk of developing cancer with Forxiga did not show this risk.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency. Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
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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.
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