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The Committee has recommended that further studies be carried out to investigate this concern. The CHMP concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation.
Drug Class and Mechanism Dapagliflozin belongs to the class of medications known as oral antihyperglycemic agents. It is used alone and in combination with other medications for the control of blood glucose in people with type 2 diabetes. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program. Dapagliflozin works by increasing the amount of glucose being removed from the body by the kidneys, which decreases the amount of sugar in the blood.
Possible Side Effects Side effects of Forxiga may include: Hypoglycemia –if taken with sulphonylureas or insulin Thrush Urinary tract infections Increased need to visit the toilet (polyuria) Pain when urinating Changes in levels of blood fats Lowering of blood pressure
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The active substance in Forxiga, dapagliflozin, works by blocking a protein in the kidneys called sodium‑glucose co‑transporter 2 (SGLT2). SGLT2 is a protein that absorbs glucose from the urine into the bloodstream as the blood is filtered in the kidneys. By blocking the action of SGLT2, Forxiga causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood.
Warnings/Precautions Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.