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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.
Dapagliflozin is not suitable for people who: Have type 1 diabetes Are pregnant or breastfeeding Have low kidney function Are galactose intolerant Have low salt levels in their body Are under the age of 18 or over the age 75 People on a course of Actos (pioglitazone) or loop diuretics should also avoid taking Forxiga.
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.
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