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General: TRAJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: Acute pancreatitis has been observed in patients taking linagliptin. If pancreatitis is suspected, TRAJENTA should be discontinued.
Hypoglycaemia: Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo.
In clinical trials of linagliptin as part of combination therapy with agents not known to cause hypoglycaemia (metformin, thiazolidinediones) rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.
Sulphonylureas are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea. A dose reduction of the sulphonylurea may be considered.
Bullous pemphigoid: Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, TRAJENTA should be discontinued.
Driving and Using machines: No studies on the effects on the ability to drive and use machines have been performed.
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