Trajenta Special Precautions

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 medicinal products not known to cause hypoglycaemia (metformin, thiazolidinediones) rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.
When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see Adverse Reactions).
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 (see Dosage & Administration).
Bullous pemphigoid: Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, Trajenta should be discontinued.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea.