Trajenta Special Precautions

General: TRAJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
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 and insulin are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea or insulin. A dose reduction of the sulphonylurea or insulin may be considered.
Bullous pemphigoid: Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, TRAJENTA should be discontinued.
Pancreatitis: Acute pancreatitis has been observed in patients taking linagliptin. After initiation of linagliptin, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, linagliptin should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using linaglitin.
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 advised that dizziness has been reported in clinical trials. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.