** Trajenta® (Linagliptin) 5 mg 30 film-coated tablets. Oral use.

** Composition: Each tablet contains: Linagliptin 5 mg.

** Therapeutic indications:

Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

as monotherapy: – in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

as combination therapy: – in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. – in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. – in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

** Dosage and administration:

Posology: – The dose of linagliptin is 5 mg once daily. When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly. – When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia.

Method of administration: Trajenta can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

** Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitor, ATC code: A10BH05.

** Mechanism of action: Linagliptin is an inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output. Linagliptin binds very effectively to DPP-4 in a reversible manner and thus leads to a sustained increase and a prolongation of active incretin levels. Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homeostasis. Linagliptin binds selectively to DPP-4 and exhibits a > 10,000 fold selectivity versus DPP-8 or DPP-9 activity in vitro.

** For indication and dosage see enclosed leaflet.

** Keep out of the reach and sight of children.

** Medicinal product subject to medical prescription.

** Any unused product or waste material should be disposed of in accordance with local requirements.

** Store below 30 degrees C.

** Manufacturer: Boehringer Ingelheim Roxane Inc., 1809 North Wilson Road, Columbus, Ohio 43228, USA

For: Boehringer Ingelheim International GmbH 55216 Ingelheim am Rhein, Germany

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