Short Version of the EU Summary of Product Characteristics (SmPC)

Medicinal Product:

Trajenta® 5mg film-coated tablets. Each tablet contains 5 mg of linagliptin. For the full list of excipients, consult section 6.1. of the full SmPC.

Therapeutic indications:

Trajenta® is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:

a) monotherapy: when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

b) combination therapy: in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Posology and method of administration:

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.

Renal impairment: For patients with renal impairment, no dose adjustment for linagliptin is required.

Hepatic impairment: Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.

Elderly: No dose adjustment is necessary based on age.

Paediatric population: The safety and efficacy of linagliptin in children and adolescents has not yet been established. No data are available.

The tablets 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.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use:

Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

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), 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. Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin. A dose reduction of the sulphonylurea or insulin may be considered.

Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. Acute pancreatitis has been observed in patients taking linagliptin. In a cardiovascular and renal safety study (CARMELINA) with median observation period of 2.2 years, adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta® should be discontinued; if acute pancreatitis is confirmed, Trajenta® should not be restarted. Caution should be exercised in patients with a history of pancreatitis.

Bullous pemphigoid has been observed in patients taking linagliptin. In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients on treatment with linagliptin and in no patient on placebo. If bullous pemphigoid is suspected, Trajenta® should be discontinued.

Interaction with other medicinal products and other forms of interaction:

Linagliptin is considered unlikely to cause interactions with other P-gp substrates. Clinical data suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low. For more detailed information on interactions with linagliptin, please consult the full version of the SPC.

Pregnancy and lactation:

The use of linagliptin has not been studied in pregnant women. As a precautionary measure, it is preferable to avoid the use of linagliptin during pregnancy.

A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Linagliptin has no or negligible influence on the ability to drive and use machines. However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin.

Undesirable effects:

Linagliptin 5 mg daily as monotherapy or as add-on therapy (in clinical studies, post-marketing experience, or cardiovascular outcome trials): very common (≥ 1/10) - hypoglycaemia (observed in combination with metformin plus sulphonylurea); common (≥ 1/100 to <1/10) - lipase increased; uncommon (≥ 1/1,000 to < 1/100) - nasopharyngitis, hypersensitivity (e.g. bronchial hyperreactivity), cough, constipation (observed in combination with insulin), rash, amylase increased; rare (≥ 1/10,000 to < 1/1,000) - pancreatitis, angioedema, urticaria, bullous pemphigoid.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/ risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems.

Revision date: October 2019

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