Trajenta 5 mg. FC tablets

TRAJENTA is indicated in adult patients with type 2 diabetes mellitus (T2DM) to improve glycaemic control in conjunction with diet and exercise, as monotherapy or as add-on to metformin, sulphonylureas, thiazolidinediones, insulin (with or without metformin and/or pioglitazone and/or sulphonylurea) or metformin plus sulphonylureas.

Adults: The recommended dose is 5 mg once daily. TRAJENTA can be taken with or without a meal at any time of the day.

Renal impairment: No dose adjustment is required for patients with renal impairment.

Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.

Elderly: No dose adjustment is necessary.

Children and adolescents: TRAJENTA is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Missed dose: 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.

Hypersensitivity to linagliptin or any of the excipients of TRAJENTA.

Pancreatitis or history of pancreatitis (see WARNINGS).

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

Pancreatitis: There have been post-marketing reports of acute pancreatitis in patients taking TRAJENTA. If pancreatitis is suspected, TRAJENTA should be discontinued (see CONTRA-INDICATIONS).

Hypoglycaemia: TRAJENTA alone showed a comparable incidence of hypoglycaemia to placebo. In clinical trials of TRAJENTA as part of combination therapy with agents not known to cause hypoglycaemia (metformin, thiazolidinediones) rates of hypoglycaemia reported with TRAJENTA were similar to rates in patients taking placebo. Sulphonylureas are known to cause hypoglycaemia. Therefore, caution is advised when TRAJENTA 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.

Rhabdomyolysis: Rhabdomyolysis has been reported during use of DPP-4 inhibitor containing products such as TRAJENTA. However, causality could not be assessed due to confounding factors such as concomitant use of medicines (statins, colchicine, etc.) or co-morbid conditions (renal failure, hypovolemia, etc.), known to cause or predispose to development of rhabdomyolysis. Close monitoring of patients using DPP-4 inhibitor containing products in presence of predisposing risk factors is recommended.

In vitro assessment of medicine interactions: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4 but does not inhibit other CYP isozymes. It is not an inducer of CYP isozymes. Linagliptin is a P-glycoprotein substrate and inhibits P-glycoprotein mediated transport of digoxin with low potency. Based on these results and in vivo medicine interaction studies, linagliptin is considered unlikely to cause interactions with other P-gp substrates.

In vivo assessment of medicine interactions: Clinical data described below suggest that the risk for clinically meaningful interactions by co-administered medicinal products is low. No clinically significant interactions requiring dose adjustment were observed. Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicine interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).

Safety in pregnancy and lactation has not been established.

Pregnancy: TRAJENTA should not be used during pregnancy.

Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of linagliptin/metabolites in milk. It is not known whether this medicine is excreted in human milk. TRAJENTA should not be used in women breastfeeding their infants.

No studies on the effects on the ability to drive and use machines have been performed.

The safety of TRAJENTA has been evaluated overall in 6 602 patients with T2DM of which 5 955 patients received the target dose of 5 mg. In placebo-controlled studies, 6 666 patients were included and 4 302 patients were treated with the therapeutic dose of 5 mg linagliptin. 3 964 patients were exposed to linagliptin 5 mg once daily for u2265 12 weeks. In the pooled analysis of the placebo-controlled trials, the overall incidence of AEs in patients treated with placebo was similar to linagliptin 5 mg (63,1 % versus 60,3 %). Discontinuation of therapy due to AEs was higher in patients who received placebo as compared to linagliptin 5 mg (4,4 % versus 3,3 %).

Side effects identified from post-marketing experience: From post-marketing experience the following side effects have been reported: Immune system disorders: angio-oedema, urticaria; Skin and subcutaneous tissue disorders: bullous pemphigoid, severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), erythema multiforme and erythroderma (generalised exfoliative dermatitis); Musculoskeletal and connective tissue disorders: rhabdomyolysis.

Symptoms: During controlled clinical trials in healthy subjects, single doses of up to 600 mg TRAJENTA (equivalent to 120 times the recommended dose) were well tolerated. There is no experience with doses above 600 mg in humans.

Treatment: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures as required.