LINAGLIPTIN SANDOZ

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. 4) Special populations 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. 2).

Therefore, treatment of children and adolescents with linagliptin is not recommended. Linagliptin has not been studied in paediatric patients under 10 years of age. Method of administration 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.

1%). 4%). 6% in placebo. 9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin. 1% were classified as severe in intensity. Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).

g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin). The placebo-controlled studies included studies where linagliptin was given as - monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add-on to insulin with or without metformin Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received 5 mg linagliptin in double-blind studies as monotherapy or as add-on therapy are presented in the table below (see table 1).

The adverse reactions are listed by absolute frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000) or not known (frequency cannot be estimated from the available data).

g. 1). The study included 3,494 patients treated with linagliptin (5 mg) and 3,485 patients treated with placebo. Both treatments were added to standard of care targeting regional standards for HbA1c and CV risk factors. The overall incidence of adverse events and serious adverse events in patients receiving linagliptin was similar to that in patients receiving placebo.

Safety data from this study was in line with previous known safety profile of linagliptin. 1% on placebo. 7% in placebo treated patients. 9% in placebo treated patients. 1% of patients treated with placebo. 2% of patients treated with linagliptin and in no patient treated with placebo.

General Linagliptin 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 medicinal products not known to cause hypoglycaemia (metformin), rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.

8). Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin. 2). Acute pancreatitis Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.

Acute pancreatitis has been observed in patients taking linagliptin. 1% of patients treated with placebo. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, linagliptin should be discontinued; if acute pancreatitis is confirmed, linagliptin should not be restarted.

Caution should be exercised in patients with a history of pancreatitis. Bullous pemphigoid Bullous pemphigoid has been observed in patients taking linagliptin. 2% of patients on treatment with linagliptin and in no patient on placebo.

If bullous pemphigoid is suspected, linagliptin should be discontinued.

1.