Galvus · 4.3 Contraindications · 1

HOS-094664 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Safety data were obtained from a total of 5 451 patients exposed to vildagliptin at a daily dose of 100 mg (50 mg twice daily) in randomised double-blind placebo-controlled trials of at least 12 weeks duration. Of these patients, 4 622 patients received vildagliptin as monotherapy and 829 patients received placebo. The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations. No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose. Hypoglycaemia has been reported in patients receiving vildagliptin concomitantly with sulphonylurea and insulin. The risk of acute pancreatitis has been reported with the use of vildagliptin (see section 4.4). Tabulated list of adverse reactions Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and 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), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 Table 1 Adverse reactions reported in patients who received vildagliptin as monotherapy or as add-on therapy in controlled clinical studies and in post-marketing experience System organ class - adverse reaction Frequency Infections and infestations Nasopharyngitis Very common Upper respiratory tract infection Common Metabolism and nutrition disorders Hypoglycaemia Uncommon Nervous system disorders Dizziness Common Headache Common Tremor Common Eye disorders Vision blurred Common Gastrointestinal disorders Constipation Common Nausea Common

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HOS-094660 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-094659 · has-indication-information · PDF-Seite 2

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: • as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

HOS-094662 · has-interaction-information · PDF-Seite 5

Vildagliptin has a low potential for interactions with co-administered medicinal products. Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes. Combination with pioglitazone, metformin and glyburide Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions. Digoxin (Pgp substrate), warfarin (CYP2C9 substrate) Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions. However, this has not been established in the target population. Combination with amlodipine, ramipril, valsartan or simvastatin Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin. Combination with ACE-inhibitors There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.(see section 4.8). As with other oral antidiabetic medicinal products the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.

HOS-094663 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no adequate data from the use of vildagliptin in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Due to lack of human data, Galvus should not be used during pregnancy. Breast-feeding It is unknown whether vildagliptin is excreted in human milk. Animal studies have shown excretion of vildagliptin in milk. Galvus should not be used during breast-feeding. Fertility No studies on the effect on human fertility have been conducted for Galvus (see section 5.3). 5

HOS-094661 · has-warning-information · PDF-Seite 3

General Galvus is not a substitute for insulin in insulin-requiring patients. Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Renal impairment There is limited experience in patients with ESRD on haemodialysis. Therefore Galvus should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2). Hepatic impairment Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2). 3 Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function test results returned to normal after discontinuation of treatment. Liver function tests should be performed prior to the initiation of treatment with Galvus in order to know the patient’s baseline value. Liver function should be monitored during treatment with Galvus at three-month intervals during the first year and periodically thereafter. Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal. Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Galvus therapy is recommended. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Galvus. Following withdrawal of treatment with Galvus and LFT normalisation, treatment with Galvus should not be reinitiated. Cardiac failure A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo. Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive (see section 5.1). There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients. Skin disorders Skin lesions, including blistering and ulceration have been reported in extremities of monkeys in non- clinical toxicology studies (se

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