Indications for use
Type 2 diabetes mellitus:
as monotherapy in combination with diet and exercise, as well as in patients with contraindications to metformin therapy or intolerance to it;
as part of dual combination therapy:
with metformin in patients with inadequate glycemic control despite the maximum tolerated dose of metformin alone,
with a sulfonylurea in patients with inadequate glycemic control despite the maximum tolerated dose of metformin alone and in patients with contraindications to metformin therapy or intolerance to it
with a thiazolidinedione in patients with inadequate glycemic control and in patients for whom therapy with a thiazolidinedione is appropriate;
as part of triple combination therapy with a sulfonylurea and metformin when diet, exercise, and dual therapy alone do not achieve adequate glycemic control;
in combination with insulin (with or without metformin) when diet, exercise, and a stable dose of insulin do not achieve adequate glycemic control.

List of information required before use
Contraindications
hypersensitivity to the active substances or to any of the excipients.

Necessary precautions for use
If insulin therapy is required, the drug is used only in combination with insulin. The drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Interactions with other drugs
Vildagliptin has a low potential for drug interactions. Since vildagliptin is not a substrate of cytochrome P (CYP) 450 enzymes, and does not inhibit or induce CYP 450 enzymes, interactions of vildagliptin with other drugs that are substrates, inhibitors or inducers of this enzyme system are unlikely.
When used simultaneously, vildagliptin also does not affect the rate of metabolism of drugs that are substrates of the enzymes: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5. Studies have been conducted on the interaction of vildagliptin with drugs often prescribed in combination for type 2 diabetes mellitus, as well as with drugs with a narrow therapeutic index.
Clinically significant interactions of vildagliptin with drugs most often used in the treatment of type 2 diabetes mellitus (glibenclamide, pioglitazone, metformin) or with a narrow therapeutic index (amlodipine, digoxin, ramipril, simvastatin, valsartan, warfarin) have not been established. There may be an increased risk of angioedema in patients receiving concomitant ACE (angiotensin converting enzyme) inhibitors.
As with other oral antidiabetic
medicines, the hypoglycemic effect of vildagliptin may be reduced by concomitant use with certain drugs, including thiazides, corticosteroids, thyroid medications and sympathomimetics.
Special warnings
Renal impairment
Experience in patients with end-stage renal disease receiving hemodialysis is limited. Therefore, vildagliptin should be used with caution in such patients.
Hepatic impairment
Vildagliptin is not recommended for patients with hepatic impairment, including patients with pre-treatment ALT or AST values >3 times the upper limit of normal.
Liver enzyme monitoring
Liver function should be checked prior to initiating treatment to ensure baseline values ​​are known. During treatment with the drug, liver function should be monitored every three months during the first year and periodically thereafter. If AST or ALT activity is 3 times or more above the upper limit of normal, the drug should be discontinued.
If jaundice or other signs of liver dysfunction develop while using the drug, therapy with the drug should be stopped immediately. After normalization of liver function parameters, treatment with the drug should not be resumed.
Heart failure
Use of the drug in patients with heart failure is not recommended.
Skin lesions
Experience in treating patients with skin diseases in diabetes is limited. Therefore, when prescribing the drug to patients with diabetes, it is recommended to monitor for skin disorders such as blisters or ulcers.
Acute pancreatitis
Use of vildagliptine is associated with the risk of developing acute pancreatitis.
Caution should be exercised when using the drug in patients with a history of acute pancreatitis.
Hypoglycemia
Sulfonylureas are known to cause hypoglycemia. Patients taking vildagliptin in combination with sulfonylureas are at risk of developing hypoglycemia. It may be necessary to reduce the dose of sulfonylurea to reduce the risk of hypoglycemia.
Special instructions regarding excipients
Lactose
The drug contains lactose as an excipient, therefore the drug is contraindicated in individuals with hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.
Sodium
This drug contains less than 1 mmol sodium (23 mg) per tablet, i.e. it contains virtually no sodium.
Pregnancy and breastfeeding
There are no sufficient data on the use of vildagliptin in pregnant women. Due to the lack of data on the effect on humans, the drug should not be used during pregnancy.
It is unknown whether vildagliptin is excreted in breast milk. The drug should not be used during breastfeeding.
Features of the drug's effect on the ability to drive a vehicle or potentially dangerous mechanisms
Studies on the effect of vildagliptin on the ability to drive vehicles or other mechanisms have not been conducted. If dizziness develops during treatment with the drug, patients should not drive vehicles or operate mechanisms.

Recommendations for use
Dosage regimen
Adult patients
The recommended dose of the drug for monotherapy or as part of a two-component combination therapy with metformin, a thiazolidinedione, or as part of a three-component combination therapy with a sulfonylurea and metformin, or in combination with insulin, is 100 mg per day, administered at 50 mg in the morning and 50 mg in the evening.
As part of a two-component combination therapy with a sulfonylurea, the recommended dose of the drug is 50 mg once a day in the morning. In this group of patients, a dose of 100 mg per day was not more effective than a dose of 50 mg per day.
When used in combination with a sulfonylurea, a reduction in the dose of the sulfonylurea should be considered to reduce the risk of hypoglycemia.
Doses exceeding 100 mg are not recommended.
The safety and efficacy of vildagliptin in triple combination therapy with metformin and a thiazolidinedione have not been established.
Elderly patients (≥ 65 years)
No dose adjustment is required in elderly patients.
Patients with renal impairment
No dose adjustment is required in patients with early renal impairment (creatinine clearance ≥ 50 mL/min). In patients with moderate to severe renal impairment or end-stage renal disease, the recommended dose is 50 mg once daily.
Patients with liver impairment
The drug should not be administered to patients with liver impairment, including patients previously treated with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3 times the upper limit of normal (ULN).
Children and adolescents under 18 years of age
It is not recommended to prescribe the drug to children and adolescents under 18 years of age. There are no data on the efficacy and safety of vildagliptin in children and adolescents under 18 years of age.
Method and route of administration
The drug is taken orally, regardless of food intake.
Measures to be taken in case of overdose
Symptoms: when using the drug at a dose of 400 mg / day, muscle pain may be observed; rarely - mild and transient paresthesia, fever, edema and a transient increase in lipase concentration (2 times higher than the ULN). When the dose is increased to 600 mg / day, swelling of the extremities with paresthesia and an increase in the concentration of CPK, ALT, C-reactive protein and myoglobin may develop. All symptoms of overdose and changes in laboratory parameters disappear after stopping the drug.
Treatment: elimination of the drug from the body by hemodialysis is unlikely. However, the main hydrolytic metabolite of vildagliptin (LAY151) can be removed from the body by hemodialysis.
Measures to take if one or more doses of the drug are missed
If the patient has missed a dose of the drug on time, the drug should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Recommendations for seeking advice from a healthcare professional
to explain how to use the drug
Ask your doctor for advice before taking the drug.

Description of adverse reactions that occur with standard use of the drug and measures to be taken in this case
When using vildagliptin as monotherapy or in combination with other drugs, pain most adverse reactions were mild, transient, and did not require discontinuation of therapy. No correlation was found between the incidence of adverse events and age, gender, ethnicity, duration of use, or dosage regimen.
Rare cases of liver dysfunction (including hepatitis) have been reported. These cases were usually asymptomatic, without clinical complications, and liver function tests returned to normal after discontinuation of therapy.
The adverse reactions listed below are presented by frequency, with the most common listed first. Combination with metformin
Common
hypoglycemia
tremor
headache, dizziness
nausea

Uncommon
fatigue

Combination with sulfonylurea
Common
hypoglycemia
tremor
headache, dizziness
asthenia
Uncommon
constipation
Very rare
nasopharyngitis
Combination with thiazolidinedione
Common
weight increase
peripheral oedema
Uncommon
hypoglycemia
headache
asthenia

Monotherapy
Common
dizziness

Uncommon
hypoglycemia
headache
peripheral oedema
constipation
arthralgia

Very rare
upper respiratory tract infection
nasopharyngitis

Combination with metformin and sulfonylurea
Common
hypoglycemia
dizziness, tremor
hyperhidrosis
asthenia

Combination with insulin
Common
decreased blood glucose
headache, chills
nausea, gastroesophageal reflux disease

Uncommon
diarrhea, bloating

Post-marketing data
Unknown
pancreatitis
hepatitis (reversible after drug discontinuation)
abnormal liver function tests (become
reversible after drug discontinuation)
myalgia
urticaria
exfoliative and bullous skin lesions, including bullous pemphigoid

If adverse drug reactions occur, contact your health care provider, pharmacist, or directly to the Adverse Drug Reactions (Actions) Information Database, including reports of drug ineffectiveness
Republican State enterprise on the Right of Economic Management National Center for Expertise of Medicines and Medical Devices of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan
http://www.ndda.kz

Additional information
Composition of the medicinal product
One tablet contains
active substance — vildagliptin 50 mg
excipients: microcrystalline cellulose, anhydrous lactose, sodium starch glycolate, magnesium stearate.

Description of appearance, smell, taste
Tablets from white to almost white, round, with a flat surface, with beveled edges, with the engraving “V15” on one side and “H” on the other side.

Release form and packaging
10 tablets are placed in a blister pack made of aluminum foil (Alu / Alu).
Or 100 tablets together with 1 g of desiccant are placed in a high-density polyethylene bottle with a child-resistant plastic cap.
3 contour packs or 1 bottle together with instructions for medical use in Kazakh and Russian are placed in a cardboard pack.

Shelf life
2 years
Do not use after the expiration date!

Storage conditions
Store at a temperature not exceeding 25 ºС.
Keep out of reach of children!

Conditions of dispensing from pharmacies
On prescription