Ayglip of the tab. of 50 mg No. 30

Ayglip is appointed for treatment of adult patients with II diabetes.

as monotherapy:

• patients which have a use only of a diet and physical exercises are not provided by sufficient control and also for patients at whom use of metformin is considered unacceptable because of existence of contraindications or intolerance.

as a part of double oral therapy in a combination with:

• metformin at patients with insufficient glycemic control, despite use of the most tolerable dose when performing monotherapy by metformin;
• sulphonylurea for patients with insufficient glycemic control, despite use of the maximum tolerable dose of sulphonylurea, and for patients at whom use of metformin is considered unacceptable because of existence of contraindications or intolerance;
• thiazlolidinedithis for patients with insufficient glycemic control for whom use of a tiazolidindion is considered acceptable.

as a part of triple oral therapy in a combination with sulphonylurea and metformin when the diet and physical exercises together with double therapy by these medicines do not provide adequate glycemic control.

In a combination with insulin (with metformin or without) when the diet and physical exercises together with a stable dose of insulin do not provide adequate glycemic control.

Structure

active ingredient: vildagliptin;

1 tablet supports a vildagliptin of 50 mg;

excipients: cellulose microcrystalline, lactose anhydrous, the hydroxypropyl cellulose low-substituted magnesium stearate.

Vildagliptin belongs to the class of the substances strengthening work of beta cells of the insular device of a pancreas is powerful and selection inhibitor dipeptidilpeptidazy-4 (DPP-4).

Contraindication

Known hypersensitivity to a vildagliptin or to any excipient.

Interaction with other medicines and other types of interactions

Vildagliptin has the low potential for interaction with other drugs. As vildagliptin is not substrate of enzyme of P450 cytochrome (CYP) and its interaction with other medicaments which are substrates, inhibitors or catalysts of these enzymes is not inhibitor or the catalyst of CYP enzymes 450, it is improbable.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy

Still is not present the corresponding researches of use of a vildagliptin to pregnant women.

Research on animals revealed reproductive toxicity at use of high doses of drug. The potential risk for the person is unknown. Due to the lack of data Ayglip it is not necessary to apply during pregnancy.

to

feeding Period a breast

Does not know to

whether gets vildagliptin into breast milk. Researches on animals revealed discharge of a vildagliptin in milk of animals. Ayglip the women nursing should not appoint.

Fertility

Researches about influence of the medicament Ayglip on fertility of the person were not conducted by

.

Children to Children and teenagers up to 18 years the use of the medicament Ayglip is not recommended to

by

due to the lack of data on safety and efficiency.

Ability to influence speed of response at control of motor transport or other mechanisms

Research about influence of medicament on ability to drive the car and to work with other mechanisms were not carried out by

. The patients who are feeling dizzy should not run motor transport or work with other mechanisms.

Route of administration and doses

At use as monotherapy, in a combination with metformin, in combination with thiazlolidinedithis, in a combination with metformin and sulphonylurea or in a combination with insulin (with metformin or without) the recommended daily dose of a vildagliptin makes 100 mg which is divided into two receptions: 50 mg in the morning and 50 mg in the evening.

At use as a part of a double combination with sulphonylurea the recommended dose of a vildagliptin makes 50 mg once a day, in the morning. In this population of patients vildagliptin in a dose of 100 mg a day was no more effective, than vildagliptin in a dose of 50 mg once a day.

At use in a combination with sulphonylurea for the purpose of reduction of risk of development of a hypoglycemia the use of low doses of sulphonylurea is possible

.

is not recommended to Exceed a dose of medicament of 100 mg.

in case of the admission of reception of a dose of the medicament Ayglip it should be accepted at once as soon as the patient remembers it. The double dose of medicament should not be accepted on the same day.

Safety and efficiency of use of a vildagliptin as a part of triple oral therapy in a combination with metformin and thiazlolidinedithis are not established to

.

Overdose

Information on overdose vildagliptiny is limited to

.

Symptoms

Information on possible symptoms of overdose was obtained by

during the research of shipping of increase in a dose with participation of the healthy volunteers receiving vildagliptin within 10 days. At a dosage of 400 mg three cases of developing of muscular pain and also several cases of slight and short-term paresthesia, fever, development of hypostases and temporary increase in levels of a lipase were observed. At a dosage of 600 mg one of volunteers had a hypostasis of legs and hands, substantial increase of level of a phosphokinase of creatinine (FKK) that was followed by increase in level of nuclear heating plant, S-reactive protein and a myoglobin. Three volunteers of this group had hypostasis of both legs that in two cases was followed by paresthesia. All symptoms and disturbances of laboratory indicators disappeared after cancellation of the studied drug.

Treatment

is recommended to carry out by

in case of overdose maintenance therapy. Vildagliptin is not brought at a hemodialysis, however the majority of metabolites of hydrolysis (LAY 151) can be removed by means of a hemodialysis.

Side reactions

Data on safety of use of a vildagliptin were obtained by

during controlled researches with participation of the patients accepting vildagliptin in a daily dose of 50 mg (once a day) or 100 mg (on 50 mg two times a day or 100 mg once a day), as monotherapy and in combination with other medicine. The majority of side reactions which arose at reception of a vildagliptin, were lungs on character and temporary and did not demand the treatment termination. Communication between development of side reactions and age or race of the patient, duration of administration of medicament or a daily dose was not revealed.

Storage conditions

are not required for

For medicine special storage conditions.

to Store

out of children's reach.

Expiration date - 3 years.

not to use medicament after the termination of the expiration date specified on packing.