Expiration date: 01/2028

Dosage form

Round, biconvex, brown-orange film-coated tablets with a risk on one side of the tablet, with an engraving "K" on one side of the risk and an engraving "100" on the other side of the risk. The tablet can be divided into equal doses.

Composition

Each tablet contains 100 mg of sitagliptin.

Other ingredients (excipients) are: microcrystalline cellulose, calcium hydrophosphate, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate

Film shell

Film-forming mix1, iron oxide red dye (E172), iron oxide yellow dye (E172)

1 Film-forming mixture: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc.

Pharmacotherapeutic group

hypoglycemic agent - dipeptidyl peptidase-4 inhibitor

Pharmacodynamics

The drug Asiglia® contains the active ingredient sitagliptin, which belongs to the dipeptylpeptidase-4 (DPP-4) inhibitors, which help reduce blood sugar levels in adults with type 2 diabetes mellitus.

This drug helps to increase the level of insulin produced after eating and reduce the amount of sugar in the blood.

Your doctor has prescribed this medication to lower your blood sugar levels, which are elevated due to your existing disease, type 2 diabetes. This medication can be used alone or in combination with some other medications (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking to treat diabetes along with diet and exercise.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body produces insufficient amounts of insulin, and the insulin produced by your body is not working as well as it should. Your body may also produce too much sugar. When this happens, blood sugar (glucose) levels rise. This can lead to serious health problems, such as heart disease, kidney disease, blindness, and amputation.

Indications

The drug Asiglia® is indicated for use in adults (over 18 years old) with type 2 diabetes mellitus as monotherapy (treatment with one drug) and in combination therapy (in combination with other medications).

Monotherapy

The drug Asiglia® is indicated as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes mellitus.

Combination therapy

Combination therapy with metformin

The drug Asiglia® in combination with metformin is indicated for adults with type 2 diabetes mellitus to improve blood sugar control as initial therapy or when diet and exercise combined with monotherapy with one of the listed drugs do not lead to adequate blood sugar control.

Combination therapy with sulfonylurea derivatives

The drug Asiglia® in combination with sulfonylurea derivatives is indicated for patients

patients with type 2 diabetes mellitus to improve blood sugar control when diet and exercise combined with monotherapy with one of the listed drugs do not lead to adequate blood sugar control.

Combination therapy with PPAR agonists?

The drug Asiglia® in combination with PPAR-? agonists (thiazolidinediones) is indicated in patients with type 2 diabetes mellitus to improve blood sugar control when diet and exercise combined with monotherapy with one of the listed drugs do not lead to adequate blood sugar control.

Combination therapy with metformin and sulfonylurea derivatives

The drug Asiglia® in combination with metformin and sulfonylurea derivatives is indicated in patients with type 2 diabetes mellitus to improve blood sugar control when diet and exercise combined with treatment with two of the listed drugs do not lead to adequate blood sugar control.

Combination therapy with metformin and PPAR agonists?

The drug Asiglia® in combination with metformin and PPAR-alpha agonists (thiazolidinediones) is indicated in patients with type 2 diabetes mellitus to improve blood sugar control when diet and exercise combined with treatment with two of the listed drugs do not lead to adequate blood sugar control.

Combination therapy with insulin

The drug Asiglia® is indicated in patients with type 2 diabetes mellitus as an adjunct to insulin (with or without metformin) in cases where diet, exercise and a stable dose of insulin do not lead to adequate blood sugar control.

Contraindications

Do not use the drug Asiglia®:

• if you are allergic to sitagliptin or any other components of the drug (listed in section 6 of the leaflet);
• if you are pregnant or breastfeeding;
• if you have been diagnosed with type 1 diabetes;
• You have been diagnosed with diabetic ketoacidosis (a complication of diabetes mellitus with high blood sugar, rapid weight loss, nausea or vomiting);
• for children under the age of 18.

If this statement applies to you (or you have doubts), be sure to inform your doctor about it.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you are pregnant, or are planning to become pregnant, consult your doctor before using the drug.

Pregnancy

There is no data on the safety of sitagliptin use in pregnant women. The drug Asiglia®, like other oral medications that lower blood sugar levels, is not recommended for use during pregnancy.

Breastfeeding

It is not known whether this drug is excreted in breast milk. If you are breastfeeding or planning to breastfeed your baby, you should not take this medication.

Method of administration and dosage

Always take this medicine in full accordance with the recommendations of your doctor. If in doubt, consult with your doctor or a pharmacy employee.

Recommended dose

The usual recommended dose is 1 tablet of 100 mg once a day.

Your doctor may prescribe this medication for you alone or together with other medications that lower blood sugar levels.

Diet and exercise will help your body to lower blood sugar better. It is important to follow the diet and exercise recommended by your doctor while taking Asiglia®.

Impaired renal function

If you have kidney problems, your doctor may prescribe a lower dose of the drug (25 mg or 50 mg).

Route and/or method of administration

Inside.

You should swallow the tablet with a glass of water. This drug can be used regardless of food intake.

If you forgot to take the drug Asiglia®, take it as soon as you remember, then take the next dose at the appropriate time according to your doctor's recommendations. However, if there is not much time left before taking the next dose, do not take the missed dose, but continue with the usual intake.

Do not take a double dose of the drug on the same day to make up for a missed pill intake.

If you have any questions about the use of the drug, contact your doctor.

Side effects

Like all medications, Asiglia® can cause undesirable reactions, but they do not occur in everyone.

Immediately stop taking the drug Asiglia® and seek medical help if you experience any of the following adverse reactions ("frequency unknown" - based on the available data, the frequency of occurrence cannot be determined):

• constant severe abdominal pain (in the stomach area), which can radiate to the back, accompanied by nausea, vomiting (or without them), as these may be signs of inflammation of the pancreas (pancreatitis);
• if you have a serious allergic reaction, including skin rash, hives, blisters on the skin, peeling of the skin, swelling of the face, lips, tongue and throat, which may cause difficulty breathing or swallowing. In this case, your doctor may prescribe treatment for an allergic reaction and change your medication to treat diabetes.

Some patients experienced the following side effects when using sitagliptin in monotherapy during clinical trials or during post-marketing use in monotherapy and/or in combination with other drugs for the treatment of diabetes mellitus:

• common (may occur in no more than 1 person out of 10) - low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, degenerative joint disease (osteoarthritis), pain in the arms or legs;
• infrequently (may occur in no more than 1 person out of 100) - dizziness, constipation, itching of the skin;
• rarely (may occur in no more than 1 person out of 1000) - decreased platelet count;
• the frequency is unknown (based on the available data, the frequency of occurrence cannot be determined) - interstitial lung disease, vomiting, angioedema, skin rash, urticaria, cutaneous vasculitis, exfoliative skin diseases, including Stevens-Johnson syndrome, bullous pemphigoid (a type of skin blisters), joint pain, muscle pain, back pain, arthropathy (joint disease), kidney problems (sometimes requiring dialysis).

The following adverse reactions were observed in some patients after the addition of sitagliptin to metformin:

• common (may occur in no more than 1 person out of 10) - nausea, bloating, vomiting;
• infrequently (may occur in no more than 1 person out of 100) - diarrhea, drowsiness.

Some patients experienced the following side effects when using sitagliptin in combination with sulfonylureas and metformin:

• very common (may occur in more than 1 person out of 10) - low blood sugar;
• often (may occur in no more than 1 person out of 10) - constipation.

Some patients experienced the following side effects when using sitagliptin in combination with pioglitazone:

• common (may occur in no more than 1 person out of 10) - bloating, swelling of the arms or legs.

Some patients experienced the following side effects when using sitagliptin in combination with pioglitazone and metformin:

• often (may occur in no more than 1 person out of 10) - swelling of the arms or legs.

Some patients experienced the following side effects when using sitagliptin in combination with insulin (with or without metformin):

• common (may occur in no more than 1 person out of 10) - flu;
• infrequently (may occur in no more than 1 person out of 100) - dry mouth.

Overdose

If you have taken more of the drug than you should, consult your doctor immediately.

In case of overdose, standard supportive measures are used: removal of the unabsorbed drug from the gastrointestinal tract, monitoring of vital signs (including electrocardiography), as well as prescribing supportive therapy (if necessary).

Sitagliptin is poorly excreted by hemodialysis. There is no data on the effectiveness of peritoneal dialysis.

Drug interaction

Tell your doctor that you are taking, have recently taken, or may start taking any other medications.

Sitagliptin had no significant effect when taken concomitantly with the following drugs:

• metformin, rosiglitazone, glibenclamide (drugs that lower blood sugar levels);
• simvastatin (used in the treatment of diseases of the cardiovascular system);
• warfarin (a drug that reduces blood clotting);
• oral contraceptives (drugs that prevent pregnancy).

Repeated administration of metformin in combination with sitagliptin had no significant effect on the effect of sitagliptin in patients with type 2 diabetes mellitus.

The following drugs had no significant effect on sitagliptin:

• hypolipidemic drugs (statins, fibrates, ezetimibe) that lower blood sugar levels;
• antiplatelet agents (clopidogrel) that reduce blood clotting;
• angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARA II), beta-blockers, calcium channel blockers, hydrochlorothiazide, used for high blood pressure and heart disease;
• nonsteroidal anti-inflammatory drugs (naproxen, diclofenac, celecoxib);
• antidepressants (bupropion, fluoxetine, sertraline);
• antihistamines (cetirizine) used in the treatment of allergic reactions;
• proton pump inhibitors (omeprazole, lansoprazole) used in diseases of the gastrointestinal tract;
• medications for the treatment of erectile dysfunction (sildenafil).

It may be necessary to monitor the concentration of digoxin (a drug for the treatment of arrhythmias and other heart problems) in the blood if it is used during treatment with Asiglia®.

It is not recommended to change the dose of Asiglia® when used concomitantly with cyclosporine (used for transplantation) and other p-glycoprotein inhibitors (for example, ketoconazole, which is used for severe fungal diseases).

Special instructions

Consult with your doctor before taking Asiglia®.

If you have severe kidney disease, your doctor may reduce the dose of the drug.

Cases of pancreatic inflammation (pancreatitis) have been reported in patients receiving Asiglia® (see section 4).

The drug Asiglia® does not seem to cause a marked decrease in blood sugar levels, as it does not work when blood sugar levels are low. However, if this drug is used in combination with a sulfonylurea preparation or with insulin, blood sugar levels may decrease significantly (hypoglycemia). Therefore, your doctor may reduce the dose of your prescribed sulfonylurea or insulin medication.

The appearance of blisters on the skin may be a sign of a skin condition called "bullous pemphigoid." Inform your doctor about this; in this case, the doctor may ask you to stop taking the drug Asiglia®.

Be sure to tell your doctor if you have or have had before:

• kidney problems in the present or the past;
• pancreatic disease (for example, pancreatitis);
• cholelithiasis, alcohol dependence, or high levels of triglycerides (a form of fat) in the blood. These conditions may increase the risk of pancreatitis (see section 4).;
• type 1 diabetes mellitus;
• diabetic ketoacidosis (a complication of diabetes mellitus in which there is high blood sugar, rapid weight loss, nausea or vomiting);
• an allergic reaction to the drug Asiglia® (see section 4).

Children and teenagers

The drug Asiglia® is not intended for use in children and adolescents under the age of 18 years.

Driving vehicles and working with mechanisms

There have been no studies on the effect of sitagliptin on the ability to drive vehicles and work with mechanisms. Nevertheless, no negative effect of the drug Asiglia® on the ability to drive vehicles and work with mechanisms is expected.

The drug Asiglia® contains sodium

1 tablet (25 mg or 50 mg or 100 mg) contains less than 1 mmol of sodium (23 mg), i.e. it can be said that the drug Asiglia® does not actually contain sodium.

Storage temperature

from 2℃ to 25℃