Do not takeVildagliptin/Metformin Viatris

• if you are allergic to vildagliptin, metformin, or any of the other ingredients in this medication (listed in section 6). If you think you may be allergic to any of these ingredients, consult your doctor before taking vildagliptin/metformin.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of Lactic Acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-coma diabetic state. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• if you have recently had a heart attack or if you have severe heart failure or circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function reduction.
• if you have a severe infection or severe dehydration (massive loss of body fluids).
• if you are to undergo a radiology contrast study (a specific type of diagnostic test using X-rays and an injectable contrast medium). For more information, see the "Warnings and Precautions" section.
• if you have liver problems.
• if you drink excessive alcohol (daily or occasionally).
• if you are breastfeeding (also see "Pregnancy and Breastfeeding").

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin.

Risk of Lactic Acidosis

Vildagliptin/metformin may cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop takingvildagliptin/metforminfor a short period of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

Stop takingvildagliptin/metforminand contact a doctor or the nearest hospital immediately if you experience any of the symptoms that cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

Lactic acidosis is a medical emergency and should be treated in a hospital.

Consult your doctor quickly to determine what to do if:

• you know you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).
• you experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraines, and hearing loss.

Vildagliptin/metformin is not a substitute for insulin. Therefore, do not take vildagliptin/metformin for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taking it with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin but had to stop due to liver disease, do not take this medication.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care and pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, stop taking vildagliptin/metformin while the procedure is performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

Perform liver function tests before starting treatment with vildagliptin/metformin, at three-month intervals during the first year, and then periodically. This is done to detect any signs of increased liver enzymes (transaminases) as soon as possible.

During treatment with vildagliptin/metformin, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Your doctor will monitor your blood sugar levels and urine periodically.

Children and Adolescents

The administration of vildagliptin/metformin is not recommended in children and adolescents under 18 years old.

Other Medications andVildagliptin/Metformin Viatris

If you need to receive an injection of a contrast medium containing iodine, such as in the context of a radiography or exploration, stop taking vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust the dose of Vildagliptin/Metformin. It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory disorders
• other active principles used to treat diabetes
• diuretics, which increase urine production
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• determinants affecting the thyroid, or
• determinants affecting the nervous system.
• determinants used to treat angina pectoris (e.g., ranolazine)
• determinants used to treat HIV infection (e.g., dolutegravir)
• determinants used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• determinants used to treat stomach acid and peptic ulcers (e.g., cimetidine)

TakingVildagliptin/Metformin Viatriswith Alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see "Warnings and Precautions").

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

If you feel dizzy while taking vildagliptin/metformin, do not drive or operate tools or machines.

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as vision difficulties. This can be hazardous in situations where these skills are important (e.g., driving or operating machines). Therefore, consult your doctor if it is recommended to drive or operate machines.