Label: information for the user

Vildagliptin/Metformin Viatris 50mg/850mg film-coated tablets EFG

Vildagliptin/Metformin Viatris 50mg/1,000mg film-coated tablets EFG

vildagliptin/metformin hydrochloride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Contents of the label

1. What Vildagliptin/Metformin Viatris is and for what it is used
2. What you need to know before starting to take Vildagliptin/Metformin Viatris
3. How to take Vildagliptin/Metformin Viatris
4. Possible adverse effects
5. Storage of Vildagliptin/Metformin Viatris
6. Contents of the package and additional information

The active ingredients of this medication, vildagliptin and metformin, belong to a group of medications called “oral antidiabetics”.

Vildagliptin/metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.

Vildagliptin/metformin is used when diabetes cannot be controlled with diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

Type 2 diabetes appears if the body does not produce enough insulin or if the insulin produced does not work properly. It can also appear if the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps to reduce blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and causes blood sugar levels to rise.

How Vildagliptin/Metformin works

Both active ingredients, vildagliptin and metformin, help to control blood sugar levels. The active ingredient vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active ingredient metformin helps the body to use insulin better.This medication has been shown to reduce blood sugar levels, which will help to prevent complications of your diabetes.

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 diabetic precoma. 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 contrast radiography (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 disease 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 inherited diabetes and deafness (MIDD).
• you experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with movement, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, 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 taken vildagliptin before 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.

Tests of liver function should be performed before starting treatment with vildagliptin/metformin, at intervals of three months during the first year, and thereafter periodically. This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

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 of age.

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 examination, 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 glucose 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 visual 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.

The dose ofvildagliptin/metforminthat each person should take varies depending on their condition. Your doctor will tell you exactly the dose ofvildagliptin/metforminthat you should take.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is a film-coated tablet of 50mg/850mg or 50mg/1,000mg twice a day.

If you have reduced renal function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medication known as a sulfonylurea.

Your doctor may prescribe this medication alone or in combination with certain medications that lower blood sugar levels.

How to useVildagliptin/Metformin

• Swallow the whole tablets with a glass of water
• Take one tablet in the morning and the other in the evening with meals or after meals. Taking the tablet after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are following a weight control diet for diabetics, continue with the diet while takingvildagliptin/metformin.

If you take moreVildagliptin/Metforminthan you should

If you have taken too many tablets of this medication or if someone else has taken your tablets,consult your doctor or pharmacist immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging and this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeVildagliptin/Metformin

If you forget to take a tablet, take it with the next meal, unless it is already time to take the usual dose. Do not take a double dose (two tablets at once) to make up for the missed doses.

If you interrupt treatment withVildagliptin/Metformin

Continue taking this medication as long as your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not stop takingvildagliptin/metforminunless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You shouldstop takingvildagliptin/metforminand see your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1 in 10,000 people):

Vildagliptin/metformin can cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you should stop takingvildagliptin/metforminand contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare:may affect up to 1 in 1,000people): symptoms that includeswollen face, tongue, or throat,difficulty swallowing, difficulty breathing, sudden appearance of hives or urticaria,which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (infrequent: may affect up to 1 in 100 people): symptoms that includeyellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (inflammation of the pancreas) (infrequent: may affect up to 1 in 100 people): symptoms that includeintense and persistent abdominal pain (stomach area), which can reach your back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while takingvildagliptin/metformin:

• Frequent (may affect up to 1 in 10people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremor, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, abdominal pain, and stomach pain.
• Infrequent (may affect up to 1 in 100people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles, or feet (edema), chills, pancreatitis, muscle pain.

• Very rare (may affect up to 1 in 10,000people): signs of having high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pale skin, fatigue, mental symptoms such as confusion or memory alterations).

Since the marketing of this product, the following side effects have also been reported:

• Unknown frequency (cannot be estimated from available data):localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or flat, red, rounded spots under the skin's surface or hematomas.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and blisterafter “CAD”/”EXP”. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Store in the original packaging to protect it from moisture.
• Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.