VILDAGLIPTIN/METFORMIN VIATRIS 50 mg/850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vildagliptin/Metformin Viatris and what is it used for
2. What you need to know before taking Vildagliptin/Metformin Viatris
3. How to take Vildagliptin/Metformin Viatris
4. Possible side effects
5. Storage of Vildagliptin/Metformin Viatris
6. Package contents and additional information

1. What is Vildagliptin/Metformin Viatris and what is it used for

The active substances 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 by diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

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

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

How Vildagliptin/Metformin works

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

2. Before taking Vildagliptin/Metformin Viatris

Do not take Vildagliptin/Metformin Viatris

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of 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 with, 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 disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor of the breath.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function impairment.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are to undergo a contrast radiography (a specific type of diagnostic test with X-rays and an injectable contrast medium). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink excessive alcohol (daily or only occasionally).
• if you are breastfeeding (see also “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 very rare but very serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

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

Stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with severe fatigue
• difficulty breathing
• reduction of body temperature and heart rate

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

Consult your doctor promptly to indicate how to proceed if:

• You know you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and deafness.

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should 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 diabetic medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care. 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, you should stop taking vildagliptin/metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when to restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (transaminases) as early 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 elderly person and/or if your renal function is deteriorating.

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

Children and adolescents

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

Other medications and Vildagliptin/Metformin Viatris

If you need to be administered a contrast medium containing iodine in your bloodstream, for example, in the context of an X-ray or scan, you should stop taking vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/metformin and when to restart it.

Tell your doctor if you are taking, have recently taken, or may 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, usually used to treat inflammation
• beta-2 agonists, usually used to treat respiratory disorders
• other active substances used to treat diabetes
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific active substances that affect the thyroid, or
• specific active substances that affect the nervous system.
• specific active substances used to treat angina pectoris (e.g., ranolazine)
• specific active substances used to treat HIV infection (e.g., dolutegravir)
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• specific active substances used to treat stomach acidity and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Viatris with alcohol

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

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also “Do not take Vildagliptin/Metformin”).

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Your concentration and reaction abilities may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as vision difficulties. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

3. How to take/use Vildagliptin/Metformin Viatris

The dose of vildagliptin/metformin that you should take varies depending on your condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

If you have reduced kidney 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 with certain medications that lower your blood sugar levels.

How to take Vildagliptin/Metformin

• Swallow the tablets whole 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 digestive discomfort.

Follow your doctor's dietary advice. In particular, if you follow a weight-control diet for diabetics, continue with the diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin than 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 have to visit a doctor or go to the nearest hospital, bring the package and this package leaflet with you.

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

If you forget to take Vildagliptin/Metformin

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

If you stop taking Vildagliptin/Metformin

Continue taking this medication while your doctor prescribes it to continue controlling your blood sugar. Do not stop taking vildagliptin/metformin unless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You must stop takingvildagliptina/metforminaand consult your doctor immediatelyif you experience any of the following adverse effects:

• Lactic Acidosis(very rare: may affect up to 1 in 10,000 people):

Vildagliptina/metformina may cause a very rare but serious adverse effect called lactic acidosis (see section "Warnings and Precautions"). If this happens to you, you must stop takingvildagliptina/metforminaand contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called "angioedema".
• Liver Disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other Adverse Effects

Some patients have experienced the following adverse effects while taking vildagliptina/metformina:

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

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

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

• Frequency not known (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rashes or pinpoint, flat, red, and round spots under the skin surface or bruising.

Reporting Adverse Effects

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

5. Storage of Vildagliptina / Metformina Viatris

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging and blister after "CAD"/"EXP". The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• Keep it in the original packaging to protect it from moisture.
• Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofVildagliptina/Metformina Viatris

• The active ingredients are vildagliptina and metformina hydrochloride.
• Each film-coated tablet of Vildagliptina/Metformina Viatris 50 mg/850 mg contains 50 mg of vildagliptina and 850 mg of metformina hydrochloride (corresponding to 660 mg of metformina).
• Each film-coated tablet of Vildagliptina/Metformina Viatris 50 mg/1,000 mg contains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride (corresponding to 780 mg of metformina).
• The other ingredients are: microcrystalline cellulose, copovidone K 25-31, crospovidone (type B), hydroxypropylcellulose, hypromellose, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol/PEG 8000, and talc.

Appearance of the Product and Package Contents

Vildagliptina/Metformina Viatris 50 mg/850 mg film-coated tablets are yellow, oval, beveled-edge tablets with a flat surface on both sides and dimensions of approximately 20.7 × 8.8 mm.

Vildagliptina/Metformina Viatris 50 mg/1,000 mg film-coated tablets are dark yellow, oval, beveled-edge tablets with a flat surface on both sides and dimensions of approximately 21.3 × 10.1 mm.

Vildagliptina/Metformina Viatris is available in packages of 10, 30, 56, 60, 120, 180, or 360 film-coated tablets or in multiple packages containing 2 packages of 90 film-coated tablets.

Only some package sizes and doses may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Bluepharma Industria Farmaceutica, S.A.

Sao Martinho do Bispo

3045-016 Coimbra

Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the EEA member states with the following names:

Denmark

Spain

Vildagliptina/Metformina Viatris 50 mg/1,000 mg film-coated tablets EFG

France

Vildagliptine/Metformine Viatris 50 mg/1000 mg film-coated tablet

Norway

Portugal

Date of the Last Revision of this Leaflet:March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/