Leaflet: information for the user

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

vildagliptin/metformin, hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

1. What isVildagliptin/Metformin pensaand what it is used for

2. What you need to know before you start takingVildagliptin/Metformin pensa

3. How to takeVildagliptin/Metformin pensa

4. Possible side effects

5. Storage ofVildagliptin/Metformin pensa

6. Contents of the pack and additional informationl

The active ingredients ofthis medication, vildagliptina and metformina,belong to a group of medications called “oral antidiabetics”.

Vildagliptina/metforminais used to treat adult patients with type2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.It is used when diabetes cannot be controlled with diet and exercise alone. It helps to control blood sugar levels. Your doctor will prescribe vildagliptina/metformina alone or in combination with other medications used to treat diabetes that you are already taking, if they have not been shown to be sufficiently effective in controlling diabetes.

Type2 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 Vildagliptina/Metformina worksthinks

Both active ingredients, vildagliptina and metformina, help to control blood sugar levels. The active ingredient vildagliptina stimulates the pancreas to produce more insulin and less glucagon. The active ingredient metformina 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 pensa

• if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (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 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 smell.
• 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 undergoing a radiology contrast (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 occasionally).
• if you are breastfeeding (also see "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very 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 disease).

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

Consult your doctor immediately to tell you what to do if:

• 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, deterioration of cognitive abilities, difficulty with movement, symptoms indicative of nerve damage (e.g., pain or numbness), migraine and hearing loss.

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

Stop takingVildagliptin/Metformin pensa and 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.

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 ifyou 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 taken together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse 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, you should 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 andthereafter on a periodic basis. This is done to detect as soon as possible any sign that indicates 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 elderly 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 18years.

Other medicines andVildagliptin/Metformin pensa

If you need to be administered in your bloodstream an injection of a contrast medium that contains iodine, for example, in the context of a radiography or exploration, you should 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 medicine. 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 medicines used to treat diabetes
• diuretics, which increase urine production
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicinesused to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• certain medicines that affect the thyroid
• certain medicines that affect the nervous system
• certain medicines used to treat angina (e.g., ranolazine)
• certain medicines used to treat HIV infection (e.g., dolutegravir)
• certain medicines used to treat a specific type of thyroid cancer(medullary thyroid cancer) (e.g., vandetanib)
• certain medicines used to treat stomach acid and ulcers(e.g., cimetidine)

TakingVildagliptin/Metformin pensa 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 intend to become pregnant, consult your doctor before using this medicine. 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 (also see "Do not take Vildagliptin/Metformin pensa").

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Vildagliptin/Metformin pensa contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free".

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 medicationas 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.

When and how to takeVildagliptin/Metformin pensa

• Swallow the whole tablets with a glass of water
• Take one tablet in the morning and the other at night 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.

The groove on the tablet is not for breaking the tablet.

If you take moreVildagliptin/Metformin pensathan 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 pensa

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 pensa

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 medicinecan 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 to1in 10,000 users):

Vildagliptin/metformin may 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 may 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 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, pointed, red, and rounded spots under the skin's surface, or bruises.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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”. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vildagliptina/Metformina pensa

- The active principles are vildagliptin and hydrochloride of metformin.

- Each film-coated tablet of Vildagliptina/Metformina 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (corresponding to 662.88 mg of metformin).

- The other components are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, stearate of fumaric acid and sodium, and ready-to-use coating material (hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow (E 172)).

Appearance of the product and contents of the packaging

Vildagliptina/Metformina pensa 50 mg/850 mg film-coated tablets are yellow-colored, oval, oblong tablets with a notch on one face and “VA” on the other face. Tablet dimensions: 19.4 × 0.5 mm.

They are presented in packaging containing 10 or 60 film-coated tablets in Alu/OPA-Alu-PVC blisters.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50,

08950 Esplugues de Llobregat, Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Vildagliptina/Metformina pensa 50 mg/850 mg film-coated tablets EFG

Portugal: Metformina +Vildagliptina toLife

Italy: Vildagliptin and Metformina Pensa

Last review date of this prospectus:February 2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)