Package Leaflet: Information for the User

Vildagliptin/Metformin Hydrochloride 50 mg/850 mg Film-Coated Tablets

vildagliptin/metformin hydrochloride

Read this leaflet carefully before you start to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

The active ingredients ofvildagliptina/metformina cinfa, vildagliptina and metformina,belong to a group of medications called “oral antidiabetics”.

Vildagliptina/metformina cinfais used to treat adult patients with type2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.

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 makes blood sugar levels increase.

How vildagliptina/metformina cinfa works

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 demonstrated reduced blood sugar levels, which will help to prevent complications of your diabetes.

Do not take vildagliptin/metformin cinfa

• 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 cinfa.
• 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 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 water).
• 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 "Warnings and precautions" section.
• if you have liver problems.
• if you drink excessive alcohol (daily or occasionally).
• if you are breastfeeding (see also "Pregnancy and breastfeeding").

Warnings and precautions

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

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 diseases).

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 inherited disease that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, 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 impairment, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine and hearing loss.

Stop taking vildagliptin/metformin 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 liquid than normal. 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 cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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

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 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 you take it together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

Diabetic 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 being 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 periodically thereafter. This is done to detect as soon as possible any sign of increased 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 worsening.

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

Children and adolescents

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

Taking vildagliptin/metformin cinfa with other medicines

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

If you need to be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or examination, 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.

You may need more frequent blood glucose and renal 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 that increase urine production
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain active principles that affect the thyroid, or
• certain active principles that affect the nervous system.

Taking vildagliptin/metformin cinfa with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin cinfa, as this may increase the risk of lactic acidosis (see "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 (see also "Do not take vildagliptin/metformin cinfa"). Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia (low blood sugar) or hyperglycemia, such as visual difficulties, dizziness, confusion or increased sweating. This can be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor if it is recommended to drive or operate machinery.

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

You should stop taking vildagliptin/metformin and see your doctor immediately if you experience any of the following side effects:

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

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

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen 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) (rare): 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 (inflammation of the pancreas) (unknown frequency): symptoms that include intense 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 taking vildagliptin/metformin:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, abdominal pain, loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, uncontrolled tremor, metallic taste, decreased blood glucose levels.
• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swollen hands, ankles, or feet (edema).

• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion, and fever; 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).

Some patients have experienced the following side effects while taking vildagliptin/metformin and a sulfonylurea:

• Common: dizziness, tremor, weakness, low blood glucose levels, excessive sweating.

Some patients have experienced the following side effects while taking vildagliptin/metformin and insulin:

• Common: headache, chills, nausea (discomfort), low blood glucose levels, stomach burning.
• Uncommon: diarrhea, flatulence.

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

• Unknown frequency (cannot be estimated from available data): itchy rash, pancreatitis,localized skin peeling or blisters, muscle pain.

Reporting 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 the 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 the blister after “CAD”. The expiration date is the last day of the month indicated.
• Store in the original packaging (blister) to protect it from light and moisture.
• This medication does not require any special storage temperature.
• Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of vildagliptin/metformin cinfa

• The active principles are vildagliptin and metformin hydrochloride.
• Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride.
• The other components are: hydroxypropylcellulose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide (E-171) and macrogol) and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Vildagliptin/metformin cinfa 50 mg/850 mg film-coated tablets EFG are yellow, oblong, biconvex, non-scored tablets marked with “VM2” on one face (size: 19 x 10.15 mm).

Vildagliptin/metformin cinfa is available in packs of 60 tablets.

Single-dose blister pack of aluminum/aluminum

Holder of the marketing authorization and responsible for manufacturing and

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 . Polígono Industrial Areta

31620 Huarte (Navarra) - España

Last review date of this leaflet: March 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85621/P_85621.html

QR code to: https://cima.aemps.es/cima/dochtml/p/85621/P_85621.html