Package Leaflet: Information for the User

Vildagliptin/Metformin Cinfa50 mg/1,000 mg Film-Coated Tablets

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, 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 shown to reduce 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 fluids).
• if you are undergoing 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 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 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 indicate how to proceed 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 fluid 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
• abdominal pain (stomach pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduced 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 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.

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 at regular intervals 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 elderly person and/or if your kidney function is deteriorating.

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

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 an 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 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 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 (also see "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 the symptoms caused by hypoglycemia (low blood sugar) or hyperglycemia, such as visual disturbances, 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.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.

The dose of vildagliptin/metformincinfathat each person should take varies depending on their condition. Your doctor will indicate exactly the dose of vildagliptin/metformincinfathat you should take.

The recommended dose is one 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.

Form of use ofvildagliptin/metformin cinfa

• 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/metformina cinfa.

If you take morevildagliptin/metformin cinfathan you should

If you have taken too many tablets ofvildagliptin/metformin,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 take vildagliptin/metformin cinfa

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 to compensate for the missed doses.

If you interrupt the treatment with vildagliptin/metformin cinfa

Continue taking this medication while your doctor prescribes it for you to continue monitoring 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay 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) (rare): 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) (unknown frequency): 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:

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

• Very rare (may affect up to 1 in 10,000people): 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, excessive sweating.

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

• Common: headache, chills, nausea (discomfort), low blood glucose, heartburn.
• 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): skin rash with itching, pancreatitis,localized skin peeling or blisters, muscle pain.

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 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 the packaging and medications you no longer need. 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 1,000 mg of metformin hydrochloride.
• The other components are: hydroxypropylcellulose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide (E-171) and macrogol) and iron oxide yellow (E-172).

Appearance of the product and contents of the packaging

Vildagliptin/metformin cinfa 50 mg/1,000 mg film-coated tablets EFG are yellow, oblong, biconvex, non-scored tablets marked with “VM” on one face (size: 20.5 x 10.9 mm).

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

Single-dose aluminum/aluminum blister

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

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/85622/P_85622.html

QR code to:https://cima.aemps.es/cima/dochtml/p/85622/P_85622.html