Package Leaflet: Information for the User

Vildagliptina/Metformina Normon 50mg/850mg Film-Coated Tablets

Vildagliptina/Metformina Normon 50mg/1.000mg Film-Coated Tablets

vildagliptine/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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

The active ingredients ofVildagliptina/Metformina Normon, vildagliptina and metformin,belong to a group of medicines called “oral antidiabetics”.

Vildagliptina/metforminis used to treat adult patients with type2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus. Vildagliptina/metformin is used when diabetes cannot be controlled with diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

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 Normon 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 medicine has demonstrated reducing blood sugar, which will help to prevent complications of your diabetes.

Do not takeVildagliptin/Metformin Normon

• If you are allergic to vildagliptin, metformin, or any of the other components of this medication (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking this medication.
• 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 an unusual fruity odor on your breath.
• 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 radiology (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

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, 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 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 metformin treatment: convulsions, cognitive decline, 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 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 symptoms of 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, do not take vildagliptin/metformin for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

Diabetic 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 takingvildagliptin/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 being performed and for a period after. Your doctor will decide when to interrupt treatment with vildagliptin/metformin and when to restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, at three-month intervals during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (hepatic transaminases) as soon 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 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 and Vildagliptin/Metformin Normon

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 recently taken, or may need to 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, 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.
• 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).

Taking Vildagliptin/Metformin Normon with 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

• If you are pregnant, think you may be pregnant, or intend 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 (also see "Do not take Vildagliptin/Metformin Normon").

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

If you feel dizzy while takingvildagliptin/metformin, do not drive or operate tools or machinery.

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.

Use ofVildagliptin/Metformin Normon

• 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/Metformin Normonthan 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 Normon

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 Normon

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.

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

• Lactic acidosis (very rare: may affect up to1in 10,000 people): vildagliptin/metformin may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking vildagliptin/metformin and 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 (infrequent: may affect 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,vomiting and severe nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decrease in vitamin B12 levels (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 bruises.

Reporting 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 blister after “CAD”. The expiration date is the last day of the month indicated.
• This medication does not require any special temperature for conservation.
• Store in the original packaging to protect it from moisture.
• Medicines 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 of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Vildagliptin/Metformin Normon

• The active ingredients are vildagliptin and metformin hydrochloride.
• • Each film-coated tablet of Vildagliptin/Metformin Normon 50mg/850mg contains 50mg of vildagliptin and 850mg of metformin hydrochloride, corresponding to 660mg of metformin.
  • Each film-coated tablet of Vildagliptin/Metformin Normon 50mg/1.000mg contains 50mg of vildagliptin and 1.000mg of metformin hydrochloride, corresponding to 780mg of metformin.
• The other components are:
• • In the tablet core:microcrystalline cellulose (E460), povidone, low-substituted hydroxypropylcellulose (E463), magnesium stearate (E572), sodium carboxymethylcellulose (type A) and anhydrous colloidal silica.
  • In the tablet coating:hypromellose (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc(E553b)and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Vildagliptin/Metformin Normon 50mg/850mg film-coated tablets arefilm-coated yellow tablets, eliptical, biconvex, printed with “VMF” on one side and “850” on the other..

Vildagliptin/Metformin Normon 50mg/1.000mg film-coated tablets arefilm-coated dark yellow tablets, eliptical, biconvex, printed with “VMF” on one side and “1000” on the other.

Aluminium/Polyamide-Aluminium-PVC blister.

Packages with 10, 30, 60, 120, 180 or 360 film-coated tablets and multiple packages with 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:March 2025

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.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/86791/P_86791.html