Prospecto: Information for the Patient

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

Vildagliptin/Metformin TecniGen 50 mg/1,000 mg Film-Coated Tablets

vildagliptin/metformin hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

Content of the Prospectus

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

Type 2 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 increase.

How vildagliptin/metformin 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 medication has been shown to reduce blood sugar, which will help to prevent complications of your diabetes.

Do not take vildagliptin/metformin

• if you are allergic to vildagliptin, metformin, or any of the other ingredients in this medicine (listed in section 6). If you think you might be allergic to any of these ingredients, consult your doctor before taking vildagliptin/metformin.
• 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 odor.
• 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.

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 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
• reduced body temperature and heart rate

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

Consult your doctor quickly to determine what to do if:

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 taking it with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

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

Perform liver function tests 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 (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 old.

Other medicines and vildagliptin/metformin

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 taken recently, or may need to take any other medicine. 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
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• medicines used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)
• substances that affect the thyroid, or
• substances that affect the nervous system.
• substances used to treat angina pectoris (e.g., ranolazine)
• substances used to treat HIV infection (e.g., dolutegravir)
• substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• substances used to treat stomach acid and peptic ulcers (e.g., cimetidine)

Taking vildagliptin/metformin 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 plan 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").

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 TecniGen contains sodium

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

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

Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is a film-coated tablet of 50 mg/850 mg or 50 mg/1,000 mg 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 of vildagliptin/metformin

• 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 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 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

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 compensate for the missed doses.

If you interrupt treatment with vildagliptin/metformin

Continue taking this medication while your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not interrupt treatment with 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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

You muststop taking vildagliptin/metformin and see your doctor immediatelyif you experience any of the following side effects:

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

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 had 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 product, 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 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 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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Vildagliptin/Metformin TecniGen Composition

• The active ingredients are vildagliptin and metformin hydrochloride:

• The other components are: In the tablet core: sodium carbonate, hydroxypropyl cellulose, magnesium stearate. Additionally, the film coating contains: hypromellose, macrogol, titanium dioxide (E-171), yellow iron oxide (E-172), talc.

Appearance of the product and contents of the package

Vildagliptin/Metformin TecniGen 50 mg/850 mg film-coated tablets

Film-coated tablets, oval, with beveled edges and a yellow color, smooth on both faces, 19.90 ± 0.2 mm in length and 7.90 ± 0.2 mm in width.

Vildagliptin/Metformin TecniGen 50 mg/1.000 mg film-coated tablets

Film-coated tablets, oval, with beveled edges and a dark yellow color, smooth on both faces, 21.00 ± 0.2 mm in length and 8.30 ± 0.2 mm in width.

Presented in ALU/ALU-Aluminum blisters, in packs of 60 film-coated tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

or

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Last review date of this leaflet: March 2025

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