VILDAGLIPTIN/METFORMIN SANDOZ 50 mg/850 mg FILM-COATED TABLETS

2. What you need to know before you take Vildagliptin/Metformin Sandoz

Do not take Vildagliptin/Metformin Sandoz

• 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, talk to 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 disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or unusual fruity odor on the breath,
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems,
• if you have severe kidney function impairment,
• if you have a severe infection or severe dehydration (massive loss of body fluids),
• if you are going to have a contrast radiology (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 only occasionally),
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Vildagliptin/Metformin Sandoz.

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 working 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 disease).

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

Talk to your doctor immediately to find out how to proceed if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).

• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive impairment, difficulty with body 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 disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Talk to 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 lactic acidosis produces,as this condition can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting,
• stomach pain (abdominal pain),
• muscle cramps,
• general feeling of discomfort, with intense fatigue,
• difficulty breathing,
• decreased 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 to treat type 1 diabetes.

Talk to your doctor or pharmacist before starting to take vildagliptin/metformin if you have or have had a pancreatic disease.

Talk to your doctor or pharmacist before starting to take vildagliptin/metformin if you are taking a diabetes medicine 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 previously taken vildagliptin but had to stop taking it due to liver disease, you should not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's recommendations for skin and foot care. Pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this happens, you should talk to your doctor immediately.

If you need to undergo major surgery, you should stop taking vildagliptin/metformin during the procedure and for a period of time after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when you can restart it.

Liver function tests 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 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 elderly person and/or if your kidney function is worsening.

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

Children and adolescents

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

Other medicines and Vildagliptin/Metformin Sandoz

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking vildagliptin/metformin before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/metformin and when you can restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood sugar and kidney function tests, or your doctor may need to adjust your vildagliptin/metformin dose. It is especially important to mention the following:

• glucocorticoids, usually used to treat inflammation,
• beta-2 agonists usually used to treat respiratory disorders,
• other active substances used to treat diabetes,
• medicines that increase urine production (diuretics),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• certain active substances that affect the thyroid,
• certain active substances that affect the nervous system,
• certain active substances used to treat angina (e.g., ranolazine),
• certain active substances used to treat HIV infection (e.g., dolutegravir),
• certain active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib),
• certain active substances used to treat stomach acidity and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Sandoz 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 are planning to have a baby, ask your doctor for advice before taking 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 Sandoz”).

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

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

3. How to take Vildagliptin/Metformin Sandoz

The dose of vildagliptin/metformin that you should take varies depending on your condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, talk to your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg film-coated tablet twice a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medicine, such as a sulfonylurea.

Your doctor may prescribe this medicine alone or with certain medicines that lower your blood sugar levels.

When and how to take Vildagliptin/Metformin Sandoz

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with meals or just after eating. Taking the tablet after meals will reduce the risk of digestive discomfort.

Follow any dietary recommendations given by your doctor. 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 Sandoz than you should

If you have taken more Vildagliptin/Metformin Sandoz than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you have taken too many vildagliptin/metformin tablets, or if someone else has taken your tablets, talk to your doctor or pharmacist immediately.You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the package and this leaflet with you.

If you forget to take Vildagliptin/Metformin Sandoz

If you forget to take a tablet, take it with your next meal, unless it is already time for your usual dose. Do not take a double dose (two tablets at the same time) to make up for forgotten doses.

If you stop taking Vildagliptin/Metformin Sandoz

Continue taking this medicine while your doctor prescribes it to keep your blood sugar under control. Do not stop taking vildagliptin/metformin unless your doctor tells you to. If you have any doubts about the duration of treatment, talk to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop 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 people): vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you should stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma,
• angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”,
• liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis),
• pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

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

• Common (may affect more than 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable shaking, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood sugar, loss of appetite, swollen ankles or feet (edema), chills, pancreatitis, muscle pain.
• Very rare (may affect up to 1 in 10,000 people): signs of having high acid levels in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or rapid breathing, skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, mental symptoms such as confusion or memory changes).

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis), which can cause skin rashes or spots, flat, red, and round patches under the skin or bruises.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina/Metformina Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and carton after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vildagliptina/Metformina Sandoz:

• The active ingredients are vildagliptina and metformina hydrochloride:

Vildagliptina/Metformina Sandoz 50 mg/850 mg contains 50 mg of vildagliptina and 850 mg of metformina hydrochloride (corresponding to 660 mg of metformina).

Vildagliptina/Metformina Sandoz 50 mg/1,000 mg contains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride (corresponding to 780 mg of metformina).

• The other ingredients are: hydroxypropylcellulose, magnesium stearate, hypromellose 2910 3cP, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000, and talc.

Appearance of the Product and Package Contents

Vildagliptina/Metformina Sandoz 50 mg/850 mg

Film-coated tablets of yellow color with beveled edges, oval-shaped with "NVR" on one side and "SEH" on the other.

Length: approximately 20.1 mm.

Width: approximately 8.0 mm.

Vildagliptina/Metformina Sandoz 50 mg/1,000 mg

Film-coated tablets of dark yellow color with beveled edges, oval-shaped, with "NVR" on one side and "FLO" on the other.

Length: approximately 21.1 mm.

Width: approximately 8.4 mm.

Vildagliptina/Metformina Sandoz is packaged in aluminum/aluminum (PA/Alu/PVC//Alu) blister packs or in polychlorotrifluoroethylene (PCTFE)/PVC//Alu blister packs or in polyvinyl chloride/polyethylene/polyvinylidene chloride/aluminum (PVC/PE/PVDC//Alu) blister packs.

Vildagliptina/Metformina Sandoz is available in packages containing 10, 30, 60, 120, 180, or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60), or 360 (6 packs of 60) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ul 57

1526 Ljubljana

Slovenia

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Slovenia

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764, 08013

Barcelona

Spain

Date of the Last Revision of this Prospectus:April 2025.

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