Package Insert: Information for the Patient

Vildagliptin/Metformin Sandoz50 mg/850 mg Film-Coated Tablets

Vildagliptin/Metformin Sandoz50 mg/1,000 mg Film-Coated Tablets

vildagliptin/hydrochloride metformin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

The active ingredients of Vildagliptina/Metformina Sandoz, 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 makes blood sugar levels increase.

How Vildagliptina/Metformina Sandoz 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 Vildagliptina/Metformina Sandoz

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medication (listed in section 6). If you think you might be allergic to any of these components, 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 water),
• if you are undergoing a radiology contrast study (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 Vildagliptina/Metformina Sandoz.

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 deafness (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 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,
• 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.

Vildagliptin/metformin is not a substitute for insulin. Therefore, do not take vildagliptin/metformin for the treatment of type 1 diabetes.

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

Consult your doctor or pharmacist 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 taken concomitantly with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

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, 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.

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 (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 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 Vildagliptina/Metformina Sandoz

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 medication. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/metformin. It is especially important to mention the following:

• glucocorticoids, 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,
• 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),
• certain active principles that affect the thyroid,
• certain active principles that affect the nervous system,
• certain active principles used to treat angina (e.g., ranolazine),
• certain active principles used to treat HIV infection (e.g., dolutegravir),
• certain active principles used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib),
• certain active principles used to treat stomach acid and peptic ulcers (e.g., cimetidine).

Taking Vildagliptina/Metformina Sandoz 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 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 Vildagliptina/Metformina Sandoz").

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

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/1000 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, such as a sulfonylurea.

Your doctor may prescribe this medication alone or with certain medications that lower the level of sugar in your blood.

When and how to take Vildagliptin/Metformin Sandoz

• Swallow the whole tablets with a glass of water.
• Take one tablet in the morning and another 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 from 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you have taken too many vildagliptin/metformin tablets, 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.

If you forget to take Vildagliptin/Metformin Sandoz

If you forget to take a tablet, take it with the next meal, unless it is already time for 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 Sandoz

Continue taking this medication while your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not stop taking 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 or pharmacist.

Like all medicines, this medicine may 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 people): 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 muststop 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 swelling of the 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 include yellowing 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 up to 1 in 100 people): 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:

• Frequent (may affect more than 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremor, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain, and abdominal pain.
• Infrequent (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, 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 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 deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (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), which may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin or bruises.

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 theSpanish 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the box after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Vildagliptin/Metformin Sandoz:

• The active ingredients are vildagliptin and hydrochloride of metformin:

Vildagliptin/Metformin Sandoz 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (corresponding to 660 mg of metformin).

Vildagliptin/Metformin Sandoz 50 mg/1,000 mg contains 50 mg of vildagliptin and 1,000 mg of hydrochloride of metformin (corresponding to 780 mg of metformin).

• The other components 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 contents of the package:

Vildagliptin/Metformin Sandoz 50 mg/850 mg

Coated tablets with a yellow film, bisected, oval, with "NVR" on one face and "SEH" on the other.

Length: approximately 20.1 mm.

Width: approximately 8.0 mm.

Vildagliptin/Metformin Sandoz 50 mg/1,000 mg

Coated tablets with a dark yellow film, bisected, oval, with "NVR" on one face and "FLO" on the other.

Length: approximately 21.1 mm.

Width: approximately 8.4 mm.

Vildagliptin/Metformin Sandoz is packaged in aluminum/aluminum (PA/Alu/PVC//Alu) blisters or in polytetrafluoroethylene (PCTFE)/PVC//Alu blisters or in polyvinyl chloride/polyethylene/polyvinylidene chloride/aluminum (PVC/PE/PVDC//Alu) blisters.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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,

9220Lendava,

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

Last review date of this prospectus:April 2025.

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