Leaflet: information for the user

Vildagliptin/Metformin Combix 50 mg/850 mg film-coated tablets EFG

Vildagliptin/hydrochloride of metformin

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, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Vildagliptin/Metformin Combix and what it is used for

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

3.How to take Vildagliptin/Metformin Combix

4.Possible side effects

5.Storage of Vildagliptin/Metformin Combix

6.Contents of the pack and additional information

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 rise.

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 levels, 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 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 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 abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor to 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 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

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.

Seek medical attention 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 metformin treatment: convulsions, cognitive decline, difficulty with movement, 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 seek medical attention 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 (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, 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.

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 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 and when to restart Vildagliptin/Metformin treatment.

Tests of liver function should be performed before starting Vildagliptin/Metformin treatment, at three-month intervals during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes as soon as possible.

During Vildagliptin/Metformin treatment, 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 worsening.

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

Vildagliptin/Metformin contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Children and adolescents

The administration of Vildagliptin/Metformin is not recommended in children and adolescents under 18 years old.

Other medications and Vildagliptin/Metformin

If you need to receive an intravenous injection of a contrast medium containing iodine, for example, 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 and when to restart Vildagliptin/Metformin treatment.

Inform your doctor if you are taking, have taken recently, 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)

-specific medications used to treat hypertension (ACE inhibitors and angiotensin II receptor antagonists)

-active principles that affect the thyroid

-active principles that affect the nervous system

-active principles used to treat angina pectoris (e.g., ranolazine)

-active principles used to treat HIV infection (e.g., dolutegravir)

-active principles used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)

-active principles used to treat stomach acid and 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 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"). 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 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 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 ofVildagliptin/Metformin

• 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.

The groove is not intended to break the tablet.

If you take moreVildagliptin/Metforminthan 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 forgot to takeVildagliptin/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 make up for the missed doses.

If you interrupt the treatment withVildagliptin/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 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 users):

Vildagliptin/metformin can cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you,you must 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) (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 (inflammation of the pancreas)infrequent: may affect up to 1 in 100 people): symptoms that includeintense 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 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 discomfort.
• 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, 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).

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 hematomas.

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 blisterafter “CAD”/”EXP”. 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 medications you no longer need at the SIGRE collection pointat 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

-The active principles are vildagliptin and hydrochloride of metformin.

-Each film-coated tablet of Vildagliptin/Metformin 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of hydrochloride of metformin (corresponding to 663 mg of metformin).

-The other components are: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, stearate of fumaric acid and sodium, and ready-to-use coating material (hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow (E 172)).

Appearance of the product and content of the container

Vildagliptin/Metformin 50 mg/850 mg film-coated tablets are yellow-colored, oval, oblong tablets with a notch on one face and “VA” on the other face.

Dimensions of the tablet: 19.4?0.5 mm.

Vildagliptin/Metformin is available in Alu/OPA-Alu-PVC blisters in containers with 10, 30, 60, 120, 180 or 360 film-coated tablets and in multiple containers with 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 – Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix (Madrid)

Spain

Last review date of this leaflet: February 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).