VILDAGLIPTIN/METFORMIN AUROVITAS 50 mg/1000 mg FILM-COATED TABLETS

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

Do not take Vildagliptin/Metformin Aurovitas

• if you are allergic to vildagliptin, metformin hydrochloride, 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, consult your doctor before taking this medicine.
• 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 of 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 water loss from the body).
• 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 "Warnings and precautions" section.
• 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

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, consult your doctor for further instructions.

Stop taking vildagliptin/metformin for a short period 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. 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 produce lactic acidosis, 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
• reduction of body temperature and heart rate

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

Consult your doctor quickly to indicate 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 present any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Vildagliptin/metformin is not a substitute for insulin. Therefore, you should not take this medicine for the treatment of type 1 diabetes.

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

Consult your doctor, pharmacist, or nurse before starting to take vildagliptin/metformin if you are taking a diabetic medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken together 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 occurs, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking vildagliptin/metformin while the procedure is being performed and for a period after it. Your doctor will decide when you should stop taking vildagliptin/metformin and when to 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 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 renal 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 Aurovitas

If you need to be administered a contrast medium containing iodine in 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 to restart it.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. 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:

• corticosteroids, 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 used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• specific medicines that affect the thyroid.
• specific medicines that affect the nervous system.
• certain medicines used to treat angina (e.g., ranolazine).
• certain medicines used to treat HIV infection (e.g., dolutegravir).
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib).
• certain medicines used to treat stomach acid and peptic ulcers (e.g., cimetidine).

Taking Vildagliptin/Metformin Aurovitas with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see "Warnings and precautions" section).

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 (see also "Do not take Vildagliptin/Metformin Aurovitas").

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Your concentration and reaction ability may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as vision difficulties. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines.

Vildagliptin/Metformin Aurovitas contains maltodextrin

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

3. How to take Vildagliptin/Metformin Aurovitas

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 in doubt, consult your doctor or pharmacist again.

The recommended dose is one 50 mg/850 mg or 50 mg/1,000 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 known 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 Aurovitas

• Swallow the tablets whole 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 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 Aurovitas than you should

If you have taken too many tablets of this medicine or if someone else has taken your tablets, consult 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.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vildagliptin/Metformin Aurovitas

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 missed doses.

If you stop taking Vildagliptin/Metformin Aurovitas

Continue taking this medicine while your doctor prescribes it to continue controlling your blood sugar. 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 medicine, ask your doctor, pharmacist, or nurse.

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 contact your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people): this medicine may cause a very rare but very serious side effect called lactic acidosis (see "Warnings and precautions" section). 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 swollen 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-colored 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 hydrochloride:

• Frequent (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, 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 hands, 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 levels of vitamin B12 (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) that can cause skin rashes or spots, flat, red, and round patches under the skin surface or bruising.

Reporting of side effects

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

5. Storage of Vildagliptina/Metformina Aurovitas

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

• Do not use this medicine after the expiry date which is stated on the blister and on the carton after "EXP". The expiry date refers to the last day of the month shown.

• Do not store above 30°C.

• Store in the original package (blister) to protect from moisture.

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

6. Package Contents and Additional Information

Composition ofVildagliptina/Metformina Aurovitas

• The active substances are vildagliptin and metformin hydrochloride.

Each film-coated tablet of Vildagliptina/Metformina Aurovitas 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).

Each film-coated tablet of Vildagliptina/Metformina Aurovitas 50 mg/1,000 mg contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

• The other ingredients are: copovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E171), talc, yellow iron oxide (E172), maltodextrin, medium-chain triglycerides.

Appearance of the Product and Package Contents

Vildagliptina/Metformina Aurovitas 50 mg/850 mg film-coated tablets EFG are yellow, oval tablets, marked with "50" on one side and "850" on the other, with the following dimensions: length 21.6 ± 0.2 mm, width 8.6 ± 0.2 mm and thickness 7.4 ± 0.4 mm.

Vildagliptina/Metformina Aurovitas 50 mg/1,000 mg film-coated tablets EFG are dark yellow, oval tablets, marked with "50" on one side and "1000" on the other, with the following dimensions: length 22.0 ± 0.2 mm, width 9.0 ± 0.2 mm and thickness 8.1 ± 0.4 mm.

Vildagliptina/Metformina Aurovitas is presented in a cardboard box containing the corresponding number of OPA/Al/PVC-Al or PVC/PCTFE-Al transparent blisters.

Vildagliptina/Metformina Aurovitas is available in packs of 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

or

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Vedfa

France: Vildagliptin/Metformine Arrow 50 mg/1000 mg, film-coated tablet

Spain: Vildagliptina/Metformina Aurovitas 50 mg/850 mg film-coated tablets EFG and Vildagliptina/Metformina Aurovitas 50 mg/1,000 mg film-coated tablets EFG

Italy: Vildagliptin and Metformin Aurobindo

Portugal: Metformin + Vildagliptin Generis

Greece: Vedfa

Cyprus: Vedfa

Date of the last revision of this leaflet: May 2025

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