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

Introduction

Package Leaflet: Information for the User

Vildagliptin/Metformin Vir 50 mg/1,000 mg film-coated tablets EFG

vildagliptin / metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What you need to know before you take Vildagliptin/Metformin Vir

1. How to take Vildagliptin/Metformin Vir

1. Possible side effects

1. Storage of Vildagliptin/Metformin Vir

1. Pack contents and further information

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

The active substances of Vildagliptin/Metformin Vir, vildagliptin and metformin, belong to a group of medicines 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 by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It can also occur when the body produces too much glucagon.

Insulin and glucagon are produced in the pancreas. Insulin helps to lower blood sugar levels, especially after meals. Glucagon promotes the production of sugar by the liver and increases blood sugar levels.

How Vildagliptin/Metformin Vir works

Both active substances, vildagliptin and metformin, help control blood sugar levels. The active substance vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active substance metformin helps the body use insulin better. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes.

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

Do not take Vildagliptin/Metformin Vir

• 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, consult 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 water loss from the body).
• if you are going to have a contrast radiography (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

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
• decrease in body temperature and heart rate

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

Consult your doctor quickly 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 vildagliptin/metformin 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 happens, 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 treatment with 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 (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 renal function is deteriorating.

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 Vir

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 treatment with 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 Vir. 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 for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain active substances that affect the thyroid, or
• 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 acid and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Vir with alcohol

Avoid excessive alcohol consumption while taking Vildagliptin/Metformin Vir, 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, 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 Vir”).

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.

3. How to take Vildagliptin/Metformin Vir

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.

How to take Vildagliptin/Metformin Vir

• 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 Vir 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin Vir

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 Vir

Continue taking this medicine while your doctor prescribes it for you to continue controlling your blood sugar. Do not stop 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 further questions on 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 takingvildagliptin/metformin andgo to your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to 1 user in 10,000):

Vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you should stop takingvildagliptin/metforminand 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) (rare): 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 (frequency not known): symptoms that include severe and persistent abdominal pain (stomach area), which can radiate to the 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, stomach pain (abdominal pain), loss of appetite.
• Common (may affect up to 1 in 10 people): dizziness, headache, tremor, metallic taste, low blood sugar.
• 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 lactic acid levels in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing, skin redness, itching; decreased levels of vitamin B12 (pallor, fatigue, mental symptoms such as confusion or memory changes).

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

• Common: dizziness, tremor, weakness, low blood sugar, excessive sweating.

Some patients have had the following side effects while taking vildagliptin/metformin and insulin:

• Common: headache, chills, nausea (discomfort), low blood sugar, heartburn.
• Uncommon: diarrhea, flatulence.

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

• Frequency not known (cannot be estimated from the available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.

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: 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 Vir

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 packaging and blister after “EXP”. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vildagliptina/Metformina Vir

• The active substances are vildagliptina and metformin hydrochloride.

• Each film-coated tablet contains 50 mg of vildagliptina and 1,000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

• The other ingredients are:
• Tablet core: hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate,
• Coating material: hypromellose, titanium dioxide (E 171), copovidone, polydextrose (E 1200), macrogol 3350, yellow iron oxide (E 172), and medium-chain triglycerides.

Appearance and Package Contents of the Product

Vildagliptina/Metformina Vir 50 mg/1,000 mg are oval, yellow-brown, biconvex, film-coated tablets, approximately 9.7 mm x 23.5 mm in size, scored on one side and engraved with “A1” on the other side.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Vildagliptina/Metformina Vir is available in aluminum/OPA/PVC-aluminum blisters of 60 film-coated tablets, aluminum/OPA/PVC-aluminum unit-dose blisters precut into 60 film-coated tablets, and a multiple pack of 60 tablets (2 subunits of 30 tablets each) in aluminum/OPA/PVC-aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 – Alcorcón (Madrid), Spain

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitza 2600

Bulgaria

Date of the Last Revision of this Leaflet: March 2025

Detailed and updated information on this medicine is available on the website of

the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/