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

Introduction

Package Leaflet: Information for the Patient

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

Vildagliptin/Metformin Teva 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

1. What is Vildagliptin/Metformin Teva and what is it used for
2. What you need to know before you take Vildagliptin/Metformin Teva
3. How to take Vildagliptin/Metformin Teva
4. Possible side effects
5. Storage of Vildagliptin/Metformin Teva
6. Contents of the pack and other information

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

The active substances of Vildagliptin/Metformin Teva, 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 appears when the body does not produce enough insulin or when the insulin produced does not work properly. It can also appear when 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 increases blood sugar levels.

How Vildagliptin/Metformin Teva 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 Teva

Do not takeVildagliptin/Metformin Tevaif:

• 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,
• 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 an unusual fruity odor of the breath,
• you have recently had a heart attack or have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems,
• you have severe kidney function impairment,
• you have a severe infection or severe dehydration (massive water loss from the body),
• 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”,
• you have liver problems,
• you drink excessive alcohol (daily or only occasionally),
• you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before taking Vildagliptin/Metformin Teva.

Risk of lactic acidosis

Vildagliptin/metformin may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work 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 disorder 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 disorder 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,
• breathing difficulties,
• 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 disorder 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 to treat 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 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 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 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.

Taking Vildagliptin/Metformin Teva with other medicines

If you need to be administered a contrast medium containing iodine in your bloodstream, for example, in the context of an X-ray or examination, 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 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:

• glucocorticoids, usually used to treat inflammation,
• beta-2 agonists, usually used to treat respiratory disorders,
• other medicines 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, or
• specific medicines that affect the nervous system.
• specific active substances used to treat angina pectoris (e.g., ranolazine)
• specific active substances used to treat HIV infection (e.g., dolutegravir)
• specific active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• specific active substances used to treat stomach acidity and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Teva with alcohol

Avoid excessive alcohol consumption while taking vildagliptin/metformin, as this can increase the risk of lactic acidosis (see section “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 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 Teva”).

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 Teva

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 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, 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 Teva

• 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.

The “I”-shaped notch is to facilitate breaking and swallowing, but not to divide the tablet into equal doses.

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 Teva than you should

If you have taken more Vildagliptin/Metformin Teva than you should, consult your doctor, pharmacistor call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

You may need medical attention. If you have to visit a doctor or go to the nearest hospital, bring the package and this leaflet with you.

If you forget to take Vildagliptin/Metformin Teva

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 Teva

Continue taking this medicine while your doctor prescribes it 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 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 go to 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 to you, you should stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

Signs of having a high level of lactic acid in the blood, including drowsiness or dizziness, severe nausea and vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing.

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swelling of the face, tongue, or throat, difficulty swallowing, breathing difficulties, 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 can reach the 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 up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, weakness, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, acidity, stomach pain and abdominal area (abdominal pain).
• Uncommon (may affect up to 1 in 100 people): fatigue, metallic taste, low blood sugar, loss of appetite, swollen hands, ankles, or feet (edema), chills, muscle pain, skin redness, hives.
• Very rare (may affect up to 1 in 10,000 people): 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 flat, red, and round spots under the skin surface or bruises.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect 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 Teva

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

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

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the 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 ofVildagliptina/Metformina Teva

• The active ingredients are vildagliptina and metformina hydrochloride.
• Each vildagliptina/metformina 50 mg/850 mg tablet contains 50 mg of vildagliptina and 850 mg of metformina hydrochloride (corresponding to 660 mg of metformina).
• Each vildagliptina/metformina 50 mg/1,000 mg tablet contains 50 mg of vildagliptina and 1,000 mg of metformina hydrochloride (corresponding to 780 mg of metformina).
• The other excipients are:

Core: Hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

Coating: Hypromellose 2910, 6cps, titanium dioxide (E171), copovidone, polydextrose, macrogol 3350, yellow iron oxide (E172), medium-chain triglycerides.

Appearance of the Product and Package Contents

Vildagliptina/Metformina Teva 50 mg/850 mg are film-coated tablets of yellow color, oval and biconvex, with a size of 8.5 x 21 mm with an "I"-shaped notch on one side and marked with "A 8" on the other side.

The "I"-shaped notch is used to break and facilitate swallowing, but not to divide the tablet into equal doses.

Vildagliptina/Metformina Teva 50 mg/1,000 mg are film-coated tablets of dark yellow color, oval and biconvex, with a size of 9.2 x 23 mm with an "I"-shaped notch on one side and marked with "A 1" on the other side.

The "I"-shaped notch is used to break and facilitate swallowing, but not to divide the tablet into equal doses.

It is available in packages of 10, 12, 30, 60, 100, and 180 film-coated tablets, multiple packages of 60 (2 packages of 30) film-coated tablets, and in single-dose packages with perforated blister of 30 x 1 and 60 x 1 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Nederland BV

Swensweg 5,

2031GA Haarlem,

Netherlands

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80, 31-546 Kraków,

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

Blaubeuren 89143, Baden-Wuerttemberg,

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25,

10000 Zagreb,

Croatia

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

Local Representative:

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Spain

Date of the Last Revision of thisProspectus:March 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/)