Prospect: 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 this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isVildagliptin/Metformin Tevaand for what it is used

2. What you need to know before starting to takeVildagliptin/Metformin Teva

3. How to takeVildagliptin/Metformin Teva

4. Possible adverse effects

5. Storage ofVildagliptin/Metformin Teva

6. Contents of the package and additional information

The active ingredients of Vildagliptina/Metformina Teva, 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 Teva 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 takeVildagliptin/Metformin Teva:

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medication (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 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 fluids),
• if you are going to have a radiology contrast study (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 occasionally),
• if you are breastfeeding (also see "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 function 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 diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking vildagliptin/metformin for a short period of time 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 of the symptoms that produce lactic acidosis,as this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain (stomach 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, you should 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 you take it together with vildagliptin/metformin to avoid low blood sugar (hypoglycemia).

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

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, you should 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.

Tests of liver function 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 as soon as possible any sign indicating an increase in liver enzymes (transaminases).

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 deteriorating.

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

Children and adolescents

The administration of vildagliptin/metformin is not recommended in children and adolescents under 18 years of age.

TakingVildagliptin/Metformin Tevawithother medications

If you need to be administered in your bloodstream an injection of a contrast medium containing iodine, for example, in the context of a radiography or an examination, you should 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 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, generally used to treat inflammation,
• beta-2 agonists, generally used to treat respiratory disorders,
• other medications used to treat diabetes,
• medications that increase urine production (diuretics),
• 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 medications that affect the thyroid,
• certain medications that affect the nervous system,
• certain active principles used to treat angina pectoris (for example, ranolazine)
• certain active principles used to treat HIV infection (for example, dolutegravir)
• certain active principles used to treat a specific type of thyroid cancer (medullary thyroid cancer) (for example, vandetanib)
• certain active principles used to treat stomach acid and peptic ulcers (for example, cimetidine)

TakingVildagliptin/Metformin Tevawithalcohol

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 intend 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 Teva").

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 of 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/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, 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 Teva

• 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.

The "I" shaped groove serves to break and facilitate 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, pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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 Teva

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 compensate for the missed doses.

If you interrupt treatment with Vildagliptin/Metformin Teva

Continue taking this medication while your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not interrupt 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 doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You shouldstop 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 "Warnings and precautions" section). If this happens, you shouldstop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Signs of having high levels of lactic acid in the blood that include drowsiness or dizziness, vomiting and severe nausea, abdominal pain, irregular heartbeat or deep, 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, 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 up to 1 in 10 people):sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremor, weakness, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, abdominal pain and stomach pain.
• Infrequent (may affect up to 1 in 100 people): fatigue, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles or feet (edema), chills, muscle pain, skin redness, urticaria.
• Very rare (may affect up to 1 in 10,000 people): decrease in vitamin B12 levels (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 bruises.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainer and blister packafter CAD. The expiration date is the last day of the month indicated.

Do not store above 25°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 containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition ofVildagliptin/Metformin Teva

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each vildagliptin/metformin 50 mg/850 mg tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
• Each vildagliptin/metformin 50 mg/1,000 mg tablet contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
• The otherexcipientsare:

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 contents of the package

Vildagliptin/Metformin Teva 50 mg/ 850 mg are yellow-coated, oval, biconvex tablets, 8.5 x 21 mm in size, with a notch in the shape of “I” on one face and marked with “A 8” on the other face.

The notch in the shape of “I” serves to facilitate swallowing, but not to divide the tablet into equal doses.

Vildagliptin/Metformin Teva 50 mg/ 1,000 mg are dark yellow-coated, oval, biconvex tablets, 9.2 x 23 mm in size, with a notch in the shape of “I” on one face and marked with “A 1” on the other face.

The notch in the shape of “I” serves to facilitate swallowing, but not to divide the tablet into equal doses.

It is available in packages of 10, 12, 30, 60, 100, and 180coated tablets, multiple packs of 60 (2 packs of 30) coated tablets, and in single-dose blister packs of 30x1 and 60x1 coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Responsible 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

Last revision date of thisleaflet:May 2023

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