Prospecto:Information for the Patient

Vildagliptina Teva 50 mg Tablets EFG

Vildagliptina

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they are not listed in this prospectus. See section 4.

1.What is Vildagliptina Teva and what is it used for

2.What you need to knowbeforestarting totake Vildagliptina Teva

3.How to take Vildagliptina Teva

4.Possible adverse effects

5Storage of Vildagliptina Teva

6.Contents of the package and additional information

The active ingredient of Vildagliptina Teva, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.

Vildagliptina Tevais used to treat adult patients with type 2 diabetes when the diabetes cannot be controlled solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribeVildagliptina Tevaalone or in combination with other antidiabetic medicines you are already taking if these are not sufficiently effective in controlling diabetes.

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 is a substance that helps reduce blood sugar levels, especially after meals. Glucagon is a substance that promotes sugar production by the liver and causes blood sugar levels to rise. Both substances are produced in the pancreas.

How Vildagliptina Teva works

Vildagliptina Tevastimulates the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medicine has been shown to reduce blood sugar, which will help prevent complications of your diabetes. Although you start taking this medicine for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended to you.

Do not take Vildagliptina Teva

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6). If you think you might be allergic to vildagliptin or any other component of Vildagliptina Teva, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptina Teva:

• if you have type 1 diabetes (i.e., your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
• if you are taking a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood sugar [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptin).
• if you are undergoing dialysis.
• if you have liver disease.
• if you have heart failure.
• if you have or have had pancreatitis.

If you have previously taken vildagliptin but had to stop taking it 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, paying special attention to the appearance of blisters or ulcers while taking vildagliptin. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptin, 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.

Children and adolescents

The administration of Vildagliptina Teva is not recommended in children and adolescents under 18 years of age.

Taking Vildagliptina Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor may change your Vildagliptina Teva dose if you are taking other medications such as:

• tiazides or other diuretics (also known as urine medications)
• corticosteroids (usually used to treat inflammation)
• thyroid medications
• certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medication.

You should not use Vildagliptina Teva during pregnancy. It is unknown whether vildagliptin passes into breast milk. Do not take vildagliptin if you are breastfeeding or plan to breastfeed.

Driving and operating machines

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

Vildagliptina Teva contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Vildagliptina Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin that each person should take varies depending on their condition. Your doctor will indicate exactly the number of Vildagliptin Teva tablets you should take. The maximum daily dose is 100mg.

The recommended dose of Vildagliptin Teva is:

• 50mg once a day in the morning, if you are taking vildagliptin with another medication known as a sulfonylurea.

• 100mg per day in two doses of 50mg in the morning and evening if you are taking vildagliptin alone, with another medication known as metformin or a glitazone, with a combination of metformin and a sulfonylurea, or with insulin.

• 50mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Vildagliptin Teva

Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin Teva

• Take Vildagliptin Teva every day as your doctor indicates. You may need to continue this treatment for a long period of time.

• Your doctor will perform regular checks to ensure that the treatment is having the desired effect.

If you take more Vildagliptin Teva than you should

If you have taken too many Vildagliptin Teva tablets, or if someone else has taken your medication,consult your doctor immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Vildagliptin Teva

If you forget to take a dose of this medication, take it as soon as you remember. Then take the next dose at your usual time. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Vildagliptin Teva

Do not stop taking Vildagliptin Teva unless your doctor tells you to. If you have doubts about the duration of treatment with vildagliptin, consult your doctor.

If you have any other questions about the use of thismedication, ask your doctor.

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

Some symptoms require immediate medical attention

You should stop taking this medicine and seek medical attention immediately if you experience any of the following side effects:

• 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 hives or urticaria, which may be indicative of a reaction called “angioedema”.
• • Liver disease (hepatitis) (unknown frequency: cannot be estimated from available data): 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 (inflammation of the pancreas) (rare: may affect up to 1 in 1,000 people): symptoms that include intense and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptin:

• Very common(may affect more than 1in 10people): sore throat, nasal congestion, fever.
• Common (may affect up to 1 in 10 people): skin rash with itching, tremor, headache, dizziness, weakness,muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating,vomiting,abdominal pain and stomach area pain, diarrhea, heartburn,nausea (discomfort), blurred vision.
• Uncommon (may affect up to 1 in 100 people): fatigue, urticaria, weight gain, chills, sexual dysfunction,low blood glucose levels, flatulence.
• Rare (may affect up to 1in 1,000people): pancreatitis.

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, pointed, red, and rounded spots under the skin 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.

Keepthis medicationout of the sight and reach of children.

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

Do not store above 25°C.

Keep in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in 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. In this way, you will help protect the environment.

Composition ofVildagliptin Teva

• The active ingredient is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other excipients are microcrystalline cellulose, lactose, carboxymethylstarch sodium (type A) from potato and magnesium stearate.

Appearance of the product and contents of the package

Vildagliptin Teva 50 mg tablets are white, round, flat, beveled-edge tablets, with a diameter of 8.5 mm and marked with “A013” on one side.

Vildagliptin Teva 50 mg tablets are available in packages containing 10, 14, 28, 30, 50, 56, 60, 90, 100, and 180 tablets and in blister packs containing 10 x 1, 30 x 1, 56 x 1, and 60 x 1 tablets.

Only some package sizes may be marketed.

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,

89143 Blaubeuren, 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 review date of this leaflet: 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/)