VILDAGLIPTINA TEVA 50 mg TABLETS

Introduction

Package Leaflet:information for the patient

Vildagliptina Teva 50 mg tablets EFG

Vildagliptina

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

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Vildagliptina Teva and what is it used for
2. What you need to know before you take Vildagliptina Teva
3. How to take Vildagliptina Teva
4. Possible side effects

5 Storage of Vildagliptina Teva

1. Contents of the pack and further information

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

The active substance in Vildagliptina Teva, vildagliptina, belongs to a group of medicines called “oral antidiabetics”.

Vildagliptina Teva is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled by diet and exercise alone. It helps to control blood sugar levels. Your doctor will prescribe Vildagliptina Teva alone or in combination with other antidiabetic medicines that you are already taking if they are not effective enough to control your diabetes.

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

How Vildagliptina Teva works

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

2. What you need to know before you take Vildagliptina Teva

Do not take Vildagliptina Teva

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptina or any other ingredient of Vildagliptina Teva, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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 an antidiabetic medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when taken together with vildagliptina to avoid low blood sugar [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptina).
• if you are on dialysis.
• if you have liver disease.
• if you have heart failure.
• if you have or have had pancreatitis.

If you have previously taken vildagliptina 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, paying special attention to the appearance of blisters or ulcers while taking vildagliptina. If this happens, you should consult your doctor as soon as possible.

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

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 medicines

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

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

• thiazides or other diuretics (also called water pills)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• certain medicines that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not use Vildagliptina Teva during pregnancy. It is not known if vildagliptina passes into breast milk. You should not take vildagliptina if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Vildagliptina Teva contains lactose

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

Vildagliptina Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Vildagliptina Teva

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptina that you should take varies depending on your condition. Your doctor will tell you exactly how many Vildagliptina Teva tablets to take. The maximum daily dose is 100 mg.

The recommended dose of Vildagliptina Teva is:

• 50 mg once daily in the morning if you are taking vildagliptina with another medicine known as a sulfonylurea.

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

• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.

How to take Vildagliptina Teva

Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Teva

• Take Vildagliptina Teva every day for as long as your doctor recommends. You may need to continue this treatment for a long time.

• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Vildagliptina Teva than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the prospectus of the medicine to the healthcare professional.

If you forget to take Vildagliptina Teva

If you forget to take a dose of this medicine, take it as soon as you remember. Then take the next dose at the 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 stop taking Vildagliptina Teva

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

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

You should stop taking this medicine and see your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”.
• • Hepatitis (frequency not known: cannot be estimated from the available data): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of hepatitis.
  • Pancreatitis (rare: may affect up to 1 in 1,000 people): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while taking vildagliptina:

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

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 rash or red, round, flat spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Teva

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 carton and blister after EXP. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Vildagliptina Teva

• The active substance is vildagliptina.

Each tablet contains 50 mg of vildagliptina.

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

Appearance of the product and pack contents

Vildagliptina Teva 50 mg tablets are white, round, flat tablets with beveled edges, 8.5 mm in diameter, and marked with “A013” on one side.

Vildagliptina Teva 50 mg tablets are available in packs containing 10, 14, 28, 30, 50, 56, 60, 90, 100, and 180 tablets, and in packs with unit-dose blisters containing 10 x 1, 30 x 1, 56 x 1, and 60 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 Krakow

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 last revision of this leaflet: May 2023

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/)