Vildagliptin Teva 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vildagliptin Teva 50 mg tablets EFG

Vildagliptin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

2. What you need to know before taking Vildagliptin Teva

3. How to take Vildagliptin Teva

4. Possible side effects

5. Storage of Vildagliptin Teva

6. Contents of the pack and other information

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

The active substance in Vildagliptina Teva, vildagliptin, 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 control blood sugar levels. Your doctor will prescribe Vildagliptina Teva alone or in combination with other antidiabetic medicines you are already taking, if these are not sufficiently effective in controlling diabetes.

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

Insulin is a substance that helps lower 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 Teva stimulates 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. Even after starting this medicine for your diabetes, it is important that you continue with the diet and/or exercise regimen recommended to you.

2. What you need to know before starting to take Vildagliptin Teva

Do not take Vildagliptin Teva

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Vildagliptin 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 sulphonylurea (your doctor may want to reduce your sulphonylurea dose when taken together with vildagliptin to avoid low blood glucose levels [hypoglycaemia]).
• 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 a disease of the pancreas.

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

Skin lesions are common complications of diabetes. Follow your doctor's or nurse's advice regarding 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, every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating an increase in liver enzymes.

Children and adolescents

The use of Vildagliptin Teva is not recommended in children and adolescents under 18 years of age.

Taking Vildagliptin Teva with other medicines

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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use Vildagliptin Teva during pregnancy. It is unknown whether vildagliptin passes into breast milk. You must not take vildagliptin if you are breastfeeding or planning to breastfeed.

Driving and use of machines

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

Vildagliptin Teva contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Vildagliptin Teva contains sodium

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

3. How to take Vildagliptin Teva

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin each person should take varies depending on their condition. Your doctor will tell you exactly how many tablets of Vildagliptin Teva you should take. The maximum daily dose is 100 mg.

The recommended dose of Vildagliptin Teva is:

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

• 100 mg daily in two divided doses of 50 mg in the morning and evening, if you are taking vildagliptin 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 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 long as your doctor tells you to. You may need to continue this treatment for a long period of time.

• Your doctor will carry out periodic 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 medicine, consult your doctor immediately. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the packaging with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Vildagliptin Teva

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

If you stop taking Vildagliptin Teva

Do not stop taking Vildagliptin Teva unless your doctor tells you to. If you have any doubts about how long you should continue treatment with vildagliptin, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Some symptoms require immediate medical attention

You must stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects:

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

Other adverse effects

Some patients experienced the following adverse effects while taking vildagliptin:

• 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, constipation, swollen hands, ankles or feet (edema), excessive sweating, vomiting, stomach and abdominal pain, diarrhea, heartburn, nausea (feeling unwell), blurred vision.
• Uncommon (may affect up to 1 in 100 people): fatigue, hives, weight gain, chills, sexual dysfunction, low blood glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): inflammation of the pancreas.

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

• Frequency not known (cannot be estimated from available data): localized skin peeling or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots beneath the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Teva

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin Teva

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

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

Appearance of the product and contents of the pack

Vildagliptin Teva 50 mg tablets are white, round, flat tablets with bevelled edges, 8.5 mm in diameter, marked with "A013" on one side.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

Teva Nederland BV

Swensweg 5,

2031GA Haarlem,

The 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, 1st floor

Alcobendas 28108 Madrid

Spain

Date of the most recent review of this leaflet: May 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)