VILDAGLIPTINA ZENTIVA 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Vildagliptina Zentiva50 mg tablets EFG

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 symptoms 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 Vildagliptina Zentiva and what is it used for
2. What you need to know before you take Vildagliptina Zentiva
3. How to take Vildagliptina Zentiva
4. Possible side effects
5. Storage of Vildagliptina Zentiva
6. Contents of the pack and other information

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

The active substance of Vildagliptina Zentiva, vildagliptina, belongs to a group of medicines called «oral antidiabetics».

Vildagliptina 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 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 Zentiva works

Vildagliptina 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 Zentiva

Do not take Vildagliptina Zentiva

? if you are allergic to vildagliptina 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 Zentiva, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking Vildagliptina Zentiva

? 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 diabetic medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when taken in combination with Vildagliptina Zentiva to avoid low blood sugar levels [hypoglycemia]).

? if you have moderate or severe kidney disease (you will need to take a lower dose of Vildagliptina Zentiva).

? 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 Zentiva. If this happens, you should consult your doctor as soon as possible.

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

Children and adolescents

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

Use of Vildagliptina Zentiva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• thiazides or other diuretics (also known as 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Vildagliptina Zentiva contains lactose and sodium

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

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

3. How to take Vildagliptina Zentiva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of 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 Zentiva tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptina is:

? 50 mg once daily in the morning if you are taking vildagliptina in combination 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 with 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 Zentiva

? Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Zentiva

? Take vildagliptina every day while your doctor tells you to. 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 Zentiva than you should

If you have taken too many vildagliptina 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 package with you.

If you forget to take Vildagliptina Zentiva

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 Zentiva

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

? Liver disease (hepatitis) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (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, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, stomach pain, and abdominal pain (abdominal pain), diarrhea, heartburn, nausea (discomfort), blurred vision.

? Uncommon (may affect up to 1 in 100 people): weight gain, chills, weakness, sexual dysfunction, low blood sugar levels, 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 rashes or red, flat, round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Zentiva

? 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"/"CAD". The expiry date is the last day of the month stated.

? Store in the original package to protect from moisture. This medicine does not require special temperature storage conditions.

• Do not use vildagliptina if you notice that the package is damaged or shows signs of deterioration.

? Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine.

This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Zentiva

? The active substance is vildagliptina.

Each tablet contains 50 mg of vildagliptina.

? The other ingredients are lactose, sodium carboxymethyl starch (type A) potato, and magnesium stearate.

Appearance of the product and pack contents

Vildagliptina Zentiva are round, white to off-white, mottled tablets, 8.00±0.5 mm in diameter.

Vildagliptina Zentiva 50 mg tablets are supplied in blister packs of: 14, 28, 30, 56, 60, and 180 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

S.C. Zentiva S.A.

B-dul Theodor Pallady nr.50, sector 3

Bucharest, cod. 032266

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Czech Republic, Portugal, France, United Kingdom (Northern Ireland), Italy, Spain Vildagliptin Zentiva

Date of last revision of this leaflet:April 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/