Package Leaflet: Information for the User

Vildagliptina Zentiva50 mg film-coated tablets

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• 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.

1. What isVildagliptina Zentivaand what it is used for

2. What you need to know before you start takingVildagliptina Zentiva

3. How to takeVildagliptina Zentiva

4. Possible side effects

5. Storage ofVildagliptina Zentiva

6. Contents of the pack and additional information

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

Vildagliptin is used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptin alone or in combination with other antidiabetic medicines you are already taking if these are not effective enough to control 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 increases blood sugar levels. Both substances are produced in the pancreas.

How Vildagliptina Zentiva works

Vildagliptin 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 diabetes complications. 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.

Do not take Vildagliptina Zentiva

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take 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 diabetes medicine known as a sulfonylurea (your doctor may want to reduce your dose of sulfonylurea when you take it together with Vildagliptina Zentiva to avoid low blood sugar [hypoglycemia]).

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

?if you are undergoing dialysis.

?if you have liver disease.

?if you have heart failure.

?if you have or have had a pancreatic disease.

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

Skin lesions are frequent complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care, paying special attention to the appearance of blisters or ulcers while taking Vildagliptina Zentiva. If this occurs, you must consult your doctor as soon as possible.

Tests of liver function should be performed before starting treatment with Vildagliptina Zentiva, at intervals of three months during the first year and thereafter on a periodic basis. This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Use of Vildagliptina Zentiva with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine.

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

-thiazides or other diuretics (also called urine medicines)

-corticosteroids (usually used to treat inflammation)

-thyroid medicines

-certain medicines that affect the nervous system.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

Vildagliptina Zentiva contains lactose and sodium

Vildagliptina Zentiva contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 Vildagliptina Zentiva tablets you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin is:

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

?100 mg per day in two doses of 50 mg 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.

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

How to take Vildagliptina Zentiva

?Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Zentiva

?Take vildagliptin every day as your doctor indicates. You may have to follow 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 Vildagliptina Zentiva than you should

If you have taken too many tablets of vildagliptin, 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.

If you forget to take Vildagliptina Zentiva

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 your next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Vildagliptina Zentiva

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

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

Any symptoms that require immediate medical attention

You should stop taking Vildagliptina Zentiva 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 includeswollen 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): 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 can reach your back, as well as nausea and vomiting.

Other side effects

Some patients experienced the following side effects while takingvildagliptin:

?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 area (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 glucose 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:

?Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red and rounded lesions under the skin surface or hematomas.

Communication 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

?Keep this medication out of the sight and reach of children.

?Do not use this medication after the expiration date that appears on the packaging and in the blister after “EXP”/”CAD”. The expiration date is the last day of the month indicated.

?Store in the original packaging to protect it from moisture.This medication does not require special temperature storage conditions.

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

?Loss medicines should not bethrown into the drains or trash. Dispose of the packaging and medicines that 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 that you no longer need.

By doing so, you will help protect the environment.

Composition of Vildagliptina Zentiva

? The active ingredient is vildagliptin.

Cada comprimido contiene 50 mg de vildagliptina.

? The other components are lactose, carboxymethylamidone sodium (type A) from potato and magnesium stearate.

Appearance of the product and contents of the packaging

Vildagliptina Zentiva are round tablets of white to off-white color, speckled with 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.

They may only be marketed in some sizes of packaging.

Marketing Authorization Holder

Z entiva, k.s.

U Kabelovny 130

102 37 Praga 10

Republic of Czech

Responsible for Manufacturing

S.C. Zentiva S.A.

B-dul Theodor Pallady nr. 50, sector 3

Bucharest, cod. 032266

Romania

For more information about this medication, please contact 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 medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

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

Last review date of this leaflet: April 2023

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