Vildagliptin Zentiva 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin Zentiva 50 mg tablets EFG

Read the entire 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, and you must not give it to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

1. What Vildagliptin Zentiva is and what it is used for
2. What you need to know before taking Vildagliptin Zentiva
3. How to take Vildagliptin Zentiva
4. Possible adverse effects
5. How to store Vildagliptin Zentiva
6. Contents of the pack and other information

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

The active substance in 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 by diet and exercise alone. It helps control blood sugar levels. Your doctor will prescribe vildagliptin either alone or in combination with other antidiabetic medicines you may already be 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 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 complications of your diabetes. Even if you start taking 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 Zentiva

Do not take Vildagliptin Zentiva

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptin 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 an antidiabetic medicine known as a sulfonylurea (your doctor may wish to reduce your sulfonylurea dose when taken together with Vildagliptin Zentiva 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 Zentiva).

• 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 must 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 Vildagliptin Zentiva. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Vildagliptin Zentiva, repeated every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating elevated liver enzymes (transaminases).

Children and adolescents

Administration of Vildagliptin Zentiva is not recommended in children and adolescents under 18 years of age.

Use of Vildagliptin Zentiva 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 Zentiva 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and use of machines

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

Vildagliptin Zentiva contains lactose and sodium

Vildagliptin Zentiva contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Vildagliptin Zentiva

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

How much to take and when

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

The recommended dose of vildagliptin is:

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

• 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 sulphonylurea, or with insulin.

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

How to take Vildagliptin Zentiva

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin Zentiva

• Take vildagliptin every day as directed by your doctor. You may need to continue this treatment for a long period of time.

• Your doctor will carry out periodic check-ups to monitor that the treatment is having the desired effect.

If you take more Vildagliptin Zentiva than you should

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

If you forget to take Vildagliptin Zentiva

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 Zentiva

Do not stop taking vildagliptin unless your doctor tells you to. If you have any doubts about the duration of treatment with vildagliptin, consult 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 Vildagliptina Zentiva 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): 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 pain in the abdomen (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, muscle pain, joint pain, constipation, swollen hands, ankles or feet (edema), excessive sweating, vomiting, stomach or abdominal pain, diarrhea, heartburn, nausea (feeling unwell), 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): 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 peeling of the skin or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and blister after “EXP”/”CAD”. The expiry date refers to the last day of the month indicated.

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

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

? Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines.

This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Zentiva

? The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

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

Nature of the product and contents of the pack

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

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

Only some 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

Further information on this medicinal product is available from 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 medicinal product 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 the most recent revision of this leaflet: April 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/