VILDAGLIPTINA AUROVITAS 50 mg TABLETS

Introduction

Package Leaflet:information for the user

Vildagliptina Aurovitas 50 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 signs of illness 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 Aurovitas and what is it used for
2. What you need to know before you take Vildagliptina Aurovitas
3. How to take Vildagliptina Aurovitas
4. Possible side effects
5. Storing Vildagliptina Aurovitas
6. Contents of the pack and other information

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

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

Vildagliptina is used to treat adult patients with type 2 diabetes. It is used 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 these 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 Aurovitas 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 can 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 Aurovitas

Do not take Vildagliptina Aurovitas

• 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 Aurovitas, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptina Aurovitas:

• 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 levels [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptina).
• if you are undergoing 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. Also, pay special attention to the appearance of blisters or ulcers while taking vildagliptina. If this occurs, 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 (transaminases) as soon as possible.

Children and adolescents

Vildagliptina is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Vildagliptina Aurovitas

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 if you are taking other medicines such as:

• thiazides or other diuretics (also known as water pills).
• corticosteroids (usually 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 take vildagliptina 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 use machines.

Vildagliptina Aurovitas contains lactose

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

Vildagliptina Aurovitas 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 Aurovitas

Follow exactly the instructions of administration 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 tablets to 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 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 undergoing dialysis.

How to take Vildagliptina Aurovitas

Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Aurovitas

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 regular checks to see if the treatment is having the desired effect.

If you take more Vildagliptina Aurovitas 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vildagliptina Aurovitas

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 forgotten doses.

If you stop taking Vildagliptina Aurovitas

Do not stop taking vildagliptina 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 other questions about the use of this medicine, ask your doctor or pharmacist.

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 and see your doctor immediately if you experience any of the following side effects:

Rare:may affect up to 1 in 1,000 people

• Angioedema: symptoms include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”.
• Pancreatitis: symptoms include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Not known:frequency cannot be estimated from the available data

• Hepatitis: symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).

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, tremors, headache, dizziness, muscle pain, joint pain, 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. Storing Vildagliptina Aurovitas

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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 you have any doubts, 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 Aurovitas

• The active substance is vildagliptina. Each tablet contains 50 mg of vildagliptina.
• The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Appearance of the product and pack contents

Vildagliptina Aurovitas 50 mg tablets are white to slightly yellowish, round, flat, beveled-edge tablets, engraved with “50” on one side, 8.1 ± 0.1 mm in diameter and 3.2 ± 0.3 mm in thickness.

Vildagliptina Aurovitas 50 mg tablets are presented in a cardboard box containing aluminum-OPA/ALU/PVC blisters with the corresponding number of tablets and a leaflet.

Presentation:

Packaging containing 28, 30, 56, or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Cyprus: Vildagliptin Pharmathen

Denmark: Vildagliptin Pharmathen

Spain: Vildagliptina Aurovitas 50 mg tablets EFG

France: Vildagliptine Arrow 50 mg, tablet

Greece: Vildagliptin/Pharmathen

Italy: Vildagliptin Aurobindo

Date of last revision of this leaflet:November 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/)