Vildagliptin Aurovitas 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Vildagliptina Aurovitas, vildagliptin, belongs to a group of medicines called "oral antidiabetics".

Vildagliptin 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 control blood sugar levels. Your doctor will prescribe vildagliptin 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 Aurovitas 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 may 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 Aurovitas

Do not take Vildagliptin Aurovitas

• if you are allergic to vildagliptin 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 Aurovitas, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Vildagliptin 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 sulfonylurea 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 must not take this medicine.

Skin lesions are common complications of diabetes. Follow your doctor’s or nurse’s advice regarding skin and foot care. Also pay 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, at three-month intervals during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating increased liver enzymes (transaminases).

Children and adolescents

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

Other medicines and Vildagliptin Aurovitas

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 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 take vildagliptin 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 using machines

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

Vildagliptin Aurovitas contains lactose

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

Vildagliptin Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially “sodium-free”.

3. How to take Vildagliptin Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 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 50 mg at night, 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 Aurovitas

Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin Aurovitas

Take vildagliptin 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 the treatment is having the desired effect.

If you take more Vildagliptin Aurovitas than you should

If you have taken too many vildagliptin 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 your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin Aurovitas

If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the 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 a missed dose.

If you stop taking Vildagliptin Aurovitas

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

4. Possible adverse effects

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

Some symptoms require immediate medical attention

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

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

• Angioedema: symptoms include swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may indicate a reaction called “angioedema”.
• Inflammation of the pancreas (pancreatitis): symptoms include severe and persistent pain in the abdomen (stomach area), which may radiate to your back, as well as nausea and vomiting.

Not known: frequency cannot be estimated from the available data

• Liver disease (hepatitis): symptoms include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).

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 and abdominal pain (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 marketing of this product, the following adverse effects have also been reported:

Frequency not known: cannot be estimated from the available data

• Localized skin peeling 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 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Aurovitas

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 on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin Aurovitas

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

Appearance of the medicinal product and contents of the pack

Vildagliptin Aurovitas 50 mg tablets are white to slightly yellow, round, flat, bevel-edged tablets, engraved with "50" on one side, with a diameter of 8.1 ± 0.1 mm and a thickness of 3.2 ± 0.3 mm.

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

Presentations:

Packs containing 28, 30, 56 or 60 tablets.

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Cyprus: Vildagliptin Pharmathen

Denmark: Vildagliptin Pharmathen

Spain: Vildagliptina Aurovitas 50 mg tablets EFG

France: Vildagliptine Arrow 50 mg, comprimé

Greece: Vildagliptin/Pharmathen

Italy: Vildagliptin Aurobindo

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

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