Prospecto:information for the user

Vildagliptin Aurovitas 50 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Vildagliptin Aurovitas

3.How to take Vildagliptin Aurovitas

4.Possible adverse effects

5.Storage of Vildagliptin Aurovitas

6.Contents of the package and additional information

The active ingredient of Vildagliptina Aurovitas, vildagliptin, belongs to a group of medications called “oral antidiabetics”.

Vildagliptin is used to treat adult patients with type 2 diabetes. It is used 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 medications 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 Aurovitas works

Vildagliptin stimulates the pancreas to produce more insulin and less glucagon. This helps control blood sugar levels. This medication has been shown to reduce blood sugar, which may help prevent complications of your diabetes. Although you start taking this medication for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended.

Do not take Vildagliptina Aurovitas

•if you are allergic to vildagliptin or any of the other ingredients of this medication (listed in section 6). If you think you might be allergic to vildagliptin or any other component of Vildagliptina Aurovitas, do not take this medication 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 a diabetes medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken together with vildagliptin to avoid low blood sugar [hypoglycemia]).

•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 pancreatitis.

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

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for 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 soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

This medication is not recommended for children and adolescents under 18 years old.

Other medications and Vildagliptina Aurovitas

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

Your doctor may change your vildagliptin dose if you are taking other medications such as:

•thiazides or other diuretics (also called urine medications).

•corticosteroids (usually used to treat inflammation).

•thyroid medications.

•certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medication.

You should not take vildagliptin during pregnancy.

The passage of vildagliptin into breast milk is unknown. Do not take vildagliptin if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

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

Vildagliptina Aurovitas contains lactose

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

Vildagliptina Aurovitas contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet; it 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 vildagliptin tablets that 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 along 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 Vildagliptin Aurovitas

Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptin Aurovitas

Take vildagliptin every day as your doctor indicates. You may need 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 Vildagliptin Aurovitas than you should

If you have taken too many vildagliptin tablets, 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.

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

If you forget to take Vildagliptin Aurovitas

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

If you interrupt treatment with Vildagliptin Aurovitas

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.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

You should stop taking vildagliptin and seek medical attention 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 hives or urticaria, which may be indicative of a reaction called “angioedema”.

•Pancreatitis (inflammation of the pancreas): symptoms include intense and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Unknown:frequency cannot be estimated from available data

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

Other side effects

Some patients experienced the following side 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

•Rash with itching, tremors, headache, dizziness, muscle pain, joint pain, constipation, swollen hands, ankles, or feet (edema), excessive sweating, vomiting, 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:

Frequency not known: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 spots under the skin's surface or hematomas.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vildagliptin Aurovitas

-The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.

-The other components are: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the package

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

Vildagliptin 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.

Presentations:

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

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 with 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

Last review date of thisleaflet:November 2023

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