VILDAGLIPTINA ALTER 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Vildagliptina Alter 50 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Vildagliptina Alter and what is it used for
2. What you need to know before taking Vildagliptina Alter
3. How to take Vildagliptina Alter
4. Possible side effects
5. Storage of Vildagliptina Alter
6. Package Contents and Additional Information

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

The active ingredient of this medication, vildagliptin, belongs to a group of medications 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 alone or in combination with other antidiabetic medications that you are already taking if they are not effective enough to control diabetes.

Type 2 diabetes occurs if the body does not produce enough insulin or if the insulin produced does not work properly. It can also occur 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 Alter 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 will 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 recommended by your doctor.

2. What you need to know before taking Vildagliptina Alter

Do not take Vildagliptina Alter

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication

• 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 medication known as a sulfonylurea (your doctor may want to reduce your sulfonylurea dose when taken in combination with vildagliptin to avoid low blood sugar levels [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 taking it due to liver disease, you should not take this medication.

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 vildagliptina. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with vildagliptin, 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

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

Other Medications and Vildagliptina Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

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

• thiazides or other diuretics (also called water pills)
• corticosteroids (generally used to treat inflammation)
• thyroid medications
• certain medications that affect the nervous system.

Pregnancy and Breastfeeding

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

You should not use vildagliptin during pregnancy. It is not known if vildagliptin passes into breast milk. You should not take vildagliptin if you are breastfeeding or planning to breastfeed.

Driving and Using Machines

Your ability to concentrate and react may be affected due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is recommended to drive or use machines. If you feel dizzy while taking vildagliptina, do not drive or operate tools or machines.

Vildagliptina Alter 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 Alter Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to Take Vildagliptina Alter

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. 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 how many vildagliptin 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 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 or with another medication known as a glitazone.
• 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 Alter

• Swallow the tablet whole with a little water.

Duration of Treatment with Vildagliptina Alter

• Take vildagliptina every day while your doctor indicates. You may need to follow this treatment for a long period.
• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If You Take More Vildagliptina Alter Than You Should

If you have taken too many vildagliptina 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, 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 medication and the amount ingested.

If You Forget to Take Vildagliptina Alter

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 Stop Taking Vildagliptina Alter

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Some Symptoms Require Immediate Medical Attention

You should stop taking vildagliptin and see your doctor immediately if you experience any of the following side effects:

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms including swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called "angioedema".
• Liver disease (hepatitis) (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (frequency not known): symptoms including severe and persistent abdominal pain (stomach area), which can radiate to the back, as well as nausea and vomiting.

Other Side Effects

Some patients experienced the following side effects while taking vildagliptin and metformin:

• Common (may affect up to 1 in 10 people): tremor, headache, dizziness, nausea, low blood sugar.
• Uncommon (may affect up to 1 in 100 people): fatigue.

Some patients experienced the following side effects while taking vildagliptin and a sulfonylurea:

• Common: tremor, headache, dizziness, weakness, low blood sugar.
• Uncommon: constipation.
• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion.

Some patients experienced the following side effects while taking vildagliptina and a glitazone:

• Common: weight gain, swollen hands, ankles, or feet (edema).
• Uncommon: headache, weakness, low blood sugar.

Some patients experienced the following side effects while taking vildagliptina alone:

• Common: dizziness.
• Uncommon: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar.
• Very rare: sore throat, nasal congestion, fever.

Some patients have had the following side effects while taking vildagliptin, metformin, and a sulfonylurea:

• Common: dizziness, tremor, weakness, low blood sugar, excessive sweating.

Some patients have had the following side effects while taking vildagliptina and insulin (with or without metformin):

• Common: headache, chills, nausea (discomfort), low blood sugar, stomach burning.
• Uncommon: diarrhea, flatulence.

Since the marketing of this product, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vildagliptina Alter

Keep this medication out of sight and reach of children.

Store in the original packaging to protect it from moisture. Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging and blister after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vildagliptina Alter

• The active ingredient is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch (type A) (potato), low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, sodium fumarate, and stearate.

Appearance of the Product and Package Contents

White, round, flat tablets with beveled edges, marked with "L" on one side and smooth on the other.

Packaging with 28 and 56 tablets in aluminum/aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the Last Revision of this Package Leaflet: July 2022

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