Vildagliptin PensA 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin pensa 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 or pharmacist.
• This medicine has been prescribed for you only, and you should 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance vildagliptin belongs to a group of medicines called "oral antidiabetics".

Vildagliptina 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 are already 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 reduce 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 vildagliptin pensa 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 from 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 that has been recommended to you.

2. What you need to know before starting to take Vildagliptina pensa

Do not take Vildagliptina pensa

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

Warnings and precautions

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

• 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 pancreatic disease.

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

You should have liver function tests before starting treatment with this medicine, every three months 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 this medicine is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptina pensa

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 use 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 use of machines

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

Vildagliptina pensa contains lactose and sodium

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

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

3. How to take Vildagliptina pensa

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 that each person should take varies 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 sulfonylurea.

• 100 mg daily in two doses (50 mg in the morning and 50 mg in the evening) if you are taking vildagliptin alone, with another medicine called metformin or a glitazone, or with a combination of metformin and a sulfonylurea.

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

How to take Vildagliptina pensa

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina pensa

• 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 Vildagliptina pensa than you should

If you have taken too many vildagliptin tablets, or if someone else has taken your medicine, consult your doctor immediately, or call the Toxicology Information Service at telephone number 91 562 04 20. You may need medical attention. If you have to visit a doctor or go to the nearest hospital, take the pack with you.

If you forget to take Vildagliptina pensa

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 Vildagliptina pensa

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 vildagliptin 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 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 and metformin:

• 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 the marketing of this product, the following adverse effects have also been reported:

• Frequency not known (cannot be estimated from 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin pensa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging following “EXP”. The expiry date is the last day of the month indicated.

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 deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina pensa

• The active substance is vildagliptin. Each tablet contains 50 mg of vildagliptin.
• The other components (excipients) are anhydrous lactose, sodium stearyl fumarate, microcrystalline cellulose, and sodium croscarmellose.

Nature of the product and contents of the container

Vildagliptina pensa are round, biconvex tablets, white to almost white in colour, approximately 8.0 mm in diameter.

It is available in packs containing 14, 28 or 56 tablets in aluminium / OPA-aluminium-PVC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

SAG MANUFACTURING, S.L.U.

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

Or

GALENICUM HEALTH, S.L.U.

Calle Sant Gabriel, 50

08950 Esplugues de Llobregat, Barcelona

Spain

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

Spain: Vildagliptina pensa 50 mg tablets EFG

Portugal: Vildagliptina toLife

Italy: Vildagliptin Pensa

Date of the most recent review of this leaflet: March 2025

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