VILDAGLIPTIN NORMON 50 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptina Normon 50 mg tablets EFG

Vildagliptin

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 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, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

The active substance in Vildagliptina Normon, vildagliptin, belongs to a group of medicines 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 medicines you are already taking if they 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 Normon 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 after starting 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 Normon

Do not take Vildagliptin Normon

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptin Normon

• 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 prevent 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 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.

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 an increase in 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 Normon

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).
• Medicines for the thyroid.
• 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 not known 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.

Vildagliptin Normon contains lactose

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

3. How to take Vildagliptina Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin 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 divided doses of 50 mg in the morning and evening if you are taking vildagliptin alone, with another medicine known as metformin or a glitazone, with a combination of metformin and a sulfonylurea, 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 Vildagliptina Normon

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptina Normon

• Take vildagliptin every day as long as your doctor instructs. You may need to continue this treatment for a long period of time.
• Your doctor will perform periodic checks to ensure the treatment is having the desired effect.

If you take more Vildagliptina Normon 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, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptina Normon

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 missed doses.

If you stop taking Vildagliptina Normon

Do not stop taking vildagliptin unless your doctor tells you to. If you have any questions about the duration of treatment or the use of this medicine, ask your doctor, pharmacist, or nurse.

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:

• 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 onset 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 darkening of the 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 extend 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 pain and abdominal discomfort (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 sugar 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, consult your doctor, pharmacist or nurse, 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 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 Vildagliptina Normon

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 refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from moisture.

Do not use Vildagliptina Normon 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 unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to get rid of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin Normon

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

Nature of the product and pack contents

Vildagliptin Normon 50 mg tablets EFG are round, white to slightly yellow, flat, bevel-edged tablets, marked with a "V" on one side and unmarked on the other.

Aluminum - Polyamide/Aluminum/PVC blisters. Packs containing 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: August 2025

Other sources of information

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86150/P_86150.html