VILDAGLIPTINA TECNIGEN 50 mg HARD CAPSULES

2. What you need to know before taking Vildagliptina TecniGen

Do not take Vildagliptina TecniGen:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take vildagliptina:

• 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 vildagliptina to avoid low blood sugar levels [hypoglycemia]).
• if you have moderate or severe kidney disease (you will need to take a lower dose of vildagliptina).
• 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 vildagliptina 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 vildagliptina, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes as soon as possible.

Children and adolescents

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

Taking Vildagliptina TecniGen with other medications

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

Your doctor may change your vildagliptina 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 vildagliptina during pregnancy. It is not known if vildagliptina passes into breast milk. You should not take vildagliptina if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking vildagliptina, do not drive or operate tools or machines.

Vildagliptina TecniGen 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.

3. How to take Vildagliptina TecniGen

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptina you should take varies depending on your condition. Your doctor will tell you exactly how many Vildagliptina TecniGen hard capsules to take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptina is:

• 50 mg once daily in the morning if you are taking vildagliptina 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 vildagliptina 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 Vildagliptina TecniGen

Swallow the hard capsule whole with a little water.

Duration of treatment with Vildagliptina TecniGen

• Take vildagliptina every day while your doctor tells you to. You may need to continue this treatment for a long time.

• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Vildagliptina TecniGen than you should

If you have taken too many vildagliptina hard capsules 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 or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vildagliptina TecniGen

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 missed doses.

If you stop taking Vildagliptina TecniGen

Do not stop taking vildagliptina unless your doctor tells you to. If you have any other questions about taking this medication, ask your doctor.

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 this medication 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".
• • Hepatitis (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of hepatitis.
  • Pancreatitis (frequency not known): symptoms including severe and persistent abdominal pain (stomach area), which may radiate to your back, as well as nausea and vomiting.

Other side effects

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

• Common (may affect up to 1 in 10 people): tremor, headache, dizziness, weakness, low blood sugar.
• Uncommon (may affect up to 1 in 100 people): 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 (may affect up to 1 in 10 people): weight gain, swollen hands, ankles, or feet (edema).
• Uncommon (may affect up to 1 in 100 people): headache, weakness, low blood sugar.

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

• Common (may affect up to 1 in 10 people): dizziness.
• Uncommon (may affect up to 1 in 100 people): headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar.
• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion, fever.

Some patients experienced the following side effects while taking vildagliptina, metformin, and a sulfonylurea:

• Common (may affect up to 1 in 10 people): dizziness, tremor, weakness, low blood sugar, excessive sweating.

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

• Common (may affect up to 1 in 10 people): headache, chills, nausea, low blood sugar, heartburn.
• Uncommon: diarrhea, flatulence.

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

• Frequency not known (cannot be estimated from 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 not listed in this 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 help provide more information on the safety of this medication.

5. Storage of Vildagliptina TecniGen

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

This medication does not require any special storage conditions.

Do not use any packaging if you notice it is damaged or shows signs of tampering.

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 thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If you have any doubts, 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 TecniGen

• The active ingredient is vildagliptina.

Each hard capsule contains 50 mg of vildagliptina.

The other excipients are:

Capsule content: lactose (anhydrous), microcrystalline cellulose, sodium glycolate starch (type A), magnesium stearate.

Capsule composition: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and package contents

Vildagliptina TecniGen 50 mg hard capsules are orange hard gelatin capsules.

Vildagliptina TecniGen 50 mg hard capsules are available in packages containing 28 and 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira,

2710-089 Sintra

Portugal

Date of the last revision of this leaflet: January 2020

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