Prospecto:Information for the Patient

Vildagliptin TecniGen 50 mg Hard Capsules EFG

Vildagliptin

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey are not listed in this prospectus. See section 4.

1.What is Vildagliptin TecniGen and how is it used

2.What you need to knowbeforestarting totake Vildagliptin TecniGen

3.How to take Vildagliptin TecniGen

4.Possible adverse effects

5Storage of Vildagliptin TecniGen

6.Contents of the package and additional information

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

Vildagliptinais used to treat adult patients with type 2 diabetes when diabetes cannot be controlled solely by diet and exercise. It helps control blood sugar levels. Your doctor will prescribe vildagliptina 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 function 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 TecniGen works

Vildagliptinastimulates 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 diabetes complications. 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 TecniGen:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6). If you think you could be allergic to vildagliptin 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 vildagliptin:,

• 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 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 any signs of increased liver enzymes as soon as possible.

Children and adolescents

The administration of vildagliptin 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 taken recently, or may need to take any other medication.

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

• tiazides or other diuretics (also known as urine medications)
• corticosteroids (generally 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 may be pregnant, consult your doctor or pharmacist before using this medication.

You should not use vildagliptin during pregnancy. It is unknown whether vildagliptin passes into breast milk. 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 tools or machinery.

Vildagliptina TecniGen contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.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 hard capsules of Vildagliptin TecniGen that you should take. The maximum daily dose is 100mg.

The recommended dose of vildagliptin is:

• 50mg once a day in the morning, if you are taking vildagliptin along with another medication known as a sulfonylurea.

• 100mg per day in two doses of 50mg 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.

• 50mg per day in the morning if you have moderate or severe kidney disease or if you are undergoing dialysis.

How to take Vildagliptin TecniGen

Swallow the hard capsule whole with a little water.

Duration of treatment with Vildagliptin TecniGen

• 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 TecniGen than you should

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

If you forget to take Vildagliptin 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 your 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 TecniGen

Do not stop taking vildagliptin unless your doctor tells you to. If you have any other doubts about the use of thismedication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention

You should stop taking this medicine 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 that 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”.
• • Liver disease (hepatitis) (rare): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may be indicative of liver disease (hepatitis).
  • Pancreatitis (inflammation of the pancreas) (unknown frequency): symptoms that include intense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

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

• Frequent (may affect up to 1 in 10 people): tremors, headache, dizziness, nausea, decreased blood glucose levels.
• Infrequent (may affect up to 1 in 100 people): fatigue.

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

• Frequent (may affect up to 1 in 10 people): tremors, headache, dizziness, weakness, decreased blood glucose levels
• Infrequent (may affect up to 1 in 100 people): constipation
• Rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion

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

• Frequent (may affect up to 1 in 10 people): weight gain, swollen hands, ankles, or feet (edema)
• Infrequent (may affect up to 1 in 100 people): headache, weakness, decreased blood glucose levels

Some patients experienced the following side effects while taking vildagliptin only:

• Frequent (may affect up to 1 in 10 people): dizziness
• Infrequent (may affect up to 1 in 100 people): headache, constipation, swollen hands, ankles, or feet (edema), joint pain, decreased blood glucose levels
• Rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion, fever

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

• Frequent (may affect up to 1 in 10 people): dizziness, tremors, weakness, low blood glucose levels, excessive sweating

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

• Frequent (may affect up to 1 in 10 people): headache, chills, nausea (discomfort), low blood glucose levels, heartburn
• Infrequent: diarrhea, flatulence

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

• Unknown frequency (cannot be estimated from available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain

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 the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

This medication does not require any special storage conditions.

Do not use any packaging if you observe that it is damaged or shows signs of manipulation.

Do not usethis medicationafter the expiration date that appears on thepackaging and blisterand after CAD. The expiration date is the last day of the month indicated.

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

Composition ofVildagliptin TecniGen

• The active ingredient is vildagliptin.

Each hard capsule contains 50 mg of vildagliptin.

The other excipients are:

Hard capsule content: lactose (anhydrous), microcrystalline cellulose, sodium glycolate cornstarch (type A), magnesium stearate.

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

Appearance of the product and contents of the packaging

Vildagliptin TecniGen 50 mg hard capsules are hard gelatin capsules of orange color.

Vildagliptin TecniGen 50 mg hard capsules are available in packaging containing 28 and 56 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira,

2710-089 Sintra

Portugal

Last review date of this leaflet: January 2020

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/)