Vildagliptin Tecnigen 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vildagliptin TecniGen 50 mg hard capsules EFG

Vildagliptin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

• 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 may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Vildagliptin TecniGen is and what it is used for

2. What you need to know before taking Vildagliptin TecniGen

3. How to take Vildagliptin TecniGen

4. Possible side effects

5. Storage of Vildagliptin TecniGen

6. Contents of the pack and other information

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

The active substance in Vildagliptina TecniGen, vildagliptina, 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 vildagliptina 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 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 TecniGen works

Vildagliptina 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 recommended to you.

2. What you need to know before taking Vildagliptina TecniGen

Do not take Vildagliptina TecniGen:

• if you are allergic to the active substance 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 Vildagliptina TecniGen, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting 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 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 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 advice on skin and foot care, paying special attention to the appearance of blisters or ulcers while taking vildagliptin. If this occurs, 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.

Children and adolescents

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

Taking Vildagliptina TecniGen with other medicines

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 TecniGen contains lactose

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

3. How to take Vildagliptina TecniGen

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 Vildagliptina TecniGen hard capsules 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 sulphonylurea.

• 100 mg daily in two divided doses of 50 mg in the morning and 50 mg in the evening, if you are taking vildagliptin alone, with another medicine known as metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.

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

How to take Vildagliptina TecniGen

Swallow the hard capsule whole with a little water.

Duration of treatment with Vildagliptina TecniGen

• 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 TecniGen than you should

If you have taken too many vildagliptin hard capsules, 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, contact your doctor or pharmacist, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptina TecniGen

If you forget to take a dose of this medicine, take it as soon as you remember. Then take your next dose at the 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 TecniGen

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

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 this medicine 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) (rare): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark-colored urine, which may indicate liver disease (hepatitis).
  • Inflammation of the pancreas (pancreatitis) (frequency not known): symptoms including severe and persistent abdominal pain (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:

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

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

• Frequent (may affect up to 1 in 10 people): tremor, headache, dizziness, weakness, decreased blood glucose levels.
• 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 adverse effects while taking vildagliptin and a glitazone:

• Frequent (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, decreased blood glucose levels.

Some patients experienced the following adverse effects while taking vildagliptin alone:

• Frequent (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, decreased blood glucose levels.
• Very rare (may affect up to 1 in 10,000 people): sore throat, nasal congestion, fever.

Some patients experienced the following adverse effects while taking vildagliptin, metformin and a sulfonylurea:

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

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin TecniGen

Keep this medicine out of sight and reach of children.

This medicine requires no special storage conditions.

Do not use any pack if it appears damaged or shows signs of tampering.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused packs and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packs and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptin TecniGen

• The active substance is vildagliptin.

Each hard capsule contains 50 mg of vildagliptin.

The other excipients are:

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

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

Appearance of the product and contents of the pack

Vildagliptin TecniGen 50 mg hard capsules are orange-coloured gelatin hard capsules.

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

Only some 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 most recent review of this leaflet: January 2020

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/)