VILDAGLIPTINA KERN PHARMA 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Vildagliptina Kern Pharma 50 mg Tablets EFG

vildagliptina

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Vildagliptina Kern Pharma and what is it used for
2. What you need to know before you take Vildagliptina Kern Pharma
3. How to take Vildagliptina Kern Pharma
4. Possible side effects
5. Storage of Vildagliptina Kern Pharma
6. Contents of the pack and further information

1. What is Vildagliptina Kern Pharma and what is it used for

The active substance in this medicine, 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 to control blood sugar levels. Your doctor will prescribe this medicine either alone or in combination with other antidiabetic medicines that you are already taking if they are not sufficiently effective in controlling your diabetes.

Type 2 diabetes occurs when the body does not produce enough insulin or when the insulin produced does not work properly. It can also occur when the body produces too much glucagon.

Insulin is a substance that helps to lower blood sugar levels, especially after meals. Glucagon is a substance that promotes the production of sugar by the liver and increases blood sugar levels. Both substances are produced in the pancreas.

How Vildagliptina Kern Pharma works

This medicine stimulates the pancreas to produce more insulin and less glucagon. This helps to control blood sugar levels. This medicine has been shown to reduce blood sugar, which will help to prevent complications of your diabetes. Although you start taking this medicine for your diabetes, it is important that you continue with the diet and/or exercise that your doctor has recommended.

2. What you need to know before you take Vildagliptina Kern Pharma

Do not take Vildagliptina Kern Pharma:

• if you are allergic to vildagliptina or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to vildagliptina or any other ingredient of Vildagliptina Kern Pharma, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you start taking Vildagliptina Kern Pharma

• 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 dose of sulfonylurea when taken in combination with this medicine 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 on 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 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 this medicine. If this occurs, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Vildagliptina Kern Pharma, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes (transaminases) as soon as possible.

Children and adolescents

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

Use of Vildagliptina Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may change your dose of Vildagliptina Kern Pharma if you are taking other medicines such as:

• thiazides or other diuretics (also called water pills)
• corticosteroids (generally used to treat inflammation)
• thyroid medicines
• 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use this medicine during pregnancy. It is not known if Vildagliptina Kern Pharma passes into breast milk. Do not take this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

If you feel dizzy while taking Vildagliptina Kern Pharma, do not drive or operate tools or machines.

Vildagliptina Kern Pharma contains lactose and sodium

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

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

3. How to take Vildagliptina Kern Pharma

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

What dose you should take and when

The dose of vildagliptina that you should take varies depending on your condition. Your doctor will tell you exactly how many tablets of Vildagliptina Kern Pharma you should take. The maximum daily dose is 100 mg.

The recommended dose of Vildagliptina Kern Pharma is:

• 50 mg once daily in the morning if you are taking vildagliptina with another medicine known as a sulfonylurea.

• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking Vildagliptina Kern Pharma alone, with another medicine known as metformin, or with a glitazone, with a combination of metformin and a sulfonylurea.

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

How to take Vildagliptina Kern Pharma

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Kern Pharma

• Take this medicine 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 Kern Pharma than you should

If you have taken too many tablets of vildagliptina, or if someone else has taken your medicine, consult your doctor immediately.You may need medical attention. If you have 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 immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vildagliptina Kern Pharma

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

If you stop taking Vildagliptina Kern Pharma

Do not stop taking Vildagliptina Kern Pharma unless your doctor tells you to. If you have doubts about the duration of treatment with Vildagliptina Kern Pharma, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention

You should stop taking Vildagliptina Kern Pharma 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 rash or hives, 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 urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (frequency not known): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to the 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 Kern Pharma and a sulfonylurea:

• Common: tremor, headache, dizziness, weakness, low blood sugar
• Uncommon: 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 Kern Pharma and a glitazone:

• Common: weight gain, swollen hands, ankles, or feet (edema)
• Uncommon: headache, weakness, low blood sugar

Some patients experienced the following side effects while taking Vildagliptina Kern Pharma alone:

• Common: dizziness
• Uncommon: headache, constipation, swollen hands, ankles, or feet (edema), joint pain, low blood sugar
• Very rare: sore throat, nasal congestion, fever

Some patients have experienced the following side effects while taking Vildagliptina Kern Pharma, metformin, and a sulfonylurea:

• Common: dizziness, tremor, weakness, low blood sugar, excessive sweating

Some patients have experienced the following side effects while taking Vildagliptina Kern Pharma and insulin (with or without metformin):

• Common: headache, chills, nausea (discomfort), 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 the available data): itchy rash, pancreatitis, localized skin peeling or blisters, muscle pain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Kern Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and on the carton after “EXP”. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Vildagliptina Kern Pharma

• The active substance is vildagliptina.
• Each tablet contains 50 mg of vildagliptina.
• The other ingredients are lactose, microcrystalline cellulose, sodium carboxymethyl starch type A (potato), and magnesium stearate.

Appearance of the product and pack contents

Vildagliptina Kern Pharma 50 mg tablets are white and round, approximately 9 x 4.06 mm ± 0.04 mm, scored on one side and with a “K” engraved on the other.

Vildagliptina Kern Pharma 50 mg is available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180, or 336 tablets and in multipacks consisting of 3 packs, each containing 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Spain Vildagliptina Kern Pharma 50 mg tablets EFG

Portugal Vildagliptina Pharmakern 50 mg tablets

Date of the last revision of this leaflet:June 2022

Other sources of information

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