VILDAGLIPTINA KRKA 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Vildagliptina Krka 50 mg tablets EFG

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

The active substance of Vildagliptina Krka, 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 vildagliptina alone or in combination with other antidiabetic medicines that you are already taking if they are not effective enough to control your diabetes.

Type 2 diabetes appears when the body does not produce enough insulin or when the insulin produced does not work properly. It can also appear 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 Krka works

Vildagliptina 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 Krka

Do not take Vildagliptina Krka

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vildagliptina Krka

• 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 together 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 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 vildagliptina. If this happens, you should consult your doctor as soon as possible.

Liver function tests should be performed before starting treatment with Vildagliptina Krka, 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 Vildagliptina Krka is not recommended in children and adolescents under 18 years of age.

Other medicines and Vildagliptina Krka

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 Krka if you are taking other medicines such as:

• thiazides or other diuretics (also known as 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.

You should not use Vildagliptina Krka during pregnancy. It is not known if this medicine passes into breast milk. You should not take vildagliptina if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Vildagliptina Krka contains sodium

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

3. How to take Vildagliptina Krka

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take and when

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

The recommended dose of vildagliptina is:

• 50 mg once a day in the morning, if you are taking vildagliptina with other medicines known as sulfonylureas.
• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking vildagliptina alone, with another medicine known as metformin or a glitazone, or 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 Krka

• Swallow the tablet whole with a little water.

Duration of treatment with Vildagliptina Krka

• Take vildagliptina every day while your doctor indicates. You may need to follow this treatment for a long period.
• Your doctor will perform periodic checks to ensure that the treatment has the desired effect.

If you take more Vildagliptina Krka than you should

If you have taken too many vildagliptina tablets, 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 Toxicology Information Service, phone 91 652 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptina Krka

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 the next dose, skip the missed dose. Do not take a double dose to make up for missed doses.

If you stop taking Vildagliptina Krka

Do not stop taking vildagliptina unless your doctor tells you to. If you have doubts about the duration of treatment with this medicine, consult your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

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 Krka 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".
• Liver disease (hepatitis) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (rare: may affect up to 1 in 1,000 people): 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 Krka:

• 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 area (abdominal pain), diarrhea, heartburn, nausea (discomfort), 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): pancreatitis.

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rash or red, flat, round spots under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptina Krka

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 carton/blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage temperature.

Keep the container in the outer carton to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Krka

• The active substance is vildagliptina.

Each tablet contains 50 mg of vildagliptina.

• The other ingredients (excipients) are mannitol (E421), hydroxypropylcellulose (type EF, 300-600 mPas), low-substituted hydroxypropylcellulose, microcrystalline cellulose (type 112), sodium carboxymethyl starch glycolate type A potato, colloidal anhydrous silica, and sodium stearyl fumarate. See section 2 "Vildagliptina Krka" contains sodium.

Appearance of the product and pack contents

White to almost white, round tablets with beveled edges, 8 mm in diameter, 3.2-5.0 mm in thickness.

Vildagliptina Krka is available in packs containing: 14, 28, 30, 56, 60, 90, 100, 112, and 180 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven, Germany

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Oficina

28108 Alcobendas, Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: August 2023

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/