Package Leaflet: Information for the User

Vildagliptina Krka 50 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Vildagliptina Krka

3.How to take Vildagliptina Krka

4.Possible side effects

5.Storage of Vildagliptina Krka

6.Contents of the pack and additional information

The active ingredient of Vildagliptina Krka, vildagliptin, belongs to a group of medicines called «oral antidiabetics».

Vildagliptin is 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 vildagliptin alone or in combination with other antidiabetic medicines 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 work 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 Krka works

Vildagliptin 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 of your diabetes. Although you start taking this medicine for your diabetes, it is essential that you continue with the diet and/or exercise that have been recommended to you.

Do not take Vildagliptina Krka

• If you are allergic to vildagliptin or to any of the other ingredients of this medication (listed in section 6). If you think you may be allergic to vildagliptin or any other component of Vildagliptina Krka, do not take this medication 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 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 taking it 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 Vildagliptina Krka, at three-month intervals during the first year, and periodically thereafter. This is done to detect as soon as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

The administration of Vildagliptina Krka is not recommended in children and adolescents under 18 years.

Other medications and Vildagliptina Krka

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Thiazides or other diuretics (also called urine medications)
• Corticosteroids (usually used to treat inflammation)
• Thyroid medications
• Certain medications that affect the nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Vildagliptina Krka during pregnancy. It is unknown whether this medication 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 Vildagliptina Krka, do not drive or operate tools or machinery.

Vildagliptina Krka contains sodium

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

Follow exactly the administration instructions of this medication 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 vildagliptin that each person should take varies depending on their condition. Your doctor will indicate exactly the number of vildagliptin tablets that you should take. The maximum daily dose is 100 mg.

The recommended dose of vildagliptin is:

• 50 mg once a day in the morning, if you are taking vildagliptin together with other medications known as sulfonylureas.
• 100 mg per day in two doses of 50 mg in the morning and evening if you are taking vildagliptin alone, with another medication 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 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 Vildagliptina Krka than you should

If you have taken too many vildagliptin tablets, 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 immediately or call the Toxicological Information Service, phone 91 652 04 20, indicating the medication and the amount ingested.

If you forget to take Vildagliptina Krka

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 the missed doses.

If you interrupt treatment with Vildagliptina Krka

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

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

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 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 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) (unknown frequency): 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) (rare: may affect up to 1 in 1,000 people): symptoms that include intense and persistent abdominal pain (stomach area), which can reach 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 glucose levels, flatulence.
• Rare (may affect up to 1 in 1,000 people): pancreatitis (inflammation of the pancreas).

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

• Unknown frequency (cannot be estimated from available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that may cause skin eruptions or pinpoint, flat, red, and rounded spots under the skin's surface or hematomas.

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

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

Do not use this medicationafter the expiration date that appears on the packaging/blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofVildagliptin Krka

• The active ingredient is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

• The other components (excipients) are mannitol (E421), hydroxypropylcellulose (type EF, 300-600 mPas), hydroxypropylcellulose of low substitution, microcrystalline cellulose (type 112),carboxymethylstarch sodium glycolate type A,colloidal anhydrous silica andstearate sodium fumarate. See section 2 “Vildagliptin Krka” contains sodium.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501Novo mesto, Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmaceutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Office

28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:August 2023

Further information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/