VILDAGLIPTIN KRKA 50 MG TABLETS EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Vildagliptin Krka 50 mg Tablets EFG

Read the entire 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, 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 or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

The active substance in Vildagliptina Krka, vildagliptine, belongs to a group of medicines called "oral antidiabetics".

Vildagliptine 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 vildagliptine 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 reduce 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 Krka works

Vildagliptine 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 you have been advised.

2. What you need to know before taking Vildagliptin Krka

Do not take Vildagliptin Krka

• if you are allergic to vildagliptin 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 Vildagliptin Krka, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Vildagliptin 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 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 a 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 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.

You should have liver function tests performed before starting treatment with Vildagliptin Krka, every three months during the first year, and periodically thereafter. This is done to detect as early as possible any signs indicating an increase in liver enzymes (transaminases).

Children and adolescents

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

Other medicines and Vildagliptin Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose of Vildagliptin Krka 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 Krka during pregnancy. It is not known whether this medicine passes into breast milk. You must not take vildagliptin if you are breastfeeding or planning to breastfeed.

Driving and using machines

If you feel dizzy while taking Vildagliptin Krka, do not drive or operate tools or machinery.

Vildagliptin Krka contains sodium

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

3. How to take Vildagliptin Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take and when

The dose of vildagliptin each person should take varies depending on their condition. Your doctor will tell you exactly how many vildagliptin tablets 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 other medicines known as sulfonylureas.
• 100 mg daily in two divided doses of 50 mg in the morning and evening if you are taking vildagliptin alone, with another medicine known as metformin or a glitazone, or with a combination of metformin and a sulfonylurea, or with insulin.
• 50 mg daily in the morning if you have moderate or severe kidney disease or are undergoing dialysis.

How to take Vildagliptin Krka

• Swallow the tablet whole with some water.

Duration of treatment with Vildagliptin Krka

• 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 Vildagliptin Krka than you should

If you have taken too many vildagliptin tablets, 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 immediately or call the Toxicology Information Service at telephone 91 652 04 20, indicating the medicine and the amount ingested.

If you forget to take Vildagliptin 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 your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Vildagliptin Krka

Do not stop taking vildagliptin unless your doctor tells you to. If you have any doubts about how long you should continue treatment with this medicine, consult your doctor.

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

4. Possible adverse effects

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

Some symptoms require immediate medical attention

You must stop taking Vildagliptin Krka and see 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) (frequency not known): symptoms including yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may indicate liver disease (hepatitis).
• Inflammation of the pancreas (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 adverse effects

Some patients experienced the following adverse effects while taking Vildagliptin 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 and abdominal pain, diarrhea, heartburn, nausea (feeling unwell), 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): inflammation of the pancreas.

Since the product has been marketed, the following adverse effects have also been reported:

• Frequency not known (cannot be estimated from available data): localized skin peeling or blistering, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots under the skin surface or bruising.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vildagliptin Krka

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

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vildagliptina Krka

• The active substance is vildagliptin.

Each tablet contains 50 mg of vildagliptin.

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

Appearance of the product and contents of the pack

White to almost white, round, bevel-edged tablets, 8 mm in diameter and 3.2–5.0 mm thick.

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

Only certain pack sizes may be marketed.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Oficina

28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: August 2023

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