Vildagliptin/metformin Krka 50 mg/850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vildagliptin/Metformin Krka 50mg/850mg film-coated tablets EFG

Vildagliptin/Metformin Krka 50mg/1,000mg film-coated tablets EFG

vildagliptin/metformin hydrochloride

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vildagliptin/Metformin Krka is and what it is used for

The active substances in this medicine, vildagliptin and metformin, belong to a group of medicines called "oral antidiabetics".

Vildagliptin/metformin is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. Vildagliptin/metformin is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulfonylureas).

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 and glucagon are produced in the pancreas. Insulin helps reduce blood sugar levels, especially after meals. Glucagon promotes sugar production by the liver and causes blood sugar levels to rise.

How vildagliptin/metformin works

Both active substances, vildagliptin and metformin, help control blood sugar levels. The active substance vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active substance metformin helps the body use insulin more effectively. This medicine has been shown to reduce blood sugar levels, which will help prevent complications of your diabetes.

2. What you need to know before starting to take Vildagliptin/Metformin Krka

Do not take Vildagliptin/Metformin Krka

• if you are allergic to vildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking Vildagliptin/Metformin Krka.
• if you have uncontrolled diabetes, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid deep breathing, drowsiness, or a fruity unusual odour on your breath.
• if you have recently had a heart attack or if you have heart failure or serious circulatory problems or breathing difficulties that may be signs of heart problems.
• if you have severely reduced kidney function.
• if you have a serious infection or severe dehydration (massive loss of body water).
• if you are due to undergo contrast radiography (a specific type of diagnostic X-ray test using an injectable contrast agent). For more information, see section "Warnings and precautions".
• if you have liver problems.
• if you drink alcohol excessively (either daily or only occasionally).
• if you are breastfeeding (see also "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/Metformin Krka may cause a very rare but serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and serious heart diseases).

If any of the above apply to you, consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Krka temporarily if you develop an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking Vildagliptin/Metformin Krka and contact a doctor or the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort with profound fatigue
• difficulty breathing
• reduced body temperature and reduced heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

Contact your doctor urgently for advice if:

• You are known to have a genetic mitochondrial disease (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, and deafness.

Vildagliptin/Metformin Krka is not a substitute for insulin. Therefore, you should not take this medicine for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting this medicine if you have or have had a disease of the pancreas.

Consult your doctor, pharmacist, or nurse before starting vildagliptin/metformin if you are taking an antidiabetic medicine known as a sulfonylurea. Your doctor may wish to reduce your sulfonylurea dose when taken together with this medicine to prevent low blood sugar levels (hypoglycaemia).

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. Pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this occurs, you must consult your doctor immediately.

If you need to undergo major surgery, you must stop taking vildagliptin/metformin during the procedure and for a period afterwards. Your doctor will decide when to interrupt treatment with this medicine and when to restart it.

Liver function tests should be performed before starting treatment with vildagliptin/metformin, repeated every three months during the first year, and periodically thereafter. This is to detect as early as possible any signs indicating increased liver enzymes.

During treatment with this medicine, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Your doctor will periodically monitor your blood and urine sugar levels.

Children and adolescents

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

Other medicines and Vildagliptin/Metformin Krka

If you need to receive an intravenous injection of an iodine-containing contrast agent, for example, during an X-ray or scan, you must stop taking vildagliptin/metformin before or at the time of the injection. Your doctor will decide when to interrupt treatment with this medicine and when to restart it.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/metformin. It is especially important to mention the following:

• glucocorticoids, generally used to treat inflammation
• beta-2 agonists, generally used to treat respiratory disorders
• other active substances used to treat diabetes
• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• certain active substances affecting the thyroid
• certain active substances affecting the nervous system
• certain active substances used to treat angina pectoris (e.g., ranolazine)
• certain active substances used to treat HIV infection (e.g., dolutegravir)
• certain active substances used to treat a specific type of thyroid cancer (medullary thyroid cancer) (e.g., vandetanib)
• certain active substances used to treat stomach acidity and peptic ulcers (e.g., cimetidine)

Taking Vildagliptin/Metformin Krka with alcohol

Avoid excessive alcohol intake while taking vildagliptin/metformin, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will inform you about the potential risks of taking vildagliptin/metformin during pregnancy.
• Do not take vildagliptin/metformin if you are pregnant or breastfeeding (see also "Do not take Vildagliptin/Metformin Krka").

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

If you feel dizzy while taking this medicine, do not drive or operate tools or machinery.

Vildagliptin/Metformin Krka contains sodium

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

3. How to take Vildagliptin/Metformin Krka

The dose of vildagliptin/metformin required by each individual varies depending on their condition. Your doctor will tell you exactly what dose of vildagliptin/metformin you should take.

Follow exactly the instructions provided by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one film-coated tablet of 50 mg/850 mg or 50 mg/1,000 mg taken twice daily.

If you have reduced kidney function, your doctor may prescribe you a lower dose. Your doctor may also prescribe a lower dose if you are taking another diabetes medicine such as a sulfonilurea.

Your doctor may prescribe this medicine alone or together with certain other medicines that lower your blood sugar levels.

How to take Vildagliptin/Metformin

• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one at night, with meals or immediately after meals. Taking the tablet after meals will reduce the risk of gastrointestinal discomfort.

Follow your doctor's dietary advice. In particular, if you are following a diabetic diet for weight control, continue this diet while taking vildagliptin/metformin.

If you take more Vildagliptin/Metformin than you should

If you have taken too many tablets of this medicine, or if someone else has taken your tablets, consult your doctor or pharmacist immediately. You may require medical attention. If you need to visit a doctor or go to the nearest hospital, take the package and this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Vildagliptin/Metformin

If you forget to take a tablet, take it with your next meal, unless it is already time for your next scheduled dose. Do not take a double dose (two tablets at once) to make up for a missed dose.

If you stop taking Vildagliptin/Metformin

Continue taking this medicine for as long as your doctor prescribes it to maintain control of your blood sugar. Do not stop treatment with vildagliptin/metformin unless your doctor tells you to. If you have any questions about how long you should continue treatment, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You must stop taking vildagliptin/metformin and contact your doctor immediately if you experience any of the following adverse effects:

• Lactic acidosis (very rare: may affect up to 1 in 10,000 people):

Vildagliptin/metformin may cause a very rare but serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking vildagliptin/metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• 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 onset of rash or hives, which may indicate a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): 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) (uncommon: may affect up to 1 in 100 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 have experienced the following adverse effects while taking vildagliptin/metformin:

• Common (may affect up to 1 in 10 people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrollable tremor, constipation, nausea (feeling unwell), vomiting, diarrhoea, flatulence, heartburn, stomach pain, and abdominal pain.

• Uncommon (may affect up to 1 in 100 people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles or feet (oedema), chills, inflammation of the pancreas, muscle pain.

• Very rare (may affect up to 1 in 10,000 people): signs of high levels of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe vomiting and nausea, abdominal pain, irregular heartbeat or deep, rapid breathing; skin redness, itching; decreased levels of vitamin B12 (pallor, tiredness, mental symptoms such as confusion or memory disturbances).

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

• Frequency not known (cannot be estimated from available data): localized peeling or blistering of the skin, inflammation of blood vessels (vasculitis) which may cause skin rashes or small, flat, red, round spots beneath 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 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/Metformin 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 and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Vildagliptin/Metformin Krka

• The active substances are vildagliptin and metformin hydrochloride.

Each film-coated tablet of Vildagliptin/Metformin Krka 50 mg/850 mg contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride.

Each film-coated tablet of Vildagliptin/Metformin Krka 50 mg/1,000 mg contains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride.

• The other components are:

In the core: hydroxypropyl cellulose (E463), mannitol (E421), sodium stearyl fumarate (E470a) and magnesium stearate (E470b).

In the coating: hypromellose (E464), titanium dioxide (E171), talc (E553b), propylene glycol (E1520) and yellow iron oxide (E172). See section 2 “Vildagliptin/Metformin Krka contains sodium”.

Appearance of the product and contents of the pack

Vildagliptin/Metformin Krka 50 mg/850 mg film-coated tablets EFG are brownish-yellow, oval, biconvex tablets, marked with V1 on one side. Tablet dimensions: approximately 20 mm x 11 mm.

Vildagliptin/Metformin Krka 50 mg/1,000 mg film-coated tablets EFG are yellow-brown, oval, biconvex tablets, marked with V2 on one side. Tablet dimensions: approximately 21 mm x 11 mm.

Vildagliptin/Metformin Krka is available in packs containing 10, 30, 60, 120 or 180 film-coated tablets and in multiple packs containing 120 (2 x 60) and 180 (3 x 60) film-coated tablets, in blisters.

Only certain 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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of the most recent review of this leaflet: September 2025

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