Package Leaflet: Information for the User

Vildagliptina/Metformina Krka 50mg/850mg Film-Coated Tablets

Vildagliptina/Metformina Krka 50mg/1.000mg Film-Coated Tablets

vildagliptine/metformin hydrochloride

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

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

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

3.How to take Vildagliptina/Metformina Krka

4.Possible side effects

5.Storage of Vildagliptina/Metformina Krka

6.Contents of the pack and additional information

The active ingredients of this medication, vildagliptina and metformina, belong to a group of medications called “oral antidiabetics”.

Vildagliptina/metformina is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.Vildagliptina/metformina is used when diabetes cannot be controlled with diet and exercise alone and/or with other medications used to treat diabetes (sulfonilureas).

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 glucagón.

Insulin and glucagón are produced in the pancreas. Insulin helps to reduce blood sugar levels, especially after meals. Glucagón promotes the production of sugar by the liver and makes blood sugar levels increase.

How vildagliptina/metformina works

Both active ingredients, vildagliptina and metformina, help to control blood sugar levels. The active ingredient vildagliptina stimulates the pancreas to produce more insulin and less glucagón. The active ingredient metformina helps the body to use insulin better.This medication has demonstrated reducing blood sugar, which will help to prevent complications of your diabetes.

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 ingredients, consult your doctor before taking Vildagliptin/Metformin Krka.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic precoma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or if your breath develops an unusual fruity odor.
• if you have recently had a heart attack or if you have severe heart failure or circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have severe kidney function impairment.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are undergoing a radiology contrast study (a specific type of diagnostic test using X-rays and an injectable contrast medium). For more information, see the "Warnings and precautions" section.
• if you have liver problems.
• if you drink excessive alcohol (daily or occasionally).
• if you are breastfeeding (also see "Pregnancy and breastfeeding").

Warnings and precautions

Risk of lactic acidosis

Vildagliptin/Metformin Krka may cause a rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

Stop taking Vildagliptin/Metformin Krka for a short period of time if you have a condition that may be associated with dehydration (significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. 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 that produce lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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

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 to take this medicine if you have or have had a pancreatic disease.

Consult your doctor, pharmacist or nurse before starting to take vildagliptin/metformin if you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when you take it with this medicine to avoid low blood sugar (hypoglycemia).

If you have taken vildagliptin in the past but had to stop taking it due to liver disease, do not take this medicine.

Skin lesions are common complications of diabetes. Follow the recommendations of your doctor or nurse for skin and foot care and pay special attention to the appearance of blisters or ulcers while taking vildagliptin/metformin. If this occurs, you should consult your doctor immediately.

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

Tests of liver function should be performed before starting treatment with vildagliptin/metformin, at intervals of three months during the first year and thereafter on a periodic basis. This is done to detect as soon as possible any sign of 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 an elderly person and/or if your kidney function is deteriorating.

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

Children and adolescents

The administration 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 be administered an injection of a contrast medium containing iodine, for example, in the context of a radiography or exploration, stop taking vildagliptin/metformin before the injection 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 taken recently or may need to take any other medicine. You may need more frequent blood sugar 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 principles used to treat diabetes
• diuretics, which increase urine production
• 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)
• active principles that affect the thyroid
• active principles that affect the nervous system
• active principles used to treat angina pectoris (for example, ranolazine)
• active principles used to treat a specific type of thyroid cancer (medullary thyroid cancer) (for example, vandetanib)
• active principles used to treat stomach acid and peptic ulcers (for example, cimetidine)

Taking Vildagliptin/Metformin Krka with alcohol

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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; that is, it is essentially "sodium-free".

The dose ofvildagliptin/metforminthat each person should take varies depending on their condition. Your doctor will tell you exactly the dose ofvildagliptin/metforminthat you should take.

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

The recommended dose is a film-coated tablet of 50mg/850mg or 50mg/1,000mg twice a day.

If you have reduced renal function, your doctor may prescribe a lower dose. Your doctor may also prescribe a lower dose if you are taking a diabetes medication known as a sulfonylurea.

Your doctor may prescribe this medication alone or with certain medications that lower blood sugar levels.

Use ofVildagliptin/Metformin

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

Follow your doctor's dietary advice. In particular, if you are following a weight control diet for diabetics, continue with the diet while takingvildagliptin/metformin.

If you take moreVildagliptin/Metforminthan you should

If you have taken too many tablets of this medication or if someone else has taken your tablets,consult your doctor or pharmacist immediately.You may need medical attention. If you need to visit a doctor or go to the nearest hospital, bring the packaging and this leaflet 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 medication and the amount ingested.

If you forget to takeVildagliptin/Metformin

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

If you interrupt treatment withVildagliptin/Metformin

Continue taking this medication while your doctor prescribes it for you so that they can continue to monitor your blood sugar levels. Do not stop takingvildagliptin/metforminunless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You shouldstop takingvildagliptin/metforminand see your doctor immediatelyif you experience any of the following side effects:

• Lactic acidosis(very rare: may affect up to1in 10,000 people):

Vildagliptin/metformin can cause a very rare but serious side effect called lactic acidosis (see the “Warnings and precautions” section). If this happens to you,you should stop takingvildagliptin/metforminand contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare:may affect up to 1 in 1,000people): symptoms that includeswollen 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) (infrequent: may affect up to 1 in 100 people): symptoms that includeyellowing 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) (infrequent: may affect up to 1 in 100 people):): symptoms that includeintense and persistent abdominal pain (stomach area), which may reach your back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side effects while takingvildagliptin/metformin:

• Frequent (may affect up to 1 in 10people): sore throat, nasal congestion, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled tremor, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain, and abdominal pain.
• Infrequent (may affect up to 1 in 100people): fatigue, weakness, metallic taste, low blood glucose levels, loss of appetite, swollen hands, ankles, or feet (edema), chills, pancreatitis, muscle pain.

• Very rare (may affect up to 1 in 10,000people): signs of having 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, fatigue, mental symptoms such as confusion or memory alterations).

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 flat, pointed, red, and rounded spots under the skin's surface or hematomas.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30° C.

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 of Vildagliptina/Metformina Krka

• The active ingredients are vildagliptin and hydrochloride of metformin.

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

Each film-coated tablet of Vildagliptina/Metformina Krka 50mg/ 1.000mg contains 50mg of vildagliptin and 1.000mg of hydrochloride of metformin.

• The other components are:

In the core: hydroxypropylcellulose (E463), mannitol (E421), stearate of fumaric acid and sodium (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 “Vildagliptina/Metformina Krka contains sodium”.

Appearance of the product and contents of the package

Vildagliptina/Metformina Krka 50mg/850mg film-coated tablets are yellow-brown, oval, biconvex, marked with V1 on one side. Tablet size: approximately 20 mm x 11 mm.

Vildagliptina/Metformina Krka 50mg/1.000mg film-coated tablets are brown-yellow, oval, biconvex, marked with V2 on one side. Tablet size: approximately 21 mm x 11 mm.

Vildagliptina/Metformina Krka is available in packages with 10, 30, 60, 120 or 180 film-coated tablets and in multiple packages containing 120 (2 x 60) and 180 (3 x 60) film-coated 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, 8501 Novo mesto, Slovenia

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

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

This medicine is authorized in the member states of the European Economic Areawith the following names:

Last revision date of this leaflet: June 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/