Package Leaflet: Information for the Patient

Vildagliptina/Metformina Kern Pharma50 mg/850 mg Film-Coated Tablets

Vildagliptina/Metformina Kern Pharma50 mg/1,000 mg Film-Coated Tablets

vildagliptin/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 give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting Vildagliptina/Metformina Kern Pharma

3.How to take Vildagliptina/Metformina Kern Pharma

4.Possible side effects

5.Storage of Vildagliptina/Metformina Kern Pharma

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 Kern Pharma is used when diabetes cannot be controlled with diet and exercise alone and/or with other medications used to treat diabetes (insulin or sulfonylureas).

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 and glucagon are produced in the pancreas. Insulin helps to reduce blood sugar levels, especially after meals. Glucagon 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 glucagon. The active ingredient metformina helps the body to use insulin better.This medication has shown to reduce blood sugar levels, which will help to prevent complications of your diabetes.

Do not takevildagliptin/metformin

• if you are allergic to vildagliptin, metformin, or any of the other ingredients in this medicine (listed in section 6). If you think you may be allergic to any of these ingredients, consult your doctor before takingvildagliptin/metformin.
• 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 stomach 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 reduction.
• if you have a severe infection or severe dehydration (massive loss of body water).
• if you are undergoing a contrast radiology (a specific type of diagnostic test using X-rays and an injectable contrast medium). For more information, see the section “Warnings and precautions”.
• 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 may cause a very rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning 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 diseases).

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

Stop takingvildagliptin/metforminfor 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 takingvildagliptin/metforminand contact a doctor or the nearest hospital immediately if you experience any of the symptoms that cause 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 is not a substitute for insulin. Therefore, do not take vildagliptin/metformin for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting to takevildagliptin/metforminif you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting to takevildagliptin/metforminif you are taking a diabetes medication known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taking it withvildagliptin/metforminto avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin 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. Pay special attention to the appearance of blisters or ulcers while takingvildagliptin/metformin. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, stop takingvildagliptin/metforminwhile the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment withvildagliptin/metforminand when to restart it.

Tests of liver function should be performed before starting treatment withvildagliptin/metformin, at intervals of three months during the first year, andperiodically thereafter. This is done to detect as soon as possible any sign indicating an increase in liver enzymes (transaminases).

During treatment withvildagliptin/metformin, 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 periodically check your blood sugar levels and urine.

Children and adolescents

The administration ofvildagliptin/metforminis not recommended in children and adolescents under 18years.

Othermedicines and vildagliptin/metformin

If you need to be administered in your bloodstream an injection of a contrast medium containing iodine, for example, in the context of a radiography or an examination, you should stop takingvildagliptin/metforminbefore the injection or at the time of the injection. Your doctor will decide when to interrupt treatment withvildagliptin/metforminand 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 ofvildagliptin/metformin. It is especially important to mention the following:

• corticosteroids, generally used to treat inflammation;
• beta-2 agonists, generally used to treat respiratory disorders;
• other active principles used to treat diabetes;
• diuretics that increase urine production;
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);
• certain medicinesused to treat hypertension (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 HIV infection (for example, dolutegravir);
• 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);

Takingvildagliptin/metforminwith alcohol

Avoid excessive alcohol consumption while takingvildagliptin/metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

If you feel dizzy while takingvildagliptin/metformin, do not drive or operate tools or machines.

Vildagliptin/Metformin Kern Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., 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 for this medicationas indicated 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/1000mg 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 in combination 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 in the evening with meals or 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 weight control diet for diabetics, continue with the diet while takingvildagliptin/metformin.

The grooves should not be used to break the tablet.

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 immediatelyor 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 to take 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 medicinemay 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 users):

Vildagliptin/metformin may cause a very rare but serious side effect called lactic acidosis (see section “Warnings and precautions”). 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, abdominal pain, and stomach 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 (pale skin, 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, red, rounded spots under the skin's surface, or hematomas.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Vildagliptin/Metformin Kern Pharma Composition

• The active ingredients arevildagliptin and metformin hydrochloride:
• Each film-coated tablet ofVildagliptin/Metformin Kern Pharma
  50 mg/850 mgcontains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
• Each film-coated tablet ofVildagliptin/Metformin Kern Pharma
  50 mg/1,000 mgcontains 50 mg of vildagliptin and 1,000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).

• The other components are: In the tablet core: hydroxypropylcellulose, lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, stearic acid fumarate, and sodium. Additionally, the film coating contains: hypromellose, titanium dioxide, macrogol, talc (E553b), and yellow iron oxide (E172).

Appearance of the product and contents of the package

Vildagliptin/Metformin Kern Pharma 50 mg/850 mg film-coated tablets

Film-coated, oval, and oblong tablets, yellow in color, with a notch on one face and the imprint "VA" on the other face. Tablet diameter: 19.4 ± 0.5 mm.

Vildagliptin/Metformin Kern Pharma 50 mg/1,000 mg film-coated tablets

Film-coated, yellow-brown, oval, and oblong tablets, with a notch between the "V" and "B" on one face and another notch on the other face. Tablet diameter: 21.1 ± 0.5 mm.

It is presented in ALU/OPA-ALU-PVC blisters,in packs of 10, 30, 60, 120, 180, and 360 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km 36

San Agustin de Guadalix 28750

Spain

Or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50, Esplugues de LLobregat

08950 Barcelona,

Spain

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

Spain:Vildagliptin/Metformin Kern Pharma 50 mg/850 mg film-coated tablets

Vildagliptin/Metformin Kern Pharma 50 mg/1,000 mg film-coated tablets

Malta:Vildagliptin/Metformin Kern Pharma 50 mg/850 mg film-coated tablets

Vildagliptin/Metformin Kern Pharma 50 mg/1,000 film-coated tablets

Portugal:Metformin + Vildagliptin Pharmakern

Last revision date of this leaflet: April 2023

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