Package Insert: Information for the Patient

Ipinzan 50 mg/1000 mg Film-Coated Tablets EFG

vildagliptin / metformin hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

The active principles of this medication, vildagliptin and metformin, belong to a group of medications called “oral antidiabetics”.

This medication is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin dependent diabetes mellitus.Vildagliptin/hydrochloride of metformin 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 function 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 causes blood sugar levels to increase.

How this medication works

Both active principles, vildagliptin and metformin, help to control blood sugar levels. The active principle vildagliptin stimulates the pancreas to produce more insulin and less glucagon. The active principle metformin 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 this medication

• if you are allergic to vildagliptin, metformin, or any of the other components of this medication (listed in section 6). If you think you may be allergic to any of these components, consult your doctor before taking this medication.
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see also "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 (significant loss of body fluids).
• if you are to undergo a contrast radiography (a specific type of diagnostic test with 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 (see also "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

Risk of lactic acidosis

Vildagliptin/hydrochloride metformin may cause a very rare but very 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 more information below), 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 this medication 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 this medication 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:

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

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

Vildagliptin/hydrochloride metformin is not a substitute for insulin. Therefore, do not take this medication for the treatment of type 1 diabetes.

Consult your doctor, pharmacist, or nurse before starting to take this medication if you have or have had a pancreatic disease.

Consult your doctor, pharmacist, or nurse before starting to take this medication 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 vildagliptin/hydrochloride metformin to avoid low blood sugar (hypoglycemia).

If you have taken vildagliptin before but had to stop taking it due to liver disease, do not take this medication.

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 this medication. If this occurs, you must consult your doctor immediately.

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

Tests of liver function should be performed before starting treatment with vildagliptin/hydrochloride metformin, at intervals of three months during the first year, and periodically thereafter. This is done to detect as soon as possible any sign indicating an increase in liver enzymes.

During treatment with vildagliptin/hydrochloride 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 worsening.

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

Children and adolescents

The administration of this medication is not recommended in children and adolescents under 18 years of age.

Other medications and interactions

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, stop taking this medication before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with vildagliptin/hydrochloride metformin and when to restart it.

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/hydrochloride 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, which increase urine production
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• medications used 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)

Taking this medication with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will inform you about the potential risks of taking vildagliptin/hydrochloride metformin during pregnancy.

Do not take this medication if you are pregnant or breastfeeding (see also "Do not take this medication").

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

This medication contains maltodextrin (glucose source)

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

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

The dosage ofIpinzanthat each person should take varies depending on their condition. Your doctor will indicate exactly the dosage ofIpinzanthat you should take.

The recommended dosage is a 50mg/850mg or 50mg/1000mg tablet taken twice a day.

If you have reduced renal function, your doctor may prescribe a lower dosage. Your doctor may also prescribe a lower dosage 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.

Form of use of this medication

• This medication is administered orally
• Swallow the tablets whole 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 on a weight control diet for diabetics, continue with the diet while takingvildagliptin/ hydrochloride of metformin.

If you take more Ipinzan than 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 forgot to take Ipinzan

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 compensate for the missed doses.

If you interrupt treatment withIpinzan

Continue taking this medication while your doctor continues to monitor your blood sugar levels. Do not stop takingvildagliptin/ hydrochloride of 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.

Youmust stop taking this medicine and see your doctor immediatelyif you experience any of the following side effects:

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

Vildagliptin/hydrochloride metformin may cause a very rare but serious side effect called lactic acidosis (see section 2 “Warnings and precautions”). If this happens to you,you must stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Angioedema (rare:may affect up to 1 in 1,000people): 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 (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 trembling, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, abdominal pain, and stomach pain.
• Infrequent (may affect up to 1 in 100people): joint pain, fatigue, constipation, swollen hands, ankles, or feet (edema).

• 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 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 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 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 the blister after “CAD”/”EXP”. 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 humidity.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Ipinzan

• The active principles are vildagliptin and hydrochloride of metformin.
• Each film-coated tablet of Ipinzan 50 mg/1000 mg contains 50 mg of vildagliptin and 1000 mg of hydrochloride of metformin (corresponding to 780 mg of metformin).
• The other components are: copovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polydextrose, titanium dioxide (E 171), talc, yellow iron oxide (E172), maltodextrin/dextrin, medium-chain triglycerides/caprilina and caprina.

Appearance of the product and contents of the package

Ipinzan 50 mg/1000 mg film-coated tablets are oval-shaped, yellow, beveled-edge tablets, marked with “50” on one face and “1000” on the other, and with the following dimensions: length: 22.0 ± 0.2mm, width: 9.0 ± 0.2mm.

Ipinzan is packaged in a cardboard box containing the appropriate number of OPA/Alu/PVC-Alu or transparent PVC/PE/PCTFE-Alu blisters.

Package sizes: 10, 30, 60 and 180 film-coated tablets.

It is possible that only some package sizes and dosages are marketed in your country.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

Or

Pharmathen S.A.

6 Dervenakion str.

Pallini, Attiki

15351

Greece

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Last review date of this leaflet:November 2023

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