IPINZAN 50 MG/1.000 MG FILM-COATED TABLETS

2. What you need to know before you take Ipinzan

Do not take this medicine

• 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 this medicine.
• if you have uncontrolled diabetes with, 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 disorder in which substances called “ketone bodies” accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity odor of the breath.
• if you have recently had a heart attack or if you have heart failure or severe circulatory problems or breathing difficulties that may be a sign of heart problems.
• if you have a severe reduction in kidney function.
• if you have a severe infection or severe dehydration (significant loss of body water).
• if you are going to have a contrast radiography (a specific type of diagnostic test with 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 only occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

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

Risk of lactic acidosis

Vildagliptin/ metformin hydrochloride may cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working 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 disorder 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 medicine for a short period of time if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking this medicine and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, as this disorder can lead to a 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.

Consult your doctor promptly so that he can indicate how to proceed if:

• You know that you have a genetic disorder that affects the mitochondria (the energy-producing components within cells), such as the MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You present any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and deafness.

Vildagliptin/ metformin hydrochloride 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 this medicine if you are taking a diabetic medicine known as a sulfonylurea. Your doctor may want to reduce your sulfonylurea dose when taken in combination with vildagliptin/ metformin hydrochloride to avoid low blood sugar (hypoglycemia).

If you have previously taken vildagliptin but had to stop taking it due to liver disease, you should 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 this medicine. If this occurs, you should consult your doctor immediately.

If you need to undergo major surgery, you should stop taking this medicine during the procedure and for a period of time after it. Your doctor will decide when you should stop taking vildagliptin/ metformin hydrochloride and when to restart it.

Liver function tests should be performed before starting treatment with vildagliptin/ metformin hydrochloride, at intervals of three months during the first year, and periodically thereafter. This is done to detect any signs of increased liver enzymes as soon as possible.

During treatment with vildagliptin/ metformin hydrochloride, 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 renal function is deteriorating.

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

Children and adolescents

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

Other medicines and Ipinzan

If you need to be given an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking this medicine before the injection or at the time of the injection. Your doctor will decide when you should stop taking vildagliptin/ metformin hydrochloride and when to restart it.

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

You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of vildagliptin/ metformin hydrochloride. It is especially important to mention the following:

• corticosteroids, usually used to treat inflammation
• beta-2 agonists, usually 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 that affect the thyroid
• certain active substances that affect the nervous system
• certain active substances used to treat angina (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 acid and peptic ulcers (e.g., cimetidine)

Taking this medicine with alcohol

Avoid excessive alcohol consumption while taking this medicine, 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 are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will inform you about the potential risks of taking vildagliptin/ metformin hydrochloride during pregnancy.

Do not take this medicine if you are pregnant or breastfeeding (see also “Do not take this medicine”).

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you feel dizzy while taking this medicine, do not drive or use tools or machines.

This medicine contains maltodextrin (a source of glucose)

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Ipinzan

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

The dose of Ipinzan that you should take varies depending on your condition. Your doctor will tell you exactly what dose of Ipinzan you should take.

The recommended dose is one 50 mg/850 mg or 50 mg/1000 mg tablet twice a day.

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

Your doctor may prescribe this medicine alone or in combination with certain medicines that lower blood sugar levels.

How to take this medicine

• This medicine is taken orally
• Swallow the tablets whole 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 digestive discomfort.
• Follow your doctor's dietary advice. In particular, if you follow a weight control diet for diabetics, continue with the diet while taking vildagliptin/ metformin hydrochloride.

If you take more Ipinzan 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 need medical attention. If you have to visit a doctor or go to the nearest hospital, take the pack and this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ipinzan

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

If you stop taking Ipinzan

Continue taking this medicine while your doctor prescribes it to continue controlling your blood sugar. Do not stop taking vildagliptin/ metformin hydrochloride unless your doctor tells you to. If you have any doubts about the duration of treatment, consult your doctor.

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

4. Possible side effects

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

You should stop taking this medicine and contact your doctor immediatelyif you experience any of the following side effects:

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

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

• Angioedema (rare: may affect up to 1 in 1,000 people): symptoms that include swollen face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives, which may be indicative of a reaction called “angioedema”.
• Liver disease (hepatitis) (uncommon: may affect up to 1 in 100 people): symptoms that include yellowing of the skin and eyes, nausea, loss of appetite, or dark urine, which may be indicative of liver disease (hepatitis).
• Pancreatitis (uncommon: may affect up to 1 in 100 people): symptoms that include severe and persistent abdominal pain (stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients have experienced the following side 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, tremors, constipation, nausea (discomfort), vomiting, diarrhea, flatulence, heartburn, stomach pain, and abdominal pain.
• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swollen hands, ankles, or feet (edema).

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

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

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blisters, inflammation of blood vessels (vasculitis) that can cause skin rashes or spots, flat, red, and round patches under the skin surface or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ipinzan

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

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Ipinzan Composition

• The active ingredients are vildagliptin and metformin hydrochloride.
• Each Ipinzan 50 mg/1000 mg film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformina).
• 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/caprylin and caprin.

Product Appearance and Packaging Contents

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

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

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

It is possible that only some packaging sizes and doses are marketed in your country.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

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 under the following names:

Date of the last revision of this prospectus:May 2025

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