Ipinzan 50 mg/1,000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ipinzan 50 mg/1000 mg 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Ipinzan 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".

This medicine 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 hydrochloride 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 this medicine 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, which will help prevent complications of your diabetes.

2. What you need to know before taking 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, 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” build up in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or fruity-smelling breath.
• if you have recently had a heart attack, or if you have heart failure, 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 (significant loss of body water).
• if you are scheduled to undergo contrast radiography (a specific type of X-ray diagnostic test using an injectable contrast agent). For more information, see the section “Warnings and precautions”.
• if you have liver problems.
• if you drink excessive amounts of alcohol (either daily or only occasionally).
• if you are breastfeeding (see also “Pregnancy and breastfeeding”).

Warnings and precautions

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

Risk of lactic acidosis

Vildagliptin/metformin hydrochloride 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 consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as acute and severe heart diseases).

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

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

Stop taking this medicine and contact your doctor or go to the nearest hospital immediately if you experience any 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 being unwell, with extreme tiredness
• difficulty breathing
• decreased body temperature and heart rate

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

Contact your doctor immediately for advice if:

• You are known to have a genetic mitochondrial disorder (the components responsible for energy production within 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, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or deafness.

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

Talk to your doctor, pharmacist, or nurse before starting this medicine if you have or have had a pancreatic disease.

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

If you previously took vildagliptin but had to stop 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 must consult your doctor immediately.

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

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

During treatment with vildagliptin/metformin hydrochloride, your doctor will monitor 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

This medicine is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Ipinzan

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 this medicine before or at the time of the injection. Your doctor will decide when you should interrupt treatment with vildagliptine/hydrochloride metformin and when to restart it.

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

You may require 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 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 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 might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will advise you about the potential risks of taking vildagliptin/hydrochloride metformin during pregnancy.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

This medicine contains maltodextrin (a source of glucose)

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ipinzan

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

The dose of Ipinzan required by each individual varies depending on their 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 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 a diabetes medication known 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 this medicine

• This medicine is taken orally
• 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 weight-control diet, continue this 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, contact 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 pack 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 telephone number: 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 next scheduled dose. Do not take a double dose (two tablets at once) to make up for forgotten doses.

If you stop taking Ipinzan

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 hydrochloride unless your doctor tells you to. If you have any questions about the duration of 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 will experience them.

You must stop taking this medicine 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 users):

Vildagliptin/metformin hydrochloride may cause a very rare but serious adverse effect called lactic acidosis (see section 2, “Warnings and precautions”). If this occurs, you must stop taking this medicine and contact a doctor or go to 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 appearance 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-colored 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, acid reflux, stomach and abdominal pain.

• Uncommon (may affect up to 1 in 100 people): joint pain, fatigue, constipation, swollen hands, ankles or feet (oedema).

• 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 of the skin or blisters, 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Ipinzan

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 “CAD”/”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 empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ipinzan

• The active substances 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 (equivalent 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/caprylic and capric acid.

Nature of the product and contents of the pack

Ipinzan 50 mg/1000 mg film-coated tablets are oval, yellow, film-coated tablets with bevelled 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 blisters or transparent PVC/PE/PCTFE-Alu blisters.

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

In your country, only certain pack sizes and strengths may be marketed.

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

Further information on this medicinal product is available from 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

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