IPINZAN 50 mg/850 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ipinzan, 50 mg + 850 mg, Film-Coated Tablets
3. Ipinzan, 50 mg + 1000 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
4. What Ipinzan is and what it is used for
   1. How Ipinzan works
5. Important information before taking Ipinzan
   1. When not to take Ipinzan
   2. Warnings and precautions
   3. You must stop taking Ipinzan temporarily if you have a condition that may lead to dehydration
   4. You must stop taking Ipinzan and contact your doctor immediately if you experience any of the symptoms of lactic acidosis
   5. Children and adolescents
   6. Ipinzan with other medicines
   7. Ipinzan with alcohol
   8. Pregnancy and breast-feeding
   9. Driving and using machines
   10. Ipinzan contains maltodextrin (a source of glucose)
6. How to take Ipinzan
   1. When and how to take Ipinzan
   2. What to do if you take more Ipinzan than you should
   3. What to do if you forget to take Ipinzan
   4. What to do if you stop taking Ipinzan
7. Possible side effects
   1. Other side effects
   2. Reporting side effects
8. How to store Ipinzan
9. Contents of the pack and other information
   1. What Ipinzan contains
   2. What Ipinzan looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Ipinzan, 50 mg + 850 mg, Film-Coated Tablets

Ipinzan, 50 mg + 1000 mg, Film-Coated Tablets

Wildagliptin + Metformin Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Ipinzan is and what it is used for
• 2. Important information before taking Ipinzan
• 3. How to take Ipinzan
• 4. Possible side 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 of Ipinzan are wildagliptin and metformin, which belong to a group of oral antidiabetic medicines.
Ipinzan is used to treat adult patients with type 2 diabetes. This type of diabetes is also called non-insulin-dependent diabetes. Ipinzan is used when diet and exercise alone are not enough to control your blood sugar levels and when your doctor decides to add Ipinzan to your treatment (with or without other antidiabetic medicines such as insulin or sulfonylureas).
Type 2 diabetes is a condition where the body does not produce enough insulin or where the insulin produced by the body does not work properly. Type 2 diabetes can also occur when the body produces too much glucagon.
Both insulin and glucagon are produced in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon is a substance that stimulates the production of sugar in the liver and increases the level of sugar in the blood.

How Ipinzan works

Both active substances, wildagliptin and metformin, help to control the level of sugar in the blood.
Wildagliptin works by stimulating the pancreas to produce more insulin and by reducing the production of glucagon. Metformin helps the body to make better use of insulin.
It has been shown that the medicine lowers the level of sugar in the blood, which may help to prevent complications of diabetes.

2. Important information before taking Ipinzan

When not to take Ipinzan

• If you are allergic to wildagliptin, 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, tell your doctor before taking Ipinzan.

If you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see also "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition where substances called ketone bodies build up in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity odor from the mouth.

• If you have recently had a heart attack or if you have heart failure or severe circulatory or breathing problems, which may be a sign of heart failure.
• If you have significantly reduced kidney function.
• If you have a severe infection or are dehydrated (have lost too much water from your body).
• If you are going to have a contrast agent injected into your bloodstream (for example, for an X-ray or CT scan). See also "Warnings and precautions" below.
• If you have liver disease.
• If you drink too much alcohol (either regularly or from time to time).
• If you are breast-feeding (see also "Pregnancy and breast-feeding" below).

Warnings and precautions

Before taking Ipinzan, talk to your doctor or pharmacist or nurse.
Risk of lactic acidosis
Ipinzan may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases if you have uncontrolled diabetes, severe infection, prolonged fasting or alcohol intake, dehydration (see below), liver problems, or any condition that interferes with oxygen delivery to tissues (e.g., severe heart failure).
If any of these conditions apply to you, tell your doctor.

You must stop taking Ipinzan temporarily if you have a condition that may lead to dehydration

(significant loss of body fluids), such as severe vomiting, diarrhea, fever, high temperature, or if you drink less fluid than you normally would. Talk to your doctor for advice.

You must stop taking Ipinzan and contact your doctor immediately if you experience any of the symptoms of lactic acidosis

as it can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe tiredness,
• difficulty breathing,
• low body temperature and slow heart rate.

Lactic acidosis is a medical emergency that requires immediate hospital treatment.
Talk to your doctor immediately if you experience any of the following:

• you have a hereditary condition that affects the mitochondria (the energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• after starting metformin, you experience any of the following symptoms: seizures, worsening of mental status, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss. Ipinzan does not replace insulin. Therefore, do not take Ipinzan to treat type 1 diabetes.
• 1. Before taking Ipinzan, tell your doctor if you have or have had pancreatitis.

Before taking Ipinzan, tell your doctor or pharmacist or nurse if you are taking a sulfonylurea, a type of antidiabetic medicine. Your doctor may want to reduce the dose of the sulfonylurea you are taking with Ipinzan to avoid low blood sugar levels (hypoglycemia).
If you have taken wildagliptin before but had to stop due to liver disease, you should not take this medicine.
Diabetic skin changes are a common complication of diabetes. Follow your doctor's or nurse's advice on skin and foot care. You should also pay particular attention to the appearance of new blisters or ulcers while taking Ipinzan.
If you notice any, talk to your doctor promptly.
If you are going to have a major surgical operation, you should not take Ipinzan during or for some time after the operation. Your doctor will decide when you should stop and restart Ipinzan.
Before and during treatment with Ipinzan, and at least every 3 months during the first year of treatment, and periodically thereafter, you will have to have liver function tests to check for signs of liver damage as soon as possible.
During treatment with Ipinzan, your doctor will regularly check your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
Your doctor will regularly check your blood sugar levels and urine.

Children and adolescents

Ipinzan should not be used in children and adolescents under 18 years of age.

Ipinzan with other medicines

If you are going to have a contrast agent injected into your bloodstream (for example, for an X-ray or CT scan), you should stop taking Ipinzan before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart Ipinzan.
Tell your doctor about all the medicines you are taking or have recently taken, and about any medicines you plan to take. You may need more frequent blood sugar tests or kidney function tests, or your doctor may need to adjust your dose of Ipinzan. It is especially important to tell your doctor if you are taking:

• corticosteroids (used to treat inflammation)
• beta-2-adrenergic receptor agonists (used to treat respiratory disorders)
• other antidiabetic medicines
• diuretics (medicines that 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)
• certain medicines that affect the thyroid gland
• certain medicines that affect the nervous system
• certain medicines used to treat angina pectoris, such as ranolazine
• certain medicines used to treat HIV infection, such as dolutegravir
• certain medicines used to treat a specific type of thyroid cancer (medullary thyroid carcinoma), such as vandetanib
• certain medicines used to treat heartburn and stomach ulcers, such as cimetidine.

Ipinzan with alcohol

Avoid excessive alcohol intake while taking Ipinzan, as this may increase the risk of lactic acidosis (see also "Warnings and precautions" above).

Pregnancy and breast-feeding

• If you are pregnant or think you may be pregnant, or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Ipinzan during pregnancy.
• Do not take Ipinzan if you are pregnant or breast-feeding (see also "Do not take Ipinzan" above). Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you experience dizziness while taking Ipinzan, do not drive or operate machinery.

Ipinzan contains maltodextrin (a source of glucose)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ipinzan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose of Ipinzan is different for each patient. Your doctor will tell you which dose to take.
The recommended dose is one tablet of 50 mg + 850 mg or 50 mg + 1000 mg twice a day.
If you have kidney problems, your doctor may prescribe a lower dose. If you are taking a sulfonylurea, a type of antidiabetic medicine, your doctor may also prescribe a lower dose.
Your doctor may prescribe this medicine alone (as monotherapy) or with other medicines that lower blood sugar levels.

When and how to take Ipinzan

• Ipinzan is taken orally.
• Swallow the tablets whole with a glass of water.
• Take one tablet in the morning and one in the evening with a meal or shortly after a meal. Taking the tablet shortly after a meal will help reduce the risk of stomach upset.
• Continue to follow your doctor's advice on diet while taking Ipinzan. Diet is especially important when you are taking a weight-controlling diet.

What to do if you take more Ipinzan than you should

If you accidentally take too many Ipinzan tablets or if someone else takes your tablets, contact your doctor or pharmacist immediately. You may need medical attention. If you need to go to a doctor or hospital, take the pack and this leaflet with you.

What to do if you forget to take Ipinzan

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

What to do if you stop taking Ipinzan

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor prescribes it. Do not stop taking Ipinzan without talking to your doctor first. If you have any questions about how long to take Ipinzan, talk to your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ipinzan can cause side effects, although not everybody gets them.
Stop taking Ipinzan and contact your doctor immediatelyif you experience any of the following serious side effects:

• Lactic acidosis(very rare: may affect up to 1 in 10,000 people): Ipinzan may very rarely cause a very serious side effect called lactic acidosis (see also "Warnings and precautions" above). If this happens to you, stop taking Ipinzan and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swelling of the face, tongue, or throat, difficulty swallowing, difficulty breathing, sudden appearance of rash or hives. These may be signs of an allergic reaction called angioedema.

Hepatic impairment (uncommon: may affect up to 1 in 100 people): Symptoms include yellowing of the skin and the whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may be signs of liver damage (hepatitis).

• Pancreatitis (uncommon: may affect up to 1 in 100 people): Symptoms 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 Ipinzan:

• Common (may affect up to 1 in 10 people): sore throat, runny nose, fever, itchy rash, excessive sweating, joint pain, dizziness, headache, uncontrolled shaking, constipation, nausea, vomiting, diarrhea, bloating, heartburn, stomach pain.
• Uncommon (may affect up to 1 in 100 people): tiredness, weakness, metallic taste, low blood sugar levels, loss of appetite, swelling of hands, feet, or ankles, chills, pancreatitis, muscle pain.
• Rare (may affect up to 1 in 10,000 people): symptoms of high lactic acid levels in the blood (such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat, or deep and rapid breathing); skin rash, itching; decreased vitamin B12 levels (anemia, tiredness, mental symptoms such as confusion or memory problems).

After this medicine has been marketed, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blistering, vasculitis (inflammation of blood vessels), which can cause skin rash or purpura (flat, red, or purple spots under the skin).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 blister or carton after "EXP". The expiry date refers to the last day of that month.
• 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ipinzan contains

• The active substances are wildagliptin and metformin hydrochloride.
• Each film-coated tablet of Ipinzan 50 mg + 850 mg contains 50 mg of wildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
• Each film-coated tablet of Ipinzan 50 mg + 1000 mg contains 50 mg of wildagliptin and 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
• The other ingredients are: copovidone (K 28), colloidal anhydrous silica, magnesium stearate, hypromellose 2910, polydextrose, titanium dioxide (E 171), talc, yellow iron oxide (E 172), maltodextrin/dextrin, medium-chain triglycerides.

What Ipinzan looks like and contents of the pack

Ipinzan 50 mg + 850 mg film-coated tablets are yellow, oval, biconvex tablets with a break line on one side and "50" and "850" engraved on the other side, 21.6 ± 0.2 mm in length and 8.6 ± 0.2 mm in width.
Ipinzan 50 mg + 1000 mg film-coated tablets are dark yellow, oval, biconvex tablets with a break line on one side and "50" and "1000" engraved on the other side, 22.0 ± 0.2 mm in length and 9.0 ± 0.2 mm in width.
Ipinzan is packaged in a cardboard box containing the appropriate number of blisters made of OPA/Aluminum/PVC/Aluminum or transparent PVC/PCTFE/Aluminum foil.
Ipinzan is available in packs of 10, 30, 60, or 180 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

PHARMATHEN INTERNATIONAL S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5,
69300 Rodopi
Greece
PHARMATHEN S.A.
Dervenakion 6
15351 Pallini Attiki
Greece
For further information on this medicine, contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
Phone: +48 22 375 92 00

Date of last revision of the package leaflet: March 2025