IPINZAN 50 mg/1000 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Ipinzan, 50 mg + 850 mg, film-coated tablets
3. Ipinzan, 50 mg + 1000 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ipinzan and what is it used for
   1. How Ipinzan works
5. Important information before taking Ipinzan
   1. When not to take Ipinzan
   2. Warnings and precautions
   3. The patient should temporarily stop taking Ipinzan if they have a condition that may lead to dehydration
   4. The patient should stop taking Ipinzan and immediately contact their doctor or the nearest hospital if they experience any symptoms of lactic acidosis
   5. Children and adolescents
   6. Ipinzan with other medicines
   7. Ipinzan with alcohol
   8. Pregnancy and breastfeeding
   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. Taking a higher dose of Ipinzan than recommended
   3. Missing a dose of Ipinzan
   4. Stopping Ipinzan treatment
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

Leaflet attached to the packaging: patient information

Ipinzan, 50 mg + 850 mg, film-coated tablets

Ipinzan, 50 mg + 1000 mg, film-coated tablets

Wildagliptin + Metformin Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ipinzan and what is it 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 is Ipinzan and what is it used for

The active substances of Ipinzan are wildagliptin and metformin, which belong to the 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 diabetes, and it can be used with other diabetes medicines (insulin or sulfonylureas).
Type 2 diabetes is a disease in which the body does not produce enough insulin or 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 lower blood sugar levels, especially after meals. Glucagon is a substance that stimulates the production of sugar in the liver and increases blood sugar levels.

How Ipinzan works

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

2. Important information before taking Ipinzan

When not to take Ipinzan

• If the patient is allergic to wildagliptin, metformin, or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic to any of these ingredients, they should tell their doctor before taking Ipinzan.

If the patient has uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see also "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate 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 the patient has recently had a heart attack or if they have heart failure or severe circulatory problems or breathing difficulties, which may be a sign of heart failure.
• If the patient has significantly reduced kidney function.
• If the patient has a severe infection or is severely dehydrated (has lost a lot of body fluids).
• If the patient is to undergo a contrast radiological examination (a special type of examination that requires the injection of a contrast agent). For more information, see also "Warnings and precautions" below.
• If the patient has liver disease.
• If the patient consumes excessive amounts of alcohol (both daily and from time to time).
• If the patient is breastfeeding (see also "Pregnancy and breastfeeding" below).

Warnings and precautions

Before starting to take Ipinzan, the patient should discuss it with their doctor, pharmacist, or nurse.
Risk of lactic acidosis
Ipinzan may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., severe heart disease).
If any of these conditions apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Ipinzan if they have a condition that may lead to dehydration

(significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Ipinzan and immediately contact their doctor or the nearest hospital if they experience any symptoms of lactic acidosis

because this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell, combined with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
The patient should contact their doctor immediately for further instructions if:

• they have a genetically inherited disease affecting the mitochondria (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, they experience any of the following symptoms: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss. Ipinzan does not replace insulin. Therefore, Ipinzan should not be used to treat type 1 diabetes.
• 1. Before starting Ipinzan, the patient should discuss it with their doctor, pharmacist, or nurse if they have or have had pancreatic disease.

Before starting Ipinzan, the patient should consult their doctor, pharmacist, or nurse if they are taking a diabetes medicine called a sulfonylurea. The doctor may want to reduce the dose of sulfonylurea taken with Ipinzan to avoid low blood sugar (hypoglycemia).
If the patient has previously taken wildagliptin but had to stop due to liver disease, they should not take this medicine.
Diabetic skin changes are a common complication of diabetes. The patient should follow their doctor's or nurse's recommendations for skin and foot care. It is also recommended that the patient pay special attention to the occurrence of new blisters or ulcers while taking Ipinzan.
If they occur, the patient should talk to their doctor as soon as possible.
If the patient is to undergo major surgery, they should not take Ipinzan during the surgery and for some time after. The doctor will decide when the patient should stop and resume Ipinzan treatment.
Before starting Ipinzan treatment and at three-month intervals during the first year of treatment, and then periodically, the patient should undergo liver function tests. This will help detect elevated liver enzyme levels as soon as possible.
During Ipinzan treatment, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.
The doctor will regularly assess the patient's blood and urine sugar levels.

Children and adolescents

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

Ipinzan with other medicines

If the patient is to receive an iodine-containing contrast agent intravenously, for example, for an X-ray examination or computed tomography, they should stop taking Ipinzan before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume Ipinzan treatment.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood sugar checks or kidney function tests, or their Ipinzan dose may need to be adjusted by their doctor. It is especially important to inform their doctor about the following medicines:

• corticosteroids, usually used to treat inflammatory conditions
• beta-2-adrenergic receptor agonists, usually used to treat respiratory disorders
• other diabetes 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 cancer), such as vandetanib
• certain medicines used to treat heartburn and stomach ulcers, such as cimetidine.

Ipinzan with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Ipinzan, as this may increase the risk of lactic acidosis (see also "Warnings and precautions" above).

Pregnancy and breastfeeding

• If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The doctor will discuss the possible risks and benefits of taking Ipinzan during pregnancy.
• Ipinzan should not be used during pregnancy or breastfeeding (see also "When not to take Ipinzan" above). Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

If the patient experiences dizziness while taking Ipinzan, they should not drive or operate machinery.

Ipinzan contains maltodextrin (a source of glucose)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Ipinzan.

3. How to take Ipinzan

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of Ipinzan varies depending on the patient's condition. The doctor will determine the dose of Ipinzan to be taken.
The recommended dose is one 50 mg + 850 mg or 50 mg + 1000 mg tablet taken twice a day.
If the patient has kidney problems, the doctor may prescribe a lower dose. If the patient is taking a diabetes medicine called a sulfonylurea, the doctor may also prescribe a lower dose.
The doctor may prescribe Ipinzan alone (as monotherapy) or with other medicines that lower blood sugar levels.

When and how to take Ipinzan

• Ipinzan is taken orally.
• The tablets should be swallowed whole with a glass of water.
• The patient should take one tablet in the morning and one in the evening with a meal or immediately after a meal. Taking the tablet immediately after a meal will help reduce the risk of stomach upset.
• The patient should continue to follow their doctor's recommendations for diet. Following a diet while taking Ipinzan is especially important if the patient is on a weight-control diet.

Taking a higher dose of Ipinzan than recommended

In case of accidental ingestion of too many Ipinzan tablets or if someone else has taken the tablets, the patient should immediately inform their doctor or pharmacist. The patient may need medical attention. If it is necessary to visit a doctor or hospital, the patient should take the packaging and leaflet with them.

Missing a dose of Ipinzan

If the patient forgets to take a tablet, they should take it during the next meal, unless it is already time for the next tablet. The patient should not take a double dose (two tablets at once) to make up for the missed tablet.

Stopping Ipinzan treatment

To maintain control of blood sugar levels, the medicine should be taken for as long as prescribed by the doctor. The patient should not stop taking Ipinzan without their doctor's advice. If the patient has any questions about how long to take Ipinzan, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ipinzan can cause side effects, although not everybody gets them.
The patient should stop taking Ipinzan and immediately consult their doctorif they experience any of the following 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 section 2 "Warnings and precautions"). If this happens to the patient, they should stop taking Ipinzan and immediately contact their doctor or the nearest hospital, 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, breathing difficulties, sudden appearance of rash or hives. These may indicate a reaction called "angioedema".

Hepatic disorder (hepatitis) (uncommon: may affect up to 1 in 100 people): Symptoms include yellowing of the skin and whites of the eyes, nausea, loss of appetite, or dark-colored urine. These may indicate a hepatic disorder (hepatitis).

• Pancreatitis (uncommon: may affect up to 1 in 100 people): Symptoms include severe and persistent abdominal pain (around the stomach area), which may radiate to the back, as well as nausea and vomiting.

Other side effects

Some patients taking Ipinzan have experienced the following side effects:

• Frequently (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, and abdominal pain.
• Uncommonly (may affect up to 1 in 100 people): fatigue, weakness, metallic taste in the mouth, low blood sugar, loss of appetite, swelling of the hands, feet, or ankles (edema), chills, pancreatitis, muscle pain.
• Very rarely (may affect up to 1 in 10,000 people): symptoms of high lactic acid levels in the blood (lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heartbeat or deep and rapid breathing; skin redness, itching; decreased vitamin B12 levels (pallor, fatigue, psychological symptoms, such as confusion or memory disorders).

After the medicine was placed on the market, the following side effects have also been reported:

• Frequency not known (cannot be estimated from the available data): localized skin peeling or blistering, vasculitis, which can cause skin rash or flat, red, round patches under the skin or bruising.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ipinzan

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister or carton after "EXP". The expiry date refers to the last day of the month stated.
• Do not store above 30°C.
• Store in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This 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 50 mg + 850 mg film-coated tablet of Ipinzan contains 50 mg of wildagliptin and 850 mg of metformin hydrochloride (equivalent to 660 mg of metformin).
• -Each 50 mg + 1000 mg film-coated tablet of Ipinzan 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 silicon dioxide, 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 tablets are yellow, oval, film-coated tablets with beveled edges, engraved with "50" on one side and "850" on the other, measuring: length: 21.6 ± 0.2 mm, width: 8.6 ± 0.2 mm.
Ipinzan 50 mg + 1000 mg tablets are dark yellow, oval, film-coated tablets with beveled edges, engraved with "50" on one side and "1000" on the other, measuring: length: 22.0 ± 0.2 mm, width: 9.0 ± 0.2 mm.
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
(logo of the marketing authorization holder)

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
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2025