Ipp 40

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

IPP 40(Pantoprazol Sandoz 40 mg)

40 mg, gastro-resistant tablets

Pantoprazolum
IPP 40 and Pantoprazol Sandoz 40 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• 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 IPP 40 and what is it used for
• 2. Important information before taking IPP 40
• 3. How to take IPP 40
• 4. Possible side effects
• 5. How to store IPP 40
• 6. Contents of the package and other information

1. What is IPP 40 and what is it used for

IPP 40 contains the active substance pantoprazole. Pantoprazole is a selective proton pump inhibitor – a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and gut diseases caused by acid.

IPP 40 is used in adults and adolescents aged 12 years and older for the treatment of:

reflux esophagitis. Esophagitis (a section of the digestive tract connecting the throat to the stomach) with reflux of acidic stomach contents into the esophagus.

IPP 40 is used in adults for the treatment of:

infection with the bacterium Helicobacter pyloriin patients with duodenal and gastric ulcer disease, in combination with two antibiotics (so-called eradication). The goal of treatment is to kill the bacteria and thus reduce the risk of ulcer disease recurrence.

gastric and duodenal ulcer disease.

Zollinger-Ellison syndrome and other disorders characterized by excessive acid production.

2. Important information before taking IPP 40

When not to take IPP 40

if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);

if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting to take IPP 40, the patient should discuss it with their doctor, pharmacist, or nurse if:

the patient has severe liver problems. The patient should inform their doctor if they have ever had liver disease in the past. The doctor will monitor liver enzyme activity more frequently, especially if the patient is taking IPP 40 for a long time. If activity increases, the doctor may stop the medicine.

the patient's vitamin B stores are decreased or there are risk factors for decreased absorption. Like all medicines that inhibit acid production in the stomach, pantoprazole may decrease vitamin B absorption.

the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) at the same time as pantoprazole, they should consult their doctor for advice.

the patient is taking a proton pump inhibitor, such as pantoprazole, especially for more than a year, as it may slightly increase the risk of hip, wrist, and spine fractures. The patient should tell their doctor if they have osteoporosis or are taking corticosteroids (medicines that increase the risk of osteoporosis).

the patient is taking pantoprazole for more than three months, as there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

the patient is going to have a specific blood test (chromogranin A measurement).

the patient has ever had a skin reaction after taking a medicine similar to IPP 40 (reducing acid production in the stomach). If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking IPP 40. The patient should also tell their doctor about any other side effects, such as joint pain.

If the patient experiences any of the following symptoms before starting or after taking the medicine, they should immediately inform their doctor, as they may indicate a more serious disease:

• unintentional weight loss,
• vomiting, especially recurring,
• bloody vomiting (which may look like the presence of dark coffee grounds in the vomit), - blood in the stool (black or tarry stools),
• difficulty swallowing,
• pale skin and feeling weak (anemia),
• chest pain,
• stomach pain,
• severe and/or persistent diarrhea, as taking this medicine is associated with a slight increase in the frequency of infectious diarrhea.

The doctor may decide to perform certain tests to rule out cancer, as pantoprazole can alleviate cancer symptoms and may delay its diagnosis. If the symptoms persist despite treatment, the doctor will consider further tests.

If the patient is taking IPP 40 for a long time (more than a year), the doctor will likely regularly monitor their health. During each visit, the patient should report any new or previously unobserved symptoms and the circumstances of their occurrence.

Children

IPP 40 is not recommended for use in children, as there are no data on its effects in patients under 12 years of age.

IPP 40 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

IPP 40 may affect the effectiveness of other medicines, so the patient should inform their doctor about taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (a medicine used to treat certain cancers), as IPP 40 may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density. Further tests may be necessary.
• medicines used to treat HIV infections, such as atazanavir;
• methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer). If the patient is receiving methotrexate, the doctor may recommend temporary discontinuation of IPP 40, as pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (a medicine used to treat depression and other mental illnesses); in patients taking fluvoxamine, the doctor may reduce the dose;
• rifampicin (a medicine used to treat infections);
• St. John's Wort (Hypericum perforatum) used to treat mild depression.

Pregnancy and breastfeeding

There are no adequate data on the use of pantoprazole in pregnant women. There are reports of pantoprazole passing into breast milk.

If the woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

The medicine can only be taken if the doctor believes that the benefits of its use for the patient outweigh the risks to the fetus or baby.

Driving and using machines

IPP 40 does not affect or has a negligible effect on the ability to drive and use machines. If the patient experiences side effects such as dizziness or vision disturbances, they should not drive or operate machines.

IPP 40 contains a dye and sodium

This medicine contains the dye cochineal red (E 124), which may cause allergic reactions.

This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, which means the medicine is considered "sodium-free".

3. How to take IPP 40

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Taking the medicine

The tablets should be taken 1 hour before a meal, swallowed whole (without chewing or breaking), with a small amount of water.

Recommended dose:

Adults and adolescents aged 12 years and older:

Treatment of reflux esophagitis
Usually, one tablet is taken per day. The doctor may recommend increasing the dose to 2 tablets per day. Treatment of reflux esophagitis usually lasts from 4 to 8 weeks. The doctor will determine exactly how long the patient should take the medicine.

Adults:

Treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcer disease, in combination with two antibiotics (eradication)
One tablet is taken twice a day, plus two antibiotics (among amoxicillin, clarithromycin, and metronidazole or tinidazole), which are taken twice a day with the pantoprazole tablet. The first tablet of IPP 40 should be taken 1 hour before breakfast, and the second 1 hour before dinner. The patient should follow the doctor's instructions and read the leaflets included with the prescribed antibiotics. Treatment usually lasts from one to two weeks.

Treatment of gastric and duodenal ulcer disease
Usually, one tablet is taken per day. The dose can be doubled after consulting the doctor. The doctor will determine exactly how long the patient should take the medicine. Treatment of gastric ulcer disease usually lasts from 4 to 8 weeks, and duodenal ulcer disease from 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other disorders with excessive acid production
The recommended initial dose is usually two tablets per day.

Both tablets should be taken 1 hour before breakfast. The doctor may later adjust the dose of the medicine depending on the amount of acid produced in the stomach. If the doctor prescribes more than two tablets per day, they should be taken twice a day. If the doctor recommends more than four tablets per day, the patient will be informed exactly when to stop taking the medicine.

Kidney problems

If the patient has kidney problems, they should not take IPP 40 for Helicobacter pylorieradication.

Liver problems

If the patient has severe liver problems, they should not take more than one 20 mg pantoprazole tablet per day (IPP 20 tablets are available).

If the patient has moderate or severe liver problems, they should not take IPP 40 for Helicobacter pylorieradication.

Use in children

IPP 40 is not recommended for use in children in this age group.

Taking a higher dose of IPP 40 than recommended

The patient should contact their doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of IPP 40

The patient should not take a double dose to make up for a missed dose. They should take the next tablet at the usual time.

Stopping treatment with IPP 40

The patient should not stop treatment without consulting their doctor or pharmacist.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, IPP 40 can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking the tablets and immediately contact their doctor or the emergency department of the nearest hospital:

• Severe allergic reactions rare:may occur less frequently than in 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylaxis), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin changes frequency not known:frequency cannot be estimated from the available data): The patient may notice one or more of the following symptoms: blisters on the skin with sudden worsening of general health, ulcers (with slight bleeding) in the eyes, nose, mouth/lips, or genitals, or rash, especially on skin areas exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., under the arms), and blood test results may show changes in certain types of white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other severe conditions frequency not known:frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation, which can progress to kidney failure).

Other side effects:

• Common(may occur less frequently than in 1 in 10 people) mild stomach polyps.
• Uncommon(may occur less frequently than in 1 in 100 people) headache; dizziness; diarrhea; nausea; vomiting; feeling full and bloated (gas); constipation; dry mouth; stomach pain and discomfort; skin rash; eczema; ulcers; itching; feeling weak, tired, or unwell; sleep disturbances, hip, wrist, or spine fractures.
• Rare(may occur less frequently than in 1 in 1000 people) taste disorders or complete loss of taste, vision disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rare(may occur less frequently than in 1 in 10,000 people) disorientation.
• Frequency not known(cannot be estimated from the available data) hallucinations, confusion (especially in patients who have experienced these symptoms before); decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2); feeling of tingling, prickling, burning, or numbness; rash, which may be accompanied by joint pain; colitis (inflammatory bowel disease) causing persistent watery diarrhea.

Side effects detected in blood tests:

• Uncommon(may occur less frequently than in 1 in 100 people) increased liver enzyme activity.
• Rare(may occur less frequently than in 1 in 1000 people) increased bilirubin levels; increased fat levels in the blood; sudden decrease in the number of granulocytes (white blood cells) in the blood, with high fever.
• Very rare(may occur less frequently than in 1 in 10,000 people) decreased platelet count, which can cause bleeding or easier bruising than usual; decreased white blood cell count, which can cause more frequent infections; abnormal decrease in the number of both white and red blood cells and platelets.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should consult 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.: +48 22 49 21 301/fax: +48 22 49 21 309/website: https://smz.ezdrowie.gov.pl.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store IPP 40

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 and carton after EXP. The expiry date refers to the last day of the month.

There are no special precautions for storage.

Do not use IPP 40 after 6 months from the first opening of the HDPE container.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What IPP 40 contains

The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

The other ingredients are: sodium carbonate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), colloidal silicon dioxide, calcium stearate.

Coating: hypromellose, titanium dioxide (E 171), macrogol 400, quinoline yellow (E 104), iron oxide yellow (E 172), cochineal red (E 124), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What IPP 40 looks like and what the package contains

IPP 40 gastro-resistant tablets are yellow, oval (with a special coating), with approximate dimensions of 11.7 x 6.0 mm. They are available in blisters (28, 56, 84, 90, 98, and 168 tablets) or containers (28 and 56 tablets).

For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Netherlands

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Lek S.A.

Ul. Domaniewska 50 c

02-672 Warsaw

Poland

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Lek Pharmaceuticals d.d.

Trimlini 2 D

9220 Lendava

Slovenia

Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu-Mures

Romania

Lek S.A.

ul. Podlipie 16

95-010 Stryków

Poland

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Marketing authorization number in the Netherlands, the country of export:

RVG 33658

Parallel import authorization number:

109/24

Date of leaflet approval: 15.03.2024

[Information about the trademark]