Ipp 40

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

IPP 40(Pantoprazole Sandoz 40 mg)

40 mg, gastro-resistant tablets

Pantoprazolum
IPP 40 and Pantoprazole 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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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 hydrochloric acid produced in the stomach. It is used to treat stomach and gut diseases caused by hydrochloric acid.
IPP 40 is used in adults and adolescents aged 12 years and older for the treatment of:

• reflux oesophagitis. Oesophagitis (a section of the digestive tract connecting the throat to the stomach) with reflux of acidic stomach contents into the oesophagus.

IPP 40 is used in adults for the treatment of:

• Helicobacter pyloriinfection in patients with duodenal and gastric ulcers, in combination with two antibiotics (so-called eradication). The goal of treatment is to kill the bacteria and thus reduce the risk of recurrence of the ulcer disease.
• gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other disorders characterized by abnormal, excessive production of hydrochloric acid.

2. Important information before taking IPP 40

When not to take IPP 40

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting to take IPP 40, you should discuss it with your doctor, pharmacist, or nurse if:

• you have severe liver problems. You should inform your doctor if you have ever had liver disease in the past. Your doctor will more frequently monitor your liver enzyme activity, especially if you are taking IPP 40 for a long time. If the activity increases, you should stop taking the medicine.
• your body's vitamin B stores are reduced or there are risk factors for reduced absorption of vitamin B. Like all medicines that inhibit the production of hydrochloric acid in the stomach, pantoprazole may reduce the absorption of vitamin B.
• you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) at the same time as pantoprazole, you should consult your doctor for advice.
• you are 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. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (medicines that increase the risk of osteoporosis).
• you are taking pantoprazole for more than three months, as there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• you are going to have a specific blood test (chromogranin A determination).
• you have ever had a skin reaction after taking a medicine similar to IPP 40 (reducing hydrochloric acid production in the stomach).

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking IPP 40. You should also tell your doctor about any other side effects that occur, such as joint pain.
If you experience any of the following symptoms before starting or after taking the medicine, you should immediately inform your 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.

Your doctor may decide to perform certain tests to rule out cancer, as pantoprazole relieves symptoms of cancer and may cause a delay in its diagnosis. If symptoms persist despite treatment, your doctor will consider further testing.
If you are taking IPP 40 for a long time (more than a year), your doctor will most likely regularly monitor your health. During each visit, you should report any new or previously unobserved symptoms and their circumstances to your doctor.

Children

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

IPP 40 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
IPP 40 may affect the effectiveness of other medicines, so you should inform your 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 testing may be necessary.
• medicines used to treat HIV infection, such as atazanavir;
• methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer). If you are receiving methotrexate, your 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 of IPP 40;
• rifampicin (a medicine used to treat infections);
• St. John's Wort ( Hypericum perforatum) used to treat mild depression.

Pregnancy and breastfeeding

There is no adequate data on the use of pantoprazole in pregnant women. There are reports of pantoprazole passing into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
The medicine can only be taken if, in the doctor's opinion, the benefit of its use for the patient outweighs the risk to the fetus or baby.

Driving and operating machinery

IPP 40 does not affect or has a negligible effect on the ability to drive and operate machinery. If you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.

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, i.e., the medicine is considered "sodium-free".

3. How to take IPP 40

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.

Taking the medicine

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

Adults

Treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication)
Treatment of gastric and duodenal ulcers
Usually, one tablet is taken per day. The dose can be doubled after consulting a doctor. The doctor will determine exactly how long you should take the medicine. Treatment of gastric ulcer usually lasts from 4 to 8 weeks, and duodenal ulcer from 2 to 4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other disorders associated with excessive production of hydrochloric acid
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 hydrochloric acid produced. If the doctor has prescribed more than two tablets per day, they should be taken twice a day. If the doctor has recommended more than four tablets per day, you will be informed exactly when to stop taking the medicine.

Kidney problems

If you have kidney problems, you should not take IPP 40 for Helicobacter pylorieradication.

Liver problems

If you have severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (IPP 20 tablets are available).
If you have moderate or severe liver problems, you 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

You should contact your doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of IPP 40

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

Stopping treatment with IPP 40

You should not stop treatment without consulting your doctor or pharmacist.
If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you experience any of the following side effects, you should stop taking the tablets and immediately contact your 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 profuse sweating.
• Severe skin changes frequency not known:frequency cannot be estimated from the available data): You may notice one or more of the following symptoms: blisters on the skin with sudden deterioration of general health, erosions (with slight bleeding) in the eyes, nose, mouth/lips, or genitals, or rash, especially on skin areas exposed to sunlight. You may also experience joint pain or flu-like symptoms, fever, swelling of 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), hypersensitivity to light).
• 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 gastric polyps.
• Uncommon(may occur less frequently than in 1 in 100 people): headache; dizziness; diarrhea; nausea; vomiting; feeling of fullness and bloating (gas); constipation; dry mouth; stomach pain and discomfort; skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disturbances, fracture in the hip, wrist, or spine.
• 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; changes in body weight; increased body temperature; swelling of 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 had these symptoms before); reduced 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 (inflammation of the large intestine) 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 may cause bleeding or easier bruising than usual; decreased white blood cell count, which may cause more frequent infections; abnormal decrease in the number of both white and red blood cells and platelets.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide 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 packaging.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does IPP 40 contain

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: anhydrous sodium carbonate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose, colloidal silicon dioxide, calcium stearate.
Coating: hypromellose, titanium dioxide (E 171), macrogol 400, quinoline yellow (E 104), yellow iron oxide (E 172), cochineal red (E 124), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What does IPP 40 look like and what does the packaging contain

IPP 40 gastro-resistant tablets are yellow, oval (with a special coating), approximately 11.7 x 6.0 mm in size. They are available in blisters of 30 or 60 tablets.
For more detailed information, you 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, D-39179 Barleben, Germany
Lek Pharmaceuticals d.o.o., Verovškova 57, 1526 Ljubljana, Slovenia
Lek S.A., ul. Domaniewska 50 c, 02-672 Warsaw, Poland
Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Târgu-Mureș, Romania

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, the country of export:RVG 33658
Parallel import authorization number:56/22
Leaflet approval date: 22.03.2022
[Information about the trademark]