PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
IPP 40 (Pantoprazol Sandoz 40 mg)
40 mg, enteric-coated tablets
Pantoprazolum
IPP 40 and Pantoprazol Sandoz 40 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are identical.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

What IPP 40 is and what it is used for
What you need to know before taking IPP 40
How to take IPP 40
Possible side effects
How to store IPP 40
Contents of the pack and other information

1. What IPP 40 is and what it is 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 in the treatment of stomach and intestinal disorders caused by hydrochloric acid.
IPP 40 is used in adults and adolescents aged at least 12 years for the treatment of:
gastroesophageal reflux disease. Inflammation of the oesophagus (the part of the digestive tract connecting the throat to the stomach) due to backflow of acidic stomach contents into the oesophagus.
IPP 40 is used in adults for the treatment of:
Helicobacter pylori infection in patients with peptic ulcer disease of the duodenum and stomach, in combination with two antibiotics (so-called eradication therapy). The aim of treatment is to eliminate the bacteria and thereby reduce the risk of recurrence of peptic ulcer disease.
gastric and duodenal ulcers.
Zollinger-Ellison syndrome and other conditions associated with abnormal, excessive secretion of hydrochloric acid.

2. Important information before using the medicine IPP 40

When not to use IPP 40 if the patient is allergic to pantoprazole or to 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, discuss this with your doctor, pharmacist or
nurse if:
the patient has severe liver function disorders. Inform the doctor if the
patient has 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 prolonged period. If this activity increases, administration of the medicine should be discontinued.
the patient's vitamin B levels are chronically reduced due to long-term treatment with pantoprazole, or if there are risk factors for reduced absorption of this vitamin. As with all medicines that inhibit gastric hydrochloric acid production, pantoprazole
may reduce the absorption of vitamin B.
the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) at the same time as pantoprazole, the patient should seek medical advice.
the patient is taking a proton pump inhibitor such as pantoprazole, especially for longer than one year, as there may be a slight increase in the risk of fractures of the hip, wrist, and spine. The patient should inform the doctor if they have osteoporosis or if they are taking corticosteroids (medicines that increase the risk of developing osteoporosis).
the patient has been taking pantoprazole for longer than three months, as there may be a reduction in blood magnesium levels. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
the patient is due to undergo a specific blood test (measurement of chromogranin A levels).
the patient has ever previously experienced a skin reaction after taking a medicine similar to IPP 40 (reducing gastric hydrochloric acid production).
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of IPP 40 may be necessary. The patient should also report any other adverse effects such as joint pain.
If any of the following symptoms occur before or after starting treatment, the patient should inform the doctor immediately, as they may indicate another, more serious illness:

unintentional weight loss,
vomiting, especially recurrent,
bloody vomiting (which may appear as dark coffee-ground-like particles in vomit),
presence of blood in stool (black or tarry stools),
difficulty swallowing,
pale skin and feeling of weakness (anaemia),
chest pain,
stomach pain,
severe and (or) persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide to perform certain tests to rule out cancer, as pantoprazole relieves symptoms of cancer and may delay its diagnosis. If symptoms persist despite treatment, the doctor will consider performing further investigations.
If the patient takes IPP 40 for a long time (longer than one year), the doctor will likely monitor their health regularly. 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 is no data on its efficacy in patients under 12 years of age.

IPP 40 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
IPP 40 may affect the efficacy of other medicines; therefore, inform the doctor about the use of:

medicines such as ketoconazole, itraconazole and posaconazole (used in the treatment of fungal infections) or erlotinib (a medicine used in the treatment of certain cancers), as IPP 40 may inhibit the proper action of these and other medicines;
warfarin and phenprocoumon, which affect blood clotting. Further tests may be necessary.
medicines used in the treatment of HIV infections, such as atazanavir;
methotrexate (a medicine used in the treatment of rheumatoid arthritis, psoriasis and cancer). If the patient is receiving methotrexate, the doctor may recommend temporarily discontinuing IPP 40, as pantoprazole may increase methotrexate blood levels;
fluvoxamine (a medicine used in the treatment of depression and other psychiatric disorders); in patients taking fluvoxamine, the doctor may reduce the dose;
rifampicin (a medicine used in the treatment of infections);
St. John's wort (Hypericum perforatum) used in the treatment of mild depression.

Pregnancy and breastfeeding
There are insufficient data on the use of pantoprazole in pregnant women. There are reports of pantoprazole passing into breast milk.
If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if, in the doctor's opinion, the benefit to the patient outweighs the risk to the foetus or infant.

Driving and operating machinery
IPP 40 has no or negligible effect on the ability to drive and operate machinery. However, if the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.

IPP 40 contains a colouring agent and sodium
This medicine contains the colouring agent cochineal red (E 124), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per enteric-coated tablet, meaning the medicine is considered "sodium-free".

3. How to use IPP 40

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Taking the medicine
The tablets should be taken one hour before a meal. Swallow them whole (without chewing or breaking) with a small amount of water.
Recommended dose:
Adults and adolescents aged at least 12 years:
Treatment of reflux esophagitis
Usually one tablet per day is prescribed. Your doctor may recommend increasing the dose to 2 tablets per day. Treatment of reflux esophagitis typically lasts from 4 to 8 weeks. Your doctor will determine exactly how long you should take the medicine.
Adults:
Treatment of Helicobacter pylori infection in patients with peptic ulcer disease of the stomach and duodenum, in combination with two antibiotics (eradication therapy)
One tablet twice daily, together with two antibiotics (selected from amoxicillin, clarithromycin, metronidazole or tinidazole), which should be taken twice daily along with the pantoprazole tablet.
The first dose of IPP 40 should be taken one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and read the package leaflets of the prescribed antibiotics. Treatment usually lasts from one to two weeks.
Treatment of gastric and duodenal ulcer disease
Usually one tablet per day is prescribed. The dose may be doubled after consultation with your doctor. Your doctor will determine exactly how long you should take the medicine. Treatment of gastric ulcer typically lasts from 4 to 8 weeks, and duodenal ulcer from 2 to 4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid production
The usual initial dose is two tablets per day.
Both tablets should be taken one hour before breakfast. Your doctor may later adjust the dose depending on the amount of gastric acid produced. If your doctor prescribes more than two tablets per day, they should be taken in two divided doses. If your doctor prescribes more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.
Renal function impairment
If you have impaired kidney function, you should not use IPP 40 for Helicobacter pylori eradication.
Hepatic function impairment
If you have severe hepatic impairment, you should not take more than one 20 mg pantoprazole tablet per day (IPP 20 tablets are available).
If you have moderate or severe hepatic impairment, you should not use IPP 40 for Helicobacter pylori eradication.
Use in children
IPP 40 is not recommended for use in children in this age group.
Taking more than the recommended dose of IPP 40
Contact your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of IPP 40
Do not take a double dose to make up for a missed dose. Take the next tablet at the usual time.
Stopping treatment with IPP 40
Do not stop treatment without consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If any of the following adverse effects occur, stop taking IPP 40 tablets immediately and contact your doctor or go to the emergency department of your nearest hospital without delay:

Severe allergic reactions (rare: may affect fewer than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, facial swelling due to allergy (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): The patient may notice one or more of the following symptoms: development of blisters on the skin with sudden worsening of general health, erosions (with slight bleeding) in the eyes, nose, mouth/lips or genital organs, or rash, particularly on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arms) may also occur, and blood tests 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 syndrome), photosensitivity).
Other severe conditions (frequency unknown: frequency cannot be estimated from 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 during urination and lower back pain (severe kidney inflammation, which may progress to kidney failure).

Other adverse effects:

Common (may affect up to 1 in 10 people): benign gastric polyps.
Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; feeling of fullness and bloating (gas); constipation; dryness of the mouth; abdominal pain and discomfort; skin rash; skin eruption; erosions; itching; feeling of weakness, fatigue or general malaise; sleep disturbances, fractures of the hip, wrist or spine.
Rare (may affect up to 1 in 1,000 people): disturbances or complete loss of taste, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; increased body temperature; swelling of limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): disorientation.
Frequency unknown (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced these symptoms); sensation of tingling, pricking, numbness, burning or stinging; rash, which may be accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects detected in blood tests:

Uncommon (may affect up to 1 in 100 people): increased liver enzyme activity.
Rare (may affect up to 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in granulocyte count (white blood cells) in blood, accompanied by high fever.
Very rare (may affect up to 1 in 10,000 people): decreased platelet count, which may lead to bleeding or easier bruising than usual; decreased white blood cell count, which may result in more frequent infections; abnormal decrease in both white and red blood cells and platelets.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine IPP 40

The medicine should be stored in a place inaccessible to and out of sight of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
box after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Do not use the medicine IPP 40 after 6 months from the first opening of the HDPE container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What IPP 40 contains
The active substance in this medicine is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
The other ingredients are: sodium carbonate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), anhydrous colloidal silicon dioxide, calcium stearate.
Coating: hypromellose, titanium dioxide (E 171), macrogol 400, quinoline yellow (E 104), yellow iron oxide (E 172), carmine red (E 124), methacrylic acid and ethyl acrylate copolymer (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate.

What IPP 40 looks like and contents of the pack
IPP 40 enteric-coated tablets are yellow, oval-shaped (coated with a special film coating), with approximate dimensions of 11.7 x 6.0 mm. They are available in blister packs (28, 56, 84, 90, 98 and 168 tablets) or in bottles (28 and 56 tablets).

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in the Netherlands, the country of export:
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
D-39179 Barleben
Germany
Lek Spółka Akcyjna
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 Târgu-Mureș
Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Poland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in the Netherlands, the country of export:
RVG 33658
Parallel Import Authorisation number: 109/24