Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 brand names for the same medicine.
Please read this leaflet carefully before using 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. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

What IPP 40 is and what it is used for
Important information 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 to treat 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 (reflux esophagitis). Esophagitis (inflammation of the esophagus – the part of the digestive tract connecting the throat with the stomach) due to backflow of acidic stomach contents into the esophagus.

IPP 40 is used in adults for the treatment of:

Helicobacter pylori infection in patients with peptic ulcer disease of the stomach and duodenum, 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 ulcer disease.
Zollinger-Ellison syndrome and other conditions characterized by abnormal, excessive secretion of hydrochloric acid.

2. Important information before using the medicine IPP 40

When not to use medicine 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 medicine IPP 40, discuss 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 medicine IPP 40 for a long time. If this activity increases, the medicine should be discontinued.
vitamin B levels in the body of a patient treated long-term with pantoprazole are reduced or if there are risk factors for decreased absorption of this vitamin. As with all medicines that inhibit gastric hydrochloric acid production, pantoprazole may reduce vitamin B absorption.
the patient is taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), at the same time as pantoprazole, the patient should consult the doctor for 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 hip, wrist, and spine fractures. Inform the doctor if the patient has osteoporosis or if the patient is taking corticosteroids (medicines that increase the risk of its development).
the patient has been taking pantoprazole for longer than three months, as there may be a risk of reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, convulsions, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
the patient is scheduled for a specific blood test (measurement of chromogranin A levels).
the patient has ever had a skin reaction after using a medicine similar to medicine IPP 40 (reducing gastric hydrochloric acid production).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of medicine IPP 40 may be necessary. Also inform the doctor about any other adverse reactions occurring, such as joint pain.
If any of the following symptoms occur before starting or after taking the medicine, 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 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 slight increase in the frequency of infectious diarrhoea.

The doctor may decide to perform certain tests on the patient to rule out cancer, as pantoprazole alleviates symptoms of cancer and may delay its diagnosis. If symptoms persist despite treatment, the doctor will consider performing further tests.
If the patient takes medicine IPP 40 for a long time (longer than one year), the doctor will most likely monitor the patient's health regularly. During each visit, report any new and previously unobserved symptoms to the doctor, as well as the circumstances of their occurrence.
Children
Use of medicine IPP 40 is not recommended in children, as there is no data on its effects in patients under 12 years of age.
Medicine IPP 40 and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken by the patient, as well as about medicines the patient plans to take, including those available without a prescription.
Medicine IPP 40 may affect the effectiveness of other medicines; therefore, inform the doctor about the use of:

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 action of these and other medicines;
warfarin and phenprocoumon, which affect blood clotting. 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 temporarily discontinuing medicine 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 used;
rifampicin (a medicine used to treat infections);
St. John's wort (Hypericum perforatum) used to treat 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 plans to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine may be taken only if, in the doctor's opinion, the benefit of treatment for the patient outweighs the risk to the fetus or infant.
Driving and operating machinery
Medicine IPP 40 has no effect or has a negligible effect on the ability to drive vehicles
and operate machinery. If the patient experiences adverse reactions such as dizziness or
visual disturbances, do not drive vehicles or operate machinery.
Medicine 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 directed by your doctor. If in doubt, consult your
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 at least 12 years
Treatment of reflux esophagitis
One tablet per day is usually recommended. Your doctor may increase the dose to 2 tablets per
day. Treatment for reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will determine
the exact duration of treatment.
Adults
Treatment of Helicobacter pylori infection in patients with peptic ulcer of the stomach and duodenum,
in combination with two antibiotics (eradication therapy)
One tablet twice daily plus two antibiotics (selected from amoxicillin, clarithromycin,
metronidazole or tinidazole), taken twice daily together with pantoprazole tablets.
The first dose of IPP 40 should be taken 1 hour before breakfast and the second 1 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
One tablet per day is usually recommended. The dose may be doubled after consultation with your
doctor. Your doctor will determine the exact duration of treatment. 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 conditions associated with excessive
gastric acid production
The usual initial dose is two tablets per day.
Both tablets should be taken 1 hour before breakfast. Your doctor may adjust the dose depending
on the amount of gastric acid produced. If your doctor prescribes more than two tablets per day,
they should be divided into two doses taken twice daily. If your doctor prescribes more than four
tablets per day, you will be given detailed instructions on when to stop taking the medicine.
Renal impairment
If you have impaired kidney function, you should not take IPP 40 for Helicobacter pylori eradication.
Hepatic impairment
If you have severe liver 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 liver impairment, you should not take 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 reactions

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

Severe allergic reactions (rare: may occur in fewer than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, facial swelling (angioedema/angioneurotic edema), 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: blistering of the skin with sudden deterioration in general health, erosions (with slight bleeding) in the eyes, nose, oral cavity/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), and blood tests showing changes in certain types of white blood cells or liver enzymes may also occur (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 reactions:

Common (may occur in fewer than 1 in 10 people): benign gastric polyps.
Uncommon (may occur in fewer than 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; feeling of fullness and bloating (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash; eruption; erosions; itching; feeling of weakness, exhaustion or general malaise; sleep disturbances, fracture of the hip, wrist or spine.
Rare (may occur in fewer than 1 in 1,000 people): disturbances or complete loss of taste, vision disorders 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 occur in fewer than 1 in 10,000 people): disorientation.
Frequency not known (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced these symptoms); decreased levels of sodium, magnesium, calcium or potassium in the blood; (see section 2); sensations of tingling, pricking, numbness, burning or stinging; rash accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected in blood tests:

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

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

5. How to store IPP 40

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should 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 pack and other information

What IPP 40 contains
The active substance is pantoprazole. Each enteric-coated 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 anhydrous silica, calcium stearate.
Coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, quinoline yellow (E 104), iron oxide yellow (E 172), carmine red (E 124), copolymer of methacrylic acid and ethyl acrylate (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 coating), with approximate dimensions of 11.7 x 6.0 mm. They are available in blisters of 30 or 60 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in the Netherlands, country of export:
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, D39179 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
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Netherlands, country of export: RVG 33658
Parallel import authorization number: 56/22