Ipp 40

Package leaflet: Information for the patient

Warning! Please 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, as you may need to read it again.
• 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What IPP 40 is and what it is 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 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 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 ulcers.
• Zollinger-Ellison syndrome and other conditions associated with abnormal, excessive hydrochloric acid secretion.

2. Important information before using the medicinal product IPP 40

When not to use IPP 40

• if the patient is allergic to pantoprazole or to any of the other ingredients of this medicinal product (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Page 1 of 7
Before starting treatment with IPP 40, consult 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 enzyme activity increases, treatment should be discontinued.
• vitamin B levels in the body of patients treated long-term with pantoprazole are reduced, or there are risk factors for impaired absorption of this vitamin. As with all drugs that inhibit gastric hydrochloric acid production, pantoprazole may reduce vitamin B absorption.
• the patient is taking protease inhibitors for HIV, such as atazanavir (used in the treatment of HIV infection), at the same time as pantoprazole, in which case medical advice should be sought.
• the patient is taking a proton pump inhibitor, such as pantoprazole, particularly for longer than one year, as this may slightly increase the risk of fractures of the hip, wrist, and spine. Inform the doctor if the patient has osteoporosis or is 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 doctor should be informed immediately. Low magnesium levels may also lead to decreased levels of potassium or calcium 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 previously experienced a skin reaction after using a medicine similar to IPP 40 (a drug that reduces 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 IPP 40 may be necessary. Also report any other adverse reactions occurring, such as joint pain.
If any of the following symptoms occur before starting or after taking the medicine, contact the doctor immediately, as they may indicate another, more serious illness:

• unintentional weight loss,
• vomiting, especially recurrent,
• vomiting blood (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 malignancy, as pantoprazole may relieve symptoms of cancer and could delay its diagnosis. If symptoms persist despite treatment, the doctor will consider further investigations.
If the patient is taking IPP 40 for a long time (longer than one year), the doctor will most likely monitor their health regularly. During each visit, report any new or previously unobserved symptoms to the doctor, along with the circumstances of their occurrence.

Children
Page 2 of 7
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 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 if the patient is 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 action of these and other medicines;
• warfarin and phenprocoumon, which affect blood clotting. Further testing may be required.
• 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 IPP 40, as pantoprazole may increase methotrexate blood levels;
• fluvoxamine (a medicine used to treat depression and other psychiatric disorders); 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 insufficient data on the use of pantoprazole in pregnant women. There have been reports of pantoprazole passing into breast milk.
If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 effect or has a negligible effect on the ability to drive and operate machinery. If the patient experiences adverse effects such as dizziness or visual disturbances, driving and operating machinery should be avoided.

IPP 40 contains a colouring agent - carmoisine (E 124) and sodium
This medicine contains the colouring agent carmoisine (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 take IPP 40

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
contact 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:
Page 3 of 7
Adults and adolescents aged at least 12 years:
Treatment of reflux esophagitis
One tablet per day is usually recommended. Your doctor may recommend increasing the dose to 2 tablets per day. Treatment of reflux esophagitis usually 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 duodenal and gastric ulcers, in combination with two antibiotics (eradication)
One tablet twice daily plus two antibiotics (chosen from amoxicillin, clarithromycin, and metronidazole or tinidazole), taken twice daily together with the pantoprazole tablet.
The first dose of IPP 40 should be taken 1 hour before breakfast and the second dose 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 ulcers
One tablet per day is usually recommended. 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 ulcers usually lasts from 4 to 8 weeks, and duodenal ulcers 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 1 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 recommends more than four tablets per day, you will be given specific instructions on when to stop taking the medicine.
Kidney function disorders
If you have impaired kidney function, you should not take IPP 40 for Helicobacter pylori eradication.
Liver function disorders
If you have severe liver function 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 function 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 IPP 40 treatment
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

Page 4 of 7
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below 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, allergic facial swelling (Quincke's edema/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: blistering of the skin with sudden deterioration in general health, erosions (with slight bleeding) in the eyes, nose, mouth/lips or genital organs, or rash, particularly in 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 enlarged kidneys, sometimes with pain during urination and lower back pain (severe kidney inflammation which may progress to kidney failure).

Other adverse effects:

• 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; dryness of the mouth; abdominal pain and discomfort; skin rash; exanthema; 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, 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 males.
• 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); sensations 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 occur in fewer than 1 in 100 people): increased liver enzyme activity.

Page 5 of 7

• 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 bruising than usual; 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 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store the medicine IPP 40

Keep the medicine out of the 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 stated month.
No special storage instructions apply.
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 pack and other information

What IPP 40 contains
The active substance in the medicine is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as
pantoprazole sodium 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), 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 enteric coating), with approximate dimensions of
11.7 x 6.0 mm. They are available in blister packs (30, 60 or 90 tablets).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Sandoz B.V., Veluwezoom 22, 1327 AH Almere, the Netherlands
Page 6 of 7
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, D-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 Târgu-Mureș, Romania
Lek S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Netherlands, country of export: RVG 33658
Parallel import authorisation number: 275/21
Page 7 of 7