Ipp

Package leaflet: Information for the patient

IPP, 40 mg, powder for solution for injection
Pantoprazole
Please read the entire leaflet carefully before using this 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, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What is IPP and what is it used for
2. Important information before using IPP
3. How to use IPP
4. Possible side effects
5. How to store IPP
6. Contents of the pack and other information

1. What is IPP and what is it used for

IPP 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.
This medicine is administered intravenously, and your doctor will recommend its use only when they consider that, at a given stage of treatment, intravenous administration of pantoprazole is more appropriate for the patient than administration in tablet form. Tablets will replace the intravenous medicine as soon as the doctor deems it possible.
IPP is used in adults to treat:
gastroesophageal reflux disease. Inflammation of the oesophagus (the part of the digestive tract connecting the throat with the stomach) due to backflow of hydrochloric acid;
peptic ulcer disease of the stomach and duodenum;
Zollinger-Ellison syndrome and other conditions characterised by abnormal, excessive secretion of hydrochloric acid.

2. Important information before using the drug IPP

When not to use the drug IPP
if the patient is allergic to pantoprazole or any of the other components of this medicine
(listed in section 6);
if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Before using the drug IPP, 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. If this
activity increases, treatment should be discontinued.
if the patient is receiving HIV protease inhibitors, e.g. atazanavir (used in the treatment of HIV
infection), at the same time as pantoprazole, as medical advice should be sought.
if the patient is receiving 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,
particularly if the patient has osteoporosis (reduced bone density) or if the doctor has informed the
patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid
medicines).
if the patient is receiving the drug IPP for longer than three months, as there may be a reduction in
magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle
spasms, disorientation, convulsions, dizziness or rapid heartbeat. If any of these symptoms occur,
the patient should immediately inform their doctor. 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.
if the patient has ever previously experienced a skin reaction after using a medicine similar to IPP
(medicines that reduce the production of hydrochloric acid in the stomach).
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their
doctor as soon as possible, as discontinuation of the drug IPP may be necessary. The patient should
also report any other adverse reactions such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN),
drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have
been reported with the use of pantoprazole. The patient should discontinue pantoprazole and seek
immediate medical advice if any symptoms associated with these serious skin reactions described in
section 4 occur.
if the patient is scheduled for a specific blood test (measurement of chromogranin A levels).
If any of the following symptoms occur (which may indicate another, more serious illness), the
patient should immediately inform the doctor before using this medicine:
unintentional weight loss
vomiting, especially recurrent
bloody vomiting (which may appear as dark, coffee-ground-like material in vomit)
presence of blood in stool (black or tarry stools)
difficulty swallowing or pain when 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 may
consider further investigations.

Children and adolescents
Use of the drug IPP is not recommended in children and adolescents, as there are no data on its
effects in patients under 18 years of age.

IPP and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take, including those available without a
prescription.
The drug IPP may affect the effectiveness of other medicines, so it is important to 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 may inhibit the proper action of these and
other medicines;
warfarin and phenprocoumon, which affect blood clotting or thinning; further tests may be required;
medicines used to treat HIV infection, such as atazanavir;
methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis and cancer);
if the patient is receiving methotrexate, the doctor may temporarily discontinue the use of IPP, as it
may increase methotrexate levels in the blood;
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.
Before starting pantoprazole, discuss this with the doctor if the patient is scheduled for a specific
urine test [for tetrahydrocannabinol (THC)].

Pregnancy, breastfeeding and fertility
There are insufficient data on the use of pantoprazole in pregnant women. There have been reports
of pantoprazole passing into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant,
she should consult her doctor or pharmacist before using this medicine.
The drug IPP may be used only when, in the opinion of the doctor, the benefit to the mother outweighs
the potential risk to the fetus or infant.

Driving and operating machinery
The drug IPP has no effect or has a 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 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use the drug IPP
A nurse or doctor administers the daily dose of the medicine intravenously as an injection lasting
between 2 and 15 minutes.

Recommended dose:
Adults
Treatment of gastric and duodenal ulcer and reflux esophagitis
One vial (40 mg of pantoprazole) per day.
Long-term treatment of Zollinger-Ellison syndrome and other disorders associated with abnormal,
excessive hydrochloric acid secretion
Two vials (80 mg of pantoprazole) per day.
The doctor may later adjust the dose depending on the amount of hydrochloric acid produced.
If the doctor prescribes more than two vials (80 mg) per day, the patient will receive the medicine in
two equal doses. The doctor may recommend temporary use of a dose exceeding four vials (160 mg)
per day. If rapid reduction of acid secretion is required, an initial dose of 160 mg (4 vials) should be
sufficient to achieve adequate acid suppression.

Patients with impaired liver function
If the patient has severe liver function disorders, the daily intravenous dose should be only 20 mg (half a vial).

Use in children and adolescents
Use of the drug IPP is not recommended in children and adolescents under 18 years of age.

Use of a higher than recommended dose of the drug IPP
Doses of the medicine are carefully checked by the nurse or doctor, so overdose is extremely unlikely.
Symptoms of overdose are not known.
If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur,
seek immediate medical attention by contacting a doctor or going to the nearest hospital emergency department:
Severe allergic reactions (uncommon: 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 rash accompanied by sudden worsening of general health, erosions (with slight bleeding) in the eyes, nose, mouth/lips, or genital organs, or skin hypersensitivity/rash, particularly on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms), and blood test results showing changes in certain white blood cells or liver enzymes may also occur.
• red, non-elevated spots or circular lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs, or eyes. Such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other severe conditions (frequency unknown): 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 affect fewer than 1 in 10 people)
inflammation of the vein wall and thrombophlebitis at the injection site, benign gastric polyps.
Uncommon (may affect 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 affect fewer than 1 in 1,000 people)
taste disturbances or complete loss of taste, visual disturbances such as blurred vision;
urticaria; joint pain; muscle pain; changes in body weight; increased body temperature; high
fever; limb swelling (peripheral oedema); allergic reactions; depression; breast enlargement in
men.
Very rare (may affect fewer than 1 in 10,000 people)
disorientation.
Frequency unknown (cannot be estimated from available data)
hallucinations, confusion (especially 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 reactions detected in blood tests:
Uncommon (may affect fewer than 1 in 100 people)
increased liver enzyme activity.
Rare (may affect fewer than 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 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 lead to more frequent infections; abnormal decrease in red blood cells, white blood cells, and platelets.
Frequency unknown (cannot be estimated from available data)
decreased blood sodium, magnesium, calcium, or potassium levels (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine IPP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store vials in the outer packaging to protect from light.
Use the prepared solution within 12 hours.
Use the prepared and diluted solution within 12 hours.
From a microbiological point of view, the product should be used immediately. If not used promptly,
it should not be stored for longer than 12 hours at a temperature not exceeding 25°C. The user is responsible
for the storage conditions and duration prior to administration.
Do not use IPP if any change in appearance is observed (e.g. due to cloudiness or precipitation).
The contents of the vial are intended for single use only. Any remaining amount of the product in the vial
should be discarded.
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 contains
Active substance: one vial of IPP contains 45.11 mg of sodium pantoprazole sesquihydrate,
equivalent to 40 mg of pantoprazole.
What IPP looks like and contents of the pack
IPP is a white or yellowish powder (powder for solution for injection) in glass vials with a red rubber stopper and an aluminium seal with a plastic protective cap.
The vials are packed in cardboard boxes. Each box contains 1 or 10 glass vials.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For more detailed information about the medicine and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Information intended exclusively for medical professionals:

A ready-to-administer solution is prepared by injecting 10 ml of 0.9% (9 mg/ml) sodium chloride injection solution into a vial containing the powder. The resulting solution should be colorless to pale yellow. The prepared solution may be administered directly or after mixing with 100 ml of 0.9% (9 mg/ml) sodium chloride injection solution or 5% (55 mg/ml) glucose monohydrate injection solution. Glass or plastic containers should be used for dilution.
IPP product must not be prepared or mixed with solutions other than those specified.
The prepared solution must be used within 12 hours. From a microbiological point of view, the product should be used immediately. If not used promptly after preparation, it should not be stored for longer than 12 hours at a temperature not exceeding 25 °C.
The user is responsible for the storage time and conditions prior to administration.
The medicinal product should be administered intravenously over 2 to 15 minutes.
The contents of the vial are intended for single use only. Any unused portion of the product or any solution showing visible changes in appearance (e.g., cloudiness or precipitation) must be discarded.