Ipp

Package Leaflet: Information for the Patient

IPP, 40 mg, Powder for Solution for Injection

Pantoprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This package leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What is IPP and what is it used for
• 2. Important information before taking IPP
• 3. How to take 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 acid produced in the stomach. It is used to treat stomach and gut conditions caused by acid.

IPP is used in adults for the treatment of:

gastroesophageal reflux disease. Esophagitis (inflammation of the esophagus) with acid reflux;

gastric and duodenal ulcers;

Zollinger-Ellison syndrome and other conditions with excessive acid production.

2. Important information before taking IPP

When not to take IPP

if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);

if the patient is allergic to other proton pump inhibitors.

Warnings and precautions

Before taking IPP, the patient should discuss with their doctor, pharmacist, or nurse:

if the patient has severe liver problems. The patient should inform their doctor if they have ever had liver disease in the past. The doctor will monitor liver enzyme activity more closely. If activity increases, the medication should be discontinued;

if the patient is taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), at the same time as pantoprazole, as they should consult their doctor for advice;

if the patient is 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, especially in patients with osteoporosis or those taking corticosteroids;

if the patient is going to have a specific blood test (chromogranin A determination);

In case of any of the following symptoms (which may indicate a more serious condition), the patient should inform their doctor before taking this medication:

unintentional weight loss;

vomiting, especially if it is repeated;

blood in the stool (black or tarry stools);

difficulty swallowing or pain when swallowing;

pale skin and feeling weak (anemia);

chest pain;

stomach pain;

severe and/or persistent diarrhea, as the use of this medication is associated with a small increased risk of infectious diarrhea.

Children and adolescents

IPP should not be used in children and adolescents under 18 years of age, as there is no data on its use in this age group.

IPP and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, including those obtained without a prescription.

IPP may affect the effectiveness of other medications, so the patient should inform their doctor about taking:

medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as IPP may inhibit the proper functioning of these and other medications;

warfarin and phenprocoumon, which can cause blood to thicken or thin; further testing may be necessary;

HIV medications, such as atazanavir;

methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer);

if the patient is taking methotrexate, their doctor may temporarily discontinue IPP, as it may increase methotrexate levels in the blood;

fluvoxamine (used to treat depression and other mental health conditions); in patients taking fluvoxamine, the doctor may reduce the dose;

rifampicin (used to treat infections);

St. John's Wort (Hypericum perforatum) used to treat mild depression.

Pregnancy, breastfeeding, and fertility

There is no sufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to pass into breast milk.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

IPP can only be used during pregnancy or breastfeeding if the doctor considers the benefits to the mother outweigh the potential risks to the fetus or baby.

Driving and using machines

IPP has no or negligible influence on the ability to drive and use machines.

If the patient experiences side effects such as dizziness or vision disturbances, they should not drive or operate machinery.

IPP contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, which means it is essentially 'sodium-free'.

3. How to take IPP

The daily dose of IPP is administered intravenously by a nurse or doctor over 2 to 15 minutes.

Recommended dose:

Treatment of gastric and duodenal ulcers and gastroesophageal reflux disease

One vial (40 mg pantoprazole) per day.

Long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid production

Two vials (80 mg pantoprazole) per day.

The doctor may adjust the dose later based on the amount of acid produced.

If the doctor prescribes more than two vials (80 mg) per day, the patient will receive the medication in two equal doses. The doctor may recommend temporary use of a dose exceeding 4 vials (160 mg) per day. If rapid reduction of acid production is necessary, an initial dose of 160 mg (4 vials) should be sufficient to achieve the desired reduction.

Patients with liver impairment

If the patient has severe liver problems, they should receive a daily intravenous dose of only 20 mg (half a vial).

Use in children and adolescents

IPP should not be used in children and adolescents under 18 years of age.

Overdose

Doses are carefully checked by the nurse or doctor, so overdose is highly unlikely.

There are no known symptoms of overdose.

In case of any further doubts about the use of this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, IPP can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should contact their doctor or the emergency department of the nearest hospital immediately:

Severe allergic reactions (rare: may occur in less than 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 a very fast heartbeat and excessive sweating.

Severe skin changes (frequency not known: frequency cannot be estimated from the available data):

The patient may notice one or more of the following symptoms:

• -blistering of the skin with rapid deterioration of general health, ulcers in the eyes, nose, mouth/lips, or genitals, or increased sensitivity of the skin/skin rash, especially in areas exposed to the sun. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood test results may also occur.
• red spots or patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other severe conditions (frequency not known):yellowing of the skin or whites of the eyes (severe liver damage, jaundice) or fever, rash, and swollen kidneys, 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 in less than 1 in 10 people)

inflammation of the vein wall and blood clot formation in the vein at the injection site, mild stomach polyps.

Uncommon(may occur in less than 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; fractures in the hip, wrist, or spine.

Rare(may occur in less than 1 in 1000 people)

disturbances or complete loss of taste, vision disturbances such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

Very rare(may occur in less than 1 in 10,000 people)

disorientation.

Frequency not known(frequency cannot be estimated from the available data)

hallucinations, confusion (especially in patients who have experienced these symptoms before); feeling of tingling, pricking, burning, or numbness; rash, which may be accompanied by joint pain; inflammation of the colon, causing persistent watery diarrhea.

Side effects detected in blood tests:

Uncommon(may occur in less than 1 in 100 people)

increased liver enzyme activity.

Rare(may occur in less than 1 in 1000 people)

increased bilirubin levels; increased fat levels in the blood; sudden decrease in the number of white blood cells in the blood, with high fever.

Very rare(may occur in less than 1 in 10,000 people)

decrease in platelet count, which may cause bleeding or easier bruising; decrease in white blood cell count, which may increase the risk of infections; abnormal decrease in the number of red and white blood cells and platelets.

Frequency not known(frequency cannot be estimated from the available data)

decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of this medication.

5. How to store IPP

The medication should be stored out of sight and reach of children.

Do not use this medication after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Vials should be stored in the outer packaging to protect from light.

Prepared solution should be used within 12 hours.

Prepared and diluted solution should be used within 12 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately after preparation, it should not be stored for more than 12 hours at a temperature below 25°C. The user is responsible for the storage conditions before administration.

IPP should not be used if the appearance of the solution has changed (e.g., due to clouding or sediment formation).

The contents of the vial are for single use only. Any remaining product in the vial should be discarded.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. 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 pantoprazole sodium 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 aluminum cap with a plastic protective cover.

The vials are packaged in cardboard boxes. Each box contains 1 or 10 glass vials.

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana, Slovenia

For more information about this medication and its names in other EU countries, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the package leaflet:12/2024

Sandoz logo

----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

The ready-to-use solution is prepared by injecting 10 ml of 0.9% (9 mg/ml) sodium chloride injection into the vial containing the powder. The resulting solution should be colorless to pale yellow. The prepared solution can be administered directly or after mixing with 100 ml of 0.9% (9 mg/ml) sodium chloride injection or 5% (55 mg/ml) glucose solution for injection. Only glass or plastic containers should be used for dilution.

IPP should not be prepared or mixed with solutions other than those listed.

The prepared solution must be used within 12 hours. From a microbiological point of view, the product should be used immediately. If not used immediately after preparation, it should not be stored for more than 12 hours at a temperature below 25°C. The user is responsible for the storage conditions before administration.

IPP should be administered intravenously over 2 to 15 minutes.

The contents of the vial are for single use only. Any remaining product in the vial or with a changed appearance (e.g., due to clouding or sediment formation) should be discarded.