PANTOPRAZOL 40 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Pantoprazol Zentiva, 40 mg, Powder for Solution for Injection
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Pantoprazol Zentiva and what is it used for
   1. Pantoprazol Zentiva is used in adults for the treatment of:
4. Important information before using Pantoprazol Zentiva
   1. When not to use Pantoprazol Zentiva
   2. Warnings and precautions
   3. Children and adolescents
   4. Pantoprazol Zentiva and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Pantoprazol Zentiva contains sodium
5. How to use Pantoprazol Zentiva
   1. Adults
   2. For the treatment of peptic ulcer disease of the stomach and duodenum and gastroesophageal reflux disease
   3. For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach
   4. Patients with liver function disorders
   5. Use in children and adolescents
   6. Overdose of Pantoprazol Zentiva
6. Possible side effects
   1. In case of any of the following side effects, inform a doctor or contact the nearest hospital with an emergency department:
   2. Reporting side effects
7. How to store Pantoprazol Zentiva
8. Contents of the pack and other information
   1. What Pantoprazol Zentiva contains
   2. What Pantoprazol Zentiva looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder in Poland:
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Pantoprazol Zentiva, 40 mg, Powder for Solution for Injection

pantoprazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this package leaflet, you may need to read it 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, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

What is Pantoprazol Zentiva and what is it used for
Important information before using Pantoprazol Zentiva
How to use Pantoprazol Zentiva
Possible side effects
How to store Pantoprazol Zentiva
Contents of the pack and other information

1. What is Pantoprazol Zentiva and what is it used for

Pantoprazol Zentiva contains the active substance pantoprazole. Pantoprazol Zentiva 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 related to acid production.
This medicine is given by injection and is only used when, in the doctor's opinion, this method of administration is more suitable for the patient than taking pantoprazole tablets. The injection will be replaced by tablets as soon as the doctor considers it appropriate.

Pantoprazol Zentiva is used in adults for the treatment of:

Gastroesophageal reflux disease. Esophagitis (inflammation of the esophagus) is accompanied by acid reflux from the stomach.
Peptic ulcer disease of the stomach and duodenum.
Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. Important information before using Pantoprazol Zentiva

When not to use Pantoprazol Zentiva

If the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
If the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting treatment with Pantoprazol Zentiva, inform a doctor, pharmacist, or nurse.
if the patient has severe liver function disorders. Inform a doctor if liver function disorders have occurred in the past. The doctor may order more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, the use of the medicine should be discontinued.
if the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), they should ask a doctor for detailed advice.
the use of a proton pump inhibitor such as pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. Inform a doctor if the patient has osteoporosis (decreased bone density) or if the doctor has informed the patient that they are at risk of osteoporosis (e.g., if the patient is taking steroid medications).
if the patient is taking Pantoprazol Zentiva for more than three months, they may experience a decrease in blood magnesium levels, which can cause fatigue, tremors, disorientation, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, inform a doctor. Low blood magnesium levels can also cause a decrease in blood potassium and calcium levels. The doctor may decide to periodically check the patient's blood magnesium levels.
if the patient has ever experienced a skin reaction after taking a medicine similar to Pantoprazol Zentiva, which reduces stomach acid production.
if the patient has ever experienced a skin rash, especially in areas exposed to sunlight, inform a doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazol Zentiva. Also, inform a doctor about any other side effects, such as joint pain.
severe skin reactions have been reported in association with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Discontinue pantoprazole and seek medical attention immediately if symptoms of these severe skin reactions occur, as described in section 4.
about a planned specific blood test (chromogranin A levels).
Inform a doctor immediatelybefore starting or during treatment with the medicine if the following symptoms occur, which may be a sign of a more serious disease:
unintentional weight loss;
vomiting, especially if it recurs;
bloody vomiting, which may look like dark coffee grounds;
blood in the stool, black or tarry stools;
difficulty swallowing or pain when swallowing;
pale skin and weakness (anemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhea, as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea.
A doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

Children and adolescents

Pantoprazol Zentiva is not recommended for use in children, as its efficacy has not been studied in children under 18 years of age.

Pantoprazol Zentiva and other medicines

Inform a 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.
Because Pantoprazol Zentiva may affect the efficacy of other medicines, inform a doctor if the patient is taking:
medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Zentiva may inhibit the proper functioning of these and other medicines.
warfarin and phenprocoumon, which affect blood density and prevent blood clots. Further tests may be necessary.
medicines used to treat HIV infection, such as atazanavir.
methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if the patient is taking methotrexate, a doctor may temporarily discontinue the use of Pantoprazol Zentiva, as pantoprazole may increase methotrexate levels in the blood.
fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, a doctor may order a dose reduction.
rifampicin (used to treat infections).
St. John's Wort (Hypericum perforatum) (used to treat mild depression).
Before starting treatment with pantoprazole, discuss it with a doctor if the patient is to undergo a specific urine test [for the presence of tetrahydrocannabinol (THC)].

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Experience with the use of pantoprazole in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.
The medicine may be used if the doctor considers that the benefit of its use is greater than the potential risk to the unborn child or infant.

Driving and using machines

Pantoprazol Zentiva has no or negligible influence on the ability to drive and use machines.
Do not drive or operate machines if side effects such as dizziness or visual disturbances occur.

Pantoprazol Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means that the medicine is considered "sodium-free".

3. How to use Pantoprazol Zentiva

The medicine is given by injection in a single daily dose over 2-15 minutes by a nurse or doctor.
The recommended needle size is 21G.
Recommended dose:

Adults

For the treatment of peptic ulcer disease of the stomach and duodenum and gastroesophageal reflux disease

One vial (40 mg of pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach

Two vials (80 mg of pantoprazole) per day.
Dosing may be adjusted by a doctor, depending on the amount of acid produced. Daily doses greater than 2 vials (80 mg) should be given in two equal doses.
It is possible to temporarily increase the dose of pantoprazole to more than four vials (160 mg) per day.
To quickly control acid production, an initial dose of 160 mg (4 vials) should be sufficient to reduce acid production.

Patients with liver function disorders

In severe liver disease, the daily dose should be 20 mg (half a vial).

Use in children and adolescents

The use of the medicine is not recommended in children and adolescents under 18 years of age.

Overdose of Pantoprazol Zentiva

A doctor or nurse will carefully check the dosage, so overdose is unlikely. The symptoms of overdose are not known.
In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of any of the following side effects, inform a doctor or contact the nearest hospital with an emergency department:

Severe allergic reactions (rare:may affect up to 1 in 1000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (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 and rapid deterioration of general condition, erosion (with minor bleeding) of the eyes, nose, mouth/throat, or genitals, or rash, especially in areas exposed to sunlight. It may also occur joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in blood test results may show changes in some white blood cells or liver enzymes.
red, non-raised spots or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence 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 reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure.
Other side effects:
Common(may affect up to 1 in 10 people)
inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site;
mild stomach polyps.
Uncommon(may affect up to 1 in 100 people)
headache;
dizziness;
diarrhea;
nausea;
vomiting;
feeling of fullness in the abdominal cavity and bloating with gas (gas);
constipation;
dry mouth;
abdominal pain and discomfort;
skin rash, redness, skin eruptions;
itching;
weakness, fatigue, or general malaise;
sleep disturbances;
fractures of the hip, wrist, or spine.
Rare(may affect up to 1 in 1000 people)
disturbances or complete loss of taste;
visual disturbances, such as blurred vision;
hives;
joint pain;
muscle pain;
weight changes;
increased body temperature;
high fever;
swelling of the limbs (peripheral edema);
allergic reactions;
depression;
breast enlargement in men.
Very rare(may affect up to 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 such symptoms before);
tingling, prickling, burning, or numbness, rash that may occur with joint pain; inflammatory bowel disease causing persistent watery diarrhea.
Side effects identified through blood tests
Uncommon(may affect up to 1 in 100 people) - increased liver enzyme activity.
Rare(may affect up to 1 in 1000 people) - increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in circulating granulocytes - white blood cells.
Very rare(may affect up to 1 in 10,000 people) - decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count, which may increase the risk of infections; concurrent, abnormal decrease in red and white blood cell count, as well as platelet count.
Frequency not known(frequency cannot be estimated from the available data)
decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If side effects occur, including those not listed in the package leaflet, inform a doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +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 the medicine.

5. How to store Pantoprazol Zentiva

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after the expiry date stated on it.
Store below 30°C.
Store the vial in the outer packaging to protect it from light.
The solution after reconstitution or after reconstitution and dilution should be used within 12 hours.
Due to the maintenance of microbiological purity, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for the storage time and conditions before use. It is not recommended to store the solution for more than 12 hours at a temperature not exceeding 25°C.
Do not use Pantoprazol Zentiva if a change in its appearance is visible (e.g., the solution becomes cloudy or precipitates).
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazol Zentiva contains

The active substance of the medicine is pantoprazole (in the form of pantoprazole sodium sesquihydrate). Each vial contains 40 mg of pantoprazole.
The other ingredients are disodium edetate and sodium hydroxide (to adjust the pH).

What Pantoprazol Zentiva looks like and contents of the pack

Pantoprazol Zentiva is a white or almost white lyophilized powder with a porous appearance.
Pantoprazol Zentiva is packaged in a 10 ml vial made of colorless glass (type I), closed with a gray cork made of chlorobutyl rubber and sealed with an aluminum cap. The whole thing is in a cardboard box.
Pack sizes: 1, 10, 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

France, Czech Republic
Pantoprazole Zentiva
Bulgaria
Пантопразол Зентива
Poland, Germany
Pantoprazol Zentiva
Italy
Pantoprazol Zentiva Lab
Hungary
Pantacid Flux
Romania
Zencopan
Slovak Republic
Ozzion
Date of last revision of the package leaflet:August 2024