Pantoprazol Sun

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Pantoprazol SUN 40 mg, powder for solution for injection

Pantoprazole sodium sesquihydrate

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Pantoprazol SUN contains the active substance pantoprazole. Pantoprazol SUN 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 excessive acid production in the
stomach.
The medicine is administered intravenously and only when the doctor decides that pantoprazole injections are
more beneficial at the time than taking pantoprazole tablets. Injections will be replaced with tablets when the doctor deems it appropriate.

Pantoprazol SUN is used in the following indications

• reflux esophagitis - inflammation of the esophagus (the tube connecting the throat to the stomach), accompanied by acid reflux from the stomach;
• gastric and duodenal ulcers;
• Zollinger-Ellison syndrome and other conditions that cause excessive acid production in the stomach.

2. Important information before using Pantoprazol SUN

When not to use Pantoprazol SUN

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting treatment with Pantoprazol SUN, you should discuss it with your doctor, pharmacist, or
nurse

• if you have severe liver disease. You should inform your doctor about any previous liver problems. The doctor may order more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, treatment should be discontinued;

in case of increased liver enzyme activity, treatment should be discontinued;

• if you are taking a protease inhibitor for HIV, such as atazanavir (used to treat HIV infection), you should ask your doctor for detailed advice.
• using 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. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis);
• if you take Pantoprazol SUN for more than three months, it is possible that the magnesium level in your blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should immediately tell your doctor. Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
• if you have ever had a skin reaction after taking a medicine similar to Pantoprazol SUN, which reduces stomach acid.
• if a rash appears on your skin, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol SUN. You should also tell your doctor about any other side effects, such as joint pain.
• if you are planning a specific blood test (chromogranin A level).

In case of the following symptoms, you should immediately inform your doctor:

• unintentional weight loss;
• vomiting, especially recurring;
• difficulty swallowing or pain when swallowing;
• bloody vomiting, which may look like coffee grounds;
• pallor and weakness (anemia);
• blood in the stool, black or tarry stools;
• 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.

Your doctor may decide to perform tests to rule out underlying cancer, as treatment with pantoprazole may alleviate symptoms of cancer and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

Children and adolescents

Pantoprazol SUN is not recommended for use in children, as its effects in children under 18 years of age have not been studied.

Pantoprazol SUN and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pantoprazol SUN may affect the effectiveness of other medicines, so you should tell your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol SUN may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density - further tests may be necessary;
• medicines used to treat HIV infection, such as atazanavir;
• methotrexate (used to treat rheumatoid arthritis, which is a type of rheumatism, psoriasis - a skin disease characterized by red skin with dry patches) and cancer) - if you are taking methotrexate, your doctor may temporarily discontinue the use of Pantoprazol SUN, as pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may order a dose reduction;
• rifampicin (used to treat infections);
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to be excreted in breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
If you are pregnant or think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor decides that the benefits of using it outweigh the risks to the unborn child or baby.

Driving and using machines

Pantoprazol SUN has no or negligible influence on the ability to drive and use machines.
You should not drive or operate machinery if you experience side effects such as dizziness or vision disturbances.

Pantoprazol SUN contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to use Pantoprazol SUN

A nurse or doctor will administer the daily dose as an intravenous injection lasting from 2 to 15
minutes.
The recommended dose is

In the treatment of gastric and duodenal ulcers and reflux esophagitis

One vial (40 mg of pantoprazole) per day.

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

Two vials (80 mg of pantoprazole) per day.
Your doctor may adjust the dose later, depending on the amount of acid produced in the stomach. If you have been prescribed more than two vials (80 mg) per day, the injections will be administered in two equal doses. Your doctor may temporarily prescribe more than four vials (160 mg) per day. If the level of acid production in the stomach requires immediate control, the initial dose of 160 mg (four vials) should be sufficient to reduce the amount of acid in the stomach.

Patients with liver function disorders

If you have severe liver disease, the daily dose administered by injection should be only 20 mg (half a vial).

Use in children and adolescents

Pantoprazol SUN is not recommended for use in children and adolescents under 18 years of age.

Using a higher dose of Pantoprazol SUN than recommended

Doses are carefully checked by a nurse or doctor, so overdose is unlikely. The symptoms of overdose are not known.
If you have any further doubts about using this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Pantoprazol SUN can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should immediately inform your doctor or contact the emergency department at your nearest hospital.

• Severe allergic reactions (rare, less than 1 in 1000 treated patients):swelling of the tongue and/or throat, difficulty swallowing, hives (a rash like nettle rash), 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 available data):one or more of the following symptoms may occur: blistering of the skin and rapid deterioration of the general condition; erosion (with slight bleeding) in the eyes, nose, mouth (mouth) or genitals or hypersensitivity of the skin/skin rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the glands (e.g. under the arms), and blood tests may show changes in some white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema, drug reaction with eosinophilia and systemic symptoms, phototoxicity) .
• Other severe reactions (frequency not known, frequency cannot be estimated from available data):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever; rash and kidney problems with kidney enlargement, sometimes painful urination and pain in the lower back (severe kidney inflammation) that can lead to kidney failure.

Other side effects include:

• Common (less than 1 in 10 people)inflammation of the vein wall and formation of blood clots (thrombophlebitis) at the injection site, mild gastric polyps.
• Uncommon (less than 1 in 100 people)headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with 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 (less than 1 in 1000 people)disorders or complete loss of taste; vision disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rare (less than 1 in 10,000 people)disorientation.
• Frequency not known (cannot be estimated from available data)hallucinations, confusion (especially in patients who have had such symptoms before) feeling of tingling, pricking, burning, or numbness; rash that may be accompanied by joint pain, colitis that causes persistent watery diarrhea.

Side effects detected by blood tests

• Uncommon (less than 1 in 100 people)increased liver enzyme activity.
• Rare (less than 1 in 1000 people)increased bilirubin levels, increased fat levels in the blood, sudden decrease in the number of circulating granulocytes - white blood cells associated with high fever.
• Very rare (less than 1 in 10,000 people)decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Frequency not known (cannot be estimated from available data)decreased sodium, magnesium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to
the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazol SUN

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after:
EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
After reconstitution or reconstitution and dilution, the solution shows chemical and physical stability for 12 hours at 25°C. From a microbiological point of view, unless the method of opening and dilution precludes the risk of microbiological contamination, the product should be used immediately.
Do not use this medicine if you notice any changes in its appearance (e.g. if it becomes cloudy or precipitates).
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazol SUN contains

• The active substance of the medicine is pantoprazole sodium sesquihydrate. Each vial contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

What Pantoprazol SUN looks like and what the pack contains

Pantoprazol SUN is a white to almost white powder for solution for injection. It is available in a 10 ml clear glass vial, closed with a red aluminum cap and a gray rubber stopper, containing 40 mg of powder for solution for injection.
Pantoprazol SUN is available in the following packs:
1, 5, 10, or 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom and Northern Ireland under the following names

Austria
Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Belgium
Pantoprazol SUN 40 mg poeder voor oplossing voor injectie
Pantoprazol SUN 40 mg poudre pour solution injectable
Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Denmark
Pantoprazol SUN
Germany
Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Finland
Pantoprazol SUN 40 mg injektiokuiva-aine, liuosta varten
France
Pantoprazole SUN 40 mg poudre pour solution injectable
Italy
Pantoprazolo SUN 40 mg polvere per soluzione iniettabile
Netherlands
Pantoprazol SUN 40 mg poeder voor oplossing voor injectie
Norway
Pantoprazol SUN 40 mg pulver til injeksjonsvæske, oppløsning
Poland
Pantoprazol SUN 40 mg proszek do sporządzania roztworu do wstrzykiwań
Romania
Pantoprazol SUN 40 mg pulbere pentru soluţie injectabilă
Sweden
Pantoprazol SUN 40 mg pulver till injektionsvätska, lösning
United Kingdom and Northern Ireland Pantoprazole 40 mg powder for solution for injection
Date of last revision of the leaflet: 12.05.2023
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Information intended for healthcare professionals only:
The ready-to-use solution is prepared by injecting 10 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) into the vial containing the dry powder. After reconstitution, the product is a clear, colorless solution, free from impurities. This solution can be administered directly or after mixing with 100 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) or glucose injection solution at a concentration of 55 mg/ml (5%). For dilution, glass or plastic containers should be used.
Pantoprazol SUN should not be mixed or prepared with any solvents other than those indicated.
The prepared solution must be used within 12 hours. From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time after opening and the storage conditions. Usually, the medicine should not be stored for more than 12 hours at a temperature not exceeding 25°C.
The medicinal product should be administered intravenously over a period of 2 to 15 minutes.
The contents of the vial are intended for single use only for intravenous administration. Any unused residue of the medicinal product or product whose appearance has changed (e.g. if cloudiness or precipitate is visible) should be discarded.