Pantoprazole Genoptim

Package Leaflet: Information for the User

Pantoprazole Genoptim, 40 mg, Powder for Solution for Injection

Pantoprazolum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Pantoprazole Genoptim and what is it used for

Pantoprazole Genoptim contains the active substance pantoprazole. Pantoprazole Genoptim 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 intestinal diseases related to acid production.
This medicine is given intravenously and is only used when, in the doctor's opinion, this route of
administration is more beneficial for the patient than taking pantoprazole in tablet form. The intravenous
medicine will be replaced with a tablet form as soon as the doctor considers it appropriate.

Pantoprazole Genoptim is used to treat:

• Reflux esophagitis. Esophagitis (inflammation of the tube connecting the throat to the stomach) is accompanied by acid reflux from the stomach.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. Important information before using Pantoprazole Genoptim

When not to use Pantoprazole Genoptim

• 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 to take Pantoprazole Genoptim, inform your doctor, pharmacist, or nurse:

• If the patient has severe liver function disorders. Inform your doctor if you have ever had liver function disorders. 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 their doctor for detailed advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If the patient is taking Pantoprazole Genoptim for more than three months, they may experience a decrease in blood magnesium levels, which can cause fatigue, tetany, disorientation, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their 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 Pantoprazole Genoptim, which reduces acid production in the stomach.
• About planned specific blood tests (chromogranin A levels).

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole Genoptim. They should also inform their doctor about any other side effects, such as joint pain.
Inform your doctor immediatelybefore starting or during treatment with the medicine, if you experience any of the following symptoms, which may be a sign of a more serious disease:

• unintentional weight loss;
• vomiting, especially recurring;
• bloody vomiting, which may look like dark coffee grounds;
• blood in the stool, black or tarry stool;
• 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.

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

Children and adolescents

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

Pantoprazole Genoptim and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Since Pantoprazole Genoptim may affect the efficacy of other medicines, inform 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 Pantoprazole Genoptim 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 you are taking methotrexate, your doctor may temporarily discontinue the use of Pantoprazole Genoptim in you, 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Experience with the use of the medicine in pregnant women is limited. The active substance of the medicine has been shown to pass into human milk.
The medicine may be used in pregnant or breastfeeding women or women who may become pregnant, only if the doctor considers that the benefit to the woman outweighs the risk to the unborn child or infant.
In animal studies, no impairment of fertility was observed after administration of pantoprazole.

Driving and using machines

Pantoprazole Genoptim has no or negligible influence on the ability to drive and use machines.
Do not drive or operate machinery if you experience side effects such as dizziness or vision disturbances.

Sodium content

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

3. How to use Pantoprazole Genoptim

The medicine is administered intravenously in a single daily dose over 2-15 minutes by a nurse or doctor.
Recommended dose:

Adults

In the treatment of gastric and/or duodenal ulcer disease and reflux esophagitis
One vial (40 mg of pantoprazole) per day.
In long-term treatment of Zollinger-Ellison syndrome and other diseases associated with excessive acid production in the stomach
Two vials (80 mg of pantoprazole) per day.
The dosage may be adjusted by the doctor, depending on the amount of acid produced. Daily doses greater than 2 vials (80 mg) should be administered in two equal doses.
It is possible to increase the dose of pantoprazole to more than four vials (160 mg) per day. For rapid control of 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 (½ vial).

Use in children and adolescents

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

Using more than the recommended dose of Pantoprazole Genoptim

The doctor or nurse will carefully check the dosage, so overdosing is unlikely. The symptoms of overdosing are not known.
If you have any further questions about the use of this medicine, ask your 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 your doctor or contact the nearest hospital where emergency services are available:

• Severe allergic reactions (rare: occurring in less than 1 in 1000 patients):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic edema of the face (Quincke's edema/anaphylactic edema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from the available data):blistering of the skin and rapid deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth, and/or genitals (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema), hypersensitivity to light.
• Other severe reactions (frequency not known: frequency cannot be estimated from the available data):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by their enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

powiększeniem, czasem z bólem podczas oddawania moczu i bólem w dolnej części
pleców (ciężkie zapalenie nerek), mogące prowadzić do niewydolności nerek.

Other known side effects that occur:

• Frequently(occurring in less than 1 in 10 patients) Inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site; mild gastric polyps.
• Less frequently(occurring in less than 1 in 100 patients) Headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (flatulence); 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.
• Rarely(occurring in less than 1 in 1000 patients) Disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; gynecomastia in men.
• Very rarely(occurring in less than 1 in 10,000 patients) Disorientation.
• Frequency not known(frequency cannot be estimated from the available data) Hallucinations, disorientation (especially in patients who have experienced such symptoms before); decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), feeling of tingling, prickling, burning, or numbness, rash that may be accompanied by joint pain, colitis that causes persistent watery diarrhea.

Side effects detected by blood tests that occur:

• Less frequently(occurring in less than 1 in 100 patients) Increased liver enzyme activity.
• Rarely(occurring in less than 1 in 1000 patients) Increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rarely(occurring in less than 1 in 10,000 patients) Decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can increase the risk of infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 492 1 309, 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 Pantoprazole Genoptim

Store the medicine 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 30°C in the original packaging to protect from light.
The solution after reconstitution should be used within 12 hours.
The solution after reconstitution and dilution should be used within 12 hours.
Due to the need to maintain 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 of 25°C.
Do not use Pantoprazole Genoptim if a change in its appearance is visible (e.g., the solution has become cloudy or a precipitate has formed).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Genoptim contains

• The active substance of the medicine is pantoprazole. Each vial contains 40 mg of pantoprazole.
• The other ingredients are disodium edetate, nitrogen.

What Pantoprazole Genoptim looks like and what the pack contains

Pantoprazole Genoptim is a white to off-white, porous "tablet" or powder for solution for injection.
A 10 ml vial made of colorless glass (type I), closed with a chlorobutyl rubber stopper and sealed with an aluminum cap, containing 40 mg of powder for solution for injection, in a cardboard box.
Pantoprazole Genoptim is available in the following packs:

• Pack containing 1 vial.
• Pack containing 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only

The ready-to-use solution is prepared by injecting 10 ml of 0.9% sodium chloride injection solution (at a concentration of 9 mg/ml) into the vial containing the dry powder. The prepared solution can be administered directly or after mixing with 100 ml of 0.9% sodium chloride injection solution (at a concentration of 9 mg/ml) or 100 ml of 5% glucose injection solution (at a concentration of 55 mg/ml). Glass or plastic containers should be used for dilution.
Pantoprazole Genoptim should not be prepared or mixed with solvents other than those specified above.
After preparation, the solution must be used within 12 hours. Due to the need to maintain 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 of 25°C.
The medicine is administered intravenously over 2-15 minutes.
The contents of the vial are intended for single use. The medicine that remains in the vial or whose appearance has changed (e.g., the solution has become cloudy or a precipitate has formed) should be destroyed.