PANTOPRAZOLE 40 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Pantoprazole Eugia, 40 mg, powder for solution for injection
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
   3. What is Pantoprazole Eugia and what is it used for
   4. Pantoprazole Eugia is used to treat the following conditions in adults:
3. Important information before taking Pantoprazole Eugia
   1. When not to take Pantoprazole Eugia
   2. Warnings and precautions
   3. Children and adolescents
   4. Pantoprazole Eugia and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Important information about some of the ingredients of Pantoprazole Eugia
4. How to take Pantoprazole Eugia
   1. Adults
   2. Patients with liver function disorders
   3. Use in children and adolescents
   4. Overdose of Pantoprazole Eugia
5. Possible side effects
   1. In case of any of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital where emergency services are available:
   2. Side effects detected by blood tests:
   3. Reporting side effects
6. How to store Pantoprazole Eugia
7. Contents of the packaging and other information
   1. What Pantoprazole Eugia contains
   2. What Pantoprazole Eugia looks like and what the pack contains
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 03/2024
   7. Information intended for healthcare professionals only:
   8. Reconstituted solution:
   9. Diluted solution:

Leaflet accompanying the packaging: information for the user

Pantoprazole Eugia, 40 mg, powder for solution for injection

Pantoprazolum

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

• You should keep this leaflet, so that 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pantoprazole Eugia and what is it used for
• 2. Important information before taking Pantoprazole Eugia
• 3. How to take Pantoprazole Eugia
• 4. Possible side effects
• 5. How to store Pantoprazole Eugia
• 6. Contents of the packaging and other information

1.

What is Pantoprazole Eugia and what is it used for

Pantoprazole Eugia contains the active substance pantoprazole. Pantoprazole Eugia 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 beneficial for the patient than taking pantoprazole in tablet form. The injectable medicine will be replaced with the tablet form as soon as the doctor considers it appropriate.

Pantoprazole Eugia is used to treat the following conditions in adults:

• -Reflux esophagitis. Esophagitis 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 taking Pantoprazole Eugia

When not to take Pantoprazole Eugia

• -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 Eugia, the patient should inform their doctor, pharmacist, or nurse:

• -If the patient has severe liver function disorders. The patient should inform their doctor if they 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, such as pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis (reduced bone density) or if they have been informed that they are at risk of osteoporosis (e.g., if they are taking steroids).
• -If the patient is taking Pantoprazole Eugia for more than three months, they may experience a decrease in magnesium levels in the blood, which can cause fatigue, muscle cramps, disorientation, seizures, dizziness, or cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low magnesium levels in the blood can also cause a decrease in potassium and calcium levels in the blood. The doctor may decide to periodically check the patient's magnesium levels.
• -If the patient has ever experienced a skin reaction after taking a medicine similar to Pantoprazole Eugia, which reduces acid production in the stomach.
• -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 Eugia. The patient should also inform their doctor about any other side effects, such as joint pain.
• -About a planned specific blood test (chromogranin A levels).

The patient should immediately inform their doctorbefore starting or during treatment if they experience any of the following symptoms, which may be a sign of a more serious condition:

• -Unintentional weight loss;
• -Vomiting, especially if it is recurrent;
• -Bloody vomiting, which may look like coffee grounds;
• -Blood in the stool, black or tarry stool;
• -Difficulty swallowing or pain when swallowing;
• -Pallor 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 condition, as treatment with pantoprazole may alleviate the symptoms of the malignant condition and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.

Children and adolescents

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

Pantoprazole Eugia and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

Since Pantoprazole Eugia may affect the efficacy of other medicines, the patient should inform their doctor if they 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 Eugia 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, the doctor may temporarily discontinue the use of Pantoprazole Eugia, as pantoprazole may increase methotrexate levels in the blood.
• -Fluvoxamine (used to treat depression and other mental disorders - if the patient is taking fluvoxamine, the doctor may order a dose reduction).
• -Rifampicin (used to treat infections).
• -St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

Experience with the use of Pantoprazole Eugia in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.

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

The medicine may be used in pregnant or breastfeeding women or women who may be pregnant only if the doctor considers that the benefits of its use outweigh the potential risks to the unborn child or infant.

Driving and using machines

Pantoprazole Eugia has no or negligible influence on the ability to drive and use machines. The patient should not drive or use machines if they experience side effects such as dizziness or vision disturbances.

Important information about some of the ingredients of Pantoprazole Eugia

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

3. How to take Pantoprazole Eugia

The medicine is given by injection 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 Eugia) per day.
• -In the long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.Two vials (80 mg of Pantoprazole Eugia) per day.

The dose may be adjusted by the doctor according to 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 only 20 mg (1/2 vial).

Use in children and adolescents

The use of Pantoprazole Eugia is not recommended in children and adolescents under the age of 18.

Overdose of Pantoprazole Eugia

The doctor or nurse will carefully check the dosage, so overdose of the medicine is unlikely. The symptoms of overdose are not known.

If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Pantoprazole Eugia can cause side effects, although not everybody gets them.

In case of any of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital where emergency services are available:

• -Severe allergic reactions (rare -not more frequent than 1 in 1,000 people): swelling of the tongue and (or) throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic edema of the face (Quincke's edema/anaphylactic shock), 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 experience one or more of the following symptoms - blistering of the skin and rapid deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genital organs, or hypersensitivity of the skin/rash, especially in areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of lymph nodes (e.g., under the arm), and changes in white blood cells or liver enzymes may also occur (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), 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, which may lead to kidney failure.

Other known side effects that may occur:

• -Common (not more frequent than 1 in 10 people)Inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site. Mild gastric polyps.
• -Uncommon (not more frequent than 1 in 100 people)

Headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (gas); constipation; dryness in the mouth; pain and discomfort in the abdominal area; skin rash, redness, skin eruptions; itching of the skin; weakness, fatigue, or general malaise; sleep disturbances; fractures of the hip, wrist, or spine.

• -Rare (not more frequent than 1 in 1,000 people)Disturbances or complete loss of taste; vision disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral edema); allergic reactions; depression; gynecomastia (enlargement of breast tissue in men).
• -Very rare (not more frequent 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 such symptoms before), feeling of tingling, prickling, tingling, burning, or numbness, rash that may be accompanied by joint pain, colitis (which causes persistent watery diarrhea).

Side effects detected by blood tests:

• -Uncommon (not more frequent than 1 in 100 people)Increased liver enzyme activity.
• -Rare (not more frequent than 1 in 1,000 people)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 rare (not more frequent 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 (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 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.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Pantoprazole Eugia

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 stated.

Store in a temperature below 30°C.

Store in the original packaging to protect from light.

After preparation, the solution must be used within 12 hours if it is diluted or within 24 hours if it is not diluted.

From a microbiological point of view, the prepared product should be used immediately.

If it is not used immediately, the user is responsible for the storage time.

Do not use Pantoprazole Eugia if its appearance has changed (e.g., the solution has become cloudy or a precipitate has formed).

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Pantoprazole Eugia contains

• The active substance of the medicine is pantoprazole. Each vial contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Excipients: disodium edetate and sodium hydroxide.

What Pantoprazole Eugia looks like and what the pack contains

Powder for solution for injection.

White or almost white powder, vial made of colorless glass (type I) closed with a bromobutyl rubber stopper and an aluminum seal with a PP cap.

Package sizes are: 1, 5 (5 x 1), 10 (10 x 1), and 20 (20 x 1) vials of powder for solution for injection in a cardboard box.

Not all package sizes may be marketed.

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.

Vault 14, level 2

Valletta Waterfront

Floriana, FRN1914

Malta

e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Belgium:

Pantoprazol Eugia 40 mg poeder voor oplossing voor injectie / poudre pour solution injectable / Pulver zur Herstellung einer Injektionslösung

Germany:

Pantoprazol PUREN 40 mg Pulver zur Herstellung einer Injektionslösung

Italy:

Pantoprazolo Aurobindo Pharma Italia

Netherlands:

Pantoprazol Aurobindo 40 mg, poeder voor oplossing voor injectie

Poland:

Pantoprazole Eugia

Portugal:

Pantoprazol Eugia

Spain:

Pantoprazol Aurovitas 40 mg polvo para solución inyectable EFG

Date of last revision of the leaflet: 03/2024

Information intended for healthcare professionals only:

Reconstituted solution:

The ready-to-use solution is obtained by injecting 10 mL of 0.9% sodium chloride injection solution (at a concentration of 9 mg/mL) into the vial containing the powder. The prepared solution may be administered directly. The reconstituted solution is chemically and physically stable for 24 hours at 25°C.

Diluted solution:

To prepare the solution, 10 mL of 0.9% sodium chloride injection solution (at a concentration of 9 mg/mL) should be injected into the vial containing the powder. This solution may be further diluted with 100 mL of 0.9% sodium chloride injection solution or 5% glucose solution for injection (i.e., at a concentration of approximately 0.4 mg/mL).

The reconstituted and diluted solution of the medicine is physically compatible and chemically stable for 12 hours with 0.9% sodium chloride injection solution and 5% glucose solution for injection at 25°C. Plastic containers should be used for dilution.

Pantoprazole Eugia should not be prepared or mixed with solvents other than those specified above.

After preparation, the solution must be used within 12 hours if it is diluted or within 24 hours if it is not diluted.

From a microbiological point of view, the prepared product should be used immediately.

If it is not used immediately, the user is responsible for the storage time.

The medicine is administered by injection 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 discarded.

The reconstituted product has the form of a clear, colorless, or slightly yellowish solution.