Pantoprazole eugia

Package leaflet: Information for the user

Pantoprazole Eugia, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Pantoprazole Eugia is and what it is used for
Pantoprazole Eugia contains the active substance pantoprazole. Pantoprazole Eugia is a selective "proton pump inhibitor", a medicine that reduces the secretion of hydrochloric acid in the stomach. It is used in the treatment of stomach and intestinal diseases associated with hydrochloric acid secretion.
This medicine is administered intravenously and is used only when, in the doctor's opinion, this route of administration is more beneficial for the patient than taking pantoprazole in tablet form. Intravenous administration will be switched to tablets as soon as the doctor considers it appropriate.
Pantoprazole Eugia is used in the treatment of adults for:

• Gastroesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat to the stomach) is accompanied by the backflow of hydrochloric acid from the stomach.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other medical conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Pantoprazole Eugia

When not to use Pantoprazole Eugia

• If the patient is allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting Pantoprazole Eugia, inform your doctor, pharmacist, or nurse:

• If the patient has severe liver function disorders. Inform the doctor if liver function problems have ever occurred. The doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, treatment should be discontinued.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), in combination with pantoprazole, they should seek detailed advice from the doctor.
• The use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or has been informed of a risk of developing osteoporosis (e.g., if the patient is taking steroids).
• If the patient uses Pantoprazole Eugia for longer than three months, blood magnesium levels may decrease, which may lead to fatigue, muscle spasms, disorientation, seizures, dizziness, or ventricular arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low blood magnesium levels may also lead to decreased potassium and calcium levels. The doctor may decide to perform periodic blood magnesium level tests.
• If the patient has ever had a skin reaction due to taking a medicine similar to Pantoprazole Eugia that reduces hydrochloric acid secretion in the stomach.
• If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Pantoprazole Eugia may be necessary. Also report any other adverse effects, such as joint pain.
• About planned specific blood tests (chromogranin A levels).

Inform the doctor immediately, before starting or during treatment,
if any of the following symptoms occur, as they may indicate another, more serious condition:

• Unintentional weight loss;
• Vomiting, particularly recurrent;
• Vomiting blood, which may appear like dark coffee grounds;
• Blood in stool, black or tarry stools;
• Difficulty swallowing or pain during swallowing;
• Pallor and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as use of this medicine is associated with a slight increase in the risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazole Eugia is not recommended for use in children, as its effects have not been studied in children under 18 years of age.
Pantoprazole Eugia and other medicines
Tell your 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.
Since Pantoprazole Eugia may affect the efficacy of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazole Eugia may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer conditions). In case of methotrexate use, the doctor may temporarily discontinue Pantoprazole Eugia, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric disorders – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose).
• Rifampicin (used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used in pregnant women, women in whom pregnancy cannot be excluded, or breastfeeding women only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Pantoprazole Eugia has no effect or negligible effect on the ability to drive motor vehicles or operate machinery. Do not drive motor vehicles or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.
Important information about certain ingredients of Pantoprazole Eugia
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Pantoprazole Eugia

The medicine is administered intravenously as a single daily dose over 2–15 minutes by a nurse or
physician.
Recommended dose:
Adults

• For the treatment of gastric and/or duodenal ulcer and reflux esophagitis. One vial (40 mg of Pantoprazole Eugia) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach. Two vials (80 mg of Pantoprazole Eugia) per day.

The dosage may be adjusted appropriately by the physician depending on the amount of acid secreted. Daily doses exceeding two vials (80 mg) should be administered in two equal doses.
Periodic dose increases of pantoprazole to more than four vials (160 mg) per day are possible. To achieve rapid control of acid secretion, an initial dose of 160 mg (4 vials) should be sufficient to reduce acid secretion.
Patients with impaired liver function
In severe liver disease, the daily dose should be only 20 mg (1/2 vial).
Use in children and adolescents
Pantoprazole Eugia is not recommended for use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazole Eugia
The physician or nurse carefully checks the dosage; therefore, overdose is unlikely. Symptoms of overdose are unknown.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, you should
immediately inform your doctor or contact the nearest hospital with an emergency department:

• Severe allergic reactions (rare - no more often than in 1 out of 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown - frequency cannot be determined from available data): the patient may experience one or more of the following symptoms - formation of skin blisters and sudden deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Other severe reactions (frequency unknown - frequency cannot be determined from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems manifested by kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), potentially leading to kidney failure.

Other known adverse reactions occurring:

• Common (no more often than in 1 out of 10 people) Inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site. Benign gastric polyps.
• Uncommon (no more often than in 1 out of 100 people)

Headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing wind (flatulence); constipation; dryness of the mouth; pain and discomfort in the abdomen; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fractures of the hip, wrist or spine.

• Rare (no more often than in 1 out of 1,000 people) Disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• Very rare (no more often than in 1 out of 10,000 people) Disorientation.
• Frequency unknown (frequency cannot be determined from available data) Hallucinations, confusion (particularly in patients who have previously experienced such symptoms), sensations of tingling, pricking, pins and needles, burning or numbness; rash possibly accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

• Uncommon (no more often than in 1 out of 100 people) Increased liver enzyme activity.
• Rare (no more often than in 1 out of 1,000 people) Increased bilirubin levels; increased blood lipid levels; fever-related sudden decrease in circulating granulocytes - white blood cells.
• Very rare (no more often than in 1 out of 10,000 people) Decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
• Frequency unknown (frequency cannot be determined from available data) Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Pantoprazole Eugia

Keep this medicine out of the 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 stated month.
Store below 30°C.
Keep in the original packaging to protect from light.
After preparation, the solution must be used within 12 hours if diluted or within 24 hours if not diluted.
From a microbiological point of view, the prepared product should be used immediately.
If not used immediately, the user is responsible for the storage duration and conditions.
Do not use Pantoprazole Eugia if there is any change in appearance (e.g. the solution becomes cloudy or a precipitate forms).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Eugia contains

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

What Pantoprazole Eugia looks like and contents of the pack
Powder for solution for injection.
White or almost white powder, in a vial made of colourless glass (type I) closed with a bromobutyl rubber stopper and an aluminium seal with a polypropylene cap.
Pack sizes: 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 pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

Information intended exclusively for medical professionals:

Reconstituted solution:
The ready-to-administer solution is obtained by injecting 10 mL of 0.9% sodium chloride solution for injection (concentration 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 diluted solution, 10 mL of 0.9% sodium chloride solution for injection (concentration 9 mg/mL) should be injected into the vial containing the powder. This solution may then be further diluted with 100 mL of 0.9% sodium chloride solution for injection or 5% glucose solution for injection (resulting in a concentration of approximately 0.4 mg/mL).

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

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

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

From a microbiological standpoint, the prepared product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions.

The medicinal product is administered intravenously over 2–15 minutes.

The contents of the vial are intended for single use only. Any medicinal product remaining in the vial or which has changed in appearance (e.g. solution becoming cloudy or precipitation occurring) should be discarded.

After reconstitution, the product is a clear, colorless or slightly yellow solution.