Polpanto

Package leaflet: Information for the user

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language.
Polpanto (Pantoprazol Normogen), 40 mg, powder for solution for injection
Pantoprazolum
Polpanto and Pantoprazol Normogen are different brand names for the same medicine.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you must inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Polpanto is and what it is used for
Polpanto contains the active substance pantoprazole. Polpanto 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 disorders associated with hydrochloric acid secretion.
This medicine is administered intravenously and is used only when, in the opinion of the doctor, this route of administration is more beneficial for the patient than oral pantoprazole tablets. Intravenous treatment will be switched to oral tablets as soon as the doctor considers it appropriate.
Polpanto is used in adults for the treatment of:

• Gastro-oesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with backflow of hydrochloric acid from the stomach.
• Gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions characterized by excessive hydrochloric acid secretion in the stomach.

2. Important information before using Polpanto

When not to use Polpanto

• 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 Polpanto, discuss this with your doctor, pharmacist, or nurse:

• If you have severe liver function impairment. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, treatment should be discontinued.
• If you are taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, you should ask your doctor for detailed advice.
• The use of a proton pump inhibitor such as pantoprazole, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you take Polpanto for longer than three months, you may experience low magnesium levels in the blood. Symptoms of low magnesium levels may include: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, inform your doctor. Low magnesium levels in the blood may also lead to low potassium and calcium levels. Your doctor may decide to perform periodic blood magnesium level tests.
• If you have ever experienced a skin reaction due to taking a medicine similar to Polpanto that reduces gastric acid secretion.
• If you develop a skin rash, especially in sun-exposed areas, inform your doctor immediately, as discontinuation of Polpanto treatment may be necessary. Also inform your doctor about other adverse effects, such as joint pain.
• Regarding planned specific blood tests (chromogranin A levels).

Contact your doctor immediately before starting or during treatment if you notice any of the following symptoms, which may indicate another, more serious condition:

• Unintentional weight loss,
• Vomiting, especially 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 slightly increased risk of infectious diarrhoea.

Your 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
Polpanto is not recommended for use in children, as its efficacy has not been demonstrated in children and adolescents under 18 years of age.
Polpanto with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
Since Polpanto 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 in certain types of cancer), as Polpanto may inhibit the proper action of these and other medicines,
• Warfarin and phenprocoumon, which affect blood clotting; additional monitoring may be necessary,
• Medicines used in the treatment of HIV infection, such as atazanavir,
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions) – when methotrexate is used, your doctor may temporarily discontinue Polpanto, as pantoprazole may increase methotrexate blood levels,
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may recommend a dose reduction,
• Rifampicin (used to treat infections),
• St John's wort ( Hypericum perforatum ) (used to treat mild depression).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human milk.
This medicine may be used in women only if the doctor considers the benefit to the woman to outweigh the risk to the unborn child or infant.
Driving and using machines
Polpanto has no effect or a negligible effect on the ability to drive and operate machinery.
Do not drive or operate machinery if you experience adverse effects such as dizziness or visual disturbances.
Polpanto contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".
The entire contents of each vial must be dissolved and diluted. The sodium content of the solvent must be taken into account when calculating the total sodium content of the prepared dilution.
Detailed information on the sodium content of the solvent is provided in the Product Information supplied by the manufacturer.

3. How to use Polpanto

The medicine is administered intravenously as a daily dose over a period of 2 to 15 minutes by a nurse or doctor.
The recommended dose is:
Adults

• For the treatment of gastric ulcer, duodenal ulcer, and reflux esophagitis One vial (40 mg of pantoprazole) 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) per day.

The dose may be adjusted appropriately by the physician depending on the amount of acid secreted. Daily doses higher than two vials (80 mg) should be administered in two equal doses. It is possible to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day. To achieve rapid control of acid secretion, an initial dose of 160 mg (four 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 (half a vial).
Use in children and adolescents
Polpanto is not recommended for use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Polpanto
The physician or nurse carefully checks the dosage; therefore, overdose is unlikely. Symptoms of overdose are unknown.
If you have any further questions about 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 contact your doctor or go to the emergency department
of your nearest hospital:

• Severe allergic reactions (rare: occur in less than 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives (rash like nettle rash), breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating
• Severe skin reactions (frequency unknown: cannot be estimated based on available data): formation of skin blisters and sudden deterioration in general condition, erosion (with slight bleeding) of the eyes, nose, mouth and/or lips or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), drug reaction with eosinophilia and systemic symptoms (DRESS), and photosensitivity
• Other severe reactions (frequency unknown: cannot be estimated based on available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions:

• Common (occur in less than 1 in 10 patients): Inflammation of the vessel wall and blood clots (thrombophlebitis) at the injection site; benign gastric polyps

• Uncommon (occur in less than 1 in 100 patients): Headache; dizziness; diarrhoea; nausea, vomiting; bloating and flatulence; constipation; dryness of the mouth; pain and discomfort in the abdomen; skin rash, urticaria,
  skin eruptions; itching of the skin; weakness, fatigue or general malaise;
  sleep disturbances; fractures of the hip, wrist or spine

• Rare (occur in less than 1 in 1,000 patients): 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 the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men

• Very rare (occur in less than 1 in 10,000 patients): Disorientation.

• Frequency unknown (cannot be estimated based on available data): Hallucinations, disorientation (particularly in patients who have previously experienced such symptoms); decreased sodium levels in blood, decreased magnesium levels in blood (see section 2), sensations of tingling, pricking, burning or numbness, rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected by blood tests:

• Uncommon (occur in less than 1 in 100 patients): Increased liver enzyme activity.
• Rare (occur in less than 1 in 1,000 patients): Increased bilirubin levels; increased blood lipid levels; fever-related sudden decrease in circulating granulocytes – white blood cells.
• Very rare (occur in less than 1 in 10,000 patients): Decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
• Frequency unknown (cannot be estimated based on available data): Decreased levels of potassium, sodium, magnesium and calcium in blood.

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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Polpanto

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
No special temperature storage requirements.
Store the vial in its original packaging to protect from light.
Use the prepared solution within 12 hours.
Use the prepared and diluted solution within 12 hours.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should usually not exceed 12 hours at a temperature not exceeding 25°C.
Do not use this medicine if visible changes are observed (e.g. if cloudiness or precipitation occurs).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Polpanto contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• Other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).

What Polpanto looks like and contents of the pack
A vial made of colourless type I glass, closed with a chlorobutyl rubber stopper and an aluminium cap, packed in a cardboard box.
The pack contains 10 vials.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain
Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain
Parallel Importer:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
Spanish Marketing Authorisation Number (country of export): 607426.8
Parallel Import Authorisation Number: 111/24
[parallel importer's logo]

Information intended exclusively for healthcare professionals:

A ready-to-administer solution is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injection solution (0.9%) into a vial containing the lyophilized powder. The resulting solution may be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution. Glass or plastic containers should be used for dilution. Polpanto must not be prepared or mixed with any solvents other than those specified above.
After preparation, the solution should be used within 12 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 12 hours at a temperature not exceeding 25°C.
The solution should be administered intravenously over 2 to 15 minutes.
The contents of the vial are intended for single intravenous administration only. Any unused solution remaining in the container or any solution that has changed in appearance (e.g., cloudiness or precipitation) should be discarded.