Polpanto

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Polpanto (Pantoprazole Normogen), 40 mg, Powder for Solution for Injection

Pantoprazolum
Polpanto and Pantoprazol Normogen are different trade names for the same medicine.

Read the 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Polpanto and what is it 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 is Polpanto and what is it used for

Polpanto contains the active substance pantoprazole. Polpanto 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 injection will be replaced by tablets as soon as the doctor considers it appropriate.

Polpanto is used in adults for the treatment of:

• Reflux oesophagitis. Inflammation of the oesophagus (the tube that connects the throat to the stomach), accompanied by acid reflux from the stomach.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomach.

2. Important information before using Polpanto

When not to use Polpanto

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

Warnings and precautions

Before starting treatment with Polpanto, discuss with your doctor, pharmacist, or nurse:

• If the patient has severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may order more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, the use of the medicine should be discontinued.

and

• 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 longer than one year, may slightly increase the risk of hip, wrist, or spine fractures.
• Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If the patient is taking Polpanto for more than three months, they may experience a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. 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 Polpanto that reduces stomach acid production.
• If a rash appears on the skin, especially in areas exposed to sunlight, the patient should inform their doctor as soon as possible, as it may be necessary to discontinue treatment with Polpanto. The patient should also inform their doctor about other side effects, such as joint pain.
• About a planned specific blood test (chromogranin A levels).

Tell your doctor immediatelybefore or during treatment with Polpanto if you notice any of the following symptoms, which may be signs of another, more serious disease:

• unintentional weight loss,
• vomiting, especially if it happens again,
• bloody vomiting, which may look like dark coffee grounds,
• blood in the stool, black or tarry stools,
• 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 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

Polpanto is not recommended for use in children, as its efficacy in children and adolescents under 18 years of age has not been established.

Polpanto and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
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 to treat certain types of cancer), as Polpanto may inhibit the proper functioning of these and other medicines,
• warfarin and phenprocoumon, which affect blood density or thinning; further tests may be necessary,
• medicines used to treat HIV infection, such as atazanavir,
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if methotrexate is used, the doctor may temporarily discontinue the use of Polpanto in the patient, 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Experience with the use of Polpanto in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.
The medicine may be used in women only if the doctor considers that the benefit to the woman outweighs the risk to the unborn child or infant.

Driving and using machines

Polpanto 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.

Polpanto contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., the medicine is considered "sodium-free".
The entire contents of each vial should be dissolved and diluted. The sodium present in the solvent should be taken into account when calculating the total sodium content in the prepared dilution.
Detailed information on the sodium content in the solvent can be found in the Summary of Product Characteristics provided by the manufacturer.

3. How to use Polpanto

The medicine is given by injection in a daily dose over a period of 2 to 15 minutes by a nurse or doctor.
The recommended dose is:

Adults

• In the treatment of stomach ulcers, duodenal ulcers, and reflux oesophagitisOne vial (40 mg of pantoprazole) per day.
• In the long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomachTwo vials (80 mg of pantoprazole) per day.

The dosage 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 periodically 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 problems

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.

Using a higher dose of Polpanto than recommended

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, Polpanto can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact your doctor or go to the emergency department at your nearest hospital immediately:

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's oedema/anaphylactic shock), severe dizziness with rapid heartbeat and excessive sweating
• Severe skin reactions (frequency not known, 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, or Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, drug reaction with eosinophilia and systemic symptoms (DRESS), and hypersensitivity to light
• Other severe reactions (frequency not known, cannot be estimated from the 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 when urinating and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

Other side effects:

• Common (may affect up to 1 in 10 people)Inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site; mild stomach polyps
• Uncommon (may affect up to 1 in 100 people)Headache; dizziness; diarrhea; nausea, vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash, itching, hives, skin eruptions; weakness, fatigue, or general feeling of being unwell; sleep disturbances; fractures of the hip, wrist, or spine

and

• Rare (may affect up to 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 the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men
• Very rare (may affect up to 1 in 10,000 people)Disorientation.
• Frequency not known (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 (inflammation of the large intestine) causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people)Increased liver enzyme activity.
• Rare (may affect up to 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 (may affect up to 1 in 10,000 people)Decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count, which may increase the risk of infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Frequency not known (cannot be estimated from the available data)Decreased levels of potassium, sodium, magnesium, and calcium in the blood.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Polpanto

Keep the 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 month stated.
There are no special storage precautions.
Store the vial in the original packaging to protect it 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 user is responsible for the storage time and conditions before use, and this should not normally exceed 12 hours at a temperature not above 25°C.
Do not use this medicine if you notice visible changes (e.g., if you notice cloudiness or sediment).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Polpanto contains

• The active substance of the medicine is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are disodium edetate and sodium hydroxide (to adjust the pH).

What Polpanto looks like and what the pack contains

A vial made of colourless type I glass, closed with a chlorobutyl rubber stopper and an aluminium cap, 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 by:

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

Marketing authorisation number in Spain, the country of export: 607426.8

Parallel import authorisation number: 111/24

Date of revision of the leaflet: 13.03.2024

[logo of the parallel importer]
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Information intended for healthcare professionals only:
The ready-to-use solution is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injection solution into the vial containing the dry powder. The prepared 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. Only glass or plastic containers should be used for dilution. Polpanto should not be prepared or mixed with solvents other than those listed above.
The solution should be used within 12 hours of preparation. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage time and conditions before use, and this should not normally exceed 12 hours, at a temperature not above 25°C.
The medicine should be administered by intravenous injection over a period of 2 to 15 minutes.
The contents of the vial are intended for single use only. Any medicine that remains in the container or has changed appearance (e.g., if cloudiness or sediment is observed) should be discarded.