Polpanto

Package Leaflet: Information for the User

Polpanto, 40 mg, Powder for Solution for Injection

Pantoprazole

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Polpanto and what is it used for
• 2. Before you use 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 diseases of the stomach and intestines associated with 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 tablet form as soon as the doctor considers it appropriate.

Polpanto is used in adults for the treatment of:

• Reflux esophagitis. Esophagitis (inflammation of the tube connecting 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. Before you use 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, you should discuss it with your doctor, pharmacist, or nurse:

• If you have severe liver problems. You should 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.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), you should ask your 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.
• You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Polpanto for more than three months, you may experience a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, you should inform your doctor. Low magnesium levels in the blood may also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to periodically check your magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid production.
• If you experience a rash on your skin, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Polpanto. You should also tell your doctor about other side effects, such as joint pain.
• About a planned specific blood test (chromogranin A level). You should immediately inform your doctorbefore starting or during treatment with this medicine if you notice any of the following symptoms, which may be a sign of a more serious disease:
• unintentional weight loss,
• vomiting, especially if it recurs,
• bloody vomiting, which may look like dark coffee grounds,
• blood in the stool, black or tarry stools,
• 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.

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

Children and adolescents

Polpanto should not be used in children, as its efficacy in children and adolescents under 18 years of age has not been demonstrated.

Polpanto and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

Because Polpanto may affect the efficacy of other medicines, you should 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 you are taking methotrexate, your doctor may temporarily discontinue the use of Polpanto 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 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 should only be used in women 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.

You should 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, which means that it 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 intravenously in 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 stomach ulcers, duodenal ulcers, and reflux esophagitisOne vial (40 mg of pantoprazole) per day.
• For 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, 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 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.

In order to quickly control acid production, the 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 should not be used in children and adolescents under 18 years of age.

Using more than the recommended dose of Polpanto

Overdose of the medicine is unlikely, as the doctor or nurse will carefully check the dosage.

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.

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 edema), 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 general condition, erosion (with slight bleeding) of the eyes, nose, mouth, and/or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), 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 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 (flatulence); constipation; dry mouth; abdominal pain and discomfort; skin rash, itching, and skin eruptions; weakness, fatigue, or general feeling of being unwell; sleep disturbances; fractures of the hip, wrist, or spine
• 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 limbs (peripheral edema); 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 (inflammative bowel disease) causing persistent watery diarrhea.

Side effects detected by 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 infection; 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, you should tell 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

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.

Reporting side effects will help to gather more information on the safety of this 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 which is stated on the carton and vial after EXP.

The expiry date refers to the last day of that month.

Store in a temperature not exceeding 30°C.

Store the vial in the original package 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 user is responsible for the storage conditions before use, and these should not exceed 12 hours at a temperature not above 25°C.

Do not use this medicine if you notice visible changes (e.g., cloudiness or sediment formation).

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

What Polpanto looks like and contents of the pack

Polpanto is a white or almost white lyophilized powder with a porous appearance.

The vial is made of colorless glass (type I) with a capacity of 10 ml, closed with an aluminum cap and a chlorobutyl rubber stopper, containing 40 mg of powder for solution for injection.

Polpanto is available in the following pack sizes:

Package containing 1 vial.

Package containing 10 vials.

Package containing 50 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

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

Czech Republic: Pantoprazole Polpharma

Slovakia: Pantoprazole Polpharma 40 mg powder for solution for injection

Bulgaria: Pantoprazole Polpharma 40 mg, powder for solution for injection

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 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 55 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 specified above.

After preparation, the solution should be used 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 conditions before use, and these should not exceed 12 hours at a temperature not above 25°C.

The medicine should be administered intravenously over a period of 2 to 15 minutes.

The contents of the vial are intended for single intravenous use only. Any medicine that remains in the container or has changed appearance (e.g., cloudiness or sediment formation) should be discarded.