Polprazol

Package Leaflet: Information for the Patient

Polprazol, 40 mg, Powder for Solution for Infusion

Omeprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Polprazol and what is it used for

Polprazol contains the active substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. Their action is to reduce the amount of acid produced in the stomach.
Polprazol in the form of powder for solution for infusion is used as an alternative to oral treatment.

2. Important information before taking Polprazol

The patient must not take Polprazol:

• if the patient is allergic (hypersensitive) to omeprazole 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 (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).

In case of any doubts before taking Polprazol, consult a doctor or pharmacist.

Warnings and precautions

Before taking the medicine, inform your doctor:

• about a planned specific blood test (chromogranin A concentration).

Polprazol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or after taking Polprazol, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting with food or blood;
• passing black stools (stool discolored with blood);
• severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea;
• serious liver problems;
• if the patient has ever had a skin reaction after taking a medicine similar to Polprazol, which reduces stomach acid production.

If a skin rash appears, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to stop taking Polprazol. Also, inform your doctor about any other side effects, such as joint pain.
Taking a proton pump inhibitor like Polprazol, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. If the patient has osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis), inform your doctor.
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Such symptoms should be reported to the attending physician.

Polprazol and other medicines

Tell your doctor, nurse, or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is important, as Polprazol may affect the action of some other medicines, and some other medicines may affect the action of Polprazol.
Do not take Polprazol if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole, itraconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart rhythm disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy);
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Polprazol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping Polprazol.
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplantation);
• St. John's Wort ( Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat intermittent claudication);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent blood clots);
• erlotinib (used to treat cancer);
• methotrexate (a chemotherapeutic agent used in high doses to treat cancer) - if you are receiving high doses of methotrexate, your doctor may recommend temporary discontinuation of Polprazol.

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin, as well as Polprazol, to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor about any other medicines you are taking.

Pregnancy and breastfeeding

Before taking Polprazol, the patient should inform the doctor if she is pregnant or trying to become pregnant. The doctor will decide whether the patient can take Polprazol at that time.
Whether a breastfeeding patient can take Polprazol will be decided by the doctor.

Driving and using machines

Polprazol does not affect the ability to drive or use tools and machines. However, possible side effects such as dizziness and visual disturbances (see section 4) may occur. If they occur, do not drive or operate machines.

Polprazol contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered “sodium-free”.
The entire contents of each vial should be dissolved and then diluted. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared solution. For accurate information on the sodium content in the solution used for dilution, refer to the product characteristics of the diluent used.

3. How to take Polprazol

• Polprazol can be administered to adults, including the elderly.
• Experience with the use of Polprazol for intravenous administration in children is limited.

During administration of Polprazol

• Polprazol will be administered to the patient by a doctor, who will decide what dose of the medicine the patient needs.
• The medicine will be administered as an infusion into one of the veins.

Administration of a higher dose of Polprazol than recommended

If the patient thinks they have received too high a dose of Polprazol, they should immediately talk to their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of any of the following rare but serious side effects, stop taking Polprazol and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It can also lead to large blisters and bleeding in the mouth, eyes, lips, genitals, and skin. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which can be signs of liver problems.

Side effects can occur with a certain frequency, which is defined as follows:
Very common:
occurring in more than 1 in 10 patients
Common:
occurring in 1 to 10 in 100 patients
Uncommon:
occurring in 1 to 10 in 1,000 patients
Rare:
occurring in 1 to 10 in 10,000 patients
Very rare:
occurring in less than 1 in 10,000 patients
Unknown:
frequency cannot be estimated from available data
Other side effects include:

Common side effects

• headache
• effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating)
• nausea or vomiting
• mild stomach polyps.

Uncommon side effects

• swelling of the feet and ankles
• sleep disturbance (insomnia)
• dizziness, tingling, or drowsiness
• feeling of spinning (vertigo)
• changes in liver function test results
• skin rash, hives, and itching
• general feeling of being unwell and lack of energy.

Rare side effects

• blood problems such as decreased white blood cell or platelet count. This can lead to weakness, easier bruising, or increased risk of infection.
• allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• feeling agitated, confused, or depressed
• change in taste
• vision problems such as blurred vision
• sudden shortness of breath or wheezing (bronchospasm)
• dry mouth
• mouth inflammation
• fungal infection that can affect the intestines and is caused by fungi
• liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• hair loss (alopecia)
• skin rash when exposed to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney problems (interstitial nephritis)
• increased sweating
• inflammation of the intestines (leading to diarrhea).

Very rare side effects

• changes in blood morphology, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling, or hearing things that do not exist (hallucinations)
• severe liver problems leading to liver failure and brain inflammation
• sudden onset of severe rash or blistering on the skin or peeling. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• muscle weakness
• breast enlargement in men.

Frequency not known

• hypomagnesemia. Taking Polprazol for a period longer than three months may cause a decrease in magnesium levels in the blood. Magnesium deficiency can cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
• rash that can occur with joint pain.

In very rare cases, critically ill patients receiving omeprazole by intravenous infusion, especially in high doses, have reported irreversible vision loss, but no causal relationship has been established between these disorders and the use of the medicine.
In very rare cases, Polprazol may affect the white blood cell count, leading to a lack of immunity. If a patient experiences an infection with symptoms such as fever with a significant deterioration in general well-being or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, consult a doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to inform the doctor about the medicine they are taking.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Polprazol

Store in the original packaging to protect from light. Do not store above 25°C.
Shelf life after preparation of the solution:
The infusion solution prepared using sodium chloride 9 mg/ml (0.9%) solution should be used within 12 hours of preparation.
The infusion solution prepared using glucose 50 mg/ml (5%) solution should be used within 6 hours of preparation.
From a microbiological point of view, the product should be used immediately after preparation, unless it has been prepared in controlled and validated aseptic conditions.
Store the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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 Polprazol contains

• The active substance of the medicine is omeprazole. Each vial of powder for solution for infusion contains 42.6 mg of omeprazole sodium, equivalent to 40 mg of omeprazole.
• Other ingredients of the medicine are sodium hydroxide and disodium edetate.

What Polprazol looks like and contents of the pack

Omeprazole is a white or almost white powder. After dissolution, it is a clear liquid.
The pack contains 1 or 5 vials. 1 vial contains 40 mg of omeprazole.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
phone: +48 22 364 61 01

Manufacturer

SOFARIMEX Indústria Química e Farmacêutica, S.A.
Av. das Indústrias - Alto de Colaride
2735-213, Cácem, Portugal
Date of last revision of the package leaflet:May 2023
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The following information is intended only for qualified medical personnel:

The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. For the preparation of the solution, use sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The stability of omeprazole depends on the pH of the infusion solution, and therefore, no other solvents or volumes other than those specified should be used for reconstitution or dilution of the product.
Preparation of the solution

• 1. Using a syringe, draw 5 ml of infusion solution from a 100 ml bottle or bag.
• 2. Introduce this volume into the vial containing the lyophilized omeprazole, mix thoroughly until the omeprazole is completely dissolved.
• 3. Draw the omeprazole solution back into the syringe.

• 4. Transfer the solution to the bag or bottle with the infusion solution.
• 5. Repeat steps 1-4 to ensure that all of the omeprazole has been transferred from the vial to the bag or bottle with the infusion solution.

Alternative preparation for infusion in elastic containers

• 1. Use a double-ended transfer needle and connect it to the injection port on the infusion solution bag. Connect the other end of the needle to the vial containing the lyophilized omeprazole.
• 2. Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion solution bag and the vial.
• 3. Ensure that all of the omeprazole has dissolved.

The infusion solution must be administered by intravenous infusion over 20-30 minutes.