Polprazol

Package leaflet: information for the patient

Polprazol, 40 mg, powder for solution for infusion
Omeprazolum
Please read the entire leaflet carefully before use, as 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 or pharmacist.
• 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Polprazol and what is it used for

Polprazol contains an active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing 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 using Polprazol

Polprazol must not be administered to patients:

• who have shown hypersensitivity (allergy) to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• who have shown hypersensitivity to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazol, rabeprazol, esomeprazole);
• who are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

If there are any doubts, consult a doctor or pharmacist before receiving Polprazol.

Warnings and precautions

Before taking the medicine, inform the doctor:

• about planned specific blood tests (chromogranin A levels).

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

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (blood-discolored faeces);
• severe or persistent diarrhoea, as use of omeprazole is associated with a slight increase in the frequency of infectious diarrhoea;
• serious liver function disorders;
• if the patient has ever experienced a skin reaction due to treatment with a drug similar to Polprazol that reduces gastric acid secretion.

If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Polprazol may be necessary. Also report any other adverse reactions occurring, such as joint pain.

Use of a proton pump inhibitor such as Polprazol, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. If the patient suffers from osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis), this should be reported to the doctor.

During treatment with omeprazole, interstitial nephritis may occur. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash and joint stiffness. Patients should report such symptoms to their physician.

Polprazol and other medicines

Inform the doctor, nurse or pharmacist about all medicines currently used, recently used, or planned for use. This is important because Polprazol may affect the action of certain other medicines, and some other medicines may influence the effect of Polprazol.

Do not take Polprazol if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform the doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment);
• phenytoin (used in epilepsy treatment). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting and stopping Polprazol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient’s condition when starting and stopping Polprazol.
• rifampicin (used to treat tuberculosis);
• atazanavir (used in the treatment of 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 in the treatment of HIV infection);
• clopidogrel (used to prevent blood clots);
• erlotinib (used in cancer treatment);
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient receives high-dose methotrexate, the doctor may recommend temporarily discontinuing Polprazol.

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Polprazol for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

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 Polprazol can be used during this period.

Whether a breastfeeding woman can take Polprazol will be decided by the doctor.

Driving and operating machinery

Polprazol does not affect the ability to drive or operate tools and machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Polprazol contains sodium

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

3. How to use Polprazol

• Polprazol may be administered to adults, including elderly patients.
• 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 physician, who will determine the amount of medication required.
• The medicine will be given as an infusion through one of the veins.

Administration of a higher than recommended dose of Polprazol
If the patient believes they have received too high a dose of Polprazol, they should immediately speak with their doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare but serious adverse reactions, stop taking Polprazol and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Large blisters and bleeding may also occur in the area of the lips, eyes, mouth, nose and genital organs. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

Adverse reactions may occur with certain frequencies defined as follows:
Very common: affecting more than 1 in 10 people
Common: affecting 1 in 10 to 1 in 100 people
Uncommon: affecting 1 in 1,000 to 1 in 10,000 people
Rare: affecting 1 in 10,000 to 1 in 100,000 people
Very rare: affecting less than 1 in 100,000 people
Not known: frequency cannot be estimated from available data

Other adverse reactions include:
Common adverse reactions

• headache
• effects on stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating)
• nausea or vomiting
• mild gastric polyps

Uncommon adverse reactions

• swelling of feet and ankles
• sleep disturbance (insomnia)
• dizziness, tingling or pricking sensation, drowsiness
• sensation of spinning (vertigo)
• changes in liver function test results
• skin rash, nodular rash (urticaria), and itchy skin
• general malaise and lack of energy

Rare adverse reactions

• blood problems such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising or increased likelihood of infection.
• allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing
• low sodium levels in the blood. This may lead to weakness, vomiting and muscle cramps.
• feeling agitated, confused or depressed
• altered sense of taste
• vision problems such as blurred vision
• sudden wheezing or shortness of breath (bronchospasm)
• dry mouth
• inflammation of the mucous membrane of the mouth
• fungal infection known as "thrush", which may affect the intestines and is caused by fungi
• liver problems, including jaundice, which may cause yellowing of the skin, dark urine and fatigue
• hair loss (alopecia)
• skin rash occurring during exposure to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney problems (interstitial nephritis)
• increased sweating
• inflammation of the intestine (leading to diarrhoea)

Very rare adverse reactions

• changes in blood cell count including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling or hearing things that are not real (hallucinations)
• severe liver problems leading to liver failure and encephalopathy
• sudden onset of severe rash or blistering or peeling of the skin. This may 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

• hypomagnesaemia. Use of Polprazol for more than three months may lead to decreased magnesium levels in the blood. Magnesium deficiency may result in symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• rash associated with joint pain.

In very rare cases, in critically ill patients receiving omeprazole as intravenous infusion, particularly at high doses, irreversible visual disturbances have been reported, although no causal relationship between these disturbances and the use of the medicine has been established.
In very rare cases, Polprazol may affect the number of white blood cells, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by significant worsening of general condition or fever with signs of local infection such as pain in the neck, throat or mouth or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis) based on blood test results. It is important that the patient informs the doctor about the use of this medicine in such a situation.

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

5. How to store Polprazol

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

What Polprazol contains

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

What Polprazol looks like and contents of the pack
Omeprazole is a white or almost white powder. After reconstitution, it forms a clear liquid.
The pack contains 1 or 5 vials. 1 vial contains 40 mg of omeprazole.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
tel. + 48 22 364 61 01

Manufacturer
SOFARIMEX Indústria Química e Farmacêutica, S.A.
Av. das Indústrias - Alto de Colaride
2735-213, Cácem, Portugal

The following information is intended for qualified medical personnel only:
The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. For reconstitution, use either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. The stability of omeprazole is pH-dependent; therefore, no other solvents or volumes different from those specified should be used for reconstitution or dilution.

Preparation of the solution

1. Using a syringe, withdraw 5 ml of infusion solution from a 100 ml infusion bag or bottle.
2. Transfer this volume into the vial containing lyophilized omeprazole and mix thoroughly until the omeprazole is completely dissolved.
3. Withdraw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle.
5. Repeat steps 1–4 to ensure that the entire amount of omeprazole has been transferred from the vial into the infusion bag or bottle.

Alternative preparation for infusion in flexible containers

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

The infusion solution must be administered as an intravenous infusion over 20–30 minutes.