Opral

Leaflet attached to the packaging: patient information

Opral, 40 mg, powder for solution for infusion

Omeprazole

Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Opral and what is it used for

Opral 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.
Opral in the form of powder for solution for infusion is used in adults as an alternative to oral treatment.

2. Important information before taking Opral

The patient must not receive Opral:

• if the patient has been diagnosed with an allergy (hypersensitivity) to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with an allergy 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).

Opral must not be given if any of the above situations apply to the patient.
In case of any doubts before taking this medicine, consult a doctor, nurse, or pharmacist.

Warnings and precautions

Before starting treatment with Opral, discuss it with your doctor or pharmacist.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported with omeprazole.
If symptoms of these severe skin reactions occur, stop taking Opral and seek medical help immediately.
Opral may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or after taking Opral, consult 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;
• severe liver dysfunction;
• any skin reaction after taking a medicine similar to Opral that reduces stomach acid production;
• in case of a planned specific blood test (chromogranin A levels).

Taking a proton pump inhibitor like Opral, especially for a period longer than one 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 their doctor.
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to stop taking Opral. They should also inform their doctor about any other side effects, such as joint pain.
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. The patient should report such symptoms to their doctor.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age. Experience with omeprazole administered intravenously in children is limited.

Opral and other medicines

Inform 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 because Opral may affect the way some other medicines work, and some other medicines may affect the way Opral works.
Do not take Opral 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 Opral.
• 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 Opral.
• 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 Opral.

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

Pregnancy, breastfeeding, and fertility

Before taking Opral, the patient should inform their doctor if they are pregnant or trying to become pregnant. The doctor will decide whether the patient can take Opral at this time.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when used at therapeutic doses. The doctor will decide whether the breastfeeding patient can take Opral.
Animal studies with omeprazole have not shown any effect on fertility.

Driving and using machines

It is very unlikely that Opral will affect the ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, do not drive or use machines.

Opral contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it 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 characteristics of the medicinal product of the diluent used.

3. How to take Opral

• Opral can be administered to adults, including elderly patients.
• Experience with Opral administered intravenously in children is limited.

During administration of Opral

• Opral will be administered to the patient by a doctor, who will decide what dose the patient needs.
• The medicine will be administered as an infusion into a vein.

Administration of a higher dose of Opral than recommended

If the patient thinks they have received too high a dose of Opral, they should consult their doctor immediately.

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 or very rare but serious side effects, stop taking Opral and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction) - rare.
• Redness of the skin with blistering or peeling. It can also cause large blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis - very rare.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) - rare.
• Red, blistering, widespread rash with skin peeling and fever, usually appearing within the first few days of treatment (acute generalized exanthematous pustulosis) - rare.
• Yellowing of the skin, dark urine, and fatigue, which can be signs of liver problems - rare.

Side effects include:

Frequent side effects (occurring in less than 1 in 10 patients)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon side effects (occurring in less than 1 in 100 patients)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, feeling of tingling and numbness, feeling of drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function test results.
• Skin rash, urticaria, and itching.
• General feeling of being unwell and lack of energy.

Rare side effects (occurring in less than 1 in 1,000 patients)

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or increased risk of infection.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, wheezing.
• DRESS or drug hypersensitivity syndrome, acute generalized exanthematous pustulosis.
• 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 wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Oral thrush (a fungal infection of the mouth).
• A fungal infection that can affect the intestines and is caused by a fungus.
• 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.
• Enteritis (leading to diarrhea).

Very rare side effects (occurring in less than 1 in 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain disease.
• Sudden onset of a severe rash or blistering of the skin, which 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 (cannot be estimated from the available data)

• Taking Opral for more 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.
• A rash that can occur with joint pain.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. 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
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 Opral

There are no special storage instructions for the medicine.
Store the vials in the outer packaging to protect them from light.
Shelf life after preparation of the solution:
The infusion solution prepared using a 9 mg/ml (0.9%) sodium chloride solution should be used within 12 hours of preparation.
The infusion solution prepared using a 50 mg/ml (5%) glucose solution should be used within 6 hours of preparation.
From a microbiological point of view, the medicine should be used immediately after preparation, unless it has been prepared in controlled and validated aseptic conditions.
Keep 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 notation 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 packaging and other information

What Opral 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 Opral looks like and contents of the packaging

Opral is a white or almost white, porous, and homogeneous lyophilized powder for solution for infusion (powder for infusion) in a 10 ml vial made of type I colorless glass.
The vial is closed with a chlorobutyl rubber stopper and sealed with an aluminum flip-off cap.
In the reconstituted form, it is a clear liquid, practically free from visible particles.
Packaging: 5 vials of 40 mg, 10 vials of 40 mg, 50 vials of 40 mg.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain
Date of last revision of the leaflet:September 2024
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Information intended for healthcare professionals only:

The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. The solution for infusion should be prepared using a 9 mg/ml (0.9%) sodium chloride solution for infusion or a 50 mg/ml (5%) glucose solution for infusion. The stability of omeprazole is affected by the pH of the infusion solution, and therefore, no other solvents or volumes 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 bottle or bag for infusion with a capacity of 100 ml.
• 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 been dissolved.

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