Opral

Patient Information Leaflet

Opral, 40 mg, powder for solution for infusion
Omeprazolum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Opral is and what it is used for

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

2. Important information before using the medicine Opral

The patient must not receive the medicine Opral:

• if the patient has a known allergy (hypersensitivity) to omeprazole or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has 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 in the treatment of HIV infection).

Opral must not be administered if any of the above situations apply to the patient.
If in any doubt, consult a doctor, nurse or pharmacist before receiving this medicine.
Warnings and precautions
Before starting treatment with Opral, discuss it with your doctor or pharmacist.
Severe skin reactions have been reported with omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP).
If any symptoms of these severe skin reactions described in section 4 occur, stop taking Opral immediately and seek medical help without delay.
Opral may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or after taking Opral, consult a doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (blood-stained faeces);
• severe or persistent diarrhoea, as there is a slightly increased risk of infectious diarrhoea associated with omeprazole use;
• severe liver function disorders;
• occurrence of any skin reaction during treatment with a medicine similar to Opral that reduces gastric acid secretion;
• if a specific blood test (chromogranin A level) is planned.

The use of a proton pump inhibitor such as Opral, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. If the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis), this should be reported to the doctor.
If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue Opral. Also report any other adverse reactions occurring, such as joint pain.
While taking omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in the urine and/or allergic reactions such as fever, rash and joint stiffness. The patient should report such symptoms to the treating physician.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age. Experience with intravenous omeprazole in children is limited.
Opral and other medicines
Tell your doctor, nurse or pharmacist about all medicines currently used, recently used or planned for use. This is important because Opral may affect the action of certain other medicines, and some other medicines may affect the action of Opral.
Opral must not be taken if the patient is using a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform your doctor or pharmacist if the patient is 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 Opral.
• 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 Opral.
• 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 is receiving high-dose methotrexate, the doctor may recommend temporarily discontinuing Opral.

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, together with Opral, 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, breastfeeding and fertility
Before taking Opral, the patient should inform the doctor whether she is pregnant or trying to become pregnant. The doctor will decide whether the patient may take Opral during this period.
Omeprazole passes into human milk, but it is unlikely to affect the infant when therapeutic doses are used. The doctor will decide whether a breastfeeding woman may take Opral.
Animal studies with omeprazole have not shown effects on fertility.
Driving and operating machinery
It is very unlikely that Opral affects the ability to drive or operate machinery. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If such symptoms occur, the patient should not drive or operate machinery.
Opral contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. 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 must be taken into account when calculating the total sodium content in the prepared diluted solution. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the product characteristics of the diluent used.

3. How to use Opral

• Opral may be administered to adults, including elderly patients.
• Experience with intravenous administration of Opral in children is limited.

During administration of Opral

• Opral will be administered to the patient by a doctor, who will decide the amount of medicine required.
• The medicine will be given as an infusion into one of the veins.

Administration of a higher than recommended dose of Opral
If the patient thinks they have received too much Opral, they should speak to their doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following rare or very rare but serious adverse effects,
you should stop taking Opral immediately
and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction) – rare.
• Skin redness with blister formation or skin peeling. There may also be formation of large blisters and bleeding affecting the lips, eyes, mouth, nose and genital organs. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis – very rare.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) – rare.
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – rare.
• Yellowing of the skin, dark urine and fatigue, which may indicate liver problems – rare.

Adverse effects include:
Common adverse effects (occurring in fewer than 1 in 10 patients)

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

Uncommon adverse effects (occurring in fewer than 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling or pricking sensations, drowsiness.
• Sensation of spinning (dizziness).
• Changes in liver function test results.
• Skin rash, nodular rash (urticaria), and itchy skin.
• General malaise and lack of energy.

Rare adverse effects (occurring in fewer than 1 in 1,000 patients)

• Blood-related problems, such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising, or increased risk of infection.
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing.
• DRESS syndrome or drug hypersensitivity syndrome, acute generalized exanthematous pustulosis.
• Low sodium levels in the blood. This may lead to weakness, vomiting and muscle cramps.
• Feeling of restlessness, confusion or depression.
• Change in taste sensation.
• Vision problems, such as blurred vision.
• Sudden sensation of wheezing or breathlessness (bronchospasm).
• Dryness of the 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 disorders, 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 disorders (interstitial nephritis).
• Increased sweating.
• Inflammation of the intestine (leading to diarrhoea).

Very rare adverse effects (occurring in fewer than 1 in 10,000 patients)

• Changes in blood counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden onset of severe rash or blistering or skin peeling. 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 (frequency cannot be estimated from available data)

• Use of Opral for longer 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, and 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 accompanied by joint pain.

In very rare cases, irreversible visual disturbances have been reported in critically ill patients receiving Opral as intravenous infusions, particularly at high doses; however, a causal relationship between these disturbances and the use of the medicine has not been established.
In very rare cases, Opral 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 deterioration in general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, the patient should consult a doctor as soon as possible to rule out possible white blood cell deficiency (agranulocytosis) based on blood test results. It is important that the patient informs the doctor about the medicine being taken.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine Opral

No special temperature storage requirements for this medicine.
Keep vials in the outer packaging to protect from light.
Stability after preparation of the solution:
The infusion solution prepared using sodium chloride 9 mg/ml (0.9%) should be used within 12 hours after preparation.
The infusion solution prepared using glucose 50 mg/ml (5%) should be used within 6 hours after preparation.
From a microbiological standpoint, the medicine should be used immediately after preparation, unless it has been prepared under 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 container. The expiry date refers to the last day of the stated month.
The label marking after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Opral contains

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

What Opral looks like and contents of the pack
Opral is a white or almost white, porous and homogeneous lyophilized powder for preparation of infusion solution (powder for infusion) in a 10 ml clear type I glass vial.
The vial is closed with a chlorobutyl rubber stopper and sealed with an aluminum flip-off cap.
In dissolved form, it is a clear liquid, practically free from visible particles.
Pack sizes: 5 vials containing 40 mg, 10 vials containing 40 mg, 50 vials containing 40 mg.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne 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

Information intended exclusively for medical professionals:

The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. The diluent used for reconstitution must be either sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no other solvents or volumes different from those specified should be used for reconstitution and 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 omeprazole is completely dissolved.
3. Withdraw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle containing the infusion solution.
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 site of the infusion bag. Attach 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 complete dissolution of omeprazole.

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