Omeprazole Sandoz

Leaflet accompanying the packaging: patient information

Omeprazole Sandoz, 40 mg, powder for solution for infusion

Omeprazole

Read 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, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Omeprazole Sandoz and what is it used for

Omeprazole Sandoz contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines work by reducing the amount of acid produced in the stomach.
Omeprazole Sandoz in the form of powder for solution for infusion can be used as an alternative to oral treatment.

2. Important information before using Omeprazole Sandoz

When not to use Omeprazole Sandoz

Do not use Omeprazole Sandoz if any of the above situations apply to the patient. In case of doubts, consult a doctor, nurse, or pharmacist before using this medicine.

Warnings and precautions

Before starting treatment with Omeprazole Sandoz, discuss it with a doctor, nurse, or pharmacist.
Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with Omeprazole Sandoz. If the patient notices any symptoms related to these severe skin reactions described in section 4, they should stop using Omeprazole Sandoz and seek medical help immediately.
This medicine may mask the symptoms of other diseases, so if the patient experiences any of the following before or during treatment with Omeprazole Sandoz, they should consult a doctor immediately:
unexplained weight loss and difficulty swallowing
stomach pain or indigestion
vomiting, including bloody vomiting
black stools (with blood)
severe liver dysfunction
planned specific blood test (chromogranin A measurement)
skin rash that occurred in the past after using a medicine similar to Omeprazole Sandoz (reducing stomach acid production).
If the patient develops 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 using Omeprazole Sandoz. The patient should also inform their doctor about any other side effects, such as joint pain.
During treatment with 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.
Using a proton pump inhibitor like Omeprazole Sandoz, 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 may increase the risk of osteoporosis), they should inform their doctor.
This medicine contains less than 1 mmol of sodium (23 mg) per 40 mg dose, which means it is considered "sodium-free".

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age. There is limited experience with the use of Omeprazole Sandoz for intravenous administration in children.

Omeprazole Sandoz and other medicines

The patient should tell their doctor, nurse, or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is important because Omeprazole Sandoz may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Sandoz works.
Do not use Omeprazole Sandoz if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
The patient should inform their doctor, nurse, or pharmacist if they are taking any of the following medicines:
ketokonazole, itraconazole, posaconazole, or voriconazole (medicines used to treat fungal infections);
digoxin (a medicine used to treat heart conditions);
diazepam (a medicine used to treat anxiety, relax muscles, or treat epilepsy);
phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, medical supervision may be necessary at the start or end of treatment with Omeprazole Sandoz.
medicines that prevent blood clotting, such as warfarin or other medicines that inhibit the action of vitamin K. Medical supervision may be necessary at the start or end of treatment with Omeprazole Sandoz. rifampicin (a medicine used to treat tuberculosis); atazanavir (a medicine used to treat HIV infection); tacrolimus (a medicine used after organ transplantation); St. John's Wort (Hypericum perforatum) (used to treat mild depression); cilostazol (a medicine used to treat intermittent claudication); saquinavir (a medicine used to treat HIV infection); clopidogrel (a medicine used to prevent blood clots); erlotinib (a medicine used to treat cancer); methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if the patient is taking high doses of methotrexate, the doctor may temporarily stop using Omeprazole Sandoz.

• If the doctor has prescribed antibiotics amoxicillin and clarithromycin in addition to Omeprazole Sandoz to treat stomach ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about any other medicines being taken.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor, nurse, or pharmacist before using this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when used at therapeutic doses. The doctor will decide whether the patient can take Omeprazole Sandoz while breastfeeding.

Driving and using machines

The effect of Omeprazole Sandoz on the ability to drive and use machines is unlikely. However, side effects such as dizziness and vision disturbances (see section 4) may occur. In such cases, the patient should not drive or operate machinery.

3. How to use Omeprazole Sandoz

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

Administration of Omeprazole Sandoz

Omeprazole Sandoz will be administered to the patient by a doctor, who will decide what dose is necessary.
The medicine will be administered as an infusion into a vein.

Using a higher dose of Omeprazole Sandoz than recommended

If the patient thinks they have received too high a dose of Omeprazole Sandoz, they should discuss it with their doctor immediately.
In case of any further doubts about using this medicine, the patient should consult a doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Omeprazole Sandoz can cause side effects, although not everybody gets them.

If any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects occur, stop using Omeprazole Sandoz and contact a doctor immediately:

sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction). This side effect is rare.
redness of the skin with blistering or peeling. It is also possible that blisters or bleeding in the lips, eyes, mouth, nose, and genitals may occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. This side effect is very rare.
widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). This side effect is rare.
red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). This side effect is rare.
yellowing of the skin, dark urine, and feeling tired, which may indicate liver problems. This side effect is rare.
Other side effects include:

Common (may affect up to 1 in 10 people)

headache
gastrointestinal symptoms: diarrhea, stomach pain, constipation, gas (with bloating)
nausea or vomiting
mild stomach polyps

Uncommon (may affect up to 1 in 100 people)

swelling of the feet and ankles
sleep disturbances (insomnia)
dizziness, feeling of tingling, drowsiness
feeling of spinning (vertigo)
changes in liver function test results
skin rash, elevated rash (hives), and itching
general feeling of being unwell and lack of energy
fracture of the hip, wrist, or spine

Rare (may affect up to 1 in 1,000 people)

blood disorders, such as decreased white blood cell or platelet count. This may cause weakness, 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 may cause weakness, vomiting, and muscle cramps
agitation, confusion, or depression
taste disturbances
vision disturbances, such as blurred vision
sudden onset of wheezing or shortness of breath (bronchospasm)
dry mouth
inflammation of the mouth mucosa
infection known as "thrush", which can affect the intestines and is caused by fungi
liver function disorders, including jaundice with yellowing of the skin, dark urine, and feeling tired
hair loss (alopecia)
skin rash due to sun exposure
joint pain or muscle pain
severe kidney dysfunction (interstitial nephritis)
increased sweating

Very rare (may affect up to 1 in 10,000 people)

changes in blood test results, including agranulocytosis (lack of white blood cells)
aggression
seeing, feeling, or hearing things that do not exist (hallucinations)
severe liver dysfunction leading to liver failure and brain inflammation
sudden development of severe rash or blisters on the skin or peeling of the skin. These symptoms 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 (cannot be estimated from the available data)

inflammation of the intestine (leading to diarrhea)skin rash, which may be accompanied by joint pain.
In isolated cases, patients in critical condition who received omeprazole in the form of intravenous injections, especially in high doses, reported irreversible vision loss, but no causal relationship between these disorders and the use of the medicine has been established.
Omeprazole Sandoz may very rarely affect the white blood cell count, with a risk of causing immunodeficiency. If the patient develops an infection with symptoms such as fever with severe deterioration of their condition or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult a doctor immediately so that a blood test can be performed to rule out agranulocytosis. It is essential to inform the doctor about taking Omeprazole Sandoz.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 gather more information on the safety of the medicine.

5. How to store Omeprazole Sandoz

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month stated.
After preparation of the solution by a doctor or nurse, it should be stored below 25°C and used within 12 hours of preparation using a 0.9% NaCl solution or within 6 hours of preparation if a glucose solution is used.
From a microbiological point of view, the product should be used immediately, unless it has been prepared in controlled and validated aseptic conditions.
Do not use the prepared solution if it contains solid particles. The contents of the vial are for single use only; any remaining product in the vial should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Omeprazole Sandoz contains

Each vial of powder for solution for infusion contains the active substance omeprazole sodium equivalent to 40 mg of omeprazole.
After reconstitution, each 1 mL of solution contains 0.4 mg of omeprazole.
The other ingredients (excipients) are sodium hydroxide and disodium edetate.
Each vial is for single infusion only.

What Omeprazole Sandoz looks like and contents of the pack

The powder for solution for infusion is white or almost white.
Omeprazole in the form of powder for solution for infusion is available in packs of 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
Manufacturer
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia
For more detailed information on this medicine, please contact:

Poland

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
tel. 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands
Omeprazol Sandoz infuus 40, poeder voor oplossing voor intraveneuze infusie 40 mg
Bulgaria
PROBITOR 40 mg/100 ml powder for solution for infusion
Czech Republic
ORTANOL
Estonia
Omeprazole Sandoz
Italy
OMEPRAZOLO SANDOZ BV
Poland
Omeprazole Sandoz
United Kingdom Omeprazole 40mg Powder for Solution for Infusion
Date of last revision of the leaflet:07/2024
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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. For reconstitution, 9 mg/mL (0.9%) sodium chloride solution for infusion or 50 mg/mL (5%) glucose solution for infusion should be used. The stability of omeprazole is affected by the pH of the infusion solution, and therefore, no other solvents or volumes than those stated should be used for reconstitution and dilution.
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, and ensure that the omeprazole is completely dissolved.
• 3. Draw the omeprazole solution back into the syringe.
• 4. Transfer the solution to the infusion bag or bottle.
• 5. Repeat steps 1-4 to ensure that all omeprazole is transferred from the vial to the infusion bag or bottle.

Alternative preparation for infusion in elastic containers

• 1. Use a double-ended transfer needle and connect it to the injection port on the infusion 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 bag and the vial.
• 3. Ensure that all omeprazole is dissolved.

The infusion solution must be administered intravenously over 20-30 minutes.
After preparation, the solution is colorless, clear, and practically free of visible particles.