Omeprazole Neupharm

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Omeprazole Neupharm(Eselan) , 40 mg, powder for solution for infusion
Omeprazolum
Omeprazole Neupharm and Eselan are different trade names for the same medicine.

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

Omeprazole Neupharm 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.
Omeprazole Neupharm in the form of powder for solution for intravenous infusion is used as an alternative to oral treatment in adult patients in the following cases:

• treatment of duodenal ulcer;
• prevention of duodenal ulcer recurrences;
• treatment of gastric ulcer;
• prevention of gastric ulcer recurrences;
• in combination with appropriate antibiotics, eradication therapy for Helicobacter pylori (H. pylori) in peptic ulcer disease;
• treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs;
• prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs in patients at risk of their occurrence;
• treatment of reflux esophagitis;
• long-term management of patients after healing of reflux esophagitis;
• treatment of symptomatic gastroesophageal reflux disease;
• treatment of Zollinger-Ellison syndrome.

2. Important information before taking Omeprazole Neupharm

When not to take Omeprazole Neupharm:

Omeprazole Neupharm should not be taken if any of the above situations apply to the patient.
In case of any doubts before receiving Omeprazole Neupharm, the patient should talk to their doctor or pharmacist.

Warnings and precautions

Before starting to take Omeprazole Neupharm, the patient should discuss it with their doctor.
During treatment with Omeprazole Neupharm, serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If the patient notices any symptoms related to these serious skin reactions described in section 4, they should stop taking Omeprazole Neupharm and seek medical help immediately.
During omeprazole treatment, 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.
Omeprazole Neupharm may mask the symptoms of other diseases. Therefore, if the patient experiences any of the following symptoms before starting or during treatment with Omeprazole Neupharm, they should immediately discuss them with their doctor:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting blood or food
• Passing black stools (stool discolored with blood)
• Severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea
• Severe liver dysfunction
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.

Before taking the medicine, the patient should inform their doctor about a planned specific blood test (chromogranin A level).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Omeprazole Neupharm. The patient should also report any other side effects, such as joint pain.
If the patient has taken Omeprazole Neupharm for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heart rate. If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels can lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
When taking proton pump inhibitors like Omeprazole Neupharm, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly.
The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Omeprazole Neupharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription. This is important because Omeprazole Neupharm may affect the way some other medicines work, and some other medicines may affect the way Omeprazole Neupharm works.
The patient should not take Omeprazole Neupharm if they are 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:

• Ketoconazole, itraconazole, posaconazole 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 the patient is taking phenytoin, their doctor will need to monitor their condition when starting or stopping Omeprazole Neupharm.
• 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 or stopping Omeprazole Neupharm.
• 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 chemotherapy medicine used in high doses to treat cancer) - if the patient is taking methotrexate in high doses, the doctor may temporarily stop Omeprazole Neupharm treatment.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin, as well as Omeprazole Neupharm, to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform their doctor about any other medicines they are taking.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or is planning to have a baby, they should consult their doctor or pharmacist before taking 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 Neupharm while breastfeeding.
Studies have not shown any effect of omeprazole on fertility.

Driving and using machines

Omeprazole Neupharm does not affect the ability to drive or use machines. However, dizziness and blurred vision (see section 4) may occur. If these symptoms occur, the patient should not drive or use machines.

Omeprazole Neupharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. the medicine is considered "sodium-free".
This medicine should be diluted by a doctor or nurse according to the information provided at the end of this leaflet, see "Instructions". When calculating the total sodium content in the prepared, diluted solution, the sodium content from the diluent should be taken into account.
To get accurate information about the sodium content in the solution used for dilution, the patient should read the leaflet of the diluent used.

3. How to take Omeprazole Neupharm

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

During administration of Omeprazole Neupharm

• Omeprazole Neupharm 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.

Taking a higher dose of Omeprazole Neupharm than recommended

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

4. Possible side effects

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

In case of any of the following rare but serious side effects, the patient should stop taking Omeprazole Neupharm and contact their doctor immediately:

• Sudden onset of 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. Large blisters and bleeding in the area of the lips, eyes, mouth, nose and genitals may also occur. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• 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).
• Jaundice, dark urine and fatigue, which can be symptoms of liver dysfunction.

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, feeling of tingling and numbness, feeling of drowsiness
• Feeling of spinning (dizziness [balance disorders])
• Changes in liver function test results
• Skin rash, urticaria and itching
• General malaise and lack of energy
• Fractures of the hip, wrist or spine (see section 2 "Warnings and precautions")

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

• Blood disorders, 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 of agitation, confusion or depression
• Change in taste
• Vision problems, such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dry mouth
• Oral mucositis
• Fungal infection that can affect the intestines and is caused by fungi
• Colitis (leading to diarrhea)
• Liver disorders, including jaundice, which can cause yellowing of the skin, dark urine and fatigue
• Hair loss (alopecia)
• Skin rash during sun exposure
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

Very rare side effects (may affect less than 1 in 1,000 people):

• Changes in blood morphology, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blistering of 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

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Hypomagnesemia
• Rash that may be accompanied by joint pain

In very rare cases, in critically ill patients receiving omeprazole as an intravenous infusion, especially in high doses, irreversible visual impairment has been reported, but no causal relationship has been established between these disorders and the use of the medicine.
In very rare cases, Omeprazole Neupharm may affect the white blood cell count, leading to immunodeficiency. If the patient experiences an infection with symptoms such as fever with a significant worsening of general condition or fever with signs of local infection, such as pain in the neck, throat or mouth or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is important for the patient to inform their doctor about the medicine they are taking.
The patient should not worry about the list of possible side effects mentioned above.
It is possible that the patient will not experience any of them.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist or nurse. 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 181 C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Omeprazole Neupharm

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and on the carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store the vial in the outer packaging to protect from light.
Vials removed from the carton should be protected from light or stored for up to 24 hours under normal indoor lighting conditions.
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.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Omeprazole Neupharm contains

The active substance of the medicine is omeprazole in the form of sodium omeprazole salt in an amount equivalent to 40 mg of omeprazole.
The other ingredient is sodium hydroxide.

What Omeprazole Neupharm looks like and contents of the package

Omeprazole Neupharm 40 mg powder for solution for infusion is supplied in a vial made of colorless glass type I, closed with a bromobutyl rubber stopper, an aluminum cap and a polypropylene plug, in a cardboard box.
A solution is prepared from the dry powder in the vial, which is then administered to the patient.
Package size: Vials 1 x 40 mg.

Marketing authorization holder in Greece, the country of export:

Anfarm Hellas S.A.
Achaias 4 & Troizinias
14 564 Kifisia-Attyka
Greece

Manufacturer:

Anfarm Hellas S.A.
61st km Nat.Rd. Athens-Lamia
32 009 Schimatari Viotias
Greece

Parallel importer:

Neupharm Sp. z o.o.
ul. Ługowa 85
96-320 Mszczonów
Poland

Repackaged by:

LABOR Pharmaceutical-Chemical Company Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
GP LABEL Ostrowski Sp. j.
ul. Obywatelska 128/152 / 2b/C
94-104 Łódź
Marketing authorization number in Greece, the country of export:54404/17/31-08-2018

Parallel import authorization number: 433/24

Date of leaflet approval: 10.12.2024

[Information about the trademark]
Information intended only for healthcare professionals:
Instructions
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, sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) 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 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 bottle or bag 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 flexible 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 intravenously over 20-30 minutes.