Omeprazole Genoptim

Leaflet accompanying the packaging: patient information

Omeprazole Genoptim, 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.
This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Omeprazole Genoptim 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 Genoptim in the form of powder for solution for intravenous infusion is used as an alternative to oral treatment.
Use in adult patients

• treatment of duodenal ulcer,
• prevention of duodenal ulcer recurrence,
• treatment of gastric ulcer,
• prevention of gastric ulcer recurrence,
• 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 (NSAIDs),
• prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) 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 using Omeprazole Genoptim

When not to use Omeprazole Genoptim:

if the patient has been found to be hypersensitive (allergic) to omeprazole or any of the other ingredients of Omeprazole Genoptim,
if the patient has been found to be hypersensitive 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).
In case of any doubts before using Omeprazole Genoptim, consult a doctor or pharmacist.

Warnings and precautions

Before taking the medicine, inform your doctor:
about a planned specific blood test (chromogranin A level).
Omeprazole Genoptim may mask the symptoms of other diseases, so if any of the following symptoms occur before or after taking the medicine, contact your doctor immediately:
unexplained weight loss and difficulty swallowing,
stomach pain or indigestion,
repeated vomiting of food or vomiting with blood,
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 similar to Omeprazole Genoptim, which reduces stomach acid production.
If a skin rash occurs, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to discontinue Omeprazole Genoptim. Also, inform your doctor about any other side effects, such as joint pain.
Taking Omeprazole Genoptim for more than three months may cause a decrease in blood magnesium levels. 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 decreased potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
Taking a proton pump inhibitor like Omeprazole Genoptim, especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. If you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis), inform your doctor.
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. Inform your doctor about such symptoms.

Omeprazole Genoptim and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. This is important because Omeprazole Genoptim may affect the action of some other medicines, and some other medicines may affect the action of Omeprazole Genoptim.
Do not take Omeprazole Genoptim 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:
ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections);
digoxin (used to treat heart conditions);
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 and stopping Omeprazole Genoptim;
medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting and stopping Omeprazole Genoptim;
rifampicin (used to treat tuberculosis);
atazanavir (used to treat HIV infection);
tacrolimus (used after 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 Omeprazole Genoptim.
If your doctor has prescribed antibiotics amoxicillin and clarithromycin in addition to Omeprazole Genoptim to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor about all other medicines you are taking.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
Your doctor will decide whether you can use Omeprazole Genoptim at this time.
Animal studies do not show an effect of omeprazole on fertility.

Driving and using machines

Omeprazole Genoptim does not affect the ability to drive or use tools and machines. However, dizziness and vision disturbances (see section 4) may occur. If they do, do not drive or operate machines.
1 vial of Omeprazole Genoptim (10 ml) contains 0.13 mmol of Na+
The product may be diluted with 0.9% sodium chloride solution or 5% glucose solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared product dilution. For accurate information on the sodium content in the solution used to dilute the product, refer to the characteristics of the medicinal product of the diluent used.

3. How to use Omeprazole Genoptim

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

Administration of Omeprazole Genoptim

Omeprazole Genoptim will be administered to you by a doctor, who will decide what dose you need.
The medicine will be administered as an infusion into one of your veins.

Administration of a higher dose of Omeprazole Genoptim than recommended

If you think you have received too high a dose of Omeprazole Genoptim, talk to your doctor immediately.

4. Possible side effects

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

If you experience any of the following rare but serious side effects, stop using Omeprazole Genoptim and contact your 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. It can also cause blisters and bleeding in the mouth, eyes, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis;
yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver dysfunction.
Other side effects include:

Common side effects (occurring in 1 to 10 in 100 patients):

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

Uncommon side effects (occurring in 1 to 10 in 1,000 patients):

swelling of the feet and ankles,
sleep disturbance (insomnia),
dizziness, tingling, and numbness, 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 (occurring in 1 to 10 in 10,000 patients):

blood disorders such as decreased white blood cell or platelet count, which can lead to weakness, easier bruising, or increased risk of infection,
allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, wheezing,
low sodium levels in the blood, which can lead to weakness, vomiting, and muscle cramps,
feeling of agitation, disorientation, or depression,
change in taste,
vision problems 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 dysfunction, 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 dysfunction (interstitial nephritis),
increased sweating.

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

changes in blood morphology, 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 onset of severe rash or blisters on the skin or peeling. These symptoms 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 (frequency cannot be estimated from available data):

low magnesium levels in the blood (hypomagnesemia),

• inflammation of the large intestine (leading to diarrhea).

In very rare cases, in severely ill patients receiving omeprazole in the form of intravenous infusion, especially in high doses, there have been reports of irreversible vision disturbances, but no causal relationship has been established between the use of this medicine and these disturbances.
In very rare cases, Omeprazole Genoptim may affect the white blood cell count, leading to immunodeficiency. If you experience an infection with symptoms such as fever with significant deterioration of general well-being or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out agranulocytosis based on blood test results. It is essential that you inform your doctor about the medicine you are taking.
Do not worry about the possibility of the above side effects. It is possible that you will not experience any of them. If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 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 to gather more information on the safety of the medicine.

5. How to store Omeprazole Genoptim

Store in a temperature below 25°C.
Store the vial in the original packaging to protect it from light.
Shelf life after preparation of the solution for infusion at 25°C:

• 12 hours after preparation of the solution by mixing with 9 mg/ml (0.9%) sodium chloride solution;
• 6 hours after preparation of the solution by mixing with 50 mg/ml (5%) glucose solution.

Shelf life after preparation of the solution for infusion at 2-8°C:

• 12 hours after preparation of the solution by mixing with 9 mg/ml (0.9%) sodium chloride solution;
• 6 hours after preparation of the solution by mixing with 50 mg/ml (5%) glucose solution.

From a microbiological point of view, the product should be used immediately after preparation.
If the product is not used immediately, the responsibility for the storage time and conditions before use lies with the user.
Store 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Omeprazole Genoptim 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 disodium edetate and sodium hydroxide.

What Omeprazole Genoptim looks like and contents of the packaging

Omeprazole Genoptim is a white to off-white porous "disk" or powder.
The packaging contains 1 or 10 vials. 1 vial contains 40 mg of omeprazole.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

Date of last revision of the leaflet:

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The following information is intended only for qualified medical personnel:

The entire contents of each vial should be dissolved in approximately 5 ml of infusion solution and then immediately diluted to 100 ml. For the preparation of the solution, use 9 mg/ml (0.9%) sodium chloride solution for infusion or 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 other than those specified should be used for dissolution 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 of solution into the vial containing the lyophilized omeprazole and mix thoroughly until the omeprazole is completely dissolved.
• 3. Draw the omeprazole solution into the syringe.
• 4. Transfer the omeprazole solution to the infusion bottle or bag.
• 5. Repeat steps 1-4 to ensure that all omeprazole is transferred from the vial to the infusion bottle or bag.

Alternative preparation of the infusion solution 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 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.