Omeprazole genoptim
PolandTable of Contents
Package leaflet: information for the patient
Omeprazole Genoptim, 40 mg, powder for solution for infusion
Omeprazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See
section 4.
Leaflet contents:
- What Omeprazole Genoptim is and what it is used for
- Important information before using Omeprazole Genoptim
- How to use Omeprazole Genoptim
- Possible side effects
- How to store Omeprazole Genoptim
- Contents of the pack and other information
1. What Omeprazole Genoptim is and what it is used for
Omeprazole Genoptim contains an active substance called 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.
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 recurrence of duodenal ulcer,
- treatment of gastric ulcer,
- prevention of recurrence of gastric ulcer,
- eradication therapy of Helicobacter pylori (H. pylori) in peptic ulcer disease, in combination with appropriate antibiotics,
- treatment of gastric and duodenal ulcers associated with the use of NSAIDs (non-steroidal anti-inflammatory drugs),
- prevention of gastric and duodenal ulcers associated with the use of NSAIDs (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 using Omeprazole Genoptim
When not to use Omeprazole Genoptim:
if the patient has a known hypersensitivity (allergy) to omeprazole or any of the
other components of Omeprazole Genoptim,
if the patient has a known hypersensitivity 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).
If there are any doubts about using Omeprazole Genoptim, the patient should discuss them with a doctor or pharmacist.
Warnings and precautions
Before taking the medicine, inform the doctor:
about any planned specific blood test (chromogranin A levels).
Omeprazole Genoptim may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before or after taking the medicine, the patient should contact a doctor immediately:
unexplained weight loss and difficulty swallowing,
stomach pain or indigestion,
repeated vomiting of food or vomiting blood,
black stools (stool discolored by blood),
severe or persistent diarrhoea, as use of omeprazole is associated with a slightly increased risk of infectious diarrhoea,
serious liver function disorders,
if the patient has ever previously experienced a skin reaction due to treatment with a medicine similar to Omeprazole Genoptim that reduces gastric acid secretion.
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as this may necessitate discontinuation of Omeprazole Genoptim. The patient should also report any other adverse reactions occurring, such as joint pain.
Using Omeprazole Genoptim for longer than three months may lead to decreased magnesium levels in the blood. Magnesium deficiency may cause symptoms such as: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.
Use of a proton pump inhibitor such as Omeprazole Genoptim, especially for longer 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), they should inform the doctor.
While taking omeprazole, interstitial nephritis (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 their doctor.
Omeprazole Genoptim and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, including those obtained without a prescription. This is important because Omeprazole Genoptim may affect the way some other medicines work, 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 in the treatment of HIV infection).
Inform the 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 in the treatment of epilepsy);
phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting and stopping Omeprazole Genoptim;
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 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 for cancer treatment) – if the patient is receiving high-dose methotrexate, the doctor may advise temporarily discontinuing Omeprazole Genoptim.
If, in addition to Omeprazole Genoptim, the doctor has prescribed the antibiotics amoxicillin and clarithromycin for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines they are taking.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will decide whether the patient can take Omeprazole Genoptim during this time.
Animal studies have not shown any effect of omeprazole on fertility.
Driving and using machines
Omeprazole Genoptim has no effect on the ability to drive or use tools and machinery. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If these occur, the patient should not drive or operate machinery.
1 vial of Omeprazole Genoptim (10 ml) contains 0.13 mmol 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 dilution. For accurate information regarding the sodium content in the solution used for dilution, refer to the product information leaflet of the diluent used.
3. How to use Omeprazole Genoptim
Omeprazole Genoptim may be administered to adults, including elderly patients.
Experience with the use of Omeprazole Genoptim for intravenous administration in children is limited.
Administration of Omeprazole Genoptim
Omeprazole Genoptim will be administered to the patient by a physician, who will decide the appropriate dose required by the patient.
The medicine will be given as an intravenous infusion into one of the veins.
Administration of a higher than recommended dose of Omeprazole Genoptim
If the patient thinks they have received too high a dose of Omeprazole Genoptim, they should speak to their doctor immediately.
4. Possible side effects
Like all medicines, Omeprazole Genoptim may cause side effects, although
not everyone will experience them.
If any of the following rare but serious side effects occur,
stop taking Omeprazole Genoptim and contact your doctor immediately:
sudden onset of wheezing, swelling of the lips, tongue or throat, or body swelling,
rash, fainting or difficulty swallowing (severe allergic reaction);
redness of the skin with formation of blisters or peeling.
Large blisters and bleeding may also occur around the lips, eyes, mouth, nose, or genital organs.
This may be Stevens-Johnson syndrome or toxic epidermal necrolysis;
yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver dysfunction.
Other side effects include:
Common side effects (occurring in 1 to 10 out of 100 patients):
headache,
gastrointestinal symptoms: diarrhoea, abdominal pain, constipation, gas (bloating), mild gastric polyps,
nausea or vomiting.
Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):
swelling of feet and ankles,
sleep disturbances (insomnia),
dizziness, tingling or prickling sensations, drowsiness,
sensation of spinning (dizziness, balance disturbances),
changes in liver function test results,
skin rash, nodular 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 out of 10,000 patients):
blood disorders such as reduced number of white blood cells or platelets, which 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,
low blood sodium levels, which may cause weakness, vomiting and muscle cramps,
feeling of restlessness, disorientation or depression,
change in taste perception,
vision problems such as blurred vision,
sudden onset of wheezing or shortness of breath (bronchospasm),
dryness of the mouth,
inflammation of the mucous membrane of the mouth,
a fungal infection known as candidiasis, which may affect the intestines and is caused by fungi,
liver function disorders, including jaundice, which may cause yellowing of the skin,
dark urine and fatigue,
hair loss (alopecia),
skin rash after exposure to sunlight,
joint pain (arthralgia) or muscle pain (myalgia),
severe kidney function disorders (interstitial nephritis),
increased sweating.
Very rare side effects (occurring in less than 1 out of 10,000 patients):
changes in blood morphology including agranulocytosis (lack of white blood cells),
aggression,
seeing, feeling or hearing things that are not real (hallucinations),
severe liver function disorders leading to liver failure and encephalopathy,
sudden appearance of severe rash or blisters on the skin or skin peeling.
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 (frequency cannot be estimated from available data):
low magnesium levels in the blood (hypomagnesaemia),
inflammation of the large intestine (leading to diarrhoea).
In very rare cases, in critically ill patients receiving omeprazole as intravenous infusion,
particularly at high doses, irreversible visual disturbances have been reported. However,
a causal relationship between the use of this medicine and these disturbances has not been established.
In very rare cases, Omeprazole Genoptim may affect the number of white blood cells, leading to
immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by
marked worsening of general condition, or fever with signs of local infection such as pain in the neck,
throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out
possible deficiency of white blood cells (agranulocytosis) based on blood test results. It is important that
the patient informs the doctor about the medicine being taken.
Patients should not be alarmed by the possibility of experiencing the side effects listed above.
It is possible that none of them will occur. If any of the side effects worsen, or if any side effects not
listed in this leaflet occur, the doctor or pharmacist should be informed.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions,
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 responsible entity.
Reporting side effects helps to provide more information on the safety of the medicine.
5. How to store Omeprazole Genoptim
Store below 25°C.
Keep the vial in the original packaging to protect from light.
Shelf life after preparation of infusion solution at 25°C:
- 12 hours after preparation of the solution by mixing with sodium chloride solution 9 mg/ml (0.9%);
- 6 hours after preparation of the solution by mixing with glucose solution 50 mg/ml (5%).
Shelf life after preparation of infusion solution at 2-8°C:
- 12 hours after preparation of the solution by mixing with sodium chloride solution 9 mg/ml (0.9%);
- 6 hours after preparation of the solution by mixing with glucose solution 50 mg/ml (5%).
From a microbiological standpoint, the product should be used immediately after preparation.
If the product is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user.
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 stated month.
Medicines must 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 pack and other information
What Omeprazole Genoptim contains
The active substance 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 are disodium edetate and sodium hydroxide.
What Omeprazole Genoptim looks like and contents of the pack
Omeprazole Genoptim is a white to off-white porous "cake" or powder.
The pack contains 1 or 10 vials. 1 vial contains 40 mg of omeprazole.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland
Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain
The following information is intended for healthcare professionals only:
The entire contents of each vial should be dissolved in approximately 5 ml of infusion solution and then immediately diluted to 100 ml. The reconstitution should be performed using 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
- Using a syringe, withdraw 5 ml of infusion solution from a 100 ml infusion bag or bottle.
- Transfer this volume into the vial containing lyophilized omeprazole and mix thoroughly until the omeprazole is completely dissolved.
- Withdraw the omeprazole solution into the syringe.
- Transfer the omeprazole solution into the infusion bag or bottle.
- 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 of infusion solution in flexible containers
- Use a double-ended transfer needle and connect it to the injection site on the infusion bag. Connect the other end of the needle to the vial containing lyophilized omeprazole.
- Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion bag and the vial.
- Ensure that all of the omeprazole has dissolved completely.
The infusion solution must be administered intravenously as an infusion over 20–30 minutes.