Esomeprazole Genoptim

Leaflet attached to the packaging: patient information

Esomeprazole Genoptim

40 mg, powder for solution for injection or infusion

Esomeprazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Esomeprazole Genoptim contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines reduce the amount of acid produced in the stomach.
Esomeprazole Genoptim is used for the short-term treatment of certain conditions where it is not possible to take medicines orally. This medicine is used to treat the following diseases and conditions:
Adults

• Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole Genoptim can also be used to prevent stomach ulcers in patients taking NSAIDs.
• Prevention of recurrence of bleeding after endoscopic treatment for acute bleeding from stomach or duodenal ulcers.

Children and adolescents from 1 year to 18 years

• Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

2. Important information before using Esomeprazole Genoptim

When not to use Esomeprazole Genoptim:

• if the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is taking a medicine containing nelfinavir (a medicine used to treat HIV infection).

If any of these situations apply to the patient, they should not be given Esomeprazole Genoptim. If the patient is unsure, they should consult their doctor or nurse before taking this medicine.

Warnings and precautions

Before using Esomeprazole Genoptim, the patient should tell their doctor or nurse:

• about severe liver disease,
• about severe kidney disease,
• if they have ever had a skin reaction after taking a medicine that reduces stomach acid,
• about a planned specific blood test (chromogranin A levels).

Taking Esomeprazole Genoptim may mask the symptoms of other diseases. Therefore, the patient should
immediately inform their doctor if they experience any of the following symptoms before or during treatment with Esomeprazole Genoptim:

Esomeprazole Genoptim may cause the following symptoms:

• significant, unintentional, and unexplained weight loss and difficulty swallowing,
• abdominal pain or symptoms of indigestion,
• vomiting food or vomiting with blood,
• black, tarry stools (stool discolored with blood).

Taking proton pump inhibitors, such as Esomeprazole Genoptim, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Therefore, the patient should inform their doctor if they have osteoporosis or are taking corticosteroids (which may increase the risk of developing osteoporosis).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should immediately inform their doctor, as it may be necessary to stop taking Esomeprazole Genoptim. The patient should also inform their doctor about any other side effects, such as joint pain.

Esomeprazole Genoptim and other medicines

The patient should tell their doctor or nurse about all medicines they are taking, or have recently taken, including those obtained without a prescription. This is important because Esomeprazole Genoptim may affect the action of other medicines, or the action of Esomeprazole Genoptim may be affected if the patient takes other medicines at the same time.
If the patient is taking a medicine containing nelfinavir (a medicine used to treat HIV infection), they should not be given Esomeprazole Genoptim.
The patient should inform their doctor or nurse if they are taking any of the following medicines:

• atazanavir (a medicine used to treat HIV infection),
• clopidogrel (a medicine used to prevent blood clots),
• ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections),
• erlotinib (a medicine used to treat cancer),
• citalopram, imipramine, or clomipramine (medicines used to treat depression),
• diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles),
• phenytoin (a medicine used to treat epilepsy) - if the patient is taking phenytoin, their doctor may recommend additional blood tests at the start and end of treatment with Esomeprazole Genoptim,
• medicines that thin the blood, such as warfarin - the doctor may recommend additional blood tests at the start and end of treatment with Esomeprazole Genoptim,
• cilostazol (a medicine used to treat intermittent claudication - leg pain that occurs when walking, caused by insufficient blood flow),
• cisapride (a medicine used to treat indigestion or heartburn),
• digoxin (used to treat heart rhythm disorders),
• methotrexate (a chemotherapy medicine used to treat cancer in high doses) - if the patient is taking methotrexate in high doses, their doctor may recommend temporarily stopping Esomeprazole Genoptim,
• tacrolimus (an immunosuppressant medicine used in organ transplant patients),
• rifampicin (used to treat tuberculosis),
• St. John's Wort (Hypericum perforatum) (used to treat depressive disorders).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should ask their doctor or pharmacist for advice before taking this medicine. The doctor will decide whether the patient can take Esomeprazole Genoptim at this time.
It is not known whether Esomeprazole Genoptim passes into breast milk. Therefore, Esomeprazole Genoptim should not be used during breastfeeding.

Driving and using machines

Esomeprazole Genoptim is not expected to affect the ability to drive or use machines. However, occasionally, side effects such as dizziness and blurred vision (see section 4) may occur. If these occur, the patient should not drive or use machines.
Esomeprazole Genoptim contains less than 1 mmol of sodium (23 mg) per vial, which means that it is essentially 'sodium-free'.

3. How to use Esomeprazole Genoptim

Esomeprazole Genoptim can be given to children and adolescents from 1 year to 18 years and adults, as well as the elderly.

How Esomeprazole Genoptim is given

Adults

• Esomeprazole Genoptim will be given by authorized medical personnel, and the doctor will determine the appropriate dose.
• The recommended dose is 20 or 40 mg once a day.
• If the patient has severe liver disease, the maximum dose is 20 mg once a day (for the treatment of gastroesophageal reflux disease - GERD).
• The medicine will be given by injection or infusion into a vein. The administration may take up to 30 minutes.
• The recommended dose to prevent recurrence of bleeding from stomach or duodenal ulcers is 80 mg, given as an intravenous infusion over 30 minutes, followed by a continuous infusion at a dose of 8 mg/hour, given for 3 days. If the patient has severe liver disease, a continuous infusion at a dose of 4 mg/hour given for 3 days may be sufficient.

Children from 1 year to 18 years

• Esomeprazole Genoptim will be given by authorized medical personnel, and the doctor will determine the appropriate dose.
• The recommended dose for children from 1 year to 11 years is 10 or 20 mg given once a day.
• The recommended dose for children from 12 to 18 years is 20 or 40 mg given once a day.
• The medicine will be given intravenously by injection or infusion. The administration may take up to 30 minutes.

Using a higher dose of Esomeprazole Genoptim than recommended

If it is suspected that a higher dose of Esomeprazole Genoptim than recommended has been used, the patient should immediately consult a doctor.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Esomeprazole Genoptim and contact their doctor immediately.

• Sudden onset of wheezing, swelling of the lips, tongue, and throat, or body, hives, fainting, or difficulty swallowing (symptoms of a severe allergic reaction).
• Redness of the skin with blisters and peeling. Blisters and bleeding in the mouth, eyes, nose, and genitals may also occur. These symptoms may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver disease.

These side effects are rare and may occur in less than 1 in 1,000 patients treated. Other side effects include:

Common (may affect up to 1 in 10 patients):

• headache,
• stomach and intestine problems, such as diarrhea, stomach pain, constipation, bloating,
• nausea or vomiting,
• reactions at the injection site,
• stomach polyps.

Uncommon (may affect up to 1 in 100 patients):

• swelling of the feet and around the ankles,
• sleep disturbances (insomnia),
• dizziness, tingling, and numbness, drowsiness,
• feeling of spinning (dizziness),
• vision disturbances such as blurred vision,
• dry mouth,
• abnormal liver function test results,
• skin rash, hives, or itching,
• fracture of the hip, wrist, or spine (if Esomeprazole Genoptim is used in high doses for a long time).

Rare (may affect up to 1 in 1,000 patients):

• blood disorders, such as reduced white blood cell or platelet count, which may cause weakness, bruising, or increased susceptibility to infections,
• reduced sodium levels in the blood, which may cause weakness, vomiting, and muscle cramps,
• feeling agitated, disoriented, or depressed,
• change in taste,
• sudden onset of wheezing or shortness of breath (bronchospasm),
• mouth inflammation,
• fungal infections of the digestive tract,
• liver disease, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue,
• hair loss (alopecia),
• skin rash that may occur after exposure to sunlight,
• joint or muscle pain,
• general feeling of being unwell and lack of energy,
• increased sweating.

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

• changes in blood cell counts, including agranulocytosis (a decrease in a type of white blood cell),
• aggression,
• seeing, feeling, or hearing things that are not there (hallucinations),
• severe liver disease leading to liver failure and encephalopathy,
• sudden onset of severe skin rash or blisters, or peeling of the skin. These may occur with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• muscle weakness,
• severe kidney disease,
• breast enlargement in men.

Frequency not known (frequency cannot be estimated from the available data):

• In the case of taking Esomeprazole Genoptim for a period longer than three months, there is a possibility of reduced magnesium levels in the blood. This may cause general weakness, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should immediately inform their doctor. Reduced magnesium levels in the blood may also lead to reduced potassium or calcium levels in the blood. The doctor may decide to perform standard blood tests to monitor the patient's magnesium levels.
• Colitis (leading to diarrhea).
• Rash that may occur with joint pain.

Esomeprazole Genoptim may very rarely affect the white blood cells, leading to impaired immunity. If the patient experiences an infection with symptoms such as high fever and severe deterioration in general health or fever with local infection symptoms such as sore throat, mouth, or urinary problems, they should immediately inform their doctor so that a blood test can be done to rule out agranulocytosis. It is important to inform the doctor that the patient is taking this medicine.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Esomeprazole Genoptim

• Hospital personnel (doctor and hospital pharmacist) are responsible for the proper storage, preparation, and administration of Esomeprazole Genoptim in the hospital.
• Do not use this medicine after the expiry date stated on the carton and on the vial after EXP. The expiry date refers to the last day of the month.
• Store the medicine out of the sight and reach of children.
• Do not store above 30°C.
• The vials should be stored in the original packaging to protect from light. The vials can be stored without the outer packaging, in daylight (indoors) for up to 24 hours.

6. Contents of the packaging and other information

What Esomeprazole Genoptim contains

The active substance is esomeprazole sodium. One vial of powder for solution for injection or infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
The other ingredients are disodium edetate and sodium hydroxide.

What Esomeprazole Genoptim looks like and contents of the pack

Esomeprazole Genoptim 40 mg is a white or almost white powder, from which a solution for injection or infusion is prepared before administration.
The vial is made of colorless glass (type I), with a rubber stopper and an aluminum seal, in a cardboard box.
Pack size: 1 vial or 10 vials.
Not all pack sizes may be marketed.

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:

The following information is intended for healthcare professionals only:

Esomeprazole Genoptim, 40 mg, powder for solution for injection or infusion contains 40 mg of esomeprazole as esomeprazole sodium. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium).
The vials are for single use only. If the entire volume of the prepared solution is not needed for a single dose, the unused solution should be discarded.
To obtain additional information on the recommended dosage and storage conditions, refer to sections 3 and 5, respectively.

Preparation and administration of the prepared solution:

To prepare the solution for injection or infusion, remove the plastic cap from the top of the Esomeprazole Genoptim vial and puncture the stopper in the center of the visible circle on the stopper, holding the needle at a right angle to ensure proper penetration of the stopper by the needle.
The prepared solution for injection or infusion should be clear and colorless or slightly yellowish. Before administration, the solution should be visually inspected for particles and discoloration; only clear solutions should be used.
The shelf-life of the prepared solution due to its chemical and physical stability is 12 hours at a temperature between 2°C and 8°C. However, from a microbiological point of view (risk of contamination), the product should be used immediately after preparation. If the solution is not used immediately after preparation, the responsibility for the storage time and conditions before use lies with the user. The storage time should not exceed 12 hours at a temperature between 2°C and 8°C, unless the reconstitution/dilution took place in controlled and validated aseptic conditions.

Administration of Esomeprazole Genoptim

Preparation of the solution for injection:
Intravenous injection of 40 mg
To prepare the solution for injection (8 mg/ml), add 5 ml of 0.9% sodium chloride solution for intravenous administration to the vial containing 40 mg of esomeprazole.
Administer the prepared solution for injection intravenously over at least 3 minutes.
For further information on the administration of the dose, refer to section 4.2 of the Summary of Product Characteristics.

Intravenous infusion of Esomeprazole Genoptim

Preparation of the solution for infusion:
Intravenous infusion of 40 mg
To prepare the solution for infusion, dissolve the contents of one vial containing 40 mg of esomeprazole in 100 ml of 0.9% sodium chloride solution for intravenous administration.
Intravenous infusion of 80 mg
To prepare the solution for infusion, dissolve the contents of two vials of esomeprazole 40 mg each in 100 ml of 0.9% sodium chloride solution for intravenous administration.
For further information on the administration of the dose, refer to section 4.2 of the Summary of Product Characteristics.

Disposal of unused material

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.