Esomeprazole genoptim

Package leaflet: Information for the patient

Esomeprazole Genoptim
40 mg, powder for solution for injection or infusion
Esomeprazolum
Please read all of this leaflet carefully before the patient uses this medicine, because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific patient only. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Esomeprazole Genoptim is and what it is 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 pack and other information

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

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

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid passes back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole Genoptim may also be used to prevent gastric ulcers if the patient is taking NSAIDs.
• Prevention of rebleeding after endoscopic treatment of acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid passes back into the oesophagus (the tube connecting 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 medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is concurrently taking a medicine containing nelfinavir (a medicine used in the treatment of HIV infection).

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

Warnings and precautions

Before taking Esomeprazole Genoptim, inform your doctor or nurse:

• if the patient has severe liver disease,
• if the patient has severe kidney disease,
• if the patient has ever had a skin reaction while taking a medicine similar to Esomeprazole Genoptim that reduces gastric acid secretion,
• about a planned specific blood test (chromogranin A level).

Treatment with Esomeprazole Genoptim may mask symptoms of other diseases. Therefore, it is essential to inform the doctor immediately if any of the following symptoms occur before or during treatment with Esomeprazole Genoptim:

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

Taking proton pump inhibitors, such as Esomeprazole Genoptim, particularly if used for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. For this reason, it is essential to inform your doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis).

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 discontinue treatment with Esomeprazole Genoptim. The patient should also report any other adverse effects such as joint pain.

Esomeprazole Genoptim and other medicines

Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription. This is important because Esomeprazole Genoptim may affect the action of other medicines, or the effect of Esomeprazole Genoptim may be altered if the patient is taking other medicines at the same time.

Esomeprazole Genoptim must not be used if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or nurse if you are taking any of the following medicines:

• atazanavir (a medicine used in the treatment of 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 taking phenytoin, the doctor may recommend additional blood tests at the beginning and after completion of treatment with Esomeprazole Genoptim,
• anticoagulant medicines such as warfarin – the doctor may recommend additional blood tests at the beginning and after completion of treatment with Esomeprazole Genoptim,
• cilostazol (a medicine used to treat intermittent claudication – leg pain occurring during walking due to inadequate blood flow),
• cisapride (a medicine used to treat indigestion or heartburn),
• digoxin (used to treat heart rhythm disorders),
• methotrexate (a chemotherapy medicine used in high doses for cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may recommend temporarily stopping Esomeprazole Genoptim,
• tacrolimus (an immunosuppressant used in organ transplant recipients),
• rifampicin (used in the treatment of tuberculosis),
• St John's wort (Hypericum perforatum) (used in the treatment of depressive disorders).

Pregnancy, breastfeeding and fertility

If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether she can take Esomeprazole Genoptim during this time.

It is not known whether Esomeprazole Genoptim passes into breast milk. Therefore, Esomeprazole Genoptim should not be used during breastfeeding.

Driving and operating machinery

No negative effect of Esomeprazole Genoptim on the ability to drive, use tools, or operate machinery is expected. However, uncommonly, adverse effects such as dizziness and blurred vision may occur (see section 4). If these occur, the patient should not drive or operate machinery.

Esomeprazole Genoptim contains less than 1 mmol of sodium ions (23 mg) per vial, i.e. the medicine is considered "sodium-free".

3. How to use Esomeprazole Genoptim

Esomeprazole Genoptim may be administered to children and adolescents from 1 year of age up to 18 years of age, as well as to adults and elderly patients.
How Esomeprazole Genoptim is administered
Adults

• Esomeprazole Genoptim will be administered by authorized medical personnel, and the doctor will determine the appropriate dose.
• The recommended dose is 20 or 40 mg once daily.
• If the patient has severe liver disease, the maximum dose is 20 mg once daily (for treatment of gastroesophageal reflux disease - GERD).
• The medicine will be given as an intravenous injection or intravenous infusion into one of the veins. Administration may last up to 30 minutes.
• The recommended dose to prevent recurrence of bleeding from gastric or duodenal ulcer is 80 mg given as a 30-minute intravenous infusion, followed by a continuous infusion of 8 mg/hour, administered for 3 days. If the patient has severe

liver disease, a continuous infusion of 4 mg/hour administered
for 3 days may be sufficient.
Children aged 1 year to 18 years

• Esomeprazole Genoptim will be administered by authorized medical personnel, and the doctor will determine the appropriate dose.
• The recommended dose for children aged 1 to 11 years is 10 or 20 mg given once daily.
• The recommended dose for children aged 12 to 18 years is 20 or 40 mg given once daily.
• The medicine will be administered intravenously as an injection or intravenous infusion. Administration may last up to 30 minutes.

Use of a higher than recommended dose of Esomeprazole Genoptim
If you suspect that a higher than recommended dose of Esomeprazole Genoptim has been administered, seek medical advice immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the serious adverse reactions described below, stop taking Esomeprazole Genoptim immediately and contact a doctor.

• Sudden onset of wheezing, swelling of the lips, tongue or throat, or body, urticaria, fainting, or difficulty swallowing (symptoms of a severe allergic reaction).
• Red rash with blistering and peeling of the skin. Ulceration and bleeding of the mouth, eyes, nose, and genital organs 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 reactions are rare and may occur in fewer than 1 in 1,000 patients treated. Other adverse reactions include:
Common (may occur in 1 out of 10 patients treated):

• Headache,
• Gastrointestinal disorders such as diarrhoea, abdominal pain, constipation, flatulence,
• Nausea or vomiting,
• Reactions at the injection site,
• Fundic gland polyps.

Uncommon (may occur in 1 out of 100 patients treated):

• Swelling of the feet and around the ankles,
• Sleep disturbances (insomnia),
• Dizziness, tingling and numbness, drowsiness,
• Sensation of spinning (dizziness),
• Visual disturbances such as blurred vision,
• Dry mouth,
• Abnormal blood test results used to assess liver function,
• Skin rash, papular rash (urticaria), or itching,
• Fracture of the hip, wrist, or spine (if Esomeprazole Genoptim is used at high doses for a prolonged period).

Rare (may occur in 1 out of 1,000 patients treated):

• Blood disorders such as reduced number of white blood cells or platelets, which may cause weakness, bruising, or increased susceptibility to infections,
• Reduced concentration of sodium ions in the blood, which may manifest as feeling weak, vomiting, and muscle cramps,
• Feeling of restlessness, disorientation, or depression,
• Altered sense of taste,
• Sudden onset of wheezing or shortness of breath/dyspnoea (bronchospasm),
• Inflammation of the mucous membrane in the mouth,
• Fungal infection of the gastrointestinal tract,
• Liver 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 or muscle pain,
• General malaise and lack of energy,
• Excessive sweating.

Very rare (may occur in 1 out of 10,000 patients treated):

• Changes in blood cell count, including agranulocytosis (absence of certain types of white blood cells),
• Aggression,
• Seeing, feeling, or hearing things that are not real (hallucinations),
• Severe liver disorders leading to liver failure and encephalopathy,
• Sudden onset of severe rash or skin ulceration, or skin peeling. May occur with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• Decreased muscle strength,
• Severe kidney disorders,
• Breast enlargement in males.

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

• When Esomeprazole Genoptim is taken for more than three months, there is a possibility of decreased magnesium levels in the blood. This may cause general weakness, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels in the blood may also lead to low potassium or calcium levels in the blood. The doctor may decide to perform routine blood tests to monitor magnesium levels in the patient's blood.
• Inflammation of the intestine (leading to diarrhoea).
• Rash which may be accompanied by joint pain.

Very rarely, Esomeprazole Genoptim may affect white blood cells, causing impaired immunity. If the patient develops an infection with symptoms such as high fever with very poor general condition or fever with symptoms of local infection such as neck, throat or mouth pain, or difficulty urinating, inform the doctor immediately so that blood tests can exclude agranulocytosis. It is important to inform the doctor that the patient is taking this medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring 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.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Esomeprazole Genoptim

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

6. Contents of the pack 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.
Excipients: disodium edetate and sodium hydroxide.

What Esomeprazole Genoptim looks like and contents of the pack
Esomeprazole Genoptim 40 mg is a white to off-white tablet or powder, from which a solution is prepared prior to administration.
Vial made of colourless glass (type I), with a chlorobutyl rubber stopper and aluminium seal, packed in a cardboard box.
Pack sizes: 1 vial or 10 vials.
Not all pack sizes may be marketed.

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 medical personnel 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 sodium).
Vials are for single use only. If the entire volume of the prepared solution is not required for administration of a single dose, any unused portion must be discarded.
For additional information on recommended dosage and storage conditions, please refer to sections 3 and 5, respectively.

Preparation and administration of the reconstituted solution:
To prepare the solution for injection or intravenous infusion, remove the plastic cap from the top of the Esomeprazole Genoptim vial and puncture the stopper in the centre of the visible circle on the stopper, holding the needle vertically to ensure proper penetration through the stopper.
The reconstituted solution for injection or intravenous infusion should be clear and colourless to pale yellow. The solution should be inspected visually for particles and discolouration prior to administration; only clear solutions should be used.

The shelf life of the prepared solution, based on its chemical and physical stability, is 12 hours at a temperature of 2°C to 8°C. However, from a microbiological standpoint (risk of contamination), the product should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for ensuring appropriate storage conditions and duration. The storage time should not exceed 12 hours at 2°C to 8°C, unless reconstitution/dilution was carried out under controlled and validated aseptic conditions.

Injection of Esomeprazole Genoptim
Preparation of solution for injection:
Intravenous injection 40 mg
To prepare a 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.
The prepared solution for injection should be administered intravenously over at least 3 minutes.
For further information on dosing, refer to section 4.2 of the Summary of Product Characteristics.

Intravenous infusion of Esomeprazole Genoptim
Preparation of solution for infusion:
Intravenous infusion 40 mg
To prepare the infusion solution, 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 80 mg
To prepare the infusion solution, 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 dosing, refer to section 4.2 of the Summary of Product Characteristics.

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