Esomeprazole adamed

Package leaflet: Information for the user

Esomeprazole Adamed, 40 mg, powder for solution for injection/infusion
Esomeprazolum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. See section 4.

Leaflet contents:

1. What Esomeprazole Adamed is and what it is used for
2. What you need to know before using Esomeprazole Adamed
3. How to use Esomeprazole Adamed
4. Possible side effects
5. How to store Esomeprazole Adamed
6. Contents of the pack and other information

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

Esomeprazole Adamed contains a substance called esomeprazole. It belongs to a group of
medicines known as proton pump inhibitors. These medicines reduce the amount of hydrochloric acid produced in the stomach.
Esomeprazole Adamed 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 hydrochloric acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole Adamed may also be used to prevent the development of stomach ulcers if the patient is taking NSAIDs.
• Prevention of re-bleeding after endoscopic treatment of acute bleeding from a stomach or duodenal ulcer.

Children and adolescents aged 1 to 18 years

• Gastro-oesophageal reflux disease (GORD). This occurs when hydrochloric acid from the stomach flows back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), causing pain, inflammation and heartburn.

2. Important information before using Esomeprazole Adamed

When not to take Esomeprazole Adamed:

• if the patient is allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in section 6.: Contents of the pack and other information),
• if the patient is allergic to other medicines from the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is currently taking a medicine containing nelfinavir (a medicine used in the treatment of HIV infection),
• if the patient has ever had a severe skin rash or skin peeling, blistering and/or oral mucosal ulcers after taking Esomeprazole Adamed or other similar medicines.

If any of the above situations apply, Esomeprazole Adamed 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 Adamed, inform the doctor or nurse:

• about severe liver disease,
• about severe kidney disease,
• if the patient has ever had a skin reaction due to taking a medicine similar to Esomeprazole Adamed that reduces gastric acid secretion. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with Esomeprazole Adamed. The patient should stop taking Esomeprazole Adamed and seek immediate medical advice if any of the symptoms related to these serious skin reactions described in section 4. occur.
• about planned specific blood test (chromogranin A level). Treatment with Esomeprazole Adamed 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 Adamed:
• significant, unintentional and unexplained weight loss and difficulty swallowing,
• abdominal pain or indigestion symptoms,
• vomiting of food or vomiting blood,
• black, tarry stools (stool discolored by blood).

Taking proton pump inhibitors, such as Esomeprazole Adamed, especially 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).

Skin rash and skin symptoms

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 Adamed. The patient should also report any other adverse reactions occurring, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4.).
The rash may cause ulceration of the mouth, throat, nose, or genital organs, as well as conjunctivitis (red, swollen eyes). Severe skin rashes often appear after flu-like symptoms such as fever, headache, and limb pain. The rash may affect large areas of the body and is accompanied by blistering and skin peeling.

If a skin rash or any other skin symptoms occur at any time during treatment (even after several weeks), the patient must stop taking this medicine and contact their doctor immediately.

Esomeprazole Adamed and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take, including medicines obtained without a prescription. This is important because Esomeprazole Adamed may alter the effect of other medicines, or the effect of Esomeprazole Adamed may be altered if the patient is taking other medicines simultaneously.

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

Inform the doctor or nurse if any of the following medicines are being taken:

• 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 in cancer treatment),
• citalopram, imipramine or clomipramine (medicines used in the treatment of 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, the doctor may recommend additional monitoring at the beginning and after completion of treatment with Esomeprazole Adamed,
• anticoagulant medicines such as warfarin. The doctor may recommend additional monitoring at the beginning and after completion of treatment with Esomeprazole Adamed,
• 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 in the treatment of heart 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 discontinuing Esomeprazole Adamed,
• tacrolimus (an immunosuppressive medicine 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 or breastfeeding, suspects she is pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient may take Esomeprazole Adamed during this time. It is not known whether Esomeprazole Adamed passes into breast milk. Therefore, Esomeprazole Adamed should not be administered during breastfeeding.

Driving and operating machinery

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

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

3. How to use Esomeprazole Adamed

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

• Esomeprazole Adamed will be administered by authorized medical personnel, and the appropriate dose will be determined by the physician.
• The recommended dose is 20 mg or 40 mg once daily.
• If the patient has severe liver disease, the maximum dose is 20 mg once daily (in the 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 an intravenous infusion over 30 minutes, followed by a continuous infusion at a rate of 8 mg/hour, administered for 3 days. If the patient has severe liver disease, a continuous infusion at a rate of 4 mg/hour administered for 3 days may be sufficient.

Use in children and adolescents

• Esomeprazole Adamed will be administered by authorized medical personnel; the appropriate dose will be determined by the physician.
• The recommended dose in children from 1 year of age up to 11 years is 10 or 20 mg once daily.
• The recommended dose in adolescents aged 12 to 18 years is 20 or 40 mg 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 Adamed
If it is suspected that a higher than recommended dose of Esomeprazole Adamed has been administered, medical advice should be sought immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following adverse reactions,
stop taking Esomeprazole Adamed and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, or face, hives, fainting or difficulty swallowing (symptoms of a severe allergic reaction). These reactions are rare and may occur in less than 1 in 1,000 patients treated.
• Reddening of the skin with blistering or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding from the lips, eyes, mouth, nose, or genitals may also appear. Skin rashes may progress to severe, widespread skin damage (detachment of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may be

erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
These reactions are very rare and may occur in less than 1 in 10,000 patients treated.

• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), occurring very rarely. Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver disease. These reactions are rare and may occur in less than 1 in 1,000 patients treated.

Other adverse reactions include:

Common (may occur in 1 out of 10 patients):

• headache,
• gastrointestinal disorders such as diarrhoea, abdominal pain, constipation, bloating,
• nausea or vomiting,
• reactions at the injection site,
• benign gastric polyps.

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

• swelling of the feet and around the ankles,
• sleep disturbances (insomnia),
• dizziness, tingling and numbness, drowsiness,
• sensation of spinning (vertigo),
• visual disturbances such as blurred vision,
• dry mouth,
• abnormal blood test results used to assess liver function,
• skin rash, nodular rash (urticaria) or itching,
• fracture of the neck of the femur, wrist or spine (if Esomeprazole Adamed is used in high doses for a prolonged period).

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

• blood disorders such as reduced number of white blood cells or platelets, which may cause weakness, bruising or increased susceptibility to infections,
• decreased concentration of sodium ions in the blood, which may manifest as feeling weak, vomiting and muscle cramps,
• feeling agitated, confused or depressed,
• altered taste sensation,
• sudden onset of wheezing or shortness of breath/dyspnoea (bronchospasm),
• inflammation of the mucous membrane in the mouth,
• fungal infection known as candidiasis, which may affect intestinal function,
• 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):

• changes in blood cell count in blood tests, including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that do not exist (hallucinations),
• severe liver disorders leading to liver failure and encephalopathy,
• sudden onset of severe rash, blisters or peeling of the skin. These may occur with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
• muscle weakness,
• severe kidney disorders,
• breast enlargement in men.

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

• when taking Esomeprazole Adamed for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. Your doctor may decide to perform routine blood tests to monitor magnesium levels in your blood,
• inflammation of the intestine (leading to diarrhoea),
• rash, possibly with joint pain.

Very rarely, Esomeprazole Adamed may affect white blood cells, impairing immunity. If a patient develops an infection with symptoms such as high fever, very poor
general condition or fever with signs of localized infection such as neck, throat or mouth pain or difficulty urinating, they should immediately inform their doctor so that blood tests can exclude agranulocytosis. It is important to inform the doctor about taking this medicine at that time.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Adamed

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial following EXP.
The expiry date refers to the last day of the stated month.
Hospital staff (physician and hospital pharmacist) are responsible for the proper storage,
preparation and administration of Esomeprazole Adamed in hospital settings.
Do not store above 30°C. Store in the original packaging to protect from light.
After reconstitution
Do not store in a refrigerator.
The solution has been shown to be chemically and physically stable for 12 hours at 30°C.
From a microbiological point of view, unless the method of reconstitution/dilution excludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions.
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 Esomeprazole Adamed contains
The active substance is esomeprazole in the form of esomeprazole sodium.
One vial of powder for solution for injection/infusion contains 42.55 mg of esomeprazole sodium, corresponding to 40 mg of esomeprazole (Esomeprazolum).
The other ingredients are: disodium edetate and sodium hydroxide.

What Esomeprazole Adamed looks like and contents of the pack
Esomeprazole Adamed is a white to off-white tablet or powder, from which a solution is prepared prior to administration.
The medicine is available in a cardboard box containing 1 vial.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:
ANFARM HELLAS S.A.
61st km NAT.RD. ATHENS-LAMIA
32009 Schimatari Viotias
Greece
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Esomeprazole Adamed

Information intended exclusively for medical professionals:

Esomeprazole Adamed contains 40 mg of esomeprazole in the form of 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 a single dose, any unused portion of the solution must be discarded.
For additional information on recommended dosing and storage conditions, please refer to sections 3 and 5, respectively.
Preparation and administration of the prepared solution:
To prepare a solution for injection/infusion, remove the colored plastic cap located on the top of the Esomeprazole Adamed vial, and puncture the stopper at the center of the visible circle on the stopper, holding the needle vertically to ensure proper penetration through the stopper.
The prepared solution for injection/infusion is clear, colorless or very pale yellow. The solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solutions should be used.
The shelf life of the prepared solution, based on its chemical and physical stability, has been determined to be 12 hours at 30°C. However, from a microbiological standpoint (risk of contamination), the product should be used immediately after preparation.
Injection of Esomeprazole Adamed
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 regarding dose administration, please refer to section 4.2 of the Product Characteristics.
Intravenous infusion of Esomeprazole Adamed
Preparation of solution for infusion:
Intravenous infusion 40 mg
To prepare a 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 80 mg
To prepare a 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 regarding dose administration, please refer to section 4.2 of the Product Characteristics.
Disposal of waste
Any unused portion of the medicinal product or waste material should be disposed of in accordance with local regulations.