ESOMEPRAZOLE 40 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Esomeprazole Adamed, 40 mg, powder for solution for injection/infusion
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Esomeprazole Adamed and what is it used for
4. Important information before taking Esomeprazole Adamed
   1. When not to take Esomeprazole Adamed:
   2. Warnings and precautions
   3. Esomeprazole Adamed and any of the following symptoms occur:
   4. Skin rash and skin symptoms
   5. Esomeprazole Adamed and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Esomeprazole Adamed contains sodium
5. How to take Esomeprazole Adamed
   1. How Esomeprazole Adamed is given
   2. Overdose of Esomeprazole Adamed
6. Possible side effects
   1. If the patient notices any of the following side effects, they should stop taking Esomeprazole Adamed and contact their doctor immediately:
   2. Common (may affect up to 1 in 10 patients):
   3. Uncommon (may affect up to 1 in 100 patients):
   4. Rare (may affect up to 1 in 1000 patients):
   5. Very rare (may affect up to 1 in 10,000 patients):
   6. Frequency not known (frequency cannot be estimated from the available data):
   7. Reporting side effects
7. How to store Esomeprazole Adamed
8. Contents of the packaging and other information
   1. What Esomeprazole Adamed contains
   2. What Esomeprazole Adamed looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 04.2025
   7. Information intended for healthcare professionals only:
   8. Preparation and administration of the prepared solution:
   9. Administration of Esomeprazole Adamed
   10. Administration of Esomeprazole Adamed by infusion
   11. Disposal of unused material

Leaflet accompanying the packaging: information for the user

Esomeprazole Adamed, 40 mg, powder for solution for injection/infusion

Esomeprazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist or nurse.
• 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 Adamed and what is it used for
• 2. Important information before taking Esomeprazole Adamed
• 3. How to take Esomeprazole Adamed
• 4. Possible side effects
• 5. How to store Esomeprazole Adamed
• 6. Contents of the packaging and other information

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

Esomeprazole Adamed contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines reduce the amount of acid produced by the stomach.
Esomeprazole Adamed is used for the short-term treatment of certain conditions where it is not possible to take medicines by mouth. 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 Adamed may also be used to prevent the formation of 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 part of the digestive tract that connects the throat to the stomach), causing pain, inflammation, and heartburn.

2. Important information before taking 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 packaging and other information),
• 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 the patient has ever had a severe skin rash or blistering, or peeling and (or) mouth sores after taking Esomeprazole Adamed or other similar medicines.

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

Warnings and precautions

Before taking Esomeprazole Adamed, the patient should inform their doctor or nurse:

• about severe liver disease,
• about severe kidney disease,
• if they have ever had a skin reaction after taking a medicine similar to Esomeprazole Adamed, which reduces stomach acid production. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Esomeprazole Adamed. The patient should stop taking Esomeprazole Adamed and seek medical attention immediately if they notice any of the symptoms of these serious skin reactions described in section 4.
• about planned specific blood tests (chromogranin A levels). Taking Esomeprazole Adamed may mask the symptoms of other diseases. Therefore, the patient should immediately inform their doctor if, before or during treatment with Esomeprazole Adamed, they experience

Esomeprazole Adamed and any of the following symptoms occur:

• significant, unintended, and unexplained weight loss and swallowing disorders,
• 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 Adamed, especially if taken for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. Therefore, it is essential to inform the doctor if the patient has osteoporosis or is taking corticosteroids (which can increase the risk of developing osteoporosis).

Skin rash and skin symptoms

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Esomeprazole Adamed. The patient should also tell their doctor about any other side effects, such as joint pain.
Patients taking esomeprazole have experienced severe skin rashes (see also section 4).
A skin rash may cause mouth sores, throat, nose, genital, and eye inflammation (red and swollen eyes). Severe skin rashes often occur after flu-like symptoms, such as fever, headache, and limb pain. The rash may cover large areas of the body and is accompanied by blistering and peeling of the skin.
If a skin rash or any skin symptoms occur at any time during treatment (even after several weeks), the patient should stop taking Esomeprazole Adamed and contact their doctor immediately.

Esomeprazole Adamed and other medicines

The patient should tell their doctor or nurse about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription. This is important because Esomeprazole Adamed may affect the action of other medicines or the action of Esomeprazole Adamed 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 take Esomeprazole Adamed.
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 Adamed,
• medicines that reduce blood clotting, such as warfarin. The doctor may recommend additional blood tests at the start and end of treatment with Esomeprazole Adamed,
• 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) - if the patient is taking methotrexate in high doses, their doctor may recommend temporarily stopping Esomeprazole Adamed,
• 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 or breastfeeding, 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 Adamed at this time.
It is not known whether Esomeprazole Adamed passes into breast milk. Therefore, Esomeprazole Adamed should not be taken during breastfeeding.

Driving and using machines

Esomeprazole Adamed is not expected to affect the ability to drive or use machines. However, the patient may experience side effects such as dizziness and blurred vision (see section 4). If these occur, the patient should not drive or use machines.

Esomeprazole Adamed contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially 'sodium-free'.

3. How to take Esomeprazole Adamed

Esomeprazole Adamed can be given to children and adolescents from 1 year to 18 years and adults, including the elderly.

How Esomeprazole Adamed is given

Adults

• Esomeprazole Adamed will be given by authorized medical personnel, and the doctor will determine the appropriate dose of the medicine.
• 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 (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 for the prevention of recurrence of bleeding from stomach or duodenal ulcers is 80 mg, given as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour, given over 3 days. If the patient has severe liver disease, a continuous infusion of 4 mg/hour, given over 3 days, may be sufficient.

Use in children and adolescents

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

Overdose of Esomeprazole Adamed

If an overdose of Esomeprazole Adamed is suspected, the patient should immediately consult their doctor.

4. Possible side effects

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

If the patient notices any of the following side effects, they should stop taking Esomeprazole Adamed and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, hives, fainting, or difficulty swallowing (symptoms of a severe allergic reaction). These effects are rare and may occur in less than 1 in 1000 patients treated.
• Redness of the skin with blistering or peeling, which may occur even after several weeks of treatment. Blisters or bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may develop into severe, widespread skin damage (exfoliative dermatitis and blistering of the skin and mucous membranes) with life-threatening consequences. This may be

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

• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome), which occurs very rarely. Yellowing of the skin, dark urine, and fatigue, which may be signs of liver disease. These effects are rare and may occur in less than 1 in 1000 patients treated. Other side effects include:

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

• headache,
• gastrointestinal disorders, such as diarrhea, abdominal pain, constipation, bloating,
• nausea or vomiting,
• injection site reactions,
• mild stomach polyps.

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

• swelling of the feet and ankles,
• sleep disorders (insomnia),
• dizziness, tingling, and numbness, drowsiness,
• vertigo (dizziness of inner ear origin),
• visual disturbances, such as blurred vision,
• dry mouth,
• abnormal liver function test results,
• skin rash, urticaria, or itching,
• fracture of the hip, wrist, or spine (if Esomeprazole Adamed is taken in high doses for a long time).

Rare (may affect up to 1 in 1000 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 fatigue, vomiting, and muscle cramps,
• restlessness, confusion, or depression,
• change in taste,
• sudden wheezing or shortness of breath (bronchospasm),
• mouth inflammation,
• a fungal infection that affects the intestines, which may cause diarrhea,
• liver disease, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue,
• hair loss,
• skin rash after sun exposure,
• joint or muscle pain,
• general malaise and lack of energy,
• increased sweating.

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

• change in blood cell count, including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver disease leading to liver failure and brain inflammation,
• sudden severe 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, drug rash with eosinophilia and systemic symptoms),
• muscle weakness,
• severe kidney disease,
• breast enlargement in men.

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

• when taking Esomeprazole Adamed for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels 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,
• inflammation of the intestine (leading to diarrhea),
• skin rash, with possible joint pain.

Very rarely, Esomeprazole Adamed may affect the white blood cells, leading to impaired immunity. If the patient experiences an infection with symptoms such as high fever, very severegeneral malaise, and signs of a local infection such as sore throat, or difficulty urinating, they should immediately inform their doctor so that a blood test can be done to rule out agranulocytosis. It is essential to inform the doctor that the patient is taking Esomeprazole Adamed.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Esomeprazole Adamed

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the month stated.
Hospital personnel (doctor and hospital pharmacist) are responsible for the proper storage, preparation, and administration of Esomeprazole Adamed in the hospital.
Do not store above 30°C. Store in the original packaging to protect from light.
After reconstitution
Do not store in the refrigerator.
It has been shown that the solution is chemically and physically stable for 12 hours at 30°C. From a microbiological point of view, unless the method of reconstitution or dilution precludes the risk of microbial contamination, the product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions.

6. Contents of the packaging and other information

What Esomeprazole Adamed contains

The active substance of Esomeprazole Adamed is esomeprazole in the form of esomeprazole sodium.
One vial of powder for solution for injection/infusion contains 42.55 mg of esomeprazole sodium, which corresponds 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 or almost white powder, from which a solution for injection/infusion is prepared before administration.
The medicine is available in a cardboard box containing 1 vial.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Poland Esomeprazole Adamed

Date of last revision of the leaflet: 04.2025

Information intended for healthcare professionals only:

Esomeprazole Adamed contains 40 mg of esomeprazole in the form of esomeprazole sodium. Each vial also contains disodium edetate and sodium hydroxide (less than 1 mmol of sodium).
The vials are for single use only. If the entire volume of the prepared solution is not needed to administer a single dose of the medicine, any unused solution should be discarded.
To obtain additional information on the recommended dosage and storage conditions, the relevant sections 3 and 5 should be consulted.

Preparation and administration of the prepared solution:

To prepare the solution for injection/infusion, the plastic, colored cap should be removed from the top of the Esomeprazole Adamed vial, and the stopper should be pierced 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/infusion is clear, colorless, or very pale yellow. The prepared solution should be inspected and checked for particulate matter or discoloration. Only a clear solution should be used.
The shelf-life of the prepared solution, due to its chemical and physical stability, is 12 hours at 30°C. However, from a microbiological point of view (risk of contamination), the product should be used immediately.

Administration of Esomeprazole Adamed

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

Administration of Esomeprazole Adamed by infusion

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

Disposal of unused material

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