Esomeprazol Accord

Leaflet accompanying the packaging: information for the user

Esomeprazol Accord, 40 mg, powder for solution for injection/infusion

Esomeprazolum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Esomeprazol Accord and what is it used for
• 2. Important information before taking Esomeprazol Accord
• 3. How to take Esomeprazol Accord
• 4. Possible side effects
• 5. How to store Esomeprazol Accord
• 6. Contents of the packaging and other information

1. What is Esomeprazol Accord and what is it used for

Esomeprazol Accord contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines reduce the production of stomach acid.

Esomeprazol Accord is used for the short-term treatment of the following conditions, when it is not possible to take oral medicines:

Adults

• Gastroesophageal reflux disease (GERD) in adults, adolescents, and children. This occurs when stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn.
• Gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Accord may also be used to prevent the formation of gastric ulcers in patients taking NSAIDs.
• Prevention of recurrence of bleeding after endoscopic treatment of acute bleeding from gastric 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 connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. Important information before taking Esomeprazol Accord

When not to take Esomeprazol Accord

• 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 take Esomeprazol Accord. If the patient is unsure, they should consult their doctor or nurse before taking this medicine.

Warnings and precautions

Before taking Esomeprazol Accord, the patient should inform their doctor or nurse if they have:

• Severe liver disease,
• Severe kidney disease,
• Skin reactions after taking a medicine similar to esomeprazole, which reduces stomach acid production
• If the patient is planning to have a specific blood test (chromogranin A)

Taking esomeprazole 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 Esomeprazol Accord:

• Significant, unintended, and unexplained weight loss and difficulty swallowing,
• Abdominal pain or indigestion,
• Vomiting food or vomiting with blood,
• Black, tarry stools (stool discolored with blood).

Taking proton pump inhibitors, such as Esomeprazol Accord, especially if taken 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 if they are taking corticosteroids (which may increase the risk of developing osteoporosis).

Rash and skin symptoms

If the patient experiences a rash, especially on sun-exposed skin, they should inform their doctor as soon as possible, as it may be necessary to discontinue treatment with Esomeprazol Accord. The patient should also inform their doctor about other accompanying side effects, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may cause mouth ulcers, 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 discontinue taking this medicine and contact their doctor immediately.

This medicine may affect the way the patient's body absorbs vitamin B. The patient should contact their doctor if they notice any of the following symptoms, which may indicate a low level of vitamin B:

• Extreme fatigue or lack of energy,
• Numbness,
• Painful or red tongue, mouth ulcers,
• Weak muscles,
• Vision problems,
• Memory problems, confusion, depression.

Esomeprazol Accord and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription. It is essential because esomeprazole may change the effect of other medicines or the effect of esomeprazole may change if the patient takes other medicines.

The patient should not take Esomeprazol Accord if they are taking a medicine containing nelfinavir (a medicine used to treat HIV infection).

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 esomeprazole treatment.
• Medicines that reduce blood clotting, such as warfarin. The doctor may recommend additional blood tests at the start and end of esomeprazole treatment.
• 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 treatment,
• Tacrolimus (used in patients who have had organ transplants),
• Rifampicin (used to treat tuberculosis),
• St. John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take this medicine at this time.

It is not known whether esomeprazole passes into breast milk. Therefore, Esomeprazol Accord should not be taken during breastfeeding.

Driving and using machines

Esomeprazol Accord is unlikely to affect the ability to drive or use tools or 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.

Esomeprazol Accord 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 Esomeprazol Accord

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

How Esomeprazol Accord is given

Use in adults

• Esomeprazol Accord will be given by a doctor, who will determine the correct dose of the medicine.
• The recommended dose is 20 mg 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 for the prevention of recurrence of bleeding from gastric 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 over 3 days. If the patient has severe liver disease, a continuous infusion at a dose of 4 mg/hour may be sufficient, given over 3 days.

Use in children and adolescents

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

Overdose of Esomeprazol Accord

If an overdose of Esomeprazol Accord is suspected, the patient should immediately consult their doctor.

4. Possible side effects

Like all medicines, Esomeprazol Accord can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Esomeprazol Accord 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). These effects are rare and may occur in less than 1 in 1000 patients.
• Sudden onset of severe skin rash or redness of the skin with blisters and peeling, which may occur even after several weeks of treatment. These may also be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), or a reaction to the medicine with eosinophilia and systemic symptoms. These effects are very rare and may occur in less than 1 in 10,000 patients.
• Jaundice, dark urine, and fatigue, which may be symptoms of liver disease. These effects are rare and may occur in less than 1 in 1000 patients.

Other side effects include:

Common (occurring in less than 1 in 10 patients):

• Headache,
• Gastrointestinal disorders, such as diarrhea, abdominal pain, constipation, bloating,
• Nausea or vomiting,
• Reactions at the injection site.
• Mild gastric polyps

Uncommon (occurring in less than 1 in 100 patients):

• Swelling of the feet and ankles,
• Sleep disorders (insomnia),
• Dizziness, numbness, and tingling, 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 Esomeprazol Accord is taken in high doses for a long time).

Rare (occurring in less than 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 weakness, vomiting, and muscle cramps.
• Feeling of agitation, confusion, or depression,
• Change in taste,
• Sudden onset of wheezing or shortness of breath (bronchospasm),
• Mouth inflammation,
• Fungal infection of the gastrointestinal tract,
• 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 feeling of being unwell and lack of energy,
• Increased sweating.

Very rare (occurring in less than 1 in 10,000 patients):

• Change in blood cell count, including agranulocytosis (a lack of a certain type of white blood cell),
• Aggression,
• Seeing, feeling, or hearing things that do not exist (hallucinations),
• Severe liver disease leading to liver failure and brain disorders,
• Sudden onset of severe skin rash or blisters and peeling. These may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), or a reaction to the medicine with eosinophilia and systemic symptoms,
• Muscle weakness,
• Severe kidney disease,
• Enlargement of the breasts in men.

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

• If Esomeprazol Accord is taken for more 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.
• Enteritis (leading to diarrhea).
• Rash, with possible joint pain

Esomeprazol Accord may rarely affect the white blood cells, leading to impaired immunity. If the patient experiences an infection with symptoms such as high fever, severe general malaise, or fever with symptoms of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should immediately inform their doctor to rule out agranulocytosis. It is essential to inform the doctor about taking this medicine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Esomeprazol Accord

The medicine should be stored out of sight and reach of children.

Hospital personnel (doctor and hospital pharmacist) are responsible for the proper storage, preparation, and administration of Esomeprazol Accord in the hospital.

Do not use this medicine after the expiration date stated on the carton and vial after EXP.

The expiration date refers to the last day of the month stated.

Do not store above 25°C.

Store 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.

It has been shown that the solution is chemically and physically stable for 12 hours at 25°C.

From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and storage time. The storage time should not exceed 24 hours at 2°C-8°C, unless reconstitution/dilution took place in controlled, validated aseptic conditions.

Do not use the medicine if the quality of the product has deteriorated, e.g., presence of residual dissolved plug or visible particles in the solution after reconstitution.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Esomeprazol Accord contains

The active substance of the medicine is esomeprazole sodium.

One vial of powder for solution for injection or infusion contains 42.5 mg of esomeprazole sodium, which corresponds to 40 mg of esomeprazole.

The other ingredients are disodium edetate and sodium hydroxide. For information on sodium content, see section 2.

What Esomeprazol Accord looks like and contents of the pack

Esomeprazol Accord is a white or almost white powder or "plug" from which a solution is prepared before administration.

Esomeprazol Accord is available in 6 ml vials made of colorless glass type I, closed with a bromobutyl rubber stopper and a purple, aluminum flip-off seal.

Esomeprazol Accord is available in packs containing 1, 10, or 50 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warsaw

Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: October 2024

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Information intended for healthcare professionals only:

The esomeprazole sodium solution for intravenous injection contains 40 mg of esomeprazole in the form of sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium ions). the solution is for single use only. if remaining contents vial are not needed, unused should be disposed in accordance with local regulations.< p>

For additional information on recommended dosing and storage conditions, see sections 3 and 5.

Preparation of the solution and method of administration:

To prepare the solution, remove the colored cap from the top of the vial and puncture the rubber stopper with a needle through the center of the designated circle. The needle should be kept in a vertical position to ensure proper puncture of the rubber stopper.

The prepared solution for injection or 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.

It has been shown that the solution is chemically and physically stable for 12 hours at 25°C.

From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and storage time. The storage time should not exceed 24 hours at 2°C-8°C, unless reconstitution/dilution took place in controlled, validated aseptic conditions.

Esomeprazole sodium for intravenous injection

Preparation of the solution for intravenous injection:

Intravenous injection 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.

The prepared solution should be administered by intravenous injection over at least 3 minutes.

For additional information on dosing, see section 3.

Esomeprazole sodium for intravenous infusion

Preparation of the solution for intravenous infusion:

Intravenous infusion 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 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 additional information on dosing, see section 3.

Disposal

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