Esomeprazole accord

Package leaflet: Information for the user

Esomeprazol Accord, 40 mg, powder for solution for injection/infusion
Esomeprazolum
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

Esomeprazol Accord 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.

Esomeprazol Accord is used for short-term treatment of the following conditions when oral administration is not possible:

Adults

• Gastro-oesophageal reflux disease (GERD) in adults, adolescents, and children. This occurs when stomach acid passes back into the oesophagus, causing pain, inflammation, and heartburn.
• Gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Accord may also be used to prevent gastric ulcers in patients taking NSAIDs.
• Prevention of re-bleeding after endoscopic treatment of acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

• Gastro-oesophageal reflux disease (GERD). 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 Esomeprazol Accord

When not to use 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 medicines from the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is taking a medicine containing nelfinavir (a medicine used in the treatment of HIV infection).

Esomeprazol Accord must not be used if any of the situations mentioned above apply to the patient.
If the patient is unsure, they should consult their doctor or nurse before taking this medicine.

Warnings and precautions

Before taking Esomeprazol Accord, inform the doctor or nurse if the patient has:

• severe liver disease,
• severe kidney disease,
• skin reactions after taking a medicine similar to esomeprazole that reduces gastric acid secretion,
• if the patient is scheduled to have a specific blood test (chromogranin A).

Treatment with esomeprazole may mask symptoms of other diseases. Therefore, it is important to inform the doctor immediately if any of the following symptoms occur before or during treatment with Esomeprazol Accord:

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

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

Rash and skin symptoms

If the patient develops a rash, especially on skin exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Esomeprazol Accord. Also inform the doctor about any other accompanying adverse reactions, 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, and may also be associated with conjunctivitis (red and 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 associated with blistering and peeling of the skin. If a skin rash or any skin symptoms occur at any time during treatment (even after several weeks), stop taking this medicine immediately and contact the doctor without delay.

This medicine may affect the way the patient's body absorbs vitamin B₁₂, especially if the patient is treated long-term. Contact the doctor if the patient experiences any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• extreme tiredness or lack of energy,
• tingling,
• painful or red tongue, mouth ulcers,
• weak muscles,
• vision disturbances,
• memory problems, confusion, depression.

Esomeprazol Accord and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. This is important because esomeprazole may alter the effects of other medicines, or the effect of esomeprazole may be altered if the patient is taking other medicines simultaneously.

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

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine. The doctor will decide whether the patient may take the medicine during this time.

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

Driving and using machines

Esomeprazol Accord is unlikely to affect the ability to drive, use tools or operate machinery. However, dizziness and blurred vision (see section 4) may occur not very commonly. If these occur, the patient should not drive or operate machinery.

Esomeprazol Accord 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 take Esomeprazol Accord

Esomeprazol Accord may be administered to children and adolescents from 1 year of age up to 18 years, as well as to adults, including elderly individuals.
How Esomeprazol Accord is administered
Use in adults

• Esomeprazol Accord will be administered by a doctor, who will determine the appropriate dose.
• 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 treatment of gastroesophageal reflux disease - GERD).
• The medicine will be given as an intravenous injection or intravenous infusion into a vein. Administration may last up to 30 minutes.
• The recommended dose to prevent recurrence of bleeding from gastric or duodenal ulcer is 80 mg, administered as an intravenous infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/hour, given for 3 days. If the patient has severe liver disease, a continuous infusion of 4 mg/hour for 3 days may be sufficient.

Use in children and adolescents

• Esomeprazol Accord will be administered by authorized medical personnel; the appropriate dose will be determined by the doctor.
• The recommended dose for children from 1 year up to 11 years of age is 10 or 20 mg given once daily.
• The recommended dose for children from 12 to 18 years of age 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.

Overdose of Esomeprazol Accord
If an overdose of Esomeprazol Accord is suspected, seek immediate medical advice from a doctor.

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 listed below, treatment with Esomeprazol Accord must be stopped immediately and the patient should contact their doctor.

• Sudden onset of wheezing, swelling of the lips, tongue, throat or body, urticaria, 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.
• Sudden occurrence of severe skin rash or redness of the skin with ulceration and peeling, which may appear even after several weeks of treatment. Ulceration and bleeding in the mouth, eyes, nose, and genital organs may also occur. Skin rashes may progress to severe, extensive damage to the skin (epidermal detachment and damage to superficial mucous membranes) with life-threatening consequences. This may be erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS). These reactions are very rare and may occur in less than 1 in 10,000 patients treated.
• 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 (occurring in less than 1 in 10 patients treated):

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

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

• 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, papular rash (urticaria), or itching of the skin,
• fracture of the hip, wrist, or spine (if Esomeprazol Accord is used at high doses for a prolonged period).

Rare (occurring in less than 1 in 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,
• decreased concentration of sodium ions in the blood, which may manifest as weakness, vomiting, and muscle cramps,
• feeling of agitation, confusion, or depression,
• altered taste sensation,
• 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,
• alopecia (hair loss),
• skin rash after exposure to sunlight,
• joint pain or muscle pain,
• general malaise and lack of energy,
• excessive sweating.

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

• changes in blood cell counts, including agranulocytosis (absence of certain types of white blood cells),
• aggression,
• seeing, feeling, or hearing things that are not real (hallucinations),
• severe liver disease leading to liver failure and impaired brain function,
• sudden onset of severe skin rash, ulceration, 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 (DRESS),
• decreased muscle strength,
• severe kidney disorders,
• breast enlargement in men.

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

• When Esomeprazol Accord is taken for longer 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, the patient should inform their doctor immediately. Low magnesium levels in the blood may also lead to decreased potassium or calcium levels in the blood. The doctor may decide to perform routine blood tests to monitor the patient's magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Rash, possibly with joint pain.

Very rarely, Esomeprazol Accord may affect white blood cells, impairing immunity. If the patient develops an infection with symptoms such as high fever, severe malaise, or fever with local signs of 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 reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. 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
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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Esomeprazol Accord

The medicine should be stored out of sight and reach of children.
Hospital staff (the physician 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 expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light. Vials may be stored without the outer carton,
exposed to daylight (inside rooms) for up to 24 hours.
The solution has been shown to be chemically and physically stable for 12 hours at 25°C.
From a microbiological standpoint, the solution should be used immediately. If the product is not
used immediately, the user is responsible for the storage conditions and duration. Under normal conditions, storage should not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.
Do not use the medicine if there is any deterioration in product quality, e.g. presence of undissolved disc or visible particles in the solution after reconstitution.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Esomeprazol Accord contains
The active substance is esomeprazole sodium.
One vial of powder for solution for injection or infusion contains 42.5 mg of esomeprazole sodium,
corresponding 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 to off-white tablet or powder, from which a solution is prepared prior to administration.
Esomeprazol Accord is available in 6 ml vials made of colourless type I glass, closed with a bromobutyl rubber stopper and a purple aluminium flip-off seal.
Esomeprazol Accord is available in packs containing 1, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer / Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

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

Information intended exclusively for healthcare professionals:

The intravenous esomeprazole sodium solution for injection contains 40 mg of esomeprazole in the form of the sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium ions). The solution is for single use only. If any portion of the vial contents remains after use and is not needed, the unused solution must be discarded according to local regulations.

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

Preparation of the solution and method of administration:

To prepare the solution, remove the colored seal from the top of the vial and then pierce the rubber stopper with a needle through the center of the marked circle. The needle should be kept in a vertical position to ensure proper penetration through the rubber stopper.

The prepared solution for intravenous injection or infusion is clear, colourless or very pale yellow. The prepared solution should be inspected visually for particulate matter or discoloration. Only clear solutions should be used.

The solution has been shown to be chemically and physically stable for 12 hours at 25°C. From a microbiological standpoint, the solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user. Under normal circumstances, the storage time should not exceed 24 hours at 2°C–8°C, unless reconstitution or dilution has been carried out under controlled and 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 as an intravenous injection over at least 3 minutes.

For further information on dosage, see section 3.

Esomeprazole sodium for intravenous infusion

Preparation of the solution for intravenous 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 (each containing 40 mg) in 100 mL of 0.9% sodium chloride solution for intravenous administration.

For further information on dosage, see section 3.

Disposal

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