Esopol

Package leaflet: Information for the user

Esopol, 40 mg, powder for solution for injection / infusion
Esomeprazole
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Esopol is and what it is used for

Esopol 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.
Esopol is used short-term in the treatment of certain conditions where oral administration is not possible. Esopol is used in the treatment of the following conditions:
Adults

• in gastroesophageal reflux disease (GERD). 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.
• in the treatment of gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Esopol may also be used to prevent gastric ulcers if the patient is taking NSAIDs.
• to prevent recurrence of bleeding after endoscopic treatment of acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

• in gastroesophageal reflux disease (GERD). 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.

2. Important information before using Esopol

When not to use Esopol

• 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 class 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 above situations apply, Esopol must not be administered. If the patient is
unsure, they should consult their doctor or nurse before taking
this medicine.
Warnings and precautions
Before starting treatment with Esopol, discuss the following with your doctor:

• if the patient has severe liver disease,
• if the patient has severe kidney disease,
• if the patient has ever had a skin reaction due to treatment with a medicine similar to Esopol that reduces gastric acid secretion,
• if the patient is scheduled for a specific blood test (chromogranin A level). Treatment with esomeprazole should be temporarily discontinued at least 5 days before laboratory testing.

Treatment with Esopol may mask symptoms of other diseases. Therefore, the patient should immediately
inform the doctor if any of the following symptoms occur before or during treatment with Esopol:

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

When taking proton pump inhibitors such as Esopol, especially for periods longer than one
year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. The patient should inform the doctor if they have been diagnosed with osteoporosis or if they are taking corticosteroid medicines (which may increase the risk of developing osteoporosis).
Esopol and other medicines
Tell your doctor or nurse about all medicines currently taken or recently used, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Esopol may affect the action of other medicines, or the action of Esopol may be altered when other medicines are taken.
If the patient is taking nelfinavir (a medicine used in the treatment of HIV infection), Esopol should not be used.
Inform your doctor or nurse if you are taking any of the following medicines:

• atazanavir (a medicine used in the treatment of HIV infection),
• 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). When taking phenytoin, the doctor may recommend additional blood tests at the beginning and after completion of Esopol treatment.
• blood-thinning medicines such as warfarin. The doctor may recommend additional blood tests at the beginning and after completion of Esopol treatment.
• 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),
• clopidogrel (an antiplatelet medicine),
• 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 Esopol,
• tacrolimus (a medicine used in organ transplant recipients),
• rifampicin (a medicine used to treat tuberculosis),
• St John’s wort (Hypericum perforatum) (used in the treatment of depressive disorders).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor before using this medicine. The doctor will decide whether
the patient may take Esopol during this time.
It is not known whether esomeprazole passes into breast milk. For this reason, Esopol should not be used
during breastfeeding.
Driving and operating machinery
No negative effect of Esopol 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.
Esopol contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".

3. How to use Esopol

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Esopol may be administered to children and adolescents aged 1 to 18 years, as well as adults, including elderly patients. Esopol is administered by a physician or nurse. The physician will determine the dose required by the patient. Inform the doctor or nurse if the patient suspects a dose has been missed or an overdose has been administered.
Detailed instructions for the physician or nurse on how to prepare and administer the medicine are provided at the end of this leaflet; see "Instructions".

Administration in adults

• The recommended dose is 20 mg or 40 mg once daily.
• In patients with severe hepatic impairment, the maximum dose for the treatment of gastroesophageal reflux disease (GERD) is 20 mg per day.
• The medicine is administered as an intravenous injection or infusion. Administration may last up to 30 minutes.
• The recommended dose for the prevention of recurrent bleeding from gastric or duodenal ulcers is 80 mg administered as a 30-minute infusion, followed by a continuous infusion over 3 days at a rate of 8 mg/hour. In patients with severe hepatic impairment, a continuous infusion over 3 days at a rate of 4 mg/hour may be sufficient for this indication.

Administration in children and adolescents

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

Use of a higher than recommended dose of Esopol
If an overdose of Esopol is suspected, seek immediate medical advice.
If there are any further doubts regarding the use of this medicine, consult a doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions listed below,
treatment with Esopol should be stopped immediately and a doctor should be contacted:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with ulceration or peeling of the skin. Severe ulceration with bleeding of the lips, eyes, mouth, nose or genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver dysfunction. These symptoms are rare and may occur in fewer than 1 in 1,000 patients.

Other adverse reactions include:
Common (occur in less than 1 in 10 patients):

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

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

• swelling of the feet and around the ankles,
• sleep disturbances (insomnia),
• dizziness, prickling sensation, tingling and numbness (paraesthesiae), drowsiness,
• sensation of spinning (dizziness),
• visual disturbances such as blurred vision,
• dryness of the oral mucosa,
• changes in blood tests assessing liver function,
• skin rash, nodular rash (urticaria) or itching,
• fracture of the neck of the femur, wrist or spine (if this medicine is used in high doses for a long time).

Rare (occur in less than 1 in 1,000 patients):

• blood disorders such as a decrease in white blood cells or platelets. This may manifest as fatigue, increased tendency to bruising and infections.
• low blood sodium levels. This may manifest as fatigue, vomiting and cramps.
• feeling of restlessness, disorientation or depression,
• altered sense of taste,
• sudden onset of wheezing or shortness of breath/dyspnoea (bronchospasm),
• inflammation in the mouth,
• fungal infection called candidiasis, which may affect intestinal function,
• liver diseases, including jaundice, which may cause yellowing of the skin, dark urine and feeling of fatigue,
• hair loss (alopecia),
• photosensitivity rash (rash after sun exposure),
• joint or muscle pain,
• general malaise, lack of energy,
• increased sweating.

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

• changes in blood cell count, including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that are not there (hallucinations),
• severe liver disease leading to liver failure and encephalopathy,
• severe rash or ulceration or sudden onset of skin peeling. These may occur together with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• muscle weakness,
• severe kidney disease,
• breast enlargement in men.

In very rare cases, esomeprazole may affect white blood cells, thereby reducing immunity. If the patient develops an infection with symptoms such as high fever with very poor general condition or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, medical advice should be sought immediately. This lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that the patient informs the doctor about taking this medicine.
Frequency not known (cannot be estimated from available data):

• rash which may be accompanied by joint pain,
• if Esopol has been taken for longer than three months, there is a risk of decreased magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• inflammation of the intestine (leading to diarrhoea).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Esopol

The doctor or nurse is responsible for the proper storage, use, and disposal of any unused or leftover medication.
Keep the medicine out of sight and reach of children.
Store the vials in their original packaging to protect from light. The vials may be kept outside the original packaging under normal indoor lighting conditions, but for no longer than 24 hours. Do not store at temperatures above 30°C.
Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the stated month. The label on the packaging shows "EXP" followed by the expiry date and "Lot" followed by the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Esopol contains

• The active substance is esomeprazole. Each vial contains 42.5 mg of sodium esomeprazole, equivalent to 40 mg of esomeprazole.
• Other components: disodium edetate, sodium hydroxide (for pH adjustment)

What Esopol looks like and contents of the pack
Esopol is a white to almost white powder. Before administration, the medicine must be dissolved.
Pack sizes: 10 vials, 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Laboratorios Normon S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Esomeprazole Polpharma

Information intended solely for healthcare professionals:

Instructions:
The prepared solution should be inspected visually for particulate matter and discoloration. Only clear solutions should be used.
The contents of the vial are intended for single use only.

Injection 40 mg
To prepare a solution for injection (8 mg/ml), add 5 ml of 0.9% sodium chloride solution for intravenous infusion to the vial containing 40 mg of esomeprazole.
If a 20 mg dose is required, only half of the prepared solution should be administered. Any unused portion of the solution must be discarded.
The prepared injection solution is clear, colourless or very pale yellow.

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 infusion.
The prepared infusion solution is clear, colourless or very pale yellow.

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 infusion.

Esopol must not be dissolved in solvents other than those specified.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Suggested route of administration
Injection
40 mg dose
Administer 5 ml of the prepared solution (8 mg/ml) intravenously as an injection over at least 3 minutes.

20 mg dose
Administer 2.5 ml of the prepared solution (8 mg/ml) intravenously as an injection over at least 3 minutes. Any unused portion of the solution must be discarded.

10 mg dose
Administer 1.25 ml of the prepared solution (8 mg/ml) intravenously as an injection over at least 3 minutes. Any unused portion of the solution must be discarded.

Infusion
40 mg dose
The prepared solution should be administered intravenously as an infusion over 10 to 30 minutes.

20 mg dose
Half of the prepared solution should be administered intravenously as an infusion over 10 to 30 minutes. Any unused portion of the solution must be discarded.

10 mg dose
One quarter of the prepared solution should be administered intravenously as an infusion over 10 to 30 minutes. Any unused portion of the solution must be discarded.

80 mg intravenous bolus injection
The prepared solution should be administered as a continuous intravenous infusion lasting 30 minutes.

8 mg/h dose
The prepared solution should be administered as a continuous intravenous infusion lasting 71.5 hours (infusion rate calculated at 8 mg/h). For the shelf life of the prepared solution, see section 6.3 of the Summary of Product Characteristics.

Shelf life
2 years

Stability after reconstitution:
Chemical, physical and microbiological stability of the prepared solution has been demonstrated for 12 hours at 30°C. However, from a microbiological standpoint, the product should be used immediately after preparation unless reconstitution/dilution has taken place under controlled and validated aseptic conditions. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user.