Esopral

Package leaflet: Information for the user

Esopral 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

esomeprazole
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esopral is and what it is used for

Esopral contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Esopral is used to treat the following conditions:
Adolescents aged 12 years and older

• “Gastroesophageal reflux disease” (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers associated with infection by bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esopral may also be used to help prevent stomach ulcers during NSAID treatment.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment to prevent recurrent bleeding from ulcers, following initial prevention with intravenous administration of Esopral.

2. What you should know before taking Esopral

Do not take Esopral:

• if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• if you have ever had a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking Esopral or other related medicines.

Do not take Esopral if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Esopral.

Warnings and precautions

Tell your doctor or pharmacist before taking Esopral:

• if you have serious liver problems.
• if you have serious kidney problems.
• if you have ever had a skin reaction after treatment with a medicine similar to Esopral that reduces stomach acidity.
• if you need to undergo a specific blood test (Chromogranin A).

Esopral may mask symptoms of other diseases. Therefore, if any of the following occur
before starting or while taking Esopral, inform your doctor immediately:

• You lose a lot of weight without reason or have difficulty swallowing.
• You develop stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools become black (stools containing blood).

If Esopral has been prescribed “as needed”, contact your doctor if symptoms persist or change in nature.

If you are taking a proton pump inhibitor such as Esopral, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.

This medicine may affect how your body absorbs Vitamin B₁₂, particularly if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B₁₂:

• Extreme tiredness or lack of energy
• Tingling sensations (paraesthesia)
• Sore or red tongue, mouth ulcers
• Muscle weakness, blurred vision
• Memory problems, confusion, depression

Skin rash and skin symptoms
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esopral. Remember to also report any other side effects such as joint pain.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Esopral treatment. Discontinue use of Esopral and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.

Children under 12 years of age
For dosing in patients aged 1–11 years, refer to other medicines available on the market in sachet form (consult your doctor or pharmacist if you need further information).

Other medicines and Esopral
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Esopral may affect how some medicines work, and some medicines may affect Esopral.

Do not take Esopral tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazolo, or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, for muscle relaxation, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor should monitor you when starting or stopping Esopral treatment.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping Esopral treatment.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a medicine used in high-dose chemotherapy for cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Esopral treatment.
• Tacrolimus (used in organ transplants).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with Esopral for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Esopral with food and drink
The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esopral during this time.

It is not known whether Esopral passes into breast milk, therefore you should not take Esopral if you are breastfeeding.

Driving and using machines
It is unlikely that Esopral affects the ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, do not drive or operate machinery.

Esopral contains sucrose
Esopral gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Esopral contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Esopral

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, you must consult your doctor or pharmacist.

• If you have been taking this medicine for a long time, your doctor will monitor you (particularly if you have been taking the medicine for more than one year).
• If your doctor has told you to take the medicine as needed, inform your doctor if there is any change in your symptoms.

How much medicine to take

• Your doctor will inform you about the number of tablets to take and for how long. This depends on your physical condition, age, and liver function.
• The recommended doses are listed below.

Use in adults aged 18 years and older
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found your oesophagus to be slightly damaged, the recommended dose is one 40 mg Esopral gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct you to continue treatment, taking the same dose, for an additional 4 weeks if the oesophagus has not healed.
• After healing of the oesophagus, the recommended dose is one 20 mg Esopral gastro-resistant tablet once daily.
• If the oesophagus is not damaged, the recommended dose is one 20 mg Esopral gastro-resistant tablet daily. When symptoms are under control, your doctor will inform you that you may take the medicine as needed, up to a maximum of one 20 mg Esopral gastro-resistant tablet per day.
• In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is one 20 mg Esopral gastro-resistant tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg Esopral gastro-resistant tablet once daily for 4 to 8 weeks.

Prevention of gastric ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg Esopral gastro-resistant tablet once daily.

Treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg Esopral tablets twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long treatment should continue. The maximum dose is 80 mg twice daily.

Long-term treatment to prevent re-bleeding of ulcers, after initial prevention with intravenous administration of Esopral:
The recommended dose is one 40 mg Esopral tablet once daily for 4 weeks.

Use in adolescents aged 12 years and older
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found your oesophagus to be slightly damaged, the recommended dose is one 40 mg Esopral gastro-resistant tablet once daily for 4 weeks. Your doctor may instruct you to continue treatment, taking the same dose, for an additional 4 weeks if the oesophagus has not healed.
• After healing of the oesophagus, the recommended dose is one 20 mg Esopral gastro-resistant tablet once daily.
• If the oesophagus is not damaged, the recommended dose is one 20 mg Esopral gastro-resistant tablet daily.
• In case of severe liver problems, your doctor will prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is one 20 mg Esopral gastro-resistant tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets, as they contain coated granules that protect the medicine from being degraded by gastric acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:
  • Place the tablets in a glass of non-carbonated water. Do not use any other liquid.
  • Stir until the tablets disintegrate (the mixture will not appear clear). Drink immediately or within 30 minutes at the latest. Always stir before drinking.
  • To ensure you have taken all the medicine, rinse the glass thoroughly by half-filling it with water and drink it. The solid particles contain the medicine and must not be chewed or crushed.
• If you are completely unable to swallow the tablet, it may be mixed with a small amount of water, drawn into a syringe, and administered through a tube directly into the stomach (gastric feeding tube).

Use in children under 12 years of age
Esopral gastro-resistant tablets are not recommended for children under 12 years of age.
Information on the dosage recommended for children aged 1 to 11 years is available for other medicinal products on the market in sachet form (consult your doctor or pharmacist if you need further information).

Elderly
Dose adjustment is not required in elderly patients.

If you take more Esopral than you should
If you have taken more Esopral than prescribed by your doctor, inform your doctor or pharmacist immediately.

If you forget to take Esopral

• If you forget to take a dose of Esopral, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects, stop taking Esopral and contact your doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden wheezing, swelling of the lips, tongue, throat, or body, rash, feeling faint, or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These side effects are very rare and may affect up to 1 in 10,000 people. Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people):

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
• Nausea or vomiting.
• Benign polyps in the stomach.

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

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Vertigo.
• Dry mouth.
• Changes in blood tests that monitor liver function.
• Skin rash, urticaria, and itching.
• Fracture of the hip, wrist, or spine (if Esopral is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people):

• Blood disorders, such as a reduced number of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Feeling agitated, confused, or depressed.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis” that may affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of being unwell and lack of strength.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells in the blood).
• Aggression.
• Seeing, sensing, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated 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 problems.
• Breast enlargement in men.

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

• If you take Esopral for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Erythema, possibly with joint pain.

Esopral, in very rare cases, may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general health or fever with signs of localized infection, such as neck, throat, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important that you inform your doctor about all the medicines you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esopral

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date stated on the carton and on the bottle after "Exp". The expiry date refers to the last day of the month.
• Store this medicine in its original packaging (blister pack) or keep the bottle tightly closed in order to protect it from moisture.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Esopral contains
The active substance is esomeprazole. Esopral gastro-resistant tablets are available in 2 strengths containing 20 mg or 40 mg of esomeprazole (as magnesium trihydrate).
The excipients are: glycerol monostearate 40-55, hypromellose, hydroxypropyl methylcellulose, iron oxide (20 mg red-brown, yellow, 40 mg red-brown), magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose spheres (sucrose and maize starch), talc, titanium dioxide (E171), triethyl citrate.

Description of the appearance of Esopral and contents of the pack

• Esopral 20 mg gastro-resistant tablets are light pink with the code A/EH on one side and 20 mg on the other.
• Esopral 40 mg gastro-resistant tablets are pink with the code A/EI on one side and 40 mg on the other.
• The tablets are supplied in blister packs, wallet blister packs and/or bottles containing:
  • 20 mg, 40 mg: bottles of 2-5-7-14-15-28-30-56-60-100-140 (28x5) tablets.
  • 20 mg, 40 mg: blister or wallet blister packs of 3-7-7x1-14-15-25x1-28-30-50x1-56-60-90-98-100x1-140 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for Esopral is:
Dompé farmaceutici S.p.A., Via San Martino 12 - 20122 Milano
Under license from Grünenthal GmbH

Manufacturers
Esopral is released by AstraZeneca AB – Södertälje – Sweden, Patheon Italia s.p.a. – Viale G.B. Stucchi 110 – 20900 Monza (MB), Italy, Doppel Farmaceutici S.r.l., Quinto de’ Stampi, Rozzano (Milan), Italy, Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero (MO), Italy.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Esopral
Sweden: Esopral

Other sources of information
More detailed information on this medicinal product is available on the AIFA website.
The following information is intended exclusively for physicians or healthcare professionals.

Administration via gastric tube

1. Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, it is necessary to disperse the tablet in 50 ml of water to prevent granules from clogging the tube.
2. Shake the syringe immediately for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip upwards and check that the tip is not blocked.
4. Connect the syringe to the tube, maintaining the above position.
5. Shake the syringe and position it with the tip downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip upwards to prevent blockage of the tip).
6. Rotate the syringe with the tip downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Refill the syringe with 25 ml of water and 5 ml of air and repeat step 5, if necessary, to flush any residue from the syringe. For some tubes, 50 ml of water may be required.

Package leaflet: information for the user

ESOPRAL 40 mg powder for injectable solution / for infusion

esomeprazole
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Esopral is and what it is used for
Esopral contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Esopral is used for short-term treatment of certain conditions when the patient is unable to take oral therapy. It is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esopral may also be used to prevent the development of stomach ulcers during NSAID treatment.
• Prevention of re-bleeding after endoscopic treatment of acute gastric or duodenal ulcer bleeding.

Children and adolescents aged 1 to 18 years

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking Esopral

Do not use Esopral:

• if you are allergic (hypersensitive) to esomeprazole or to any of the excipients in this medicine (listed in section 6: Contents of the pack and other information).
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• if you have ever had a severe skin rash or skin peeling, or skin rash with blisters and/or mouth ulcers after taking Esopral or other related medicines.

Esopral must not be given to you if any of the above apply. If in doubt, consult your doctor or nurse before using this medicine.
Warnings and precautions
Consult your doctor or nurse before using Esopral if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esopral that reduces gastric acidity.
• You need to undergo a specific blood test (Chromogranin A).

Esopral may mask symptoms of other diseases. Therefore, if any of the following occur before or after
treatment with Esopral, inform your doctor immediately:

• You lose weight significantly without reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (stools containing blood).

If you take a proton pump inhibitor such as Esopral, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect the way your body absorbs Vitamin B_, particularly if you need to take it for a long period. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B_:

• Extreme tiredness or lack of energy
• Tingling (paresthesia)
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression
• Skin rash and skin symptoms

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esopral. Remember to also report any other adverse effects such as joint pain.
Severe skin reactions have been reported in association with Esopral treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking Esopral and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
OTHER MEDICINES AND ESOPRAL
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Esopral may affect how some medicines work, and some medicines may affect Esopral.
Esopral must not be given to you if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor or nurse if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, for muscle relaxation, or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will monitor you when starting or stopping treatment with Esopral.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with Esopral.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a medicine used in high-dose chemotherapy to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with Esopral.
• Tacrolimus (used in organ transplants).
• Rifampicin (used to treat tuberculosis).
• St John’s wort (Hypericum perforatum) (used to treat depression).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Esopral. Your doctor will decide whether Esopral can be given to you during this time.
It is not known whether Esopral passes into breast milk, therefore you must not take Esopral if you are breastfeeding.
Driving and using machines
It is unlikely that Esopral affects the ability to drive or use tools or machinery. However, side effects such as dizziness and blurred vision may very rarely occur (see section 4). If these occur, you must not drive or operate machinery.

3. How to use Esopral

• Esopral can be administered to children and adolescents from 1 to 18 years of age, as well as adults, including the elderly.

Administration of Esopral
Use in adults

• Esopral will be administered by your doctor, who will decide the required dose.
• The recommended dose is 20 mg or 40 mg once daily.
• If you have severe liver problems, the maximum dose is 20 mg per day (for gastro-oesophageal reflux disease).
• The medicine will be given as an injection or infusion into a vein. The procedure will last no more than 30 minutes.
• The recommended dose for prevention of re-bleeding from gastric or duodenal ulcers is 80 mg administered as a 30-minute intravenous infusion, followed by a continuous infusion of 8 mg/h for 3 days. If you have severe liver problems, a continuous infusion of 4 mg/h for 3 days may be sufficient.

Use in children aged 1 to 18 years

• Esopral will be administered by your doctor, who will determine the amount of medicine you need.
• In children aged 1 to 11 years, the recommended dose is 10 or 20 mg administered once daily.
• In children aged 12 to 18 years, the recommended dose is 20 or 40 mg administered once daily.
• The medicine will be administered as an injection or intravenous infusion. The infusion will last up to 30 minutes.

If you use more Esopral than you should
If you think you have been given too much Esopral, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop taking Esopral and contact your doctor immediately:

• Yellowing of the skin, dark urine, and fatigue may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of a severe skin rash or reddening of the skin with blisters or peeling may occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes may progress to serious widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
• Nausea or vomiting.
• Reactions at the site of administration.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Vertigo.
• Vision problems, such as blurred vision.
• Dry mouth.
• Changes in blood tests that monitor liver function.
• Skin rash, hives, and itching.
• Fracture of the hip, wrist, or spine (if Esopral is used at high doses and for prolonged periods).

Rare (may affect up to 1 in 1,000 people)

• Blood disorders, for example, a reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased susceptibility to infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Feeling agitated, confused, or depressed.
• Altered taste.
• Sudden feeling of breathlessness or shortness of breath (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis”, which may affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of illness and lack of strength.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells in the blood).
• Aggression.
• Seeing, sensing, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated 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 problems.
• Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

• If you take Esopral for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether to periodically monitor your blood magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Erythema, possibly with joint pain.

In very rare cases, Esopral may affect white blood cells, leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general health or fever with symptoms of local infection, such as neck, throat, or mouth pain or difficulty urinating, you must contact your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about the medicines you are taking.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esopral

• The physician and the hospital pharmacist are responsible for the correct storage, use, and disposal of Esopral.
• Do not use this medicinal product after the expiry date stated on the carton and vial after Exp. The expiry date refers to the last day of the month.
• This medicinal product must be stored in a safe place out of the sight and reach of children.
• Do not store above 30°C.
• Keep the vial in the outer packaging to protect the medicinal product from light. However, vials may be exposed to normal indoor light and kept outside their packaging for up to 24 hours.

Description of the appearance of Esopral and contents of the pack
Esopral is a "lyophilisate" or white or almost white powder. It is reconstituted into a solution before
administration.
Packs: 1 vial, 10 vials.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Esopral is:
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Under licence from Grünenthal GmbH
Esopral is released by AstraZeneca AB - Gärtunavägen – 152-57 – Södertälje SWEDEN, Famar Italia
S.p.A. Baranzate (MI)
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Member States Name of the medicinal product
Italy Esopral
Sweden Esopral
Other sources of information
More detailed information on this medicinal product is available on the AIFA website.

The following information is intended exclusively for healthcare professionals:

Esopral IV 40 mg contains 40 mg of esomeprazole as the sodium salt. Each vial also contains disodium edetate and sodium hydroxide (< 1 mmol of sodium).
The vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, the unused solution must be discarded.
For further information on dosage recommendations and storage conditions, see sections 3 and 5, respectively.
Preparation and administration of the reconstituted solution:
To reconstitute the solution, remove the colored plastic cap located on top of the Esopral vial and pierce the stopper in the center of the designated circle, keeping the needle vertical to ensure proper penetration through the stopper.
The reconstituted solution for injection or infusion must be clear and colorless to very pale yellow. It must be visually inspected for the presence of suspended particles and discoloration prior to administration. Only clear solutions should be used.
It has been demonstrated that the chemical and physical stability of the reconstituted solution remains valid for 12 hours at 30°C. However, from a microbiological standpoint, the product should be used immediately.
Esopral Injection
To prepare a solution for injection:
Injection 40 mg
For a reconstituted solution containing 8 mg/ml of esomeprazole: Prepare the solution by adding 5 ml of 0.9% sodium chloride solution for intravenous use to the 40 mg esomeprazole vial.
The reconstituted solution for injection must be administered intravenously over a period of at least 3 minutes.
For further information on dose administration, see SmPC section 4.2.
Esopral Infusion
To prepare a solution for infusion:
Infusion 40 mg
Dissolve the contents of one 40 mg esomeprazole vial in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
Infusion 80 mg
Dissolve the contents of two 40 mg esomeprazole vials in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
For further information on dose administration, see SmPC section 4.2.
Disposal
Any unused product or waste material must be disposed of in accordance with local requirements.