ESOPRAL 20 mg Enteric-Coated Tablets

Зміст інструкції

1. Esopral 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. What Esopral is and what it is used for
   2. What you need to know before you take Esopral
   3. How to take Esopral
   4. Possible side effects
   5. How to store Esopral
   6. Package contents and other information
2. ESOPRAL 40 mg powder for injectable solution/for infusion
   1. What you need to know before taking Esopral
   2. How to use Esopral
   3. Possible side effects
   4. How to store Esopral
   5. Package contents and other information

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

esomeprazole

Read this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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
called “proton pump inhibitors”, which work by reducing the amount of acid produced by the
stomach.
Esopral is used for the treatment of the following conditions:

Adolescents aged 12 years and over

• “Gastroesophageal reflux disease” (GERD). This occurs when acid from the stomach leaks back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers of the stomach or the upper part of the intestine with infection by bacteria called “ Helicobacter pylori”. If you have these conditions, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Ulcers of the stomach caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esopral can also be used to prevent the formation of stomach ulcers while taking NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment of re-bleeding ulcers, after prevention with intravenous administration of Esopral.

2. What you need to know before you take Esopral

Do not take Esopral:

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines that reduce stomach acid (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used for the treatment of HIV infection). Do not take Esopral if any of the above applies to you. If you are unsure, ask your doctor or pharmacist before taking Esopral.

Warnings and precautions
Tell your doctor or pharmacist before you take Esopral:

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a medicine similar to Esopral that reduces stomach acid.
• you are going to have a specific blood test (Chromogranin A)

Esopral can mask the symptoms of other diseases. Therefore, if any of the following occurs
before you start taking or while you are taking Esopral, tell your doctor immediately:

• You lose a lot of weight without reason or have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start to vomit food or blood.
• Your stools are black (stools with blood in them).

If you have been prescribed Esopral “as needed”, contact your doctor if the symptoms should persist or
change in nature.
If you take a proton pump inhibitor such as Esopral, especially for a period longer than one
year, there may be a slight increase in the risk of fractures of the hip, wrist or spine.
If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of
osteoporosis) consult your doctor.
Skin rash and skin symptoms
If you notice the appearance of 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
report any other undesirable effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also
section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such
as fever, headache, muscle pain. The rash can cover large
parts of the body with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a rash
or any of these skin symptoms, stop taking this medicine and contact
your doctor immediately.
Children under 12 years of age
For dosage in patients aged 1-11 years, reference should be made to other medicines
available on the market in sachets (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 available without a prescription. This is because Esopral can affect
the way some medicines work and some medicines can have an effect on Esopral.
You must not take Esopral tablets if you are taking a medicine containing nelfinavir(used
for the treatment of HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used for the treatment of fungal infections).
• Erlotinib (used for the treatment of cancer).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, for muscle relaxation or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Esopral.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with Esopral.
• Cilostazol (used for the treatment of intermittent claudication - a pain in the legs when walking, which is 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 transplantation).
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort ( Hypericum perforatum) (used for the treatment of depression).

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect 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 period.
It is not known whether Esopral passes into breast milk, so do not take Esopral if you are breastfeeding.

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

Esopral contains sucrose
Esopral gastro-resistant tablets contains sucrose, which is a type of sugar. If your doctor has
told you that you have an intolerance to certain sugars, consult him before taking the 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 your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

• If you are taking this medicine for a long time, your doctor will monitor you (especially if you are taking the medicine for more than one year).
• If your doctor has told you to take the medicine when needed, as required, inform your doctor if there are any changes in your symptoms.

How much medicine to take

• Your doctor will tell you how many tablets to take and for how long. This depends on your physical condition, age and liver function.
• The recommended doses are given below.

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

• If your doctor has found your esophagus to be slightly damaged, the recommended dose is one gastro-resistant tablet of Esopral 40 mg once a day for 4 weeks. Your doctor may tell you to continue treatment, taking the same dose, for another 4 weeks if the esophagus has not healed.
• After the esophagus has healed, the recommended dose is one gastro-resistant tablet of Esopral 20 mg once a day.
• If the esophagus is not damaged, the recommended dose is one gastro-resistant tablet of Esopral 20 mg every day. When your symptoms are under control, your doctor will tell you that you can take the medicine when needed, up to a maximum of one gastro-resistant tablet of Esopral 20 mg per day.
• If you have severe liver problems, your doctor will give you a lower dose.

Treatment of ulcers caused by infection withHelicobacter pyloriand prevention of their
recurrence:

• The recommended dose is one gastro-resistant tablet of Esopral 20 mg twice a day for one week.
• Your doctor will also tell 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 gastro-resistant tablet of Esopral 20 mg once a day for 4 to 8 weeks.

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

• The recommended dose is one gastro-resistant tablet of Esopral 20 mg once a day.

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

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

Prolonged treatment of re-bleeding ulcers, after prevention with
intravenous administration of Esopral:
The recommended dose is one tablet of Esopral 40 mg once a day for 4 weeks.

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

• If your doctor has found your esophagus to be slightly damaged, the recommended dose is one gastro-resistant tablet of Esopral 40 mg once a day for 4 weeks. Your doctor may tell you to continue treatment, taking the same dose, for another 4 weeks if the esophagus has not healed.
• After the esophagus has healed, the recommended dose is one gastro-resistant tablet of Esopral 20 mg once a day.
• If the esophagus is not damaged, the recommended dose is one gastro-resistant tablet of Esopral 20 mg every day.
• If you have severe liver problems, your doctor will give you a lower dose.

Treatment of ulcers caused by infection withHelicobacter pyloriand prevention of their
recurrence:

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

Taking this medicine

• You can take the tablets at any time of the day.
• You can 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 granules that protect the medicine from being degraded by stomach 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. No other liquids should be used.
• Mix until the tablets disintegrate (the mixture will not look clear). Drink immediately or at least within 30 minutes. Always mix before drinking.
• To make sure you have taken all of the medicine, rinse the glass thoroughly by filling it halfway with water and drink. Solid particles contain the medicine and should not be chewed or crushed.
• If you are absolutely unable to swallow, the tablet can be mixed with a little water, placed in a syringe and administered directly into the stomach through a feeding tube.

Use in children under 12 years of age
Esopral gastro-resistant tablets are not recommended in children under 12 years of age.
Information regarding the dosage indicated for children from 1 to 11 years of age should refer to
other medicines available on the market in sachets (consult your doctor or pharmacist if you need
further information).

Elderly
Dose adjustment is not required in the elderly.

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 to take your next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for the missed dose. If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, which 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, and throat or body, rash, feeling of fainting or difficulty swallowing (severe allergic reaction). These effects are rare, and may affect up to 1 in 1,000 people.
• The sudden onset of a severe rash or reddening of the skin with blisters or peeling can also occur after several weeks of treatment. Severe blisters and bleeding can also appear on the lips, eyes, mouth, nose, and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may be ‘“multiforme erythema”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or “drug reaction with eosinophilia and systemic symptoms”. 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.
• Effects on the stomach or intestines: diarrhea, 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 check how the liver is working.
• Rash, hives and itching.
• Hip, wrist or spine fracture (if Esopral is used at high doses and for prolonged periods).

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

• Blood problems, such as a reduced number of white blood cells and platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling of agitation, confusion or depression.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden feeling of wheezing or shortness of breath (bronchospasm).
• Inflammation of the inside of the mouth.
• An infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of unwellness and lack of strength.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, perceiving or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (multiforme erythema, 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, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium or calcium levels. The doctor should decide whether to periodically check magnesium levels in the blood.
• Inflammation of the intestine (which can lead to diarrhea).
• Erythema, with possible joint pain.

Esopral, in very rare cases, can affect white blood cells leading to immunodeficiency.
If you have an infection with symptoms such as fever with severedeterioration of general physical condition or
fever with symptoms of local infection, such as sore throat, sore throat or mouth or difficulty urinating,
you should consult a doctor as soon as possible, so that the lack of white blood cells in
the blood (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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 30°C.
• Do not use this medicine after the expiry date which is stated on the carton on the bottle after Exp. The expiry date refers to the last day of the month.
• Keep this medicine in its original packaging (blister) or keep the bottle tightly closed to protect it from moisture.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Esopral and package contents

• Esopral 20 mg gastro-resistant tablets are light pink with the inscription A/EH on one side and 20 mg on the other.
• Esopral 40 mg gastro-resistant tablets are pink with the inscription A/EI on one side and 40 mg on the other.
• The tablets are in blister packs, wallets and/or bottles containing
• 20 mg, 40 mg: bottle of 2-5-7-14-15-28-30-56-60-100-140 (28x5) tablets.
• 20 mg, 40 mg blister or wallet blister 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 Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Esopral is:
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan
Under license from Grünenthal GmbH
Manufacturer
Esopral is released by AstraZeneca AB – Sodertalje – Sweden, AstraZeneca GmbH, Wedel,
Germany, Corden Pharma GmbH, Plankstadt, Germany, 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 authorised in the Member States of the European Economic Area under the
following denominations:
Italy Esopral
Sweden Esopral

Other sources of information
More detailed information on this medicine 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 in a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, it is necessary to disperse the tablet in 50 ml of water to prevent granules from blocking the tube.
• 2. Immediately shake the syringe for about 2 minutes to disperse the tablet.
• 3. Hold the syringe with the tip up and check that the tip is not blocked.
• 4. Connect the syringe to the tube while maintaining the above position.
• 5. Shake the syringe and position it with the tip facing down. Immediately inject 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip facing up to prevent blockage of the tip).
• 6. Rotate the syringe with the tip facing down and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
• 7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5, if necessary, to wash any sediment in the syringe. For some tubes, 50 ml of water are required.

ESOPRAL 40 mg powder for injectable solution/for infusion

esomeprazole

Read this leaflet carefully before you start to use 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 get any side effects, even 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 you use 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
called “proton pump inhibitors”, which work by reducing the amount of acid produced by the
stomach.
Esopral is used for the short-term treatment of certain conditions, when the patient is unable to
take treatment by mouth. It is used for the treatment of the following conditions:
Adults

• Gastro-oesophageal reflux disease (GERD). This is when acid from the stomach leaks back up into the oesophagus (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esopral can also be used to prevent stomach ulcers from forming when taking NSAIDs.
• Prevention of re-bleeding after endoscopic treatment of acute bleeding from gastric or duodenal ulcers.

Children and adolescents from 1 to 18 years of age

• Gastro-oesophageal reflux disease (GERD). This is when acid from the stomach leaks back up into the oesophagus (the tube that connects 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 any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• if you are allergic to other medicines proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used for the treatment of HIV infection). Esopral should 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 serious liver problems.
• You have serious kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esopral that reduces stomach acid.
• You need to undergo a specific blood test (Chromogranin A)

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

• You lose a lot of weight without reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (stools with blood stains).

If you take a proton pump inhibitor such as Esopral, especially for a period longer than one
year, there may be a slight increase in the risk of fractures of the hip, wrist or spine.
If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of
osteoporosis) consult your doctor.
Skin redness and skin symptoms
If you notice the appearance of skin redness, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop treatment with Esopral. Remember to
report any other unwanted effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also
section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such
as fever, headache, muscle pain. The rash can cover large
parts of the body with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a rash
or any of these skin symptoms, stop taking this medicine and contact
your doctor immediately.

OTHER MEDICINES AND ESOPRAL
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. This is because Esopral can affect
the way some medicines work and some medicines can have an effect on Esopral.
Esopral should not be given to you if you are taking a medicine containing nelfinavir (used
for the treatment of HIV infection).
Tell your doctor or nurse if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used for the treatment of fungal infections).
• Erlotinib (used for the treatment of cancer).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, for muscle relaxation or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Esopral.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with Esopral.
• Cilostazol (used for the treatment of intermittent claudication - a pain in the legs when walking, which is 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 transplantation).
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort ( Hypericum perforatum) (used in the treatment of depression).

Pregnancy, breastfeeding and fertility.
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking Esopral. The doctor will decide whether you can be
given Esopral during this period.
It is not known whether Esopral passes into breast milk, so you should not receive Esopral if you are
breastfeeding.

Driving and operating machinery
It is unlikely that Esopral will affect your ability to drive or operate tools or machinery.
However, unwanted effects such as dizziness and blurred vision may occur rarely
(see section 4). If these occur, do not drive or use machinery.

3. How to use Esopral

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

Administration of Esopral
Use in adults

• Esopral will be administered to you by your doctor, who will decide the amount of medication needed.
• The recommended dose is 20 mg or 40 mg once a day.
• If you have severe liver problems, the maximum dose is 20 mg per day (Gastro-esophageal reflux disease).
• The medication will be administered as an injection or infusion into a vein. The procedure will last a maximum of 30 minutes.
• The recommended dose for the prevention of re-bleeding of gastric or duodenal ulcers is 80 mg administered by intravenous infusion for 30 minutes 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 from 1 to 18 years of age

• Esopral will be administered to you by your doctor, who will decide the amount of medication you need.
• In children from 1 to 11 years of age the recommended dose is 10 or 20 mg administered once a day.
• In children from 12 to 18 years of age the recommended dose is 20 and 40 mg administered once a day.
• The medication will be administered in the form of an injection or intravenous infusion. The latter 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 gets 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 can 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 and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• The sudden onset of a severe skin rash or reddening of the skin with blisters or peeling can also occur after several weeks of treatment. Severe blisters and bleeding can also appear on the lips, eyes, mouth, nose and genitals. The rashes can develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or “drug reaction with eosinophilia and systemic symptoms”. 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.
• Effects on the stomach or intestines: diarrhea, 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 check how the liver is working.
• 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 problems, for example a reduced number of white blood cells or platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling of agitation, confusion or depression.
• Alteration of taste.
• Sudden feeling of breathlessness or shortness of breath (bronchospasm).
• Inflammation of the inside of the mouth.
• Infection called “candidiasis”, which can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of strength.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, perceiving or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash or blisters or peeling of the skin. 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.
• Enlargement of the breasts in men.

Not known (frequency cannot be estimated from available data)

• If you take Esopral for more than three months, it is possible that blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to periodically check magnesium levels in the blood.
• Inflammation of the intestine (which can lead to diarrhea).
• Erythema, with possible joint pain.

Esopral, in very rare cases, can affect white blood cells leading to immunodeficiency.
If you have an infection with symptoms such as fever with severedeterioration of general physical condition or
fever with symptoms of local infection, such as sore throat, sore throat or mouth or difficulty urinating,
you should consult a doctor as soon as possible so that the lack of white blood cells (agranulocytosis) can be
excluded through a blood test. It is important for you to provide information about the medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Esopral.
• Do not use this medicine after the expiry date which is reported on the carton and vial after Scad. The expiry date refers to the last day of the month.
• This medicine must be stored in a safe place, where children cannot see or reach it.
• Do not store at a temperature above 30°C.
• Keep the vial in the outer packaging to protect the medicine from light. However, vials may be stored for up to 24 hours exposed to normal indoor light outside of their packaging.

6. Package contents and other information

What Esopral contains

Description of Esopral’s appearance and package contents
Esopral is a “lyophilized” or white to off-white powder. It is converted into a solution before
administration.
Pack sizes: 1 vial, 10 vials.
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 Milan
Under license from Grünenthal GmbH
Esopral is released by AstraZeneca GmbH Wedel - Germany, AstraZeneca AB - Gärtunavägen -
151 85 – Södertälje SWEDEN, Famar Italia S.p.A. Baranzate (MI)

This medicinal product is authorized in the Member States of the European Economic Area with the
following designations:
Member StatesProduct name
Italy Esopral
Sweden Esopral

Other sources of information
More detailed information about this medicine 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 contents of the vial are 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 puncture the stopper in the center of the designated circle, keeping the needle vertical
so that it correctly passes 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 color change before administration. Only clear solutions should be used.
It has been demonstrated that the validity period after reconstitution in terms of chemical-physical stability is
12 hours at 30° C. However, from a microbiological point of view, the product must be used
immediately.

Esopral injection
To prepare a solution for injection:
Injection 40 mg
For a reconstituted solution of 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 a volume of up to 100 ml of a
0.9% sodium chloride solution for intravenous use.

Infusion 80 mg
Dissolve the contents of two 40 mg esomeprazole vials in a volume of up to 100 ml of a
0.9% sodium chloride solution for intravenous use.
For further information on dose administration, see SmPC section 4.2.

Disposal
Unused or waste product must be disposed of in accordance with local requirements.