Esomeprazole Sun

1. What is Esomeprazole SUN and what is it used for

Esomeprazole SUN contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines reduce the amount of acid produced by the stomach.
Esomeprazole SUN is used for the short-term treatment of certain conditions where it is not possible to take medicines by mouth. This medicine is used to treat the following diseases:
Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole SUN may also be used to prevent stomach ulcers in patients taking NSAIDs.
• Prevention of recurrence of bleeding after endoscopic treatment for acute bleeding from stomach or duodenal ulcers.

Children and adolescents from 1 year to 18 years

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

2. Important information before using Esomeprazole SUN

When not to use Esomeprazole SUN:

• 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 proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, omeprazole).

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• If you are taking a medicine containing nelfinavir (a medicine used to treat HIV infection).
• If you have ever had a severe skin rash or blistering, or peeling and (or) mouth sores after taking Esomeprazole SUN or other similar medicines.

If any of the above applies to you, do not take Esomeprazole SUN. If you are not sure, consult your doctor or nurse before taking this medicine.

Warnings and precautions

Before starting treatment with Esomeprazole SUN, tell your doctor or nurse:

• about severe liver disease
• about severe kidney disease
• if you have ever had a skin reaction due to a medicine that reduces stomach acid. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Esomeprazole SUN. You should stop taking Esomeprazole SUN and seek medical attention immediately if you notice any of the symptoms associated with these severe skin reactions described in section 4.
• about planned specific blood test (chromogranin A levels).

Taking Esomeprazole SUN may mask the symptoms of other diseases. Therefore, you should
immediately inform your doctor if, before or during treatment with Esomeprazole SUN, you experience any of the following symptoms:

Esomeprazole SUN and other medicines

Tell your doctor or nurse about all the medicines you are taking now or have taken recently, including those obtained without a prescription. This is important because Esomeprazole SUN may affect the action of other medicines, or the action of Esomeprazole SUN may be affected if you are taking other medicines.

• atazanavir (a medicine used to treat HIV infection)
• clopidogrel (a medicine used to prevent blood clots)
• ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections)
• erlotinib (a medicine used to treat cancer)
• citalopram, imipramine, or clomipramine (medicines used to treat depression)
• diazepam (a medicine used to treat anxiety, to relax muscles, or to treat epilepsy)
• phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor may recommend additional blood tests at the start and end of treatment with Esomeprazole SUN
• medicines that reduce blood clotting, such as warfarin. Your doctor may recommend additional blood tests at the start and end of treatment with Esomeprazole SUN
• cilostazol (a medicine used to treat intermittent claudication - leg pain when walking, caused by insufficient blood flow)
• cisapride (a medicine used to treat indigestion or heartburn)
• digoxin (used to treat heart conditions)
• methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking methotrexate in high doses, your doctor may recommend temporarily stopping Esomeprazole SUN
• tacrolimus (used in patients who have had organ transplants)
• rifampicin (used to treat tuberculosis)
• St. John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole SUN during this time.
It is not known whether Esomeprazole SUN passes into breast milk. Therefore, Esomeprazole SUN should not be used during breastfeeding.

Driving and using machines

Esomeprazole SUN is not expected to affect your ability to drive or use machines. However, occasionally, it may cause side effects such as dizziness and blurred vision (see section 4). If this happens, do not drive or use machines.

Esomeprazole SUN contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, which is essentially 'sodium-free'.

3. How to use Esomeprazole SUN

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

How Esomeprazole SUN is given Use in adults

• Esomeprazole SUN will be given to you by a doctor, who will decide the correct dose for you.
• The recommended dose is 20 mg or 40 mg once daily
• If you have severe liver disease, the maximum dose is 20 mg once daily (for the treatment of gastroesophageal reflux disease - GERD)
• The medicine will be given as an injection or infusion into a vein. The injection may take up to 30 minutes.
• The recommended dose for the prevention of recurrence of bleeding from stomach or duodenal ulcers is 80 mg, given as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour, given over 3 days. If you have severe liver disease, a continuous infusion of 4 mg/hour, given over 3 days, may be sufficient.

Use in children and adolescents

• Esomeprazole SUN will be given to you by a doctor, who will decide the correct dose for you.
• The recommended dose for children from 1 year to 11 years is 10 mg or 20 mg once daily.
• The recommended dose for children from 12 to 18 years is 20 mg or 40 mg once daily.
• The medicine will be given as an injection or infusion into a vein. The injection may take up to 30 minutes.

Using more than the recommended dose of Esomeprazole SUN

If you think you have used more than the recommended dose of Esomeprazole SUN, contact your doctor immediately.

4. Possible side effects

Like all medicines, Esomeprazole SUN can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Esomeprazole SUN and contact your doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which can be symptoms of liver disease. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of severe rash, swelling of the face, lips, tongue, or throat, or difficulty swallowing. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of severe skin rash or blistering, or peeling and (or) mouth sores, which can occur even after several weeks of treatment. These effects are rare and may affect up to 1 in 10,000 people.
• Severe skin rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome), which occurs very rarely.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache
• Gastrointestinal disorders: diarrhea, abdominal pain, constipation, bloating
• Nausea or vomiting
• Injection site reactions
• Mild gastric polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling, and numbness, drowsiness
• Feeling of spinning (dizziness)
• Visual disturbances, such as blurred vision
• Dry mouth
• Changes in blood tests that check liver function
• Skin rash, hives, and itching
• Fracture of the hip, wrist, or spine (if Esomeprazole SUN is used in high doses for a long time).

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

• Blood disorders, such as reduced white blood cell or platelet count. This may cause weakness, bruising, or increased risk of infection
• Low sodium levels in the blood. This may cause tiredness, vomiting, and muscle cramps
• Feeling agitated, disoriented, or depressed
• Change in taste
• Sudden onset of shortness of breath, difficulty breathing (bronchospasm)
• Mouth inflammation
• Fungal infection that can affect the intestines, caused by Candida
• Liver disease, including jaundice, which can cause yellowing of the skin, dark urine, and tiredness
• Hair loss (alopecia)
• Sensitivity to light (rash after sun exposure)
• Joint or muscle pain
• General feeling of being unwell and lack of energy
• Increased sweating.

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

• Change 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 brain disease
• Sudden onset of severe skin rash or blistering, or peeling and (or) mouth sores, which can occur with high fever and joint pain (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Severe kidney disease
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from the available data)

• If you take Esomeprazole SUN for more than three months, it is possible that the level of magnesium in your blood may decrease. Low magnesium levels may cause tiredness, muscle cramps, disorientation, seizures, and rapid heartbeat. If you experience any of these symptoms, you should contact your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor your magnesium levels.

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If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.

5. How to store Esomeprazole SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after EXP. The expiry date refers to the last day of that month.
Store in a temperature below 30°C. Store in the original package to protect from light.
It has been shown that the solution is chemically and physically stable for 12 hours at 30°C. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the storage conditions and storage time are the responsibility of the user. The storage time should not be longer than 24 hours at 2°C-8°C, unless reconstitution has taken place in controlled and sterile conditions.

6. Contents of the packaging and other information

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What Esomeprazole SUN contains

• The active substance is esomeprazole sodium. Each vial contains 42.6 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
• The other ingredients are disodium edetate and sodium hydroxide (to adjust the pH).

What Esomeprazole SUN looks like and contents of the pack

Esomeprazole SUN is a white to off-white powder. It is available in a colorless, glass vial with a capacity of 5 ml, with a gray rubber stopper and a gray, aluminum flip-off seal, containing 40 mg of powder for solution for injection/infusion.
Esomeprazole SUN is available in packs containing

• 1 vial
• 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands

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

Denmark:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
Germany:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
France:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
Italy:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
Netherlands:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
Sweden:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
Poland:
Esomeprazole SUN
Romania:
Esomeprazole SUN 40 mg powder for solution for injection/infusion
United Kingdom (Northern Ireland):
Esomeprazole 40 mg powder for solution for injection/infusion.
Date of last revision of the leaflet: 03.03.2025
NL/H/2156/001/ IA/024
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The following information is intended for healthcare professionals only:

Incompatibilities

Do not mix Esomeprazole SUN with other medicinal products, except for those mentioned below.

Shelf life and storage conditions

Store in a temperature below 30°C. Store in the original package to protect from light.
Product packaged:
18 months
Product diluted:
It has been shown that the solution is chemically and physically stable for 12 hours at 30°C. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the storage conditions and storage time are the responsibility of the user. The storage time should not be longer than 24 hours at 2°C-8°C, unless reconstitution has taken place in controlled and sterile conditions.

Special precautions for disposal and preparation

The prepared solution should be visually inspected for particulate matter and discoloration. Only a clear solution should be used. The solution is for single use only.
If a dose of 20 mg is to be administered, only half of the prepared solution should be administered. Any remaining solution should be discarded.

Administration of Esomeprazole SUN

Preparation of the solution for injection:
Intravenous injection 40 mg
To prepare the solution for injection, add 5 ml of 0.9% sodium chloride solution for injection to the vial of esomeprazole.
The prepared solution for injection is clear and colorless to slightly yellow.

Administration of Esomeprazole SUN

Preparation of the solution for infusion:
Intravenous infusion 40 mg
To prepare the solution for infusion, add the contents of one vial of esomeprazole to 100 ml of 0.9% sodium chloride solution for injection.
The prepared solution for infusion is clear and colorless to slightly yellow.
Intravenous infusion 80 mg
To prepare the solution for infusion, add the contents of two vials of esomeprazole (each 40 mg) to 100 ml of 0.9% sodium chloride solution for injection.
For further information on the administration of the dose, refer to section 4.2 of the Summary of Product Characteristics.

Disposal of unused material

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