NEXIUM 40 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Nexium 40 mg Powder for Solution for Injection and Infusion

esomeprazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What is Nexium and what is it used for
2. What you need to know before you are given Nexium
3. How Nexium will be given to you
4. Possible side effects
5. Storing Nexium
6. Contents of the pack and other information

1. What is Nexium and what is it used for

Nexium contains a medicine called esomeprazole which belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid that the stomach produces.

Nexium is used to treat the following conditions when treatment by mouth is not possible:

Adults

• Gastroesophageal reflux disease (GORD). This is when acid from the stomach goes back up into the esophagus (the tube that takes food from the mouth to the stomach) causing pain, inflammation, and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Nexium can also be used to prevent stomach ulcers if you are taking NSAIDs.
• Prevention of rebleeding after endoscopic treatment for acute bleeding gastric or duodenal ulcers.

Children and adolescents from 1 to 18 years of age

• Gastroesophageal reflux disease (GORD). This is when acid from the stomach goes back up into the esophagus (the tube that takes food from the mouth to the stomach) causing pain, inflammation, and heartburn.

2. What you need to know before you are given Nexium

You will not be given Nexium

• 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 of the same class as esomeprazole (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin rash or blistering or peeling of the skin after taking Nexium or other medicines of the same class.

If you are in any of these situations, you will not be given Nexium. If you are not sure, consult your doctor, pharmacist, or nurse before you are given this medicine.

Warnings and precautions

Tell your doctor or nurse before you are given Nexium 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 Nexium to reduce stomach acid.
• You are due to have a specific blood test (Chromogranin A).

Nexium may mask the symptoms of other diseases. Therefore, if you notice any of the following before you are given Nexium or after you have been given it, contact your doctor immediately:

• You lose a lot of weight without reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

Taking a proton pump inhibitor like Nexium, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you get a skin rash, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop treatment with Nexium. Remember to mention any other symptoms that you may notice, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Nexium treatment. Stop taking Nexium and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Nexium with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Nexium may affect how some medicines work and some medicines may affect how Nexium works.

You will not be given Nexium if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor if you are using any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, clomipramine (for depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Nexium.
• Medicines that make your blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking Nexium.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Nexium.
• Tacrolimus (after organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Your doctor will decide whether you can be given Nexium during this time.

It is not known if Nexium passes into breast milk. Therefore, you should not take Nexium during breastfeeding.

Driving and using machines

Nexium is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you experience any of these effects.

3. How Nexium will be given to you

Nexium can be given to children and adolescents from 1 to 18 years of age and to adults, including the elderly.

Administration of Nexium

Use in adults

• Nexium will be given to you by your doctor who will decide the dose you need.
• 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 (GORD).
• The medicine will be given to you as an injection or as an infusion into one of your veins. This will take up to 30 minutes.
• The recommended dose for the prevention of rebleeding due to gastric or duodenal ulcers is 80 mg given as an intravenous infusion over 30 minutes followed by 8 mg/h given as a continuous infusion for 3 days. If you have severe liver problems, 4 mg/h given as a continuous infusion for 3 days may be sufficient.

Use in children and adolescents

• Nexium will be given to you by your doctor who will decide the dose you need.
• For children from 1 to 11 years of age, the recommended dose is 10 mg or 20 mg once a day.
• For children from 12 to 18 years of age, the recommended dose is 20 mg or 40 mg once a day.
• The medicine will be given to you as an injection or as an infusion into one of your veins. This will take up to 30 minutes.

If you are given too much Nexium

If you think you have been given too much Nexium, tell your doctor immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, stating the medicine and the amount given.

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 Nexium and contact a doctor immediately:

• Yellow skin, dark urine, and tiredness which can be symptoms of liver problems.

These effects are rare and may affect up to 1 in 1,000 people.

• Sudden difficulty breathing, swelling of the lips, tongue, and 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, even after several weeks of treatment. This can also include blistering of the eyes, mouth, and genitals. The skin rash may become a serious and potentially life-threatening condition with widespread skin peeling and potentially fatal outcomes (Stevens-Johnson syndrome, toxic epidermal necrolysis). These effects are very rare and may affect up to 1 in 10,000 people.
• Widespread skin rash, high temperature, and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS). 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: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Reaction at the injection site.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, feeling of tingling or numbness, drowsiness.
• Eye disorders such as blurred vision.
• Feeling of vertigo.
• Dry mouth.
• Changes in blood tests that show how the liver is working.
• Skin rash, itching, or hives.
• Fracture of the hip, wrist, or spine (if Nexium is used at high doses and for a long period).

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Sudden onset of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation in the mouth.
• A fungal infection called “candidiasis” that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice which can cause yellowing of the skin, dark urine, and tiredness.
• Loss of hair (alopecia).
• Skin rash caused by sunlight.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of being unwell and lack of energy.
• Increased sweating.

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

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Liver problems that can lead to liver failure or inflammation of the brain.
• Sudden onset of severe skin rash, blisters, or peeling of the skin. These symptoms can be accompanied by high fever and pain in the joints (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.

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

• If you are treated with Nexium for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• Inflammation of the intestine (which can lead to diarrhea).
• Skin rash, possibly with pain in the joints.

In very rare cases, Nexium may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severe deterioration of your general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, or difficulty urinating, you should contact your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) by a blood test. It is important that you inform your doctor about your medication.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Nexium

• Keep this medicine out of the sight and reach of children.
• The doctor and pharmacist in the hospital are responsible for the correct storage, handling, and disposal of Nexium.
• Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date is the last day of the month stated.
• Do not store above 30°C.

Store the vial in the outer packaging to protect it from light. However, the vials can be stored outside the packaging exposed to indoor light for up to 24 hours.

6. Container Contents and Additional Information

Nexium Composition

• The active ingredient is sodium esomeprazole. Each vial of powder for injectable and infusion solution contains 42.5 mg of sodium esomeprazole, equivalent to 40 mg of esomeprazole.

• The other components are disodium edetate and sodium hydroxide. This medication contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

Product Appearance and Container Contents

Nexium is a porous cake or white to off-white powder. Before administration, it is reconstituted into a solution.

Packages: 1 vial, 10 vials. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer

AstraZeneca AB, 152 57Södertälje, Sweden

Grünenthal GmbH, Zieglerstrasse 6- D- 52078 Aachen, Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: May 2025

Other Sources of Information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

Nexium 40 mg contains 40 mg of esomeprazole, as sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium).

The vials are for single use. If the complete contents of the reconstituted vial are not used for a single dose, the unused solution must be discarded.

For more 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 from the top of the Nexium vial and puncture the stopper in the center of the marked circle, keeping the needle in a vertical position, in order to correctly pierce the stopper.

The reconstituted solution for injection or infusion must be transparent and colorless to slightly yellow. It must be visually inspected for particles and discoloration before administration and only the clear solution should be used.

The shelf life after reconstitution has been demonstrated in terms of physical and chemical stability for 12 hours at 30°C. However, from a microbiological point of view, the product must be used immediately.

Nexium Injection

To prepare an injection solution:

40 mg Injection

For a reconstituted solution of 8 mg/ml of esomeprazole: Prepare the solution by adding 5 ml of sodium chloride 0.9% for intravenous use to the vial of esomeprazole 40 mg.

The reconstituted solution for injection must be administered intravenously over a period of at least 3 minutes.

For more information on dose administration, please see the summary of product characteristics, section 4.2.

Nexium Infusion

To prepare an infusion solution:

40 mg Infusion

Dissolve the contents of one vial of esomeprazole 40 mg in up to 100 ml of sodium chloride 0.9% for intravenous use.

80 mg Infusion

Dissolve the contents of two vials of esomeprazole 40 mg in up to 100 ml of sodium chloride 0.9% for intravenous use.

For more information on dose administration, please consult the summary of product characteristics, section 4.2.

Disposal

Any remaining medication or waste material must be disposed of in accordance with local procedures.