Nexium 40 mg powder for injection and for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nexium 40 mg Powder for injectable solution and for infusion

esomeprazole

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is not one of the side effects listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Nexium is and what it is used for

Nexium contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Nexium is used for the treatment of the following conditions when oral treatment is not possible:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Gastric ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Nexium may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Prevention of rebleeding after therapeutic endoscopy performed for acute gastric or duodenal ulcer bleeding.

Children and adolescents from 1 to 18 years of age

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

2. What you need to know before Nexium is administered to you

Nexium will not be administered to you if:

• You are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• You are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• You are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
• You have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Nexium or other related medicines.

Nexium will not be administered to you if you are in any of these situations. If you are unsure, consult your doctor, pharmacist, or nurse before this medicine is administered.

Warnings and precautions

Talk to your doctor or nurse before Nexium is administered 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 used to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

Nexium may mask symptoms of other diseases. Therefore, if you experience any of the following events before or after receiving Nexium, contact your doctor immediately:

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

Taking a proton pump inhibitor such as Nexium, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Nexium. Remember to mention any other symptoms 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 symptoms related to these severe skin reactions described in section 4.

Use of Nexium with other medicines

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Nexium may affect how some medicines work, and some medicines may influence the effect of Nexium.

Nexium will not be administered to you if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazol, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for treatment of 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 starting or stopping Nexium.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Nexium.
• Cilostazol (used to treat intermittent claudication – leg pain while walking caused by insufficient blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily discontinue your Nexium treatment.
• Tacrolimus (used in 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 plan to become pregnant, consult your doctor or pharmacist before this medicine is administered. Your doctor will decide whether Nexium can be administered during this period.

It is unknown whether Nexium passes into breast milk. Therefore, Nexium should not be taken during breastfeeding.

Driving and using machines

Nexium is unlikely to affect your ability to drive or operate tools or machinery. However, adverse effects such as dizziness or blurred vision may occur rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

3. How Nexium is administered

Nexium may be administered to children and adolescents aged 1 to 18 years and to adults, including elderly patients.

Administration of Nexium

Use in adults

• Nexium will be administered by your doctor, who will decide the dose you need.
• 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 (GERD).
• The medicine will be given as an injection or as an intravenous infusion into one of your veins. This will last up to 30 minutes.
• The recommended dose for prevention of rebleeding due to gastric or duodenal ulcer is 80 mg administered as a 30-minute intravenous infusion, followed by a continuous intravenous 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 and adolescents

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

If you are given more Nexium than you should

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking Nexium and contact a doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which may 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, or throat, or swelling of the whole 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 appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), with potentially life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhoea, 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.
• Sleep disturbances (insomnia).
• Dizziness, tingling and numbness, drowsiness.
• Eye disorders such as blurred vision.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, urticaria, itching of the skin.
• Fracture of 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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” which may affect the oesophagus.
• Liver problems including jaundice, which may cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (reduction in white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. These symptoms may be accompanied by high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Breast enlargement in men.

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

• If you are being treated with Nexium 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, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• Inflammation of the intestine (which may lead to diarrhoea).

• Skin rash, possibly with joint pain.

In very rare cases, Nexium may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) with a blood test. It is important that, in this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nexium

• Keep this medicine out of the sight and reach of children.
• The hospital doctor and pharmacist are responsible for the proper storage, handling, and disposal of Nexium.
• 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 the month indicated.
• Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of Nexium

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

• The other components are disodium edetate and sodium hydroxide. This medicinal product contains less than 23 mg (1 mmol) of sodium per vial and is therefore considered essentially “sodium-free”.

Nature of the product and contents of the container

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

Pack sizes: 1 vial, 10 vials. Only certain pack 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 57 Södertälje, Sweden

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

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

Date of the most recent review of this leaflet: May 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

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 entire contents of the reconstituted vial for a single dose are not used, the unused solution must be discarded.

For further information on dosage recommendations and storage conditions, refer to 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 to ensure proper penetration through the stopper.

The reconstituted solution for injection or infusion must be clear and colourless to slightly yellow. It should be inspected visually for particles and discolouration before administration, and only clear solutions 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 standpoint, the product should be used immediately.

Nexium Injection

To prepare a solution for injection:

40 mg Injection

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

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

For further information on dose administration, please see the Summary of Product Characteristics, section 4.2.

Nexium Infusion

To prepare a solution for infusion:

Infusion 40 mg

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

Infusion 80 mg

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

For further information on dose administration, please consult the Summary of Product Characteristics, section 4.2.

Disposal

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