Prospect: Information for the user

Esomeprazole NORMON 40 mg powder for injectable solution and for infusion EFG

Esomeprazole

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any doubts, consult your doctor, pharmacist, or nurse.

- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect.

1. What isEsomeprazole NORMONand for what it is used

2. What you need to know before starting to use Esomeprazole NORMON

3. How to use Esomeprazole NORMON

4. Possible adverse effects

5. Storage ofEsomeprazole NORMON

6. Contents of the package and additional information

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

Esomeprazol NORMON is used for the treatment of the following disorders when oral treatment is not possible:

• Gastroesophageal reflux disease (GERD) in adults, adolescents, and children. It occurs when stomach acid rises up the esophagus (the tube that goes from the throat to the stomach) producing pain, inflammation, and burning.

• Gastric ulcers in adults caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol NORMON may also be used to prevent the formation of ulcers if you are taking NSAIDs.

• Prevention of bleeding in adults after a therapeutic endoscopy performed in case of acute bleeding due to gastric or duodenal ulcer.

Do not administer Esomeprazol NORMON

• If you are allergic (hypersensitive) to esomeprazole or to any of the other components of this medication (listed in the section 6: packaging information additional information).

• If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

• If you have ever developed a severe skin rash or skin peeling, blistering or ulcers in the mouth after taking Esomeprazol NORMON or other related medications.

If you are in any of these situations, Esomeprazol NORMON will not be administered to you. If you are unsure, consult your doctor, pharmacist or nurse before they administer this medication to you.

Warnings and precautions

Consult your doctor or nurse before they administer Esomeprazol NORMON if:

• You have severe liver problems.

• You have severe kidney problems.

• You have ever had a skin reaction after treatment with a similar medication to Esomeprazol NORMON to reduce stomach acid.

• You are scheduled to have a specific blood test (Cromogranin A).

If you develop a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol NORMON. 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 relation to treatment with Esomeprazol NORMON. Stop taking Esomeprazol NORMON and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Esomeprazol NORMON may mask symptoms of other diseases.Therefore, if you notice any of the following events before Esomeprazol NORMON is administered to you or after its administration, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.

• You experience stomach pain or indigestion.

• You start vomiting food or blood.

• Your stools appear black (blood-stained).

Use of Esomeprazol NORMON with other medications

Inform your doctor if you are using or have recently used other medications, even those purchased without a prescription. This is because Esomeprazol NORMON may affect how some medications work and some medications may influence the effect of Esomeprazol NORMON.

Esomeprazol NORMON will not be administered to you if you are taking:

• A medication that contains nelfinavir (used for the treatment of HIV infection).

Inform your doctor if you are using any of the following medications:

• Atazanavir (used for the treatment of HIV infection).

• Ketoconazole, itraconazole or voriconazole (for fungal infections).

• Erlotinib (used in cancer treatment)

• Citalopram, imipramine, clomipramine (for depression treatment).

• Diazepam (used for anxiety treatment, as a muscle relaxant or for epilepsy).

• Phenobarbital (for epilepsy). If you are taking phenobarbital, your doctor will need to monitor when you start or stop taking Esomeprazol NORMON.

• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol NORMON.

• Cilostazol (used for intermittent claudication – pain in the legs when walking caused by intermittent blood flow).

• Cisapride (used for indigestion and stomach burning).

• Digoxin (used for heart problems).

• Methotrexate (chemotherapy medication used at high doses in cancer treatment) - if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol NORMON.

• Rifampicin (used for tuberculosis treatment).

• St. John's Wort (Hypericum perforatum) (used to treat depression).

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor. Your doctor will decide if Esomeprazol NORMON can be administered to you during this period.

The passage of Esomeprazol NORMON into breast milk is unknown. Therefore, Esomeprazol NORMON should not be taken during breastfeeding.

Driving and operating machines

Esomeprazol NORMON is unlikely to affect your ability to drive or use tools or machines.

Esomeprazol NORMON contains sodium

This medication contains less than 1 mmol sodium (23 mg) per vial, which is essentially "sodium-free".

• Esomeprazol NORMON can be administered to children and adolescents from1 to18 years and to adults, including elderly patients.

Esomeprazol NORMON Administration

Adults

• Esomeprazol NORMON will be administered by a doctor who will decide the dose needed.

• The usual dose is 20 mg or 40 mg once a day.

• If you have severe liver problems, the maximum dose is 20 mg per day (ERGE).

• The medication will be administered as an injection or as an infusion in one of your veins. This will last up to 30 minutes.

• The usual dose for the prevention of bleeding due to gastric or duodenal ulcer is 80 mg administered as an intravenous infusion for 30 minutes followed by 8 mg/h as a continuous infusion for 3 days. If you have severe liver problems, 4 mg/h as a continuous infusion for 3 days may be sufficient.

Use in Children from 1 to 18 years

• Esomeprazol NORMON will be administered by a doctor who will decide the dose needed.

• For children from1 to11 years, the usual dose is 10 or 20 mg once a day.

• For children from12 to18 years, the usual dose is 20 or 40 mg once a day.

• The medication will be administered as an injection or as an infusion in one of your veins. This will last up to 30 minutes.

If You Are Given Too Much Esomeprazol NORMON

If you consider that you have been given too much Esomeprazol NORMON, consult with your doctor or pharmacist immediately.

For cases of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

Like all medications, Esomeprazol NORMON may cause side effects, although not everyone will experience them.

If you notice any of the following severe side effects, stop taking Esomeprazol NORMON and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

• Skin redness with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."

• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These side effects are rare, occurring between 1 and 10 of every 10,000 patients.

Other side effects include:

Frequent (mayaffect up to 1in 10 people)

• Headache.

• Gastrointestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).

• Nausea or vomiting.

• Reaction at the injection site.

• Benign stomach polyps.

Occasional(mayaffect up to 1in 100 people)

• Swelling of the feet and ankles.

• Sleep disturbances (insomnia).

• Dizziness, tingling, numbness, somnolence.

• Eye disorders such as blurred vision.

• Dizziness.

• Dry mouth.

• Abnormal blood test results indicating liver function.

• Skin rash, urticaria, itching.

Rare(mayaffect up to 1in 1,000 people)

• Blood disorders such as decreased white blood cell or platelet count.

• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.

• Agitation, confusion, or depression.

• Alteration of taste.

• Sudden feeling of lack of air or difficulty breathing (bronchospasm).

• Inflammation in the mouth.

• A known infection called "candidiasis" that can affect the esophagus and is caused by a fungus.

• Liver problems, including jaundice, which can cause yellow skin, dark urine, and fatigue.

• Hair loss (alopecia).

• Dermatitis caused by exposure to sunlight.

• Joint pain (arthritis) or muscle pain (myalgia).

• General feeling of discomfort and lack of energy.

• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (decreased white blood cell count).

• Aggression.

• Seeing, feeling, or hearing things that do not exist (hallucinations).

• Liver disorders that can lead to liver failure or brain inflammation.

• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms may be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Muscle weakness.

• Severe kidney disorders.

• Increased breast size in men.

Frequency unknown (the frequency cannot be estimated from available data)

• Inflammation in the intestine (may cause diarrhea)

• Skin rash, possibly with joint pain

If you are taking Esomeprazol NORMON for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Esomeprazol NORMON, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, or spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (may increase the risk of osteoporosis)

In very rare cases, Esomeprazol NORMON may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever and severe worsening of your general condition or fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in white blood cell count (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case.

Do not be alarmed by this list of possible side effects. It is likely that you will not experience any of them. If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

The doctor and the hospital pharmacist are responsible for the correct conservation, handling, and disposal of Esomeprazol NORMON.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the carton after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Esomeprazol NORMON Composition

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

The other components are disodium edetate and sodium hydroxide.

Appearance of the product and contents of the package

Esomeprazol NORMON is a white or almost white lyophilized powder with a porous appearance. Before administration, it is reconstituted into a solution.

Esomeprazol NORMON 40 mg powder for injection and infusion is presented in a closed glass vial with a stopper and sealed with a capsule in packages containing 1 vial and clinical packs with 50 vials.

Marketing authorization holder and manufacturer responsible

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

This leaflet was revised in February 2025

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/76898/P_76898.html

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This information is only intended for healthcare professionals:

Esomeprazol NORMON contains 40 mg of esomeprazole as sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1>

The vials are for single use. If the reconstituted solution is not used completely for a single dose, it must be discarded.

For more information on dosage recommendations and storage conditions, please refer to sections 3 and 5, respectively.

Preparation and administration of the reconstituted solution

To reconstitute the solution, remove the plastic cap from the top of the vial of Esomeprazol NORMON and pierce the stopper in the center of the marked circle, keeping the needle in a vertical position, in order to correctly pass through the stopper.

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

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

Injection of Esomeprazol NORMON

For preparing a solution for injection:

Injection of 40 mg

To prepare 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 by intravenous route over a period of at least 3 minutes.

For more information on the administration of the doses, please refer to the technical data sheet, section 4.2.

Perfusion ofEsomeprazol NORMON

For preparing a solution for perfusion:

Infusion 40 mg

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

Infusion 80 mg

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 the administration of the dose, please refer to the technical data sheet, section 4.2.

Elimination

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