ESOMEPRAZOL NORMON 40 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

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

Esomeprazole

Read all of this leaflet carefully before you start taking 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.

Contents of the pack

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

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

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

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

• Gastroesophageal reflux disease (GERD) in adults, adolescents, and children. This occurs when stomach acid rises up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Gastric ulcers in adults caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole NORMON can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Prevention of rebleeding in adults after therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

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

You will not be given Esomeprazole NORMON

• 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 in the same group 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 developed a severe skin rash, blistering, or peeling of the skin after taking Esomeprazole NORMON or other medicines related to it.

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

Warnings and precautions

Consult your doctor or nurse before you are given Esomeprazole NORMON 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 Esomeprazole NORMON to reduce stomach acid.
• You are scheduled to have a specific blood test (Chromogranin A).

If you get a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazole NORMON. Remember to mention any other symptoms you may notice, such as joint pain.

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

Esomeprazole NORMON may mask the symptoms of other diseases. Therefore, if you notice any of the following events before you are given Esomeprazole NORMON or after it is given, contact your doctor immediately:

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

Using Esomeprazole NORMON with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because Esomeprazole NORMON may affect how some medicines work and some medicines may affect the effect of Esomeprazole NORMON.

You will not be given Esomeprazole NORMON if you are taking:

• A medicine that contains nelfinavir (used to treat HIV infection).

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

• Atazanavir (used to treat HIV infection).
• 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 Esomeprazole NORMON.
• Medicines that make your blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole NORMON.
• Cilostazol (used to treat intermittent claudication - pain in the legs when walking caused by intermittent blood pumping).
• 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 Esomeprazole NORMON.
• Rifampicin (used to treat tuberculosis).
• 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 or are planning to have a baby, ask your doctor. Your doctor will decide whether you can be given Esomeprazole NORMON during this period.

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

Driving and using machines

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

Esomeprazole NORMON contains sodium

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

3. How to use Esomeprazole NORMON

• Esomeprazole NORMON can be given to children and adolescents from 1 to 18 years and to adults, including elderly patients.

Administration of Esomeprazole NORMON

Adults

• Esomeprazole NORMON will be given to you by a doctor who will decide the dose you need.
• 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 (GERD).
• The medicine will be given as an injection or as an infusion into one of your veins. This will take up to 30 minutes.
• The usual 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 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

• Esomeprazole NORMON will be given to you by a doctor who will decide the dose you need.
• For children from 1 to 11 years, the usual dose is 10 mg or 20 mg once a day.
• For children from 12 to 18 years, the usual dose is 20 mg or 40 mg once a day.
• The medicine will be given 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 Esomeprazole NORMON

If you think you have been given too much Esomeprazole NORMON, talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420.

4. Possible side effects

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

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

• A sudden difficulty in breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Blisters in the mouth and eyes can also occur. This could be a sign of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine, and tiredness, which can be symptoms of liver problems.
• Widespread rash, high body temperature, and increased size of lymph nodes (DRESS or drug hypersensitivity syndrome), which is very rare.

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

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 the feet and ankles.
• Disturbance of sleep (insomnia).
• Dizziness, feeling of tingling and numbness, drowsiness.
• Eye disorders such as blurred vision.
• Feeling of vertigo.
• Dry mouth.
• Abnormal liver function tests.
• Skin rash, urticaria, itching of the skin.

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

• Blood disorders such as a decrease in the number of white cells or platelets.
• Low levels of sodium in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Disturbance of taste.
• Sudden difficulty in breathing or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as “candidiasis” that can affect the esophagus and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellow 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 cells).
• 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 can be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

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

• Inflammation of the intestine (can lead to diarrhea)
• Skin rash, possibly with joint pain

• If you are taking Esomeprazole NORMON 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, and increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• If you are taking proton pump inhibitors like Esomeprazole NORMON, especially for a period of more than one year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis)

In very rare cases, Esomeprazole NORMON can affect the white blood cells, leading to immune system deficiency. If you have an infection with symptoms such as fever with a severe worsening 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 consult your doctor as soon as possible to rule out a decrease in the number of white cells (agranulocytosis) with a blood test. It is important that, in this case, you inform about your medication.

Do not be alarmed by this list of possible side effects. You will probably not get any of them. If you get side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Esomeprazole NORMON

The doctor and pharmacist in the hospital are responsible for the correct storage, handling, and disposal of Esomeprazole NORMON.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Esomeprazol NORMON Composition

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

The other components are disodium edetate and sodium hydroxide.

Product Appearance and Container Contents

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

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

Marketing Authorization Holder and Manufacturer

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

This prospectus was revised in February 2025

“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/”

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (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 intended only for healthcare professionals:

Esomeprazol NORMON contains 40 mg of esomeprazol, 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, consult sections 3 and 5, respectively.

Preparation and Administration of the Reconstituted Solution

For reconstitution of the solution, remove the colored plastic cap from the top of the Esomeprazol NORMON 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 transparent 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.

Esomeprazol NORMON Injection

To prepare an injection solution:

40 mg Injection

For a reconstituted solution of 8 mg/ml of esomeprazol: Prepare the solution by adding 5 ml of sodium chloride 0.9% for intravenous use to the vial of esomeprazol 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 technical sheet, section 4.2.

Perfusion of Esomeprazol NORMON

To prepare an infusion solution:

40 mg Infusion

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

For more information on dose administration, please consult the technical sheet, section 4.2.

Elimination

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