Esomeprazole Normon 40 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Esomeprazol Normon 40 mg powder for concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start taking 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Esomeprazol Normon is and what it is used for

Esomeprazol Normon 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.

This medicine is used to treat the following conditions when oral treatment is not possible:

Adults

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

Children and adolescents aged 1 to 18 years

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

2. What you need to know before using Esomeprazol Normon

Esomeprazol Normon 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 proton pump inhibitor group (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

• You are taking a medicine containing nelfinavir (used to treat HIV infection).

• You have ever developed a severe skin rash, peeling skin, blistering, or mouth ulcers after taking Esomeprazol Normon or other related medicines.

If any of these apply to you, Esomeprazol Normon will not be administered. If you are unsure, consult your doctor, pharmacist, or nurse before receiving this medicine.

Warnings and precautions

Consult your doctor or nurse before receiving Esomeprazol 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 Esomeprazol Normon used to reduce stomach acid.
• You are scheduled to have a specific blood test (chromogranin A).

Esomeprazol Normon may mask the symptoms of other conditions. Therefore, if you experience any of the following symptoms before or after receiving Esomeprazol Normon, contact your doctor immediately:

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

Taking a proton pump inhibitor such as Esomeprazol Normon, 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-related symptoms

If you develop a skin rash, especially on areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazol Normon. Remember to mention any other symptoms you may notice, such as joint pain.

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

Use of Esomeprazol Normon with other medicines

Inform your doctor 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 Esomeprazol Normon may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Normon.

Esomeprazol Normon will not be administered 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, itraconazole, 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 when you start or stop taking Esomeprazol Normon.

• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Normon.

• Cilostazol (used to treat intermittent claudication – leg pain while walking caused by poor 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 stop your Esomeprazol Normon treatment.

• Tacrolimus (organ transplant).

• 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 become pregnant, consult your doctor or pharmacist before receiving this medicine. Your doctor will decide whether Esomeprazol Normon can be administered during this time.

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

Driving and using machines

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

Esomeprazol NORMON contains sodium

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

3. How to use Esomeprazol Normon

This medicine can be given to children and adolescents aged 1 to 18 years and to adults, including elderly patients.

Administration of Esomeprazol Normon

Use in Adults

• Esomeprazole will be administered by a physician 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 usual dose for prevention of re-bleeding due to gastric or duodenal ulcer is 80 mg administered as a 30-minute intravenous infusion, followed by a continuous infusion of 8 mg/hour for 3 days. If you have severe liver impairment, a continuous infusion of 4 mg/hour for 3 days may be sufficient.

Use in Children and Adolescents

• Esomeprazole will be administered by a physician who will decide the dose you need.
• For children aged 1 to 11 years, the recommended dose is 10 mg or 20 mg once daily.
• For adolescents aged 12 to 18 years, the recommended dose is 20 mg 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 Esomeprazol Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If you experience any of the following serious adverse effects, stop taking Esomeprazole Normon and contact a doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, 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, throat, or entire 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 redness of the skin with blisters or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to 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, 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.
• 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, hives, skin itching.
• Fracture of hip, wrist, or spine (if Esomeprazole Normon 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 sodium levels in blood. This may cause weakness, vomiting, and cramps.

• Restlessness, confusion, or depression.

• Taste disturbances.

• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).

• Inflammation inside the mouth.

• A fungal infection known as “candidiasis” that may affect the esophagus.

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

• 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).
• Aggression.
• 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.
• Enlargement of the breasts in men.

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

• If you are taking Esomeprazole Normon 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 (may lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazole Normon may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a localized 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) via a blood test. It is important that, in this case, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Normon

The hospital doctor and pharmacist are responsible for the proper storage, handling, and disposal of Esomeprazol Normon.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Esomeprazol Normon

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

The other components are disodium edetate and sodium hydroxide.

Appearance of the product and contents of the pack

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

Esomeprazol Normon 40 mg powder for injectable solution and for infusion is supplied in glass vials closed with a stopper and sealed with a cap, in packs containing 1 vial and clinical packs containing 50 vials.

Marketing Authorization Holder and Manufacturer

Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of the most recent revision of this summary: February 2026.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) (http://www.aemps.gob.es/).

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may also access this information at the following internet address:

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

This information is intended exclusively for healthcare professionals:

Esomeprazol Normon 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 only. If the reconstituted vial content is not completely used for a single dose, the unused solution must be discarded.

For further 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 colored plastic cap from the top of the Esomeprazol Normon vial and puncture the stopper at 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 discoloration prior to 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.

Injection of Esomeprazol Normon

To prepare a solution for injection:

40 mg injection

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

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.

Infusion of Esomeprazol Normon

To prepare a solution for infusion:

Infusion 40 mg

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

Infusion 80 mg

Dissolve the contents of two 40 mg esomeprazole vials 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 must be disposed of in accordance with local procedures.