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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazol Demo 40mg Powder for injectable solution and for infusion EFG

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 a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Esomeprazol Demo is and what it is used for
2. What you need to know before you are given Esomeprazol Demo
3. How Esomeprazol Demo is administered
4. Possible side effects
5. How to store Esomeprazol Demo

Pack contents and other information

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

Esomeprazol Demo 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.

Esomeprazol Demo is used for short-term treatment of certain conditions when oral treatment is not possible. It is used to treat the following conditions:

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). Esomeprazol Demo may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Prevention of rebleeding in adults following therapeutic endoscopy performed for acute gastric or duodenal ulcer bleeding.

Children and adolescents aged 1–18 years

• 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 Esomeprazol DEMO is administered to you

Do not be given Esomeprazol DEMO:

• If you are allergic (hypersensitive) to esomeprazole or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

If any of these situations apply to you, you must not use Esomeprazol DEMO. If you are unsure, consult your doctor or nurse before being administered this medicine.

• If you have ever developed a severe skin rash, peeling of the skin, blistering, or mouth ulcers after taking Esomeprazol DEMO or other related medicines.

Warnings and precautions

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

Consult your doctor or nurse before starting Esomeprazol DEMO 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 DEMO that reduces stomach acid.
• You are scheduled to undergo a specific blood test (chromogranin A).

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following events before or after receiving Esomeprazol DEMO, 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 (stained with blood).

Taking a proton pump inhibitor such as Esomeprazol DEMO, especially for more than one year, may slightly increase the risk of fracture 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 Esomeprazol DEMO. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include mouth, throat, nose, or genital ulcers, and conjunctivitis (red, swollen eyes). These severe skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blistering and skin peeling.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Use of Esomeprazol DEMO with other medicines

Tell your doctor or nurse if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription. This is because Esomeprazole may affect how some medicines work, and some medicines may influence the effect of Esomeprazole.

You must not use Esomeprazol DEMO if you are taking a medicine containing nelfinavir (used for the treatment of HIV infection).

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

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for the treatment of depression).
• Diazepam (used for 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.
• Medicines used to thin the blood such as warfarin. Your doctor will need to monitor when you start or stop taking Esomeprazol.
• Cilostazol (used for the treatment of 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 interrupt your treatment with Esomeprazol.
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of 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, pharmacist, or nurse before using this medicine. Your doctor will decide whether you can take Esomeprazol during this period.

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

Driving and using machines

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

However, adverse reactions such as dizziness or visual disturbances (see section 4) are uncommon. If these occur, patients should not drive or use machines.

Esomeprazol DEMO contains sodium

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

3. How Esomeprazol Demo is administered

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

Administration of Esomeprazol Demo

Use in adults

• Esomeprazol Demo 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. 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 8 mg/h as a continuous intravenous infusion for 3 days. If you have severe hepatic impairment, 4 mg/h as a continuous intravenous infusion for 3 days may be sufficient.

Use in children and adolescents

• Esomeprazol Demo will be administered by your doctor, who will decide the dose you need.
• For children aged 1–11 years, the recommended dose is 10 mg or 20 mg once daily.
• For adolescents aged 12–18 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. This will last up to 30 minutes.

If you are given more Esomeprazol Demo than you should

If you think you have been given too much Esomeprazol Demo, speak to your doctor immediately.

4. Possible adverse effects

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

If you experience any of the following serious adverse effects, stop taking EsomeprazolDemo 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, throat, or body in general, 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. 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) with potentially life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)". 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), which is very rarely observed.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, 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 disturbance (insomnia).
• Dizziness, tingling sensation, numbness, drowsiness.
• Sensation of vertigo.
• Eye disorders such as blurred vision.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, itchy skin.
• Fracture of hip, wrist, or spine (if Esomeprazol Demo is used at high doses and for a long period).

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

• Blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or increase the likelihood of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Altered taste.
• Sudden feeling of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" that may affect the intestine.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe 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.

Adverse effects with unknown frequency (cannot be estimated from available data)

• If you are taking Esomeprazol Demo for more than three months, your blood magnesium levels 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, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and 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).

• Rash, possibly with joint pain.

In very rare cases, Esomeprazol Demo may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by 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) through 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 adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Demo

• The hospital physician and pharmacist are responsible for the proper storage, handling, and disposal of Esomeprazol Demo.
• Do not use this medicine after the expiry date stated on the packaging and vial following EXP. The expiry date refers to the last day of the month indicated.
• Keep this medicine out of the sight and reach of children.
• Store the vial in its 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.
• Reconstitute immediately after first opening of the container and use immediately. Discard any unused portion.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

Period of validity after reconstitution

Chemical and physical in-use stability has been demonstrated for 12 hours at (30 ± 2)°C. From a microbiological standpoint, the product should be used immediately.

Store below 30°C.

6. Contents of the package and other information

Composition of Esomeprazole Demo

• The active substance is esomeprazole sodium. Each vial of powder for injectable solution and for infusion contains 42.6 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.

• The other components are disodium edetate and sodium hydroxide. See section 2.

Nature of the product and contents of the container

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

Pack sizes: 1, 5, 10, 20 vials. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

DEMO S.A., PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece

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: 09/2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Care (Agencia Española de Medicamentos y Productos Sanitarios) at http://www.aemps.es

This information is intended exclusively for healthcare professionals:

Esomeprazol DEMO 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 only. 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, see sections below.

Preparation and administration of the reconstituted solution:

The reconstituted solution for injection or infusion must be clear and colourless to slightly yellow. The reconstituted solution should be inspected visually for particulate matter and discoloration before administration. Only clear solutions should be used.

Chemical and physical in-use stability has been demonstrated for 12 hours at 30 ± 2°C. From a microbiological standpoint, the product should be used immediately.

Esomeprazol Demo Injection

To prepare a solution for injection:

Injection 40 mg

For a solution for injection (8 mg/ml), prepare the solution by adding 5 ml of 0.9% sodium chloride for intravenous use to the vial containing 40 mg of 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 refer to the Summary of Product Characteristics, section 4.2.

Esomeprazol Demo Infusion

To prepare a solution for infusion:

Infusion 40 mg

For a solution for infusion, dissolve the contents of one vial of esomeprazole 40 mg in up to 100 ml of 0.9% sodium chloride for intravenous use.

Infusion 80 mg

For a solution for infusion, dissolve the contents of two vials of esomeprazole 40 mg 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 materials must be disposed of in accordance with local procedures.