ESOMEPRAZOL DEMO 40 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you are given Esomeprazol Demo

Esomeprazol Demo should not be given to you:

• If you are allergic (hypersensitive) to esomeprazol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the same group as esomeprazol (e.g., pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If you are in any of these situations, you should not use Esomeprazol Demo. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you start using 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 that reduces stomach acid, similar to Esomeprazol Demo.
• You are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol may mask the symptoms of other diseases. Therefore, if you notice any of the following events before you are given Esomeprazol or after you are given it, 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).

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

Skin rashes and skin symptoms

If you get a skin rash, especially in areas of the skin exposed to the sun, talk to your doctor as soon as possible, as you may need to stop treatment with Esomeprazol Demo. Remember to mention any other symptoms that you notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazol (see also section 4). The rash can include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes often appear after symptoms similar to those of the flu, such as fever, headache, and body pain. The rash can cover large areas of the body with blisters and peeling skin.

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.

Using Esomeprazol Demo with other medicines

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

Do not use Esomeprazol if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor or nurse 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 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 Esomeprazol.
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when you start or stop taking Esomeprazol.
• Cilostazol (used to treat intermittent claudication – leg pain when 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 to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol.
• Tacrolimus (after 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, think you may be pregnant, or plan to become pregnant, talk to your doctor, pharmacist, or nurse before using this medicine. Your doctor will decide if you can take Esomeprazol during this period.

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

Driving and using machines

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

However, rare adverse reactions such as dizziness or blurred vision (see section 4) can occur. If they do, patients should not drive or use machines.

Esomeprazol Demo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; this is essentially "sodium-free".

3. How Esomeprazol Demo is given

Esomeprazol Demo can be given to children and adolescents from 1 to 18 years and to adults, including elderly patients.

Administration of Esomeprazol Demo

Use in adults

• Esomeprazol Demo will be given to you by your doctor, who will decide the dose you need.
• The recommended 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 recommended dose for the prevention of rebleeding due to gastric or duodenal ulcer is 80 mg administered 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 and adolescents

• Esomeprazol Demo will be given to you by your doctor, who will decide the dose you need.
• For children from 1 to 11 years, the recommended dose is 10 or 20 mg once a day.
• For children from 12 to 18 years, the recommended dose is 20 or 40 mg once a day.
• The medicine will be given as an injection or as an infusion into a vein. This will take up to 30 minutes.

If you are given too much Esomeprazol Demo

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

4. Possible side effects

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

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

• Yellow skin, dark urine, and tiredness, which can 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, and throat, or body, 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. This can also include blisters in the mouth, eyes, nose, and genitals. The skin rash can become a serious and potentially life-threatening condition with widespread skin peeling and blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms). These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestine effects: diarrhea, 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 the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Feeling of vertigo.
• Eye disorders such as blurred vision.
• Dry mouth.
• Abnormal liver blood tests.
• Skin rash, hives, itching.
• Fracture of the 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 a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Abnormal taste.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash caused by sunlight.
• Joint pain (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 blood cell counts, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Severe liver problems that can lead to liver failure or brain inflammation.
• Sudden appearance of a severe skin rash, blisters, or peeling of the skin. These symptoms can be accompanied by high fever and joint pain (Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

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

• If you are taking Esomeprazol Demo 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, see 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 regular blood tests to monitor your magnesium levels.

• Inflammation in the intestine (can lead to diarrhea).
• Rash, possibly with joint pain.

In very rare cases, Esomeprazol Demo 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 conditionor fever with symptoms of a local infection such as pain in the neck, throat, mouth, or difficulty urinating, you should see your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) with a blood test. It is important that you inform your doctor about your medication.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Esomeprazol Demo

• The hospital doctor and pharmacist are responsible for the correct storage, handling, and disposal of Esomeprazol Demo.
• Do not use this medicine after the expiry date stated on the packaging and vial after EXP. The expiry date is the last day of the month indicated.
• Keep this medicine out of the sight and reach of children.
• Store the vial in the outer packaging to protect it from light. However, the vials can be stored outside the packaging exposed to indoor light for up to 24 hours.
• Reconstitute after the first opening of the container and use immediately. Discard any leftovers.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Shelf life after reconstitution

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

Store below 30°C.

6. Container Contents and Additional Information

Esomeprazol Demo Composition

• The active ingredient is esomeprazol sodium. Each vial of powder for injection and infusion solution contains 42.6 mg of esomeprazol sodium, equivalent to 40 mg of esomeprazol.

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

Product Appearance and Container Contents

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

Presentation: 1, 5, 10, 20 vials. Only some package 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 Last Revision of this Leaflet:12/2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.es

This information is intended only for healthcare professionals:

Esomeprazol DEMO 40 mg 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 entire 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, see the following sections

Preparation and Administration of the Reconstituted Solution:

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

Chemical and physical stability has been demonstrated for 12 hours at 30 ± 2°C. From a microbiological point of view, the product must be used immediately.

Esomeprazol Demo Injection

To prepare an injection solution:

40 mg Injection

For an injection solution (8 mg/ml), 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.

Esomeprazol Demo Infusion

To prepare an infusion solution:

40 mg Infusion

For an infusion solution, 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

For an infusion solution, 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.

Disposal

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