Label: information for the user

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

Esomeprazole

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Contents of the package and additional information

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

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

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Stomach ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Demo 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.

Children and adolescents aged 1 - 18 years

• Gastroesophageal reflux disease (GERD).This occurs when acid from the stomach rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

You should not take Esomeprazol Demo:

• If you are allergic (hypersensitive) to esomeprazole or to any of the other ingredients of this medication (listed in section 6).
• 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 find yourself in any of these situations, you should not use Esomeprazol Demo. If you are unsure, consult your doctor or nurse before they administer this medication to you.

Warnings and precautions

Consult your doctor or nurse before starting to use Esomeprazol Demo if:

• You have severe liver problems.
• You have severe kidney problems.
• You have had any skin reaction after treatment with a similar medication to Esomeprazol Demo that reduces stomach acid.

If you have a skin rash, especially in sun-exposed areas, inform your doctor as soon as possible, as you may need to stop treatment with Esomeprazol Demo. Remember to also mention other negative effects such as joint pain

Esomeprazol may mask symptoms of other diseases.Therefore, if you observe any of the following events before taking Esomeprazol 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).

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

Use of Esomeprazol Demo with other medications

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication, even those acquired without a prescription. This is because Esomeprazol may affect how some medications work and some medications may influence the effect of Esomeprazol.

You should not use Esomeprazol if you are taking a medication that contains nelfinavir (used for HIV treatment).

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

• Atazanavir (used for HIV treatment).
• Clopidogrel (used for preventing blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used for anxiety, muscle relaxation, or epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol.
• Medications used to make blood thinner, such as warfarin. Your doctor will need to monitor when you start or stop taking Esomeprazol.
• Cilostazol (used for intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• 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.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• 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 plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication. Your doctor will decide if you can take Esomeprazol during this period.

The passage of Esomeprazol into breast milk is unknown. Therefore, do not take Esomeprazol during breastfeeding.

Driving and operating machinery

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

However, rare side effects such as dizziness or vision disturbances (see section 4) may occur. If they do, patients should not drive or use machines

Esomeprazol Demo contains sodium

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

Esomeprazol Demo can 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 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 into one of your veins. This will last up to 30 minutes.
• The recommended dose for the prevention of bleeding 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 administered by your doctor who will decide the dose you need.
• For children aged 1–11 years, the recommended dose is 10 or 20 mg once a day.
• For children aged 12–18 years, the recommended dose is 20 or 40 mg once a day.
• The medication will be administered as an injection or as an infusion into a vein. 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 immediately with your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Sudden difficulty 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. 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 that may be symptoms of liver problems.

These side effects are rare and may affect 1 in 1,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Reaction at the injection site.
• Benign polyps in the stomach.

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, and numbness, drowsiness.
• Sensation of vertigo.
• Eye disorders such as blurred vision.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if EsomeprazolDemois 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 sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• An infection known as "candidiasis" that can affect the intestines and is caused by a fungus.
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue.
• Loss of hair (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthralgia) or muscles (myalgia).
• General feeling of discomfort 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 blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that may 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 problems.
• Enlargement of the breasts in men.

Side effects of unknown frequency (cannot be estimated from available data)

• If you are taking EsomeprazolDemofor 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, increased heart rate. If you experience any of these symptoms, see a 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.

• Inflammation in the intestine (may cause diarrhea).
• Rash, possibly with joint pain

In rare cases, EsomeprazolDemomay affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as fever with asevere worseningof the 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 the number of white blood cells (agranulocytosis) through a blood test. It is essential to report your medication in this case.

Reporting side effects

If you experience any type of side effect, consult your doctor,pharmacistor nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• The doctor and the hospital pharmacist are responsible for the correct conservation, handling, and disposal of Esomeprazole Demo.
• Do not use this medication after the expiration date that appears on the packaging and vial after CAD. The expiration date is the last day of the month indicated.
• Keep this medication out of the sight and reach of children.
• Store the vial in the outer packaging to protect it from light. However, vials can be stored outside the packaging exposed to interior light for up to 24 hours.
• Reconstitute after the first opening of the container and use immediately. Discard any leftovers.
• Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. This will help protect the environment.

Shelf life after reconstitution

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

Store below 30 °C.

Composition of Esomeprazol Demo

- The active ingredient 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

Appearance of the product and contents of the package

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

Presentations: 1, 5, 10, 20 vials.Some package sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

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

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:07/2020.

For detailed information about this medicine, please visit the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.es

This information is intended solely 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>

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, see the sections below

Preparation and administration of the reconstituted solution:

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

Esomeprazole Demo Injection

To prepare a solution for injection:

Injection of 40 mg

To prepare a solution for injection (8 mg/ml), add 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 intravenously over a period of at least 3 minutes.

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

Esomeprazole Demo Infusion

To prepare a solution for infusion:

Infusion 40 mg

To prepare a solution for infusion, 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

To prepare a solution for infusion, 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 consult the technical data sheet, section 4.2.

Elimination

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