Esomeprazole Demo

Package leaflet: Information for the user

Esomeprazolo DEMO 40 mg powder for solution for injection/infusion

esomeprazole
Generic medicine
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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. See section 4.

Contents of this leaflet

1. What Esomeprazolo DEMO is and what it is used for
2. What you need to know before you are given Esomeprazolo DEMO
3. How Esomeprazolo DEMO is administered
4. Possible side effects
5. How to store Esomeprazolo DEMO
6. Contents of the pack and other information

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

Esomeprazole DEMO contains a medicine called esomeprazole. It belongs to a group of
medicines known as "proton pump inhibitors", which work by reducing the amount of acid
produced by the stomach.
Esomeprazole DEMO is used for short-term treatment of certain conditions when the
patient is unable to take oral therapy. It is used to treat the following conditions:

Adults

• “Gastroesophageal reflux disease” (GERD). This condition occurs when acid from the stomach flows back into the esophagus (the passage between the throat and the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole may also be used to prevent the development of stomach ulcers during NSAID treatment.
• Prevention of recurrent bleeding after endoscopic treatment of acute gastric or duodenal ulcer bleeding.

Children and adolescents aged 1 to 18 years

• “Gastroesophageal reflux disease” (GERD). This condition occurs when acid from the stomach flows back into the esophagus (the passage between the throat and the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before being given Esomeprazole DEMO

Do not be given Esomeprazole DEMO:

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

Esomeprazole DEMO must not be administered if you fall into any of the above categories. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before being given Esomeprazole 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 Esomeprazole DEMO that reduces stomach acid
• you need to undergo a specific blood test (Chromogranin A).

Esomeprazole DEMO may mask symptoms of other diseases. Therefore, if any of the following occur
before or after receiving Esomeprazole DEMO, contact your doctor immediately:

• you lose weight significantly without a clear reason and have difficulty swallowing
• you experience stomach pain or indigestion
• you vomit food or blood
• your stools are black (stools containing blood spots).

The use of a proton pump inhibitor such as Esomeprazole DEMO may slightly increase the risk of fractures of the hip, wrist, or spine, especially if used for longer than one year. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), inform your doctor.

Skin rash and skin-related symptoms
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Esomeprazole DEMO. Remember to report any other adverse effects such as joint pain.
Severe skin reactions have occurred in patients taking esomeprazole (see also section 4). The skin rash may cause ulcers in the mouth, throat, nose, genitals and may include conjunctivitis (red and swollen eyes). These severe skin reactions often occur after flu-like symptoms such as fever, headache, and muscle pain. The rash may cover large areas of the body, with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin-related symptoms, stop taking this medicine and contact your doctor immediately.

Other medicines and Esomeprazole DEMO
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Esomeprazole DEMO may affect how some medicines work, and some medicines may affect the activity of Esomeprazole DEMO.
Esomeprazole DEMO must not be administered if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform 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 (used to treat fungal infections)
• Erlotinib (used to treat cancer)
• Citalopram, imipramine or clomipramine (used to treat depression)
• Diazepam (used to treat anxiety, for muscle relaxation or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Esomeprazole DEMO.
• Medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping treatment with Esomeprazole DEMO.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood circulation)
• Cisapride (used for indigestion and heartburn)
• Digoxin (used for heart problems)
• Methotrexate (a medicine used in high-dose chemotherapy for cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazole DEMO.
• Tacrolimus (used in organ transplants)
• 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, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before being given this medicine. Your doctor will decide whether you can take Esomeprazole DEMO during this time.
It is not known whether Esomeprazole DEMO passes into breast milk. Therefore, Esomeprazole DEMO must not be administered if you are breastfeeding.

Driving and using machines
It is unlikely that Esomeprazole DEMO affects the ability to drive or use machinery. However, adverse effects such as dizziness or blurred vision may rarely occur (see section 4). If affected, do not drive or operate machinery.

Esomeprazole DEMO contains disodium edetate and sodium hydroxide
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Esomeprazole DEMO is administered

Esomeprazole DEMO may be administered to children and adolescents aged between 1 and 18 years, as well as to adults, including the elderly.

Administration of Esomeprazole DEMO

Use in adults

• Esomeprazole DEMO will be administered by a doctor who will determine the dose necessary for you.
• The recommended dose is 20 mg or 40 mg administered once daily.
• If you have severe liver problems, the maximum dose is 20 mg daily (gastroesophageal reflux disease, GERD).
• The medicine will be administered as an injection or intravenous infusion. The procedure will last up to 30 minutes.
• The recommended dose for prevention of re-bleeding from gastric or duodenal ulcers is 80 mg administered by intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/h for 3 days. If you have severe liver problems, a continuous infusion of 4 mg/h for 3 days may be sufficient.

Use in children and adolescents

• Esomeprazole DEMO will be administered by a doctor who will determine the necessary dose.
• For children aged between 1 and 11 years, the recommended dose is 10 mg or 20 mg once daily.
• For children aged between 12 and 18 years, the recommended dose is 20 mg or 40 mg once daily.
• The medicine will be administered as an injection or intravenous infusion. Administration will last up to 30 minutes.

If you are given more Esomeprazole DEMO than you need
If you think you have been given an excessive amount of Esomeprazole DEMO, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Esomeprazole DEMO and contact your doctor immediately:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of severe skin rashes or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. The rashes may progress to severe widespread skin damage (exfoliation of the epidermis and superficial mucosa) with potentially life-threatening consequences. These may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)". These side 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 intestinal problems: diarrhoea, stomach pain, constipation, flatulence (gas)
• Feeling unwell (nausea) or sickness (vomiting)
• Injection site reaction
• Benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles
• Disturbed sleep (insomnia)
• Dizziness, tingling, drowsiness
• Feeling of vertigo
• Visual disturbances such as blurred vision
• Dry mouth
• Changes in blood test results assessing liver function
• Skin rash, hives, and itching
• Fractures of the hip, wrist, or spine (when Esomeprazole DEMO is used at high doses and for a long time)

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 increased susceptibility to infections.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting), and cramps.
• Feeling agitated, confused, or depressed
• Altered taste
• Sudden feeling of breathlessness or shortness of breath (bronchospasm)
• Inflammation inside the mouth
• Infection called "candidiasis" which may affect the intestine and is caused by a fungus
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash after exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• General feeling of being unwell and lack of strength
• Increased sweating

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

• Changes in blood cell counts including agranulocytosis (absence of white blood cells)
• Aggression
• Seeing, sensing, or hearing things that are not real (hallucinations)
• Severe liver problems leading to liver failure and brain inflammation
• Sudden onset of severe skin rashes or redness of the skin with blisters or peeling. These may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness
• Severe kidney problems
• Breast enlargement in men

Not known (frequency cannot be estimated from the available data)

• If you take Esomeprazole DEMO 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, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazole DEMO may affect white blood cells and cause immunodeficiency.
If you develop an infection with symptoms such as fever and a severe deterioration in your general physical condition, or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that absence of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you provide information about the medicines you are taking.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole DEMO

• The physician or hospital pharmacist is responsible for the proper storage, use, and disposal of Esomeprazole DEMO.
• Do not use this medicinal product after the expiry date stated on the vial after "Exp.". The expiry date refers to the last day of that month.
• Keep this medicine out of the sight and reach of children.
• Store the vial in the outer cardboard carton to protect the medicine from light. However, vials may be kept under normal indoor lighting conditions outside the carton for up to 24 hours.
• Reconstitute immediately after first opening of the container and use immediately. Discard any remaining unused portion.
• Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Period of stability after reconstitution for injection/infusion
Chemical and physical in-use stability has been demonstrated for 12 hours at a temperature of 30 ± 2°C.
From a microbiological standpoint, the product should be used immediately.
Store below 30°C.

6. Package contents and other information

What Esomeprazolo DEMO contains

• The active substance is esomeprazole sodium. Each vial of powder for injectable/infusion solution 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 Esomeprazolo DEMO contains disodium edetate and sodium hydroxide.

Description of the appearance of Esomeprazolo DEMO and contents of the pack
Esomeprazolo DEMO is presented as a porous mass or a white or almost white powder. It is reconstituted into a solution before administration.
Pack sizes: 1, 5, 10, 20 vials. Not all 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
T: +30 210 8161802, F: +30 2108161587

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Esomeprazol DEMO 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
Greece: DEMOLOX 40 mg Κόνις για ενέσιμο διάλυμα και διάλυμα προς έγχυση
Spain: Esomeprazole Demp 40mg Polvo para solucion inyectable y para perfusion EFG
Cyprus: DEMOLOX 40 mg Κόνις για ενέσιμο διάλυμα και διάλυμα προς έγχυση
Netherlands: Esomeprazol DEMO 40 mg poeder voor oplossing voor injectie/infusie
Austria: Esomeprazol DEMO 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
France: ESOMEPRAZOLE DEMO 40 mg, poudre pour solution injectable/pour perfusion
Finland: Esomeprazole Demo S.A. 40 mg injektio-/infuusiokuiva-aine, liuosta varten
Ireland: Esomeprazole 40 mg powder for solution for injection/infusion
Italy: Esomeprazolo DEMO
Norway: Esomeprazole Demo S.A.
Poland: Esomeprazole DEMO
Portugal: Esomeprazol DEMO
Sweden: Esomeprazole Demo S.A.
Denmark: Esomeprazole Demo S.A.

The following information is intended exclusively for physicians or healthcare professionals.
Esomeprazolo DEMO 40 mg contains 40 mg of esomeprazole as sodium salt. Each vial contains disodium edetate and sodium hydroxide (sodium <1 mmol).
The vials are for single use only. If the entire reconstituted content of a vial is not required for a single dose, any unused solution must be discarded.
For further information on dosage recommendations and storage conditions, see below.

Preparation and administration of the reconstituted solution
The reconstituted injectable/infusion solution must be clear and colorless to very pale yellow. Before administration, it should be inspected visually for particulate matter and discoloration, and only clear solutions should be used.
Chemical and physical in-use stability has been demonstrated for 12 hours at a temperature of 30 ± 2°C. From a microbiological standpoint, the product should be used immediately.

Esomeprazolo DEMO injection
Preparation of the injectable solution
40 mg injection
The injectable solution (8 mg/mL) is prepared by adding 5 mL of 0.9% sodium chloride for intravenous use to the 40 mg esomeprazole vial.
The reconstituted injectable solution must be administered intravenously over at least 3 minutes.
For further information on dose administration, see section 4.2 of the SmPC.

Esomeprazolo DEMO infusion
Preparation of the infusion solution
40 mg infusion
The infusion solution is prepared by dissolving the contents of one 40 mg esomeprazole vial in 100 mL of 0.9% sodium chloride for intravenous use.
80 mg infusion
The infusion solution is prepared by dissolving the contents of two 40 mg esomeprazole vials in 100 mL of 0.9% sodium chloride for intravenous use.
For further information on dose administration, see section 4.2 of the SmPC.

Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.