Esomeprazole Zentiva

Package Leaflet: Information for the Patient

Esomeprazole Zentiva, 40 mg, Powder for Solution for Injection/Infusion

Esomeprazole

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further 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 the Pack

• 1. What is Esomeprazole Zentiva and What is it Used For
• 2. Before You Use Esomeprazole Zentiva
• 3. How to Use Esomeprazole Zentiva
• 4. Possible Side Effects
• 5. How to Store Esomeprazole Zentiva
• 6. Contents of the Pack and Other Information

1. What is Esomeprazole Zentiva and What is it Used For

Esomeprazole Zentiva contains the active substance esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These medicines reduce the amount of acid produced in the stomach.
Esomeprazole Zentiva is used for short-term treatment of certain diseases when the patient is not able to take oral medicines. This medicine is used for the treatment of the following diseases:
Adults

• Gastroesophageal reflux disease. This is when stomach acid flows back into the gullet (the tube between the mouth and the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole can also be used to prevent stomach ulcers in patients taking NSAIDs.
• Prevention of re-bleeding after endoscopic treatment for acute bleeding ulcers.

Children and Adolescents Aged 1 to 18 Years

• Gastroesophageal reflux disease. This is when stomach acid flows back into the gullet (the tube between the mouth and the stomach), causing pain, inflammation, and heartburn.

2. Before You Use Esomeprazole Zentiva

Esomeprazole Zentiva Must Not Be Given to Patients Who:

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

Esomeprazole Zentiva must not be used in patients who have any of the above conditions. If you are not sure, talk to your doctor or nurse before using Esomeprazole Zentiva.

Warnings and Precautions

Before starting treatment with Esomeprazole Zentiva, tell your doctor 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.
• you are due to have a specific blood test (chromogranin A).

Esomeprazole may mask the symptoms of other diseases. You should tell your doctor immediately if you notice any of the following symptoms before or while using Esomeprazole Zentiva:

• if you lose a lot of weight without explanation and have difficulty swallowing.
• if you get stomach pain or indigestion.
• if you start vomiting food or blood.
• if you pass black stools (blood-stained stools).

Taking a proton pump inhibitor like esomeprazole, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with esomeprazole. Also, remember to mention any other side effects like joint pain.
Severe skin reactions have occurred in patients taking esomeprazole (see also section 4). These can include blistering of the skin and mucous membranes (Stevens-Johnson syndrome), and a condition known as toxic epidermal necrolysis.

Esomeprazole Zentiva with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because esomeprazole may affect the way some medicines work and some medicines may affect the way esomeprazole works.

• atazanavir (a medicine used to treat HIV infection).
• clopidogrel (a medicine used to prevent blood clots).
• ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
• erlotinib (a medicine used to treat cancer).
• citalopram, imipramine, or clomipramine (medicines used to treat depression).
• diazepam (a medicine used to treat anxiety, relax muscles, or treat epilepsy).
• phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazole.
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazole.
• cilostazol (a medicine used to treat intermittent claudication, a condition where the legs do not get enough blood).
• cisapride (a medicine used to treat indigestion and heartburn).
• digoxin (a medicine used to treat heart conditions).
• methotrexate (a medicine used to treat cancer and autoimmune diseases). If you are taking high doses of methotrexate, your doctor may need to temporarily stop your esomeprazole treatment.
• tacrolimus (a medicine used to prevent organ rejection after transplant).
• rifampicin (a medicine used to treat tuberculosis).
• St. John’s Wort (a herbal remedy used to treat mild depression).

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will decide whether you can take Esomeprazole Zentiva during this time.

Breast-feeding

It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Zentiva if you are breast-feeding.

Driving and Using Machines

Esomeprazole Zentiva is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision may occur (see section 4). If affected, you should not drive or use machines.

3. How to Use Esomeprazole Zentiva

Esomeprazole can be given to children and adolescents aged 1 to 18 years and adults, including the elderly.

Patient Groups

Adults

• Esomeprazole Zentiva will be given to you by your doctor, who will decide how much you need.
• The recommended dose is 20 mg or 40 mg once a day.
• For patients with severe liver problems, the maximum dose for the treatment of gastroesophageal reflux disease is 20 mg per day.
• The medicine will be given to you as an injection or infusion into one of your veins. This will take up to 30 minutes.
• The recommended dose for the prevention of re-bleeding from stomach or duodenal ulcers is 80 mg given as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for 3 days. For patients with severe liver problems, a continuous infusion of 4 mg/hour for 3 days may be sufficient.

Children and Adolescents Aged 1 to 18 Years

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

Overdose

If you think you have been given too much Esomeprazole Zentiva, tell your doctor immediately.

4. Possible Side Effects

Like all medicines, Esomeprazole Zentiva can cause side effects, although not everybody gets them.

If You Experience Any of the Following Serious Side Effects, Stop Taking Esomeprazole Zentiva and Contact Your Doctor Immediately:

• Sudden onset of severe rash, swelling of the face, lips, tongue, and/or throat, or difficulty swallowing (severe allergic reaction) (rare).
• Sudden onset of severe skin rash or skin lesions, or blistering of the skin and/or mucous membranes, which may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Yellowing of the skin or whites of the eyes (jaundice), dark urine, pale stools, and/or loss of appetite, as these may be signs of liver problems (rare).

Other side effects include:

Common (affects less than 1 in 10 people):

• Headache.
• Stomach or gut problems: diarrhea, stomach pain, constipation, gas.
• Nausea or vomiting.
• Reaction at the site of injection.
• Mild gastric polyps.

Uncommon (affects less than 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, or fatigue.
• Feeling of spinning (vertigo).
• Visual disturbances, such as blurred vision.
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Rash, itchy skin, or hives.
• Fracture of the hip, wrist, or spine (if esomeprazole is used in high doses and for a long time).

Rare (affects less than 1 in 1,000 people):

• Blood disorders, such as a reduced number of white blood cells or platelets. This may cause weakness, bruising, or make you more likely to get infections.
• Low levels of sodium in the blood. This may cause weakness, confusion, and fits.
• Agitation, confusion, or depression.
• Disturbances in taste.
• Sudden onset of wheezing, swelling of the lips, tongue, and/or throat, or difficulty swallowing (angioedema).
• Oral thrush (infection of the mouth and/or throat).
• Fungal infections (e.g. thrush).
• Liver problems, including jaundice, which may cause yellowing of the skin and eyes, dark urine, and pale stools.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint pain or muscle pain.
• General feeling of being unwell and lack of energy.
• Increased sweating.

Very Rare (affects less than 1 in 10,000 people):

• Changes in blood count, including agranulocytosis (low white blood cell count).
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy (a condition that affects the brain and nervous system).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

Frequency Not Known: frequency cannot be estimated from the available data.

• If you take esomeprazole for more than three months, it is possible that the levels of magnesium in your blood may fall. Low magnesium can cause fatigue, involuntary muscle contractions, disorientation, and increased heart rate. If you get any of these symptoms, you should tell your doctor promptly. Low magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Colitis (inflammation of the colon, which can cause diarrhea).
• Rash, sometimes with joint pain.

In very rare cases, esomeprazole may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever and serious deterioration of your general condition, or fever with symptoms of a local infection such as sore throat/pharynx/mouth or urinary problems, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important to inform your doctor about your medicine.

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Esomeprazole Zentiva

Keep this medicine out of the sight and reach of children.
Your doctor or hospital pharmacist are responsible for the proper storage, use, and disposal of Esomeprazole Zentiva.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from light. Vials may be stored and exposed to light inside the room for up to 24 hours outside of the carton. Do not store in a refrigerator.
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not use the solution if you notice any signs of deterioration.

6. Contents of the Pack and Other Information

What Esomeprazole Zentiva Contains

The active substance is esomeprazole in the form of esomeprazole sodium.
Each vial of powder for solution for injection/infusion contains 42.5 mg esomeprazole sodium, equivalent to 40 mg esomeprazole.
The other ingredients are disodium edetate and sodium hydroxide (for pH adjustment).
Each vial contains less than 1 mmol (23 mg) sodium, i.e. essentially sodium-free.

What Esomeprazole Zentiva Looks Like and Contents of the Pack

Esomeprazole Zentiva, 40 mg, powder for solution for injection/infusion is a white to off-white porous disk or powder. Before administration, it is reconstituted to form a solution.
Esomeprazole Zentiva is provided in a vial made of colorless glass type I, with a capacity of 5 mL, closed with a dark grey butyl rubber stopper and an aluminum flip-off seal, in a cardboard box.
Esomeprazole Zentiva is available in packs containing 1, 10, or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer

Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Country Name of the Medicinal Product

Germany
Esomeprazole Tillomed 40 mg Powder for Solution for Injection/Infusion
Italy
Esomeprazole Tillomed
France
ESOMEPRAZOLE TILLOMED 40 mg, powder for solution for injection/infusion
Poland
Esomeprazole Zentiva
Austria
Esomeprazole Tillomed 40 mg Powder for Solution for Injection/Infusion
Netherlands
Esomeprazole Tillomed 40 mg powder for solution for injection/infusion
Ireland
Esomeprazole Tillomed 40 mg powder for solution for injection/infusion

For Further Information on This Medicinal Product, Please Contact the Representative of the Marketing Authorization Holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of Last Revision of the Leaflet:January 2025

Information Intended for Healthcare Professionals Only:

Esomeprazole Zentiva, 40 mg, powder for solution for injection/infusion contains 40 mg esomeprazole in the form of esomeprazole sodium. Each vial contains disodium edetate and sodium hydroxide (<1 mmol sodium).
The vials are for single use only. If the full reconstituted contents of the vial are not used for a single dose, any unused solution should be discarded.
For further information on dosing and storage conditions, see sections 3 and 5 respectively.

Preparation and Administration of the Reconstituted Solution

In order to reconstitute the solution, remove the plastic color-coded cap from the top of the vial of Esomeprazole Zentiva, 40 mg, powder for solution for injection/infusion and insert the needle through the center of the rubber stopper and inject the recommended amount of solvent. The reconstituted solution for injection/infusion should be clear and colorless to very pale yellow. Before administration, inspect the solution visually for particulate matter and discoloration. Only clear solutions should be used.

Esomeprazole Zentiva, 40 mg, Powder for Solution for Injection/Infusion

Preparation of the Solution for Injection:
Dose of 40 mg for Injection
To prepare the reconstituted solution of esomeprazole 8 mg/mL: add 5 mL of 0.9% sodium chloride solution for injection to the vial containing 40 mg esomeprazole.
The reconstituted solution for injection should be administered intravenously over a period of at least 3 minutes.
For further information on dosing, see SmPC section 4.2.
Preparation of the Solution for Infusion:
Dose of 40 mg for Infusion (400 μg/mL or 0.4 mg/mL)
Dissolve the contents of one vial containing 40 mg esomeprazole in up to 100 mL 0.9% sodium chloride solution for injection.
Dose of 80 mg for Infusion (800 μg/mL or 0.8 mg/mL)
Dissolve the contents of two vials containing 40 mg esomeprazole in up to 100 mL 0.9% sodium chloride solution for injection.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.