Esomeprazole zentiva

Package leaflet: Information for the patient

Esomeprazole Zentiva, 40 mg, powder for solution for injection / infusion
Esomeprazolum
Please read all of this leaflet carefully before receiving this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Esomeprazole Zentiva is and what it is used for
2. Important information before receiving Esomeprazole Zentiva
3. How Esomeprazole Zentiva is administered
4. Possible side effects
5. How to store Esomeprazole Zentiva
6. Contents of the pack and other information

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

Esomeprazole Zentiva contains an active substance called esomeprazole. It belongs to a group of
medicines known as "proton pump inhibitors". These medicines reduce the amount of acid
produced in the stomach.
Esomeprazole Zentiva is used for short-term treatment of certain conditions when the patient
is unable to take oral medication. This medicine is used to treat the following
conditions:
Adults

• Gastro-oesophageal reflux disease (GORD). This condition occurs when stomach acid passes from the stomach into the oesophagus (the tube between the throat and the stomach), causing pain, inflammation, and heartburn.
• Gastric ulcers caused by the use of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Ezomeprazole may also be used to prevent gastric ulcers in patients taking NSAIDs.
• Prevention of re-bleeding after endoscopic haemostasis due to acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

• Gastro-oesophageal reflux disease (GORD). This condition occurs when stomach acid passes from the stomach into the oesophagus (the tube between the throat and the stomach), causing pain, inflammation, and heartburn.

2. Important information before receiving Esomeprazole Zentiva

Do not administer Esomeprazole Zentiva to the patient if:

• The patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• The patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking esomeprazole or other similar medicines.
• The patient is allergic to other medicines in the proton pump inhibitor group (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• The patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Esomeprazole Zentiva must not be used in patients if any of the above situations apply. If in doubt, consult a doctor or nurse before administering this medicine.

Warnings and precautions

Before starting treatment with Esomeprazole Zentiva, discuss with a doctor if:

• The patient has severe liver problems.
• The patient has severe kidney problems.
• The patient has previously experienced a skin reaction after taking a medicine similar to Esomeprazole Zentiva that reduces stomach acid secretion.
• The patient is scheduled for a specific blood test (chromogranin A levels).

Esomeprazole may mask symptoms of other diseases. The patient should immediately inform the doctor
if any of the following symptoms occur before or after receiving Esomeprazole Zentiva:

• Unintentional significant weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• Vomiting food or blood.
• Passing black stools (bloody stools).

Taking a proton pump inhibitor such as esomeprazole may lead to a slight increase in the risk of fractures of the hip, wrist, or spine, particularly if the medicine is taken for more than one year. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

If the patient develops a skin rash, especially in areas exposed to sunlight, they should contact their doctor as soon as possible, as this may require discontinuation of esomeprazole treatment. Also report any other adverse reactions, such as joint pain.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. The patient should stop taking esomeprazole and seek immediate medical advice if any symptoms related to these severe skin reactions occur, as described in section 4.

If a skin rash or any other skin symptoms develop at any time during treatment (even after several weeks), treatment with this medicine should be stopped immediately and the patient should contact their doctor without delay.

Esomeprazole Zentiva and other medicines

Inform the doctor about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription. This is because esomeprazole may affect how some medicines work, and some medicines may affect the action of esomeprazole.

Do not take esomeprazole if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform the doctor or nurse if the patient is taking any of the following medicines:

• 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 malignant tumours).
• Citalopram, imipramine, or clomipramine (medicines used to treat depression).
• Diazepam (a medicine used to treat anxiety, to relax muscles, or in epilepsy treatment).
• Phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting or stopping esomeprazole.
• Medicines used to reduce blood clotting, such as warfarin. The doctor may need to monitor the patient when starting or stopping esomeprazole.
• Cilostazol (a medicine used to treat intermittent claudication, i.e. leg pain during walking due to poor blood circulation).
• Cisapride (a medicine used for indigestion and heartburn).
• Digoxin (a medicine used for heart conditions).
• Methotrexate (a medicine used in high doses in cancer chemotherapy) – if the patient is taking high-dose methotrexate, the doctor may temporarily suspend esomeprazole treatment.
• Tacrolimus (a medicine used after organ transplantation).
• Rifampicin (a medicine used to treat tuberculosis).
• St John's wort (Hypericum perforatum) (a herbal remedy used to treat depression).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

The doctor will decide whether the patient can take esomeprazole during pregnancy.

Breastfeeding

It is not known whether esomeprazole passes into human breast milk. Therefore, esomeprazole should not be given to women who are breastfeeding.

Driving and operating machinery

There is a small possibility that esomeprazole may affect the ability to drive or operate tools or machines. However, uncommon adverse effects such as dizziness and blurred vision may occur (see section 4). If these adverse effects occur, the patient should not drive or operate machinery.

3. How Esomeprazole Zentiva is given

Esomeprazole may be given to children and adolescents aged 1 to 18 years and adults, including elderly people.
Patient groups
Adults

• Esomeprazole Zentiva will be administered by a doctor, who will decide how much medicine the patient needs.
• The recommended dose is 20 mg or 40 mg once daily.
• In patients with severe liver problems, the maximum dose for the treatment of gastroesophageal reflux disease is 20 mg once daily.
• This medicine will be given as an injection or infusion into a vein. It will take up to 30 minutes.
• The recommended dose to prevent re-bleeding from a stomach or duodenal ulcer is 80 mg given as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for 3 days. In 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 administered by a doctor, who will decide how much medicine the patient needs.
• In children aged 1 to 11 years, the recommended dose is 10 mg or 20 mg once daily. In children aged 12 to 18 years, the recommended dose is 20 mg or 40 mg once daily.
• This medicine will be given as an injection or infusion into a vein. It will take up to 30 minutes.

If more Esomeprazole Zentiva than recommended has been given
If the patient thinks they have been given too much Esomeprazole Zentiva, tell the doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the serious adverse effects listed below occur, stop taking Esomeprazole Zentiva and contact your doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Sudden occurrence of severe skin rash or redness of the skin with the appearance of blisters or peeling, which may occur even several weeks after starting treatment. Severe blistering and bleeding from the lips, eyes, mouth, nose and genitals may also occur. Skin rashes may progress to serious, extensive skin damage (detachment of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms (DRESS)" (very rare).
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (very rare).
• Yellowing of the skin, dark urine and fatigue – these may be symptoms of liver problems (rare).

Other adverse effects include:
Common: (affects no more than 1 in 10 patients)

• Headache.
• Gastrointestinal symptoms: diarrhoea, abdominal pain, constipation, flatulence (bloating).
• Nausea or vomiting.
• Reaction at the injection site.
• Benign gastric polyps.

Uncommon: (affects no more than 1 in 100 patients)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, fatigue.
• Sensation of spinning (vertigo).
• Visual disturbances, e.g. blurred vision.
• Dry mouth.
• Abnormal blood test results indicating liver function abnormalities.
• Skin rash, raised itchy rash (urticaria), and itching (pruritus).
• Fractures of the hip, wrist or spine (if esomeprazole is used at high doses and for a long time).

Rare: (affects no more than 1 in 1000 patients)

• Blood disorders, e.g. reduced number of white blood cells or platelets. This may manifest as fatigue, increased tendency to bruising or increased risk of infections.
• Low sodium levels in the blood. This may manifest as fatigue, vomiting and muscle cramps.
• Restlessness, disorientation or depression.
• Taste disturbances.
• Sudden onset of wheezing or shortness of breath (bronchospasm).
• Inflammation of the mucous membrane of the mouth.
• Fungal infection known as "thrush", which may affect the intestines.
• 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 or muscle pain.
• General malaise and lack of energy.
• Increased sweating.

Very rare: (affects no more than 1 in 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy.
• Muscle weakness.
• Severe kidney problems.
• Enlargement of male breasts.

Frequency not known: frequency cannot be estimated from the available data.

• If a patient takes esomeprazole for longer than three months, low magnesium levels in the blood may occur. Low magnesium levels may manifest as fatigue, uncontrollable muscle spasms, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, the patient should inform their doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may perform regular blood tests to monitor magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Skin rash, sometimes accompanied by joint pain.

In very rare cases, esomeprazole may affect white blood cells and lead to
immunodeficiency. If a patient develops an infection with symptoms such as fever and a very poor
general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or
difficulty urinating, they should immediately consult a doctor to rule out, via blood test, the absence of white blood cells in the blood (agranulocytosis). It is important to inform the doctor about all medicines being taken at the time.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.

5. How to store Esomeprazole Zentiva

The medicine should be stored out of sight and reach of children.
The physician or hospital pharmacist is responsible for the proper storage, use, and disposal of Esomeprazole Zentiva.
Do not use this medicine after the expiry date stated on the carton and vial following: Expiry (EXP). The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from light. Vials may be kept and exposed to room light outside the carton for up to 24 hours. Do not store in the refrigerator.
Chemical and physical stability of the medicine has been demonstrated for 12 hours at 30°C.
From a microbiological standpoint, if the preparation method does not eliminate the risk of microbiological contamination, the product should be used immediately.
If not used immediately, the person administering the product is responsible for the duration and conditions of storage.
Do not use the solution if signs of deterioration are observed.

6. Contents of the package and other information

What Esomeprazole Zentiva contains
The active substance is esomeprazole in the form of esomeprazole sodium salt.
Each vial of powder for solution for injection/infusion contains 42.5 mg of esomeprazole sodium salt, equivalent to 40 mg of esomeprazole.
The other ingredients are: disodium edetate and sodium hydroxide (used to adjust pH).
Each vial contains less than 1 mmol (23 mg) of sodium, i.e. the medicine is considered "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 tablet or powder. A solution is prepared from this powder before administration to the patient.
Esomeprazole Zentiva is supplied in a 5 mL type I clear glass vial, closed with a dark grey bromobutyl rubber stopper and an aluminium flip-off seal, packed in a cardboard box.
Esomeprazole Zentiva is available in packs containing 1, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area under the following names:

| Country | Name of the medicinal product | |--------|-------------------------------| | Germany | Esomeprazol Tillomed 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung | | Italy | Esomeprazolo Tillomed | | France | ESOMEPRAZOLE TILLOMED 40 mg, poudre pour solution injectable/pour perfusion | | Poland | Esomeprazole Zentiva | | Austria | Esomeprazol Tillomed 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung | | Netherlands | Esomeprazol Tillomed 40 mg poeder voor oplossing voor injectie/infusie | | Ireland | Esomeprazole Tillomed 40 mg powder for solution for injection/infusion |

For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00

Information intended exclusively for professional medical personnel:

Esomeprazole Zentiva, 40 mg, powder for solution for injection / infusion contains
40 mg of esomeprazole as the sodium salt. Each vial contains disodium edetate and sodium
hydroxide (< 1 mmol sodium).
Vials are for single use only. If the entire reconstituted contents of the vial are not required for a single dose, any unused portion of the solution must be discarded.
Further information on dosage recommendations and storage conditions can be found in sections 3 and 5, respectively.
Preparation and administration of the reconstituted solution
To reconstitute the solution, remove the coloured plastic cap from the top of the vial of Esomeprazole Zentiva, 40 mg, powder for solution for injection / infusion and pierce the stopper at the center of the marked circle, holding the needle vertically to ensure proper penetration of the stopper.
The reconstituted solution for injection / infusion should be clear and colourless to very pale yellow. The solution should be visually inspected for particulate matter or discoloration prior to administration. Only clear solutions should be used.
Do not store in the refrigerator.
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C.
From a microbiological point of view, if the reconstitution method does not exclude the risk of microbial contamination, the product should be used immediately.
If not used immediately, responsibility for the duration and conditions of storage lies with the user.
Esomeprazole Zentiva, 40 mg, powder for solution for injection / infusion
Preparation of solution for injection:
40 mg dose for injection
To obtain a reconstituted esomeprazole solution of 8 mg/mL: Prepare the solution by adding 5 mL of 0.9% sodium chloride for intravenous administration to the vial containing 40 mg of esomeprazole.
The reconstituted solution for injection should be administered intravenously over at least 3 minutes.
Further information on dose administration, see SmPC section 4.2.
Preparation of solution for infusion:
40 mg dose for infusion (400 µg/mL or 0.4 mg/mL)
Dissolve the contents of one vial containing 40 mg of esomeprazole in up to 100 mL of 0.9% sodium chloride for intravenous administration.
80 mg dose for infusion (800 µg/mL or 0.8 mg/mL)
Dissolve the contents of two vials, each containing 40 mg of esomeprazole, in up to 100 mL of 0.9% sodium chloride for intravenous administration.
Further information on dose administration, see SmPC section 4.2.
Disposal
Any unused portions of the product or waste materials must be disposed of in accordance with national regulations.