ESOMEPRAZOLO 40 mg Powder For Intravenous Infusion Solution

Зміст інструкції

1. Esomeprazolo Tillomed 40 mg powder for solution for injection/for infusion
   1. What is Esomeprazolo Tillomed and what it is used for
   2. What you need to know before you are given Esomeprazole Tillomed
   3. How Esomeprazolo Tillomed is administered
   4. Possible side effects
   5. How to store Esomeprazolo Tillomed
   6. Package Contents and Other Information

Esomeprazolo Tillomed 40 mg powder for solution for injection/for infusion

Esomeprazolo

Generic medicine

Read this leaflet carefully before you start to receive 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section
• 4.

Contents of this leaflet

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

1. What is Esomeprazolo Tillomed and what it is used for

Esomeprazolo Tillomed contains a medicine called esomeprazole. It belongs to a
group of medicines called “proton pump inhibitors”, which work by
reducing the amount of acid produced by the stomach.
Esomeprazolo Tillomed is used for the short-term treatment of certain conditions,
when the patient is unable to take treatment orally. It is used for the
treatment of the conditions listed below:

Adults

• “Gastroesophageal Reflux Disease” (GERD). This condition occurs when stomach acid flows back into the esophagus (the tube between the throat and stomach) causing pain, inflammation and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole can also be used to prevent the development of stomach ulcers while taking NSAIDs.
• Prevention of recurrence of bleeding following endoscopic treatment for acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

• “Gastroesophageal Reflux Disease” (GERD). This condition occurs when stomach acid flows back into the esophagus (the tube between the throat and stomach) causing pain, inflammation and heartburn.

2. What you need to know before you are given Esomeprazole Tillomed

You must not be given Esomeprazole Tillomed:

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines that are 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 Tillomed must not be given to you if you fall into any of the above cases. If you have any doubts, ask your doctor or nurse before you are given this medicine.

Warnings and precautions
Speak to your doctor or pharmacist before you are given Esomeprazole Tillomed 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 Tillomed that reduces stomach acid
• you are going to have a specific blood test (Chromogranin A).

Esomeprazole can mask the symptoms of other diseases. Therefore, if any of the following occurs before or after you are given Esomeprazole Tillomed, seek immediate medical attention:

• you lose a lot of weight without any obvious reason and have difficulty swallowing
• you experience stomach pain or digestive problems
• you vomit food or blood
• your stools are black (stools containing blood).

The use of a proton pump inhibitor such as esomeprazole may slightly increase the risk of fractures of the hip, wrist or spine, especially if used for a period longer than a year. If you suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis) tell your doctor. 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 stop treatment with esomeprazole. Remember to also report any other unwanted effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may cause ulcers in the mouth, throat, nose, genitals and include conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle aches. The rash can 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 rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Other medicines and Esomeprazole Tillomed
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including those you obtained without a prescription. In fact, esomeprazole can affect the way some medicines work and some medicines can affect the activity of esomeprazole.
Esomeprazole must not be given to you if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Tell your doctor or nurse if you are using any of the following treatments:

• 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 for epilepsy)
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with esomeprazole.
• medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when you start or stop treatment with esomeprazole.
• cilostazol (used to treat intermittent claudication - a pain in the legs when walking, which is caused by insufficient blood circulation).
• cisapride (used for indigestion and heartburn)
• digoxin (used for heart problems)
• methotrexate (a medicine used in high-dose chemotherapy to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazole.
• 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before you are given this medicine.

Pregnancy
Your doctor will decide whether you can take esomeprazole during this period.

Breastfeeding
It is not known whether esomeprazole passes into breast milk. Therefore, you should not receive esomeprazole if you are breastfeeding.

Driving and operating machinery
It is unlikely that esomeprazole will affect your ability to drive or operate machinery. However, unwanted effects such as dizziness or blurred vision may occur rarely (see section 4). If affected, do not drive or operate machinery.

3. How Esomeprazolo Tillomed is administered

Esomeprazolo can be administered to children and adolescents aged between 1 and
18 years, as well as to adults, including the elderly.

Method of administration

Adults

• Esomeprazolo Tillomed will be administered by a doctor, who will decide the necessary dose for you.
• The recommended dose is 20 mg or 40 mg administered once a day.
• If you have severe liver problems, the maximum dose is 20 mg per day (gastroesophageal reflux disease).
• The medicine will be administered in the form of an injection or infusion into a vein. The procedure will last up to 30 minutes.
• The recommended dose for preventing re-bleeding of gastric or duodenal ulcers is 80 mg administered by intravenous infusion for a period of 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.

Children and adolescents aged 1 to 18 years

• Esomeprazolo Tillomed will be administered by the doctor, who will decide the necessary dose.
• For children aged between 1 and 11 years, the recommended dose is 10 or 20 mg once a day.
• For children aged between 12 and 18 years, the recommended dose is 20 or 40 mg once a day.
• The medicine will be administered in the form of an injection or infusion into a vein. The administration will last up to 30 minutes.

If you are given more Esomeprazolo Tillomed than you should
If you think you have been given too much Esomeprazolo Tillomed,
inform your doctor immediately.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking
Esomeprazolo Tillomed and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Sudden onset of severe skin rashes or blistering and peeling of the skin, which can also occur after several weeks of treatment. Severe blistering and bleeding of the lips, eyes, mouth, nose and genitals may also occur. The rashes may progress to widespread severe skin damage (epidermal and mucous membrane peeling) with life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms (DRESS)" (very rare).
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems (rare).

Other side effects include:
Common: (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach and/or intestines: diarrhea, stomach pain, constipation, flatulence (gas)
• Feeling unwell (nausea) or sickness (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 disturbances (insomnia)
• Dizziness, tingling, fatigue
• Feeling faint
• Visual disturbances such as blurred vision
• Dry mouth
• Changes in blood test values that assess liver function
• Skin rash, hives and itching
• Hip, wrist or spine bone fracture (when esomeprazole is used at high doses and for a long period of time)

Rare: (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or an increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and muscle spasms.
• Agitation, confusion, depression
• Changes in taste
• Sudden shortness of breath or wheezing (bronchospasm)
• Inflammation of the inside of the mouth
• Infection called “candidiasis” that can affect the intestines and is caused by a fungus
• Liver problems, including jaundice, which can 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 lacking energy
• Increased sweating

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

• Changes in the blood cell count including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, perceiving or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and brain inflammation (encephalitis)
• Muscle weakness
• Severe kidney problems
• Breast enlargement in men

Not known: frequency cannot be estimated based on available data

• If you take esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest with fatigue, involuntary muscle contractions, confusion, cramps, dizziness or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to decreased blood levels of potassium or calcium. Your doctor may perform periodic checks of your blood magnesium levels.
• Inflammation of the intestine (which can lead to diarrhea).
• Skin rash, possibly associated with joint pain.

In very rare cases, esomeprazole can affect white blood cells and cause
immunodeficiency. If you have an infection with symptoms such as fever and a serious worsening
of your general physical condition or fever with symptoms of local infection, such as a sore
throat, sore throat or mouth or difficulty urinating, you should consult your doctor as soon as
possible so that a lack of white blood cells (agranulocytosis) can be
excluded through a blood test. It is important for you to provide information about the
medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://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 Esomeprazolo Tillomed

Keep this medicine out of sight and reach of children.
The doctor or hospital pharmacist are responsible for the correct storage, use and
disposal of Esomeprazolo Tillomed.
Do not use this medicine after the expiry date that is reported on the vial after
“EXP.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original package to protect the medicine from light. However, the
vials may be stored in normal indoor lighting conditions outside
the box for a maximum of 24 hours.

Do not refrigerate.

Chemical and physical stability in use has been demonstrated for 12 hours at a temperature of

30 °C.

From a microbiological point of view, the product must be used immediately, unless

the reconstitution method precludes the risk of microbial contamination.

If not used immediately, the conditions and storage times in use are

the responsibility of the user.
Do not use the solution if its appearance is altered.

6. Package Contents and Other Information

What Esomeprazolo Tillomed Contains
The active ingredient is sodium esomeprazole. Each vial of powder for solution
for injection/infusion contains 42.5 mg of sodium esomeprazole, equivalent to 40 mg of
esomeprazole.
The other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).
Each vial contains less than 1 mmol of sodium (23 mg), therefore it is essentially
“sodium-free”.

Description of Esomeprazolo Tillomed Appearance and Package Contents
Esomeprazolo Tillomed 40 mg powder for solution for injection/infusion appears
as a porous mass or a white to off-white powder. It is transformed into
solution before administration.
Esomeprazolo Tillomed is contained
in a 5 ml clear type I glass vial with a grey-dark bromobutyl rubber stopper
and a removable violet aluminum seal.
Esomeprazolo Tillomed is available in packs of 1, 10 and 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milan
Italy

Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland

This medicinal product is authorised in the Member States of the European Economic Area
under the following designations:
CountryProduct Name
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
________________________________________________________________________

The following information is intended for healthcare professionals only.
Esomeprazolo Tillomed 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 (sodium <1 mmol).
The vials are for single use only. If the entire
reconstituted contents in the vial are not needed for a single dose, the unused solution must
be discarded.
For further information on dosage recommendations and storage conditions, see sections 3 and 5 respectively.

Preparation and Administration of the Reconstituted Solution
To reconstitute the solution, remove the colored plastic cap from the
top of the Esomeprazolo Tillomed 40 mg powder for solution
for injection/infusion vial and puncture the stopper in the center of the drawn circle, keeping
the needle in a vertical position, in order to properly puncture the stopper.
The reconstituted solution for injection/infusion should be clear and from colorless to
very pale yellow. Before administration, it must be visually inspected for
the presence of particulate matter and any discoloration, and only a clear solution should be
used.

Do not refrigerate.

Chemical and physical stability in use has been demonstrated for 12 hours at a temperature of

30 °C.

From a microbiological point of view, the product should be used immediately, unless

the reconstitution procedure precludes microbial contamination.

If not used immediately, the conditions and duration of storage in use are the

responsibility of the user.

Esomeprazolo Tillomed 40 mg powder for solution for injection/infusion

Preparation of the injectable solution

Injection of 40 mg
For the reconstituted esomeprazole solution of 8 mg/ml: prepare the solution by adding
5 ml of 0.9% sodium chloride solution for intravenous use to the 40 mg esomeprazole vial.
The reconstituted injectable solution should be administered intravenously for
at least 3 minutes.
For further information on dose administration, see section 4.2
of the SmPC.

Preparation of the infusion solution

Infusion of 40 mg (400 µg/ml or 0.4 mg/ml)
Dissolve the contents of one 40 mg esomeprazole vial in 100 ml of 0.9% sodium chloride
solution for intravenous use.

Infusion of 80 mg (800 µg/ml or 0.8 mg/ml)
Dissolve the contents of two 40 mg esomeprazole vials in 100 ml of 0.9% sodium chloride
solution for intravenous use.
For further information on dose administration, see section 4.2
of the SmPC.

Disposal
Unused medicinal product and waste materials derived from such medicinal product should be
disposed of in accordance with local regulations.