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ESOMEPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): ESOMEPRAZOLE SODIUM

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• If you are taking a medicine containing nelfinavir (used
to treat HIV infection).

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Esomeprazole 40 mg
Powder for Solution for Injection/Infusion
esomeprazole
Read all of 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 further questions, ask your doctor,
nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse
or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Esomeprazole is and what it is used for
2. What you need to know before you use Esomeprazole
3. How to use Esomeprazole
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information

1. What Esomeprazole is and what it is used for
Esomeprazole contains a medicine called esomeprazole.
This belongs to a group of medicines called ‘proton pump
inhibitors’. They work by reducing the amount of acid that
your stomach produces.
Esomeprazole is used for the short-term treatment of
certain conditions, when you are unable to have treatment
by mouth. It is used to treat:
• ‘Gastro-oesophageal reflux disease’ (GORD) in adults,
adolescents and children. This is where acid from
the stomach escapes into the gullet (the tube which
connects your throat to your stomach) causing pain,
inflammation and heartburn.
• Stomach ulcers in adults caused by medicines called
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Esomeprazole can also be used to stop stomach ulcers
from forming if you are taking NSAIDs.
• Prevention of rebleeding in adults following therapeutic
endoscopy for acute bleeding gastric or duodenal
ulcers.

2. What you need to know before you use
Esomeprazole
Do not use Esomeprazole:
• If you are allergic (hypersensitive) to esomeprazole or
any of the other ingredients of this medicine (listed in
Section 6: Further information).
• If you are allergic to other proton pump inhibitor
medicines (e.g. pantoprazole, lanzoprazole,
rabeprazole, omeprazole).

Esomeprazole 40 mg
Powder for Solution for Injection/Infusion
The following information is intended for healthcare
professionals only:
Esomeprazole 40 mg contains 42.5 mg esomeprazole sodium
equivalent to 40 mg esomeprazole. Each vial also contains
disodium edetate and sodium hydroxide (<1 mmol sodium).

You must not be given esomeprazole if any of the above
apply to you. If you are not sure, talk to your doctor or
nurse before you are given this medicine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Esomeprazole:
• If you have severe liver problems.
• If you have severe kidney problems.
Esomeprazole may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before
you are given Esomeprazole or after you are given it,
talk to your doctor straight away:
• You lose a lot of weight for no reason and have
problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
Taking a proton pump inhibitor like esomeprazole,
especially over a period of more than one year, may
slightly increase your risk of fracture in the hip, wrist or
spine. Tell your doctor if you have osteoporosis or if you
are taking corticosteroids (which can increase the risk of
Osteoporosis).

Other medicines and Esomeprazole
Tell your doctor, pharmacist or nurse if you are taking,
or have recently taken, any other medicines. This
includes medicines that you buy without a prescription.
This is because esomeprazole can affect the way some
medicines work and some medicines can have an effect
on esomeprazole.
You must not be given esomeprazole if you are taking a
medicine containing nelfinavir (used to treat HIV).
Tell your doctor or nurse if you are taking any of the
following medicines:
• Atazanavir (used to treat HIV infection).
• 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, relax muscles or in
epilepsy).
• Phenytoin (used in epilepsy). If you are taking
phenytoin, your doctor will need to monitor you when
you start or stop having esomeprazole.
• Medicines that are used to thin your blood, such as
warfarin. Your doctor may need to monitor you when
you start or stop having esomeprazole.
• Cilostazol (used to treat intermittent claudication – a
pain in your legs when you walk which is caused by an
insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Clopidogrel (used for prevention of blood clots).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used in high
doses to treat cancer) – if you are taking a high dose
of methotrexate, your doctor may temporarily stop your
esomeprazole treatment.

Vials are for single use only. If the entire reconstituted
content of the vial is not required for a single dose, any
unused solution should be discarded. For further information
on dose recommendations and storage conditions, see
sections 3 and 5, respectively.

Preparation and Administration of Reconstituted
Solution:
For the reconstitution of solution, withdraw the coloured
plastic cap at the top of the vial of Esomeprazole, and pierce
the stopper in the centre of the designed circle, by maintaining
the needle vertically, in order to be able to cross the stopper
correctly.

• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat
depression).

Pregnancy and breast-feeding
If you are pregnant, breast-feeding, or think you may be
pregnant, ask your doctor for advice before taking this
medicine. Your doctor will decide whether you can be
given Esomeprazole during this time.
It is not known if esomeprazole passes into breast milk.
Therefore, you should not be given esomeprazole if you
are breastfeeding.

Driving and using machines
Esomeprazole is not likely to affect you being able to drive
or use any tools or machines.
Esomeprazole contains less than 1 mmol sodium
(23 mg) i.e. essentially ‘sodium-free’.

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

Being given Esomeprazole
Adults
• Esomeprazole will be given to you by your doctor who
will decide how much you need.
• The usual dose is 20 mg or 40 mg once a day.
• If you have severe liver problems, the maximum dose
for GORD is 20 mg a day.
• The medicine will be given to you as an injection or
infusion into one of your veins. This will last for up to
30 minutes.
• For prevention of rebleeding gastric or duodenal ulcers,
the usual dose is 80 mg administered as intravenous
infusion over 30 minutes followed by a continuous
infusion of 8 mg/hr given over 3 days. If you have
severe liver problems for this indication, a continuous
infusion of 4 mg/hr given over 3 days may be sufficient.
Use in children and adolescents
• Esomeprazole will be given by your doctor who will
decide how much you need.
• For children 1-11 years, the usual dose is 10 or 20 mg
given once a day.
• For children 12-18 years, the usual dose is 20 or 40 mg
given once a day.
• The medicine will be given as an injection or infusion
into a vein. This will last for up to 30 minutes.

If you use more Esomeprazole than you should
If you think you have been given too much esomeprazole,
talk to your doctor straight away.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

If you notice any of the following serious side effects,
stop taking Esomeprazole and contact a doctor
immediately:
• Sudden wheezing, swelling of your lips, tongue and
throat or body, rash, fainting or difficulties in swallowing
(severe allergic reaction).

The reconstituted solution for injection or infusion should
be clear and colourless to very slightly yellow. It should be
inspected visually for particulate matter and discolouration
before administration and only clear solution should be used.
The shelf life after reconstitution in terms of chemical and
physical stability has been demonstrated for 12 hours at 30°C.
However, from a microbiological point of view, the product
should be used immediately. If not used immediately, in-use
storage times and conditions prior to use are the responsibility
of the user.

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• Reddening of the skin with blisters or peeling. There
may also be severe blisters and bleeding in the
lips, eyes, mouth, nose and genitals. This could be
‘Stevens-Johnson syndrome’ or ‘toxic epidermal
necrolysis’.
• Yellow skin, dark urine and tiredness which can be
symptoms of liver problems.
These effects are rare, affecting less than
1 in 1,000 people.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach
pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Injection site reaction.
Uncommon (may affect up to 1 in 100 people)
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as “pins and needles”,
feeling sleepy.
• Spinning feeling (vertigo).
• Eyesight problems such as blurred vision.
• Dry mouth.
• Changes in blood tests that check how the liver is
working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Fracture of the hip, wrist or spine (if Esomeprazole is
used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people)
• Blood problems such as a reduced number of white
cells or platelets. This can cause weakness, bruising or
make infections more likely.
• Low levels of sodium in the blood. This may cause
weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Suddenly feeling wheezy or short of breath
(bronchospasm).
• An inflammation of the inside of the mouth.
• An infection called “thrush” which can affect the gut and
is caused by a fungus.
• Liver problems, including jaundice which can cause
yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Generally feeling unwell and lacking energy.
• Increased sweating.
Very rare (may affect up to 1 in 10,000 people)
• Changes in blood count including agranulocytosis (lack
of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there
(hallucinations).
• Severe liver problems leading to liver failure and
inflammation of the brain.

Esomeprazole Injection

• Sudden onset of a severe rash or blistering or peeling
skin. This may be associated with a high fever and
joint pains (Erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Enlarged breasts in men.
Not known (frequency cannot be estimated from the
available data)
• If you are on esomeprazole for more than three months
it is possible that the levels of magnesium in your blood
may fall. Low levels of magnesium can be seen as
fatigue, involuntary muscle contractions, disorientation,
convulsions, dizziness or increased heart rate. If you
get any of these symptoms, please tell your doctor
promptly. Low levels of 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.
• Inflammation in the gut (leading to diarrhoea).
Esomeprazole may in very rare cases affect the white
blood cells leading to immune deficiency. If you have an
infection with symptoms such as fever with a severely
reduced general condition or fever with symptoms of a
local infection such as pain in the neck, throat or mouth
or difficulties in urinating, 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 for you to give information about your medication
at this time.

After reconstitution
Chemical and physical in-use stability has been
demonstrated for 12 hours at 30°C. From a microbiological
point of view, the product should be used immediately. If
not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user.
Do not use this medicine if you notice visually particulate
matter and discoloration prior to administration after
reconstitution.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Esomeprazole contains
The active substance is esomeprazole sodium. Each
vial of powder for solution for injection/infusion contains
42.5 mg of esomeprazole sodium, equivalent to 40 mg of
esomeprazole.
The other ingredients are disodium edetate and sodium
hydroxide (for pH adjustment).

What Esomeprazole looks like and contents of the
pack
Esomeprazole is a white to off-white ‘cake’ or powder. It is
supplied in a glass vial. This is made into a solution before
it is given to you.

Do not be concerned by this list of possible side effects.
You may not get any of them. If any of the side effects get
serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Pack sizes: 1 vial, 1 x 5 vials, 1 x 10 vials, 1 x 25 vials.
Not all pack sizes may be marketed.

Reporting of side effects

Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom

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

Marketing Authorisation Holder and Manufacturer

This leaflet was last revised in July 2014

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5. How to store Esomeprazole
• The doctor and hospital pharmacist are responsible for
storing, using and disposing of Esomeprazole correctly.
• Do not use this medicine after the expiry date (EXP)
shown on the carton or vial. The expiry date refers to
the last day of that month.
• Keep this medicine out of sight and reach of children.
• Store below 25°C.
• Store in the original package, in order to protect from
light.

For further information on dose administration, please see
SmPC section 4.2.

To prepare a solution for injection:
Injection 40 mg

Esomeprazole Infusion

For 8 mg/ml esomeprazole reconstituted solution: Prepare the
solution by adding 5 ml of 0.9% (9 mg/ml) sodium chloride for
intravenous use to the esomeprazole 40 mg vial.

To prepare a solution for infusion:

The reconstituted solution for injection should be administered
intravenously over a period of at least 3 minutes.

Dissolve the content of one esomeprazole 40 mg vial in up to
100 ml of 0.9% (9 mg/ml) sodium chloride for intravenous use.

Infusion 40 mg

Infusion 80 mg
Dissolve the contents of two esomeprazole 40 mg vials in up
to 100 ml of 0.9% (9 mg/ml) sodium chloride for intravenous
use.
For further information on dose administration, please see
SmPC section 4.2.
Disposal
Any unused product or waste material should be disposed of
in accordance with local requirements.

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LEA-xxxxxx-00

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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