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ESOMEPRAZOLE 40MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ESOMEPRAZOLE SODIUM / ESOMEPRAZOLE SODIUM / ESOMEPRAZOLE SODIUM

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V7 Ireland
AZEVENDOS Esomeprazole 40 mg PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 40mg
powder for solution for injection or infusion
Esomeprazole
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
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).
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 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 following
therapeutic endoscopy for acute bleeding
gastric or duodenal ulcers.

2. What you need to know before
you use Esomeprazole
You must not be given Esomeprazole if:
• you are allergic to esomeprazole or any of
the other ingredients of this medicine
(listed in Section 6).
• you are allergic to other proton pump
inhibitor medicines.
• you are taking a medicine containing
nelfinavir (used to treat HIV).
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 or nurse before you are
given Esomeprazole if:
• you have severe liver problems.
• you have severe kidney problems.
Esomeprazole may hide the symptoms of
other diseases. Therefore, if any of the
following symptoms happen to you before
or after you are given Esomeprazole, talk to
your doctor straight away:
• If your weight decreases for no reason and
you have problems in swallowing.
• If you get stomach pains or indigestion.
• If you begin to vomit food or blood.
• If 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).
Talk to your doctor before taking Esomeprazole:
• if you have ever had a skin reaction after
treatment with a medicine similar to
Esomeprazole that reduces stomach acid.
• if you are due to have a specific blood test
(Chromogranin A).
If you get a rash on your skin, especially in
areas exposed to the sun tell your doctor as
soon as you can, as you may need to stop
your treatment with Esomeprazole.
Remember to also mention any other ill-effects
like pain in your joints.
Other medicines and Esomeprazole
Tell your doctor or nurse if you are taking, have
recently taken or might take any other

medicines, including medicines obtained
without a prescription. 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).
• Ketoconazole, itraconazole or voriconazole
(used to treat infections caused by a fungus).
• 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 being
given 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).
• 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.
• Rifampicin (used for treatment of
tuberculosis).
• St. John’s wort (Hypericum perforatum)
(used to treat depression).
• Medicines that are used to thin your blood,
such as warfarin. Your doctor may need to
monitor you when you start or stop being
given Esomeprazole.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor for advice before
being given 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 sodium
This medicine contains 1 mmol sodium
(17 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Esomeprazole
Esomeprazole can be given to children and
adolescents under 18 years of age, and adults,
including elderly people.
Being given Esomeprazole
Esomeprazole will be given to you by a 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 is 20 mg a day (for GORD).
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 an infusion into one of your
veins over 30 minutes followed by a
continuous infusion of 8 mg/hr given over
3 days. If you have severe liver problems, a
continuous infusion of 4 mg/hr given over
3 days may be sufficient.

This Version: Laboratórios Azevedos as MA Holder
PL 24065/0003

Children aged 1-18 years
Esomeprazole will be given by your doctor
who will decide how much you need.
For children aged 1-11 years, the recommended
dose is 10 or 20 mg given once a day.
For children aged 12-18 years, the
recommended 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 up to 30
minutes.
If you are given more Esomeprazole than
you should
If you think you have been given too much
Esomeprazole, talk to your doctor straight away.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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).
• 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 (affects less than 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 (affects less than 1 in 100 people)
• Swelling of the legs and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings, paresthesias
(sensitivity changes), 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, hives and itchy skin.
Rare (affects less than 1 in 1,000 people)
• Blood changes 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).
• Inflammation of the inside of the mouth.
• 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 (affects less than 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.
• 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.
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.
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,
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.
• Rash possibly with pain in the joints.
Do not be concerned by this list of possible
side effects.
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:
UK: the Yellow Card Scheme at:
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.
By reporting side effects you can help provide
more information on the safety of this
medicine.

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 the sight and reach
of children.
Do not store above 25ºC.
Keep the vial in the outer carton in order to
protect from light.
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.
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.
What Esomeprazole looks like and content
of the pack
Esomeprazole 40 mg powder for solution for
injection or infusion is a white to off-white
powder, with a porous and uniform
appearance. This is prepared into a solution
before it is given to you.
The product is packed in Type I glass vials,
sealed with a stopper made of bromobutyl
rubber, cap made of aluminium and a plastic
polypropylene lid, in packs containing 1 and 10
units. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratórios Azevedos –
Indústria Farmacêutica, S.A.
Estrada Nacional 117-2,
Alfragide
2614-503 Amadora,
Portugal
Manufacturer
Sofarimex –
Indústria Química e Farmacêutica, S.A.
Av. das Indústrias,
Alto do Colaride
2735-213 Cacém,
Portugal
This leaflet was last revised in 09/2016.

INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for medical
or healthcare staff only:
The reconstituted solution should be inspected
visually for particulate matter and discoloration
prior to administration. Only clear solutions
should be used. For single use only.

If the entire reconstituted content of the vial is not
required any unused solution should be
discarded in accordance with local requirements.
Injection
A solution for injection (8 mg/ml) is prepared by
adding 5 ml of 0.9% sodium chloride for
intravenous use to the vial.
The reconstituted solution for injection is clear
and colourless to very slightly yellow.

Infusion
A solution for infusion is prepared by dissolving
the contents of one or two vials in up to 100 ml of
0.9% sodium chloride for intravenous use.
The reconstituted solution for infusion is clear and
colourless to very slightly yellow.

Shelf-life 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.

200507.01

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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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