NEXIUM I.V. 40MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance: ESOMEPRAZOLE SODIUM

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PS00713

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nexium IV 40 mg
Powder for solution for injection/infusion
esomeprazole

Please read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor,
nurse or pharmacist.
In this leaflet:
1. What Nexium is and what it is used for
2. Before Nexium is given to you
3. How Nexium is given to you
4. Possible side effects
5. How to store Nexium
6. Further information
1. What Nexium is and what it is used for
Nexium 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.
Nexium 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). Nexium 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. Before Nexium is given to you
You must not be given Nexium if:
• You are allergic (hypersensitive) to esomeprazole or any of the other
ingredients of this medicine (listed in Section 6: Further information).
• You are allergic to other proton pump inhibitor medicines
(e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• You are taking a medicine containing nelfinavir (used to treat HIV).
You must not be given Nexium 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.
Take special care with Nexium
Check with your doctor or nurse before you are given Nexium if:
• You have severe liver problems.
• You have severe kidney problems.
Nexium may hide the symptoms of other diseases. Therefore, if any of
the following happen to you before you are given Nexium 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 Nexium, 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).
Using other medicines
Please tell your doctor 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 Nexium can affect the way some medicines
work and some medicines can have an effect on Nexium.
You must not be given Nexium 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 having Nexium.
• Medicines that are used to thin your blood, such as warfarin. Your
doctor may need to monitor you when you start or stop having Nexium.
• 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 Nexium treatment.
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).
Pregnancy and breast-feeding
Before you are given Nexium, tell your doctor if you are pregnant or
trying to get pregnant. Your doctor will decide whether you can be given
Nexium during this time.
It is not known if Nexium passes into breast milk. Therefore, you should
not be given Nexium if you are breastfeeding.
Driving and using machines
Nexium is not likely to affect you being able to drive or use any tools or
machines.
3. How Nexium is given to you
Nexium can be given to children and adolescents aged 1-18 years and
adults, including the elderly.
Being given Nexium
Adults
• Nexium 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.
Children aged 1-18 years
• Nexium 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 are given too much Nexium
If you think you have been given too much Nexium, talk to your doctor
straight away.
4. Possible side effects
Like all medicines, Nexium can cause side effects, although not
everybody gets them.
If you notice any of the following serious side effects, stop taking
Nexium 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 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 Nexium is used in high doses
and over long duration).

Rare (affects less than 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 (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.
Not known (frequency cannot be estimated from the available data)
• If you are on Nexium 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).
Nexium 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.
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.
5. How to store Nexium
• The doctor and hospital pharmacist are responsible for storing, using
and disposing of Nexium correctly.
• Do not use this medicine after the expiry date (EXP) shown on the
carton or vial. The expiry date refers to the last of that month.
• This medicine should be kept in a safe place where children cannot
reach or see it.
• Do not store above 30°C.
• Keep the vial in the outer carton in order to protect from light. Vials
can, however, be stored exposed to normal indoor light outside the
box for up to 24 hours.
6. Further information
What Nexium 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. Each
vial contains less than 1 mmol sodium (23 mg) i.e. essentially ‘sodium-free’.
What Nexium looks like and contents of the pack
Nexium is a white to off-white ‘cake’ or powder. This is made into a
solution before it is given to you.
Pack sizes: 1 vial, 10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Nexium is held by
AstraZeneca UK Limited, 600 Capability Green, Luton LU1 3LU,
United Kingdom.
Nexium is released by AstraZeneca AB, S-151 85, Södertälje,
Sweden; AstraZeneca UK Ltd, Macclesfield, UK; AstraZeneca GmbH,
Wedel, Germany; Corden Pharma GmbH, Plankstadt, Germany;
AstraZeneca Reims, Reims, France; Recipharm Monts, Monts, France
or NV AstraZeneca SA, Brussels, Belgium.

To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name
Reference number
Nexium IV 40 mg 17901/0221
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was prepared in July 2012.
© AstraZeneca 2012
Nexium is a trade mark of the AstraZeneca group of companies.
GI 12 0145a
----------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Nexium IV 40 mg contains 40 mg of esomeprazole, as a sodium salt. Each
vial also contains disodium edetate and sodium hydroxide (<1mmol sodium).
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 plastic cap of colour at
the top of the vial of Nexium, 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.
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.
Nexium Injection
To prepare a solution for injection:
Injection 40 mg
For 8 mg/ml esomeprazole reconstituted solution: Prepare the solution
by adding 5 ml of 0.9% sodium chloride for intravenous use to the
esomeprazole 40 mg vial.
The reconstituted solution for injection should be administered
intravenously over a period of at least 3 minutes.
For further information on dose administration, please see SmPC section 4.2.
Nexium Infusion
To prepare a solution for infusion:
Infusion 40 mg
Dissolve the content of one esomeprazole 40 mg vial in up to 100 ml of
0.9% sodium chloride for intravenous use.
Infusion 80 mg
Dissolve the contents of two esomeprazole 40 mg vials in up to 100 ml
of 0.9% 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.
Marketing Authorisation Holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU,
United Kingdom.
Leaflet updated: July 2012
© AstraZeneca 2012
Nexium is a trademark of the AstraZeneca group of companies.
GI 12 0145a

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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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