Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using NEXIUM IV?
NEXIUM IV contains the active ingredient esomeprazole sodium. NEXIUM IV is used to
treat Reflux Oesophagitis, Bleeding Peptic Ulcers and Upper gastrointestinal symptoms
associated with non-steroidal anti-inflammatory drugs (NSAIDs) therapy. NEXIUM IV
will only be used if you are unable to take tablets.
2. What should I know before I use NEXIUM IV?
Do not use if you have ever had an allergic reaction to NEXIUM IV or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with NEXIUM IV and affect how it works.
4. How do I use NEXIUM IV?
NEXIUM IV can be either injected into a vein over a period of at least 3 minutes for
adults or injected slowly over a period of 10 to 30 minutes in either adults or children.
It must only be given by a nurse or doctor.
The dosage and the period of time over which it is given will depend on your condition.
Your doctor will have had experience injecting NEXIUM IV and will choose the best
dose for you.
5. What should I know while using NEXIUM IV?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using NEXIUM IV.
Tell your doctor or nurse as soon as possible if you do not feel well while you are
being given NEXIUM IV.
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Things you should not do
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Do not stop using NEXIUM IV suddenly, unless you have discussed this with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how NEXIUM
IV affects you.
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Looking after your medicine
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NEXIUM IV will be stored by your doctor or pharmacist under the recommended conditions.
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6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. These include constipation, nausea or vomiting, diarrhoea,
headache, wind, stomach pain, skin rash, itchy skin, injection site reaction such
as redness, discomfort or swelling, dizziness and dry mouth.
Active ingredient:
esomeprazole sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using NEXIUM IV. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using NEXIUM IV.
Where to find information in this leaflet:
1. Why am I using NEXIUM IV?
NEXIUM IV contains the active ingredient esomeprazole sodium. NEXIUM IV is a type of medicine called a proton-pump inhibitor. NEXIUM IV works
by decreasing the amount of acid made by the stomach, to give relief of symptoms and
allow healing to take place. This does not stop food being digested in the normal
way.
Reflux Oesophagitis
NEXIUM IV is used to treat reflux oesophagitis or reflux disease in the short-term.
This can be caused by "washing back" (reflux) of food and acid from the stomach into
the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising
up to the throat, also known as heartburn.
Bleeding Peptic Ulcers
Peptic ulcers are ulcers in the stomach or duodenum (tube leading out from the stomach).
When these ulcers become severe enough, they start to bleed. In adults, NEXIUM IV
can be injected into your veins to treat these bleeding ulcers. Treatment with NEXIUM
IV should be followed with other therapy to reduce the amount of acid made by the
stomach. This is to help your ulcer/s to heal.
Upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs
(NSAIDs) therapy
In adults, if you are unable to eat or drink NEXIUM IV may be given to treat the symptoms
of pain or discomfort in the stomach caused by NSAIDs (medicines used to treat pain
or inflammation). NEXIUM IV may also be used to help and prevent ulcers caused by
NSAIDs.
2. What should I know before I use NEXIUM IV?
Warnings
Do not use NEXIUM IV if:
you have allergies to esomeprazole sodium, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have allergies to any medicines containing a proton-pump inhibitor.
Some of the symptoms of an allergic reaction may include:
skin rash
difficulty in breathing
hayfever
feeling faint
Do not use NEXIUM IV if you are taking atazanavir or cilostazol.
Please check with your doctor or pharmacist if you are taking these medicines. These
medicines will be affected by NEXIUM IV.
Check with your doctor if you have:
allergies to any other medicines, foods, dyes or preservatives
any other medical conditions; e.g. liver disease
been diagnosed with osteoporosis
ever had a skin reaction after treatment with a medicine similar to NEXIUM IV that
reduces stomach acid
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not use NEXIUM IV if you are pregnant or breastfeeding unless your doctor says
so. Ask your doctor about the risks and benefits involved.
It is not known if it is safe for you to be given NEXIUM IV while you are pregnant.
It may affect your baby.
It is not known if your baby can take in NEXIUM IV from breast milk if you are breastfeeding.
Children younger than 1 year
NEXIUM IV is not approved for use in children less than than 1 year of age.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not use NEXIUM IV if you are taking the following medicines:
atazanavir and nelfinavir - medicines used to treat Human Immunodeficiency Virus (HIV)
cilostazol - a medicine used to treat intermittent claudication
Some medicines may interfere with NEXIUM IV and affect how it works. These include:
phenytoin - a medicine used to treat epilepsy
warfarin and clopidogrel - medicines used to prevent blood clots
diazepam - a medicine used to treat anxiety and some other conditions
ketoconazole, itraconazole and voriconazole - medicines used to treat fungal infections
citalopram, clomipramine and imipramine - medicines used to treat depression
St John's wort - a herbal remedy used to treat mood disorders
clarithromycin, erythromycin and rifampicin - medicines used to treat bacterial infections
digoxin - a medicine used to treat heart conditions
methotrexate - a medicine used to treat arthritis and some types of cancer
tacrolimus and mycophenolate mofetil - medicines used to assist in organ transplants
erlotinib or related medicines used to treat cancer
These medicines may be affected by NEXIUM IV or may affect how well it works. You
may need different amounts of your medicine, or you may need to take different medicines.
Your doctor can tell you what to do if you are taking any other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while you are being given NEXIUM IV.
If you have not told your doctor about any of these things, tell them before you are
given NEXIUM IV.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NEXIUM IV.
4. How is NEXIUM IV given to you?
How you are given NEXIUM IV
NEXIUM IV can be either injected into a vein over a period of at least 3 minutes for
adults or injected slowly over a period of 10 to 30 minutes in either adults or children.
This is called an intravenous infusion. In adults, NEXIUM IV can be infused slowly
over a longer period of 3 days.
The dosage and the period of time over which it is given will depend on your condition.
Your doctor will have had experience injecting NEXIUM IV and will choose the best
dose for you. They will be willing to discuss this decision with you.
In most patients, NEXIUM IV relieves symptoms rapidly and it will be replaced with
oral treatment as soon as you are well enough to swallow.
If you miss an appointment to get NEXIUM IV
Call your doctor right away to reschedule your appointment.
It is very important that you do not miss a dose of this medicine.
If you stop receiving NEXIUM IV
Do not stop treatment with NEXIUM IV unless you have discussed this with your doctor.
If you have any further questions about your treatment, ask your doctor.
5. What should I know while using NEXIUM IV?
Things you should do
Tell your doctor or nurse as soon as possible if you do not feel well while you are
being given NEXIUM IV.
Call your doctor straight away if you:
have a serious allergic reaction to NEXIUM IV. Symptoms may include swelling of your
face, lips, tongue or other parts of the body, wheezing or difficulty breathing.
Remind any doctor, dentist or pharmacist you visit that you are using NEXIUM IV.
Things you should not do
Do not stop using NEXIUM IV suddenly, unless you have discussed this with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NEXIUM
IV affects you.
Looking after your medicine
NEXIUM IV will be stored by your doctor or pharmacist under the recommended conditions.
It should be kept in a cool, dry place, out of the reach of children where the temperature
stays below 25°C.
NEXIUM IV will only be used if the solution is clear, the package is undamaged and
the use by (expiry) date marked on the pack has not been passed.
Getting rid of any unwanted medicine
Any NEXIUM IV which is not used will be disposed of in a safe manner by your doctor
or pharmacist.
NEXIUM IV contains no antimicrobial agent. Each NEXIUM IV vial is for single use in
one patient only. Any remaining contents should be discarded.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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constipation
nausea or vomiting
diarrhoea
headache
wind
stomach pain
skin rash, itchy skin
injection site reaction such as redness, discomfort or swelling
dizziness
dry mouth
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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muscle pain or weakness, joint pain
"pins and needles"
changes in sleep patterns
fever
mood changes, confusion or depression
increase in breast size (males)
increased bruising
increased sweating
hair loss
changes in vision
tremor
yellowing of the eyes and skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
severe skin reaction which may include rash, itching, redness, blistering or peeling
of the skin
blood in the urine
skin reaction, especially in sun-exposed areas, with joint pain
muscle twitching or jerking movements
irregular (fast or slow) heartbeat
loss of consciousness or awareness
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Tell your doctor immediately if you notice any of the following.
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Occasionally, NEXIUM IV may be associated with changes in your liver or blood, which
may require your doctor to do certain blood tests.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Some people may get other side effects while being given NEXIUM IV.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What NEXIUM IV contains
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Active ingredient
(main ingredient)
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esomeprazole sodium
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Other ingredients
(inactive ingredients)
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disodium edetate
sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What NEXIUM IV looks like
NEXIUM IV is in powder form and has to be mixed with normal saline before injection
or infusion. (AUST R 96678)
Who distributes NEXIUM IV
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in Jun 2024.
NEXIUM® IV is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2024
VV-RIM-01378517 V10.0