Active ingredient
- esomeprazole sodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17901/0221.
Nexium I.V. 40mg Powder for solution for injection/infusion
Package leaflet: Information for the user
Nexium IV 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.
What is in this leaflet:
1. What Nexium is and what it is used for
2. What you need to know before Nexium is given to you
3. How Nexium is given to you
4. Possible side effects
5. How to store Nexium
6. Contents of the pack and other 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 the following conditions:
Adults
Children and adolescents aged 1-18 years
2. What you need to know before Nexium is given to you
You must not be given Nexium:
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.
Warnings and precautions
Talk to your doctor or nurse before you are given Nexium if:
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:
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).
Rash and skin symptoms
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 Nexium. Remember to also mention any other ill effects like pain in your joints.
Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes often come after flu-like symptoms such as fever, headache, body ache. The rash may cover large parts of the body with blistering and peeling of the skin.
If at any time during the 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 Nexium
Tell your doctor or nurse if you are taking, have recently taken, or might take 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 infection).
Tell your doctor or nurse if you are taking any of the following medicines:
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Your doctor will decide whether you can take 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. However, side effects such as dizziness and blurred vision may uncommonly occur (see section 4). If affected, you should not drive or use 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
Use in adults
Use in children and adolescents
If you are given more Nexium than you should
If you think you have been given too much Nexium, 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 Nexium and contact a doctor immediately:
Other side effects include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nexium
6. Contents of the pack and other 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
Nexium is manufactured by
Distributed by
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 medicine is authorised in the Member States of the EEA under the following names:
Member States Name of the medicinal product
Austria, Denmark, Finland, Greece, Iceland, Ireland, Italy, The Netherlands, Norway, Poland, Spain, Sweden, United Kingdom Nexium
Belgium, Luxembourg Nexiam
France Inexium
Portugal Nexium I.V.
This leaflet was last revised in December 2021.
© AstraZeneca 2021
Nexium is a trade mark of the AstraZeneca group of companies.
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