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
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). 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). Nexium 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.
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.
- 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).
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).
- 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.
- Cisapride (used for indigestion and heartburn).
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.
How Nexium is given to you
- Nexium can be given to adults including the elderly.
- It should not be given to children or young people under the age of 18.
Being given Nexium
- Nexium 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 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.
If you are given too much Nexium
If you think you have been given too much Nexium, talk to your doctor straight away.
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.
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.
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.
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.
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.
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 released by
or
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: Nexium IV 40 mg
Reference number: 17901/0221
This is a service provided by the Royal National Institute of Blind People.
This leaflet was prepared in September 2009.
© AstraZeneca 2009
Nexium is a trade mark of the AstraZeneca group of companies.
GI 08 0053a
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