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ESOMEPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ESOMEPRAZOLE SODIUM

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IBI Esomeprazole 40 mg PIL

VICTOR DESIGN

Version 3a Created 08.02.12, 4a created 11th May 2012
Font: VAG Rounded Light & Bold 9pt (leading 11pt as shown)
NOW Version (5a(ii) dated 22nd December 2015)
Profile size shown is 130 x 315 (as advised 02.02.12)
Sheet 1 (sides one and two) & Sheet 2 (sides one and two

5a(ii)

This Version: Ibigen as MA Holder ( from 13.02.12)
text updated 22.12.15

Sheet 1 side one

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 40 mg, powder for solution for infusion/injection
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 Esomeprazole is and what it is used for
2. Before Esomeprazole is given to you
3. How Esomeprazole is given to you
4. Possible side effects
5. How to store Esomeprazole
6. Further information
1.

WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR

Esomeprazole 40 mg, powder for solution for infusion/injection 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.
It 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 (gastric ulcer) 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 re-bleeding following therapeutic endoscopy for acute bleeding of stomach ulcers or ulcers in the
upper part of your intestine (duodenal ulcers).

2.

BEFORE ESOMEPRAZOLE IS GIVEN TO YOU

You must not be given Esomeprazole 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 called nelfinavir (used to treat HIV).
Take special care with Esomeprazole
Check with your doctor or nurse before you are given Esomeprazole if:
• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces
stomach acid.
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.
Esomeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before
you are given Esomeprazole 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 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).
Using other medicines
Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines including
medicines that you buy without a prescription. This is because Esomeprazole can affect the way some
medicines work and some medicines can have an effect on Esomeprazole .

Sheet 1 side two
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).
• 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 Esomeprazole.
• Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you
start or stop having Esomeprazole.
• Cisapride (used for indigestion and heartburn).
• Clopidogrel (used to prevent blood clots)
Pregnancy and breast-feeding
Before you are given Esomeprazole, tell your doctor if you are pregnant or trying to get pregnant. 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.
Important information about some of the ingredients of Esomeprazole
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3.

HOW TO USE ESOMEPRAZOLE

Esomeprazole will be given to you by a doctor or nurse. Your doctor will decide how much you need. Please tell
them if you think you have missed a dose or have been given too much medicine.
Detailed instructions for your doctor or nurse on how to prepare and administer this medicine are given at the
end of this leaflet, see “Handling instructions”.
• 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 a slow injection or infusion into one of your veins. The injection will be
given over a period of at least 3 minutes, and the infusion over a period of 10 to 30 minutes.
• For prevention of re-bleeding gastric or duodenal ulcers, the usual dose is 80 mg administered as intravenous
infusion over 30 minutes followed by a continuous infusion dose of 8 mg/hr given over 3 days. If you have severe
liver problems for this indication, a continuous infusion dose of 4 mg/hr given over 3 days may be sufficient.
Children and adolescents
Esomeprazole should not be given to children or young people under the age of 18.
Elderly patients
No dose adjustment is necessary.
If you are given more Esomeprazole than you should be
Your doctor or nurse will always ensure that you receive the correct dose. If you are accidentally given an
overdose you will be given the appropriate treatment.
If you have any further questions on the use of this product ask your doctor or nurse.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Esomeprazole 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 to swallow
(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.

Sheet 2 side one
Uncommon (affects less than 1 in 100 people but more than 1 in 10)
• 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 but more than 1 in 100)
• 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).
INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for medical or healthcare staff only:
Handling instructions:
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to
administration. Only clear solution should be used.
The content of the vial is for single use only.






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 but more than 1 in 1,000)
• 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.
• Low levels of magnesium in the blood. This may cause weakness, being sick (vomiting), cramps, tremor and
arrhythmias (heart rhythm disturbances).
Not known (frequency cannot be estimated from the available data)
• Rash, possibly with pain in the joints.
If you are on Esomeprazole for more than three months it is possible that the levels of magnesium in your
blood may fall.
Injection
A solution for injection is prepared by adding 5 ml of 0.9% sodium chloride for intravenous use to the vial with
esomeprazole.
When administering a 20 mg dose only half of the reconstituted solution should be used. Any unused solution
should be discarded.
The reconstituted solution for injection is clear and colourless to very slightly yellow.
Infusion
A solution for infusion is prepared by dissolving the content of one vial with esomeprazole in up to 100 ml 0.9%
sodium chloride for intravenous use.
The reconstituted solution for infusion is clear and colourless to very slightly yellow.

Sheet 2 side two

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.
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.
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 nurse.

6.
FURTHER INFORMATION
What Esomeprazole contains
• The active substance is esomeprazole sodium. Each vial contains 42.5 mg of esomeprazole
sodium, equivalent to 40 mg of esomeprazole.

5.

Pack sizes: 1 vial, 5 vials or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder:
Manufacturer:
Ibigen Srl
Valdepharm
Via Fossignano 2
Parc Industriel d’incaville – BP 606
04011 Aprilia (LT), Italy
27106 Val de Reuil Cedex, France

HOW TO STORE ESOMEPRAZOLE

Your doctor or nurse is responsible for storing, using and disposing of your medicine correctly.
Keep out of the reach and sight of children
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.
Do not store above 30°C.
Keep the vial in the outer carton in order to protect from light.

Infusion 80 mg
A solution for infusion is prepared by dissolving the content of two vials of esomeprazole 40 mg in
up to 100 ml of 0.9% sodium chloride for intravenous use.
Esomeprazole should not be reconstituted with diluents other than that stated.
Any unused product or waste material should be disposed of in accordance with local requirements.

• The other ingredients are:
- disodium edetate
- sodium hydroxide for pH adjustment
What Esomeprazole looks like and contents of the pack
Esomeprazole 40 mg, powder for solution for infusion/injection is a white to almost white freeze dried ‘cake’ or
powder. This is made into a solution before it is given to you.

This leaflet was revised in 12/2015

Shelf-life
As packaged for sale: 18 months
Chemical and physical in-use stability has been demonstrated at concentrations between
0.4 mg/ml and 8.0 mg/ml for 12 hours at 25ºC.
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 12 hours at not more than 25ºC.

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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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