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ESOMEPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ESOMEPRAZOLE SODIUM / ESOMEPRAZOLE SODIUM / 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 8pt (leading 11pt as shown)
NOW Version V11 dated 16th December 2016)
Profile size shown is 130 x 315 (as advised 02.02.12)
Sheet 1 (sides one and two) & Sheet 2 (sides one and two)

V11

This Version: Ibigen as MA Holder ( from 13.02.12)

Sheet 1 side one

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 40 mg, powder for solution for injection/infusion
Esomeprazole

Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Esomeprazole is and what it is used for
2. What you need to know before Esomeprazole is given to you
3. How Esomeprazole is given to you
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information
1. WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR
Esomeprazole 40 mg, powder for solution for injection/infusion 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.
Esomeprazole 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
• 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). 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. WHAT YOU NEED TO KNOW BEFORE ESOMEPRAZOLE IS GIVEN TO YOU
You must not be given Esomeprazole if:
• You are allergic to esomeprazole or any of the other ingredients of this medicine (listed in Section 6).
• 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 infection).
You must not be given Esomeprazole 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
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.
• You are due to have a specific blood test (Chromogranin A).
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 side 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).
Other medicines and Esomeprazole
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because Esomeprazole
can affect the way some medicines work and some medicines can have an effect on Esomeprazole.
You must not be given Esomeprazole 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:
• Atazanavir (used to treat HIV).
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).

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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
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.
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).
Clopidogrel (used to prevent blood clots).
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 esomeprazole treatment.
Tacrolimus (organ transplantation).
Rifampicin (used for treatment of tuberculosis).
St. John’s wort (Hypericum perforatum) (used to treat depression).

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 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. However, side effects such as
dizziness and blurred vision may uncommonly occur (see section 4). If affected, you should not drive or use machines.
Esomeprazole injection/infusion contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
3. HOW ESOMEPRAZOLE IS GIVEN TO YOU





Esomeprazole will be given to you by a doctor or nurse who will decide how much you need.
The recommended dose is 20 mg or 40 mg once a day.
If you have severe liver problems, the maximum dose is 20 mg a day (GORD).
The medicine will be given to you as a slow injection or infusion into one of your veins. This will last for up to 30 minutes.

• The recommended dose for prevention of re-bleeding gastric or duodenal ulcers 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, a continuous infusion dose of 4 mg/hr given over 3 days may be sufficient.
Use in 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 too much Esomeprazole
Your doctor or nurse will always ensure that you receive the correct dose. Please tell them if you think you have missed a dose
or have been given too much medicine.
If you have any further questions on the use of this medicine ask your doctor or nurse.
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 Esomeprazole 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 and may affect up to 1 in 1,000 people.
Other side effects include:
Common (may affect up to 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 (may affect up to 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).

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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 Esomeprazole is used in high doses and over long duration).

Rare (may affect up to 1 in 1,000 people)
• Blood problems such as a reduced number of white blood 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.

INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for medical or healthcare professionals 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.

Very rare (may affect up to 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 Esomeprazole 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,
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).
• Rash, possibly with pain in the joints.
• 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.
Injection 40 mg
A solution for injection (8 mg/ml) is prepared by adding 5 ml of 0.9% sodium chloride for intravenous use to the
esomeprazole 40 mg vial.
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 40 mg
A solution for infusion is prepared by dissolving the content of one vial with esomeprazole 40 mg in up to 100 ml
0.9% sodium chloride for intravenous use.

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Reporting of side effects
If you get any side effects, talk to your doctor 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. By reporting side effects
you can help provide more information on the safety of this medicine.
5. HOW TO STORE ESOMEPRAZOLE
The doctor and hospital pharmacist are responsible for storing, using and disposing of your medicine correctly.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the
last day of that month.
Do not store above 30°C.
Keep the vial in the outer carton in order to protect from light.
6. CONTENTS OF THE PACK AND OTHER 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.
• The other ingredients are:
- disodium edetate
- sodium hydroxide for pH adjustment
(See section 2. Esomeprazole injection/infusion contains sodium)

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.
The reconstituted solution for infusion is clear and colourless to very slightly yellow.
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.

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.
Pack sizes: 1 vial, 5 vials or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ibigen Srl
Via Fossignano 2
04011 Aprilia (LT), Italy
Manufacturer
Valdepharm
Parc Industriel d'incarville - CS 10606
27106 Val de Reuil Cedex, France
This leaflet was revised in 12/2016

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.

Expand Transcript

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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