NEXIUM 40MG TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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P033833

Package leaflet: Information for the patient

Nexium 20 mg gastro-resistant tablets
Nexium 40 mg gastro-resistant tablets
esomeprazole

Read all of this leaflet carefully before you
start taking 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 or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• If you get any side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Nexium is and what it is used for
2. What you need to know before you take Nexium
3. How to take Nexium
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 to treat the following conditions:
Adults
• ‘Gastroesophageal reflux disease’ (GERD).
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.
• Ulcers in the stomach or upper part of the gut
(intestine) that are infected with bacteria called
‘Helicobacter pylori’. If you have this condition,
your doctor may also prescribe antibiotics to
treat the infection and allow the ulcer to heal.
• 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.
• Too much acid in the stomach caused by
a growth in the pancreas (Zollinger-Ellison
syndrome).
• Prolonged treatment after prevention of
rebleeding of ulcers with intravenous Nexium.
Adolescents aged 12 years and above
• ‘Gastroesophageal reflux disease’ (GERD).
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.
• Ulcers in the stomach or upper part of the gut
(intestine) that are infected with bacteria called
‘Helicobacter pylori’. If you have this condition,
your doctor may also prescribe antibiotics to
treat the infection and allow the ulcer to heal.
2. What you need to know before you take
Nexium
Do not take Nexium:
• If you are allergic to esomeprazole or any of
the other ingredients of this medicine (listed in
Section 6).
• If you are allergic to other proton pump inhibitor
medicines (e.g. pantoprazole, lansoprazole,
rabeprazole, omeprazole).
• If you are taking a medicine containing
nelfinavir (used to treat HIV infection).
Do not take Nexium if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Nexium.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Nexium:
• If you have severe liver problems.
• If you have severe kidney problems.
Nexium may hide the symptoms of other diseases.
Therefore, if any of the following happen to you
before you start taking Nexium or while you
are taking 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).
If you have been prescribed Nexium “on demand”
you should contact your doctor if your symptoms
continue or change in character.
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).
Children under the age of 12 years
Information on dosing for children aged 1 to
11 years is provided in Nexium sachet product
information (ask your doctor or pharmacist if you
require further information).
Other medicines and Nexium
Tell your doctor or pharmacist 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.
Do not take Nexium Tablets if you are taking a
medicine containing nelfinavir (used to treat HIV
infection).
Tell your doctor or pharmacist if you are taking
any of the following medicines:
• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole
(used to treat infections caused by a fungus).
• 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 taking Nexium.
• Medicines that are used to thin your blood, such
as warfarin. Your doctor may need to monitor
you when you start or stop taking Nexium.
• 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).
• 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 Nexium treatment.
• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used
to treat depression).
If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as Nexium
to treat ulcers caused by Helicobacter pylori
infection, it is very important that you tell your
doctor about any other medicines you are taking.
Nexium with food and drink
You can take your tablets with food or on an
empty stomach.
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 taking 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
take 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 or rarely occur (see section 4).
If affected, you should not drive or use machines.
Nexium contains sucrose
Nexium contains sugar spheres which contain
sucrose, a type of sugar. If you have been told
by your doctor that you have an intolerance to
some sugars, talk to your doctor before taking this
medicine.
3. How to take Nexium
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• If you are taking this medicine for a long time,
your doctor will want to monitor you (particularly
if you are taking it for more than a year).
• If your doctor has told you to take this medicine
as and when you need it, tell your doctor if your
symptoms change.
How much to take
• Your doctor will tell you how many tablets to
take and how long to take them for. This will
depend on your condition, how old you are and
how well your liver works.
• The recommended doses are given below.
Adults aged 18 and above
To treat heartburn caused by
gastroesophageal reflux disease (GERD):
• If your doctor has found that your food pipe
(gullet) has been slightly damaged, the
recommended dose is one Nexium 40 mg
gastro-resistant tablet once a day for 4 weeks.
Your doctor may tell you to take the same dose
for a further 4 weeks if your gullet has not yet
healed.
• The recommended dose once the gullet has
healed is one Nexium 20 mg gastro-resistant
tablet once a day
• If your gullet has not been damaged, the
recommended dose is one Nexium 20 mg
gastro-resistant tablet each day. Once the
condition has been controlled, your doctor may
tell you to take your medicine as and when you
need it, up to a maximum of one Nexium 20 mg
gastro-resistant tablet each day.
• If you have severe liver problems, your doctor
may give you a lower dose.
To treat ulcers caused by Helicobacter pylori
infection and to stop them coming back:
• The recommended dose is one Nexium 20 mg
gastro-resistant tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics
for example amoxicillin and clarithromycin.
To treat stomach ulcers caused by NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is one Nexium 20 mg
gastro-resistant tablet once a day for 4 to
8 weeks.
To prevent stomach ulcers if you are taking
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is one Nexium 20 mg
gastro-resistant tablet once a day.
To treat too much acid in the stomach caused
by a growth in the pancreas (Zollinger-Ellison
syndrome):
• The recommended dose is Nexium 40 mg
twice a day.
• Your doctor will adjust the dose depending on
your needs and will also decide how long you
need to take the medicine for. The maximum
dose is 80 mg twice a day.
Prolonged treatment after prevention of
re-bleeding of ulcers with intravenous Nexium:
• The recommended dose is one Nexium 40 mg
tablet once a day for 4 weeks.
Adolescents aged 12 or above
To treat heartburn caused by gastroesophageal
reflux disease (GERD):
• If your doctor has found that your food pipe
(gullet) has been slightly damaged, the
recommended dose is one Nexium 40 mg
gastro-resistant tablet once a day for 4 weeks.
Your doctor may tell you to take the same dose
for a further 4 weeks if your gullet has not yet
healed.
• The recommended dose once the gullet has
healed is one Nexium 20 mg gastro-resistant
tablet once a day.
• If your gullet has not been damaged, the
recommended dose is one Nexium 20 mg
gastro-resistant tablet each day.
• If you have severe liver problems, your doctor
may give you a lower dose.
To treat ulcers caused by Helicobacter pylori
infection and to stop them coming back:
• The recommended dose is one Nexium 20 mg
gastro-resistant tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics
for example amoxicillin and clarithromycin.

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Taking this medicine
• You can take your tablets at any time of the day.
• You can take your tablets with food or on an
empty stomach.
• Swallow your tablets whole with a drink of
water. Do not chew or crush the tablets.
This is because the tablets contain coated
pellets which stop the medicine from being
broken down by the acid in your stomach. It is
important not to damage the pellets.
What to do if you have trouble swallowing the
tablets
• If you have trouble swallowing the tablets:
- Put them into a glass of still (non-fizzy)
water. Do not use any other liquids.
- Stir until the tablets break up (the mixture
will not be clear). Then drink the mixture
straight away or within 30 minutes. Always
stir the mixture just before drinking it.
- To make sure that you have drunk all of
the medicine, rinse the glass very well with
half a glass of water and drink it. The solid
pieces contain the medicine - do not chew
or crush them.
• If you cannot swallow at all, the tablet can be
mixed with some water and put into a syringe. It
can then be given to you through a tube directly
into your stomach (‘gastric tube’).
Children under the age of 12 years
Nexium gastro-resistant tablets are not
recommended for children less than 12 years old.
Information on dosing for children aged 1 to
11 years is provided in Nexium sachet product
information (ask your doctor or pharmacist if you
require further information).
Older people
Dose adjustment is not required in the elderly.
If you take more Nexium than you should
If you take more Nexium than prescribed by
your doctor, talk to your doctor or pharmacist
straight away.
If you forget to take Nexium
• If you forget to take a dose, take it as soon as
you remember it. However, if it is almost time
for your next dose, skip the missed dose.
• Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
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:
• 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).
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).
• 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 Nexium 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 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.
• Eyesight problems such as blurred vision.
• 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 (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 Nexium 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 or 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).
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.
The following information is intended for
healthcare professionals only:
Administration through gastric tube
1. Put the tablet into an appropriate syringe and
fill the syringe with approximately 25 ml water
and approximately 5 ml air. For some tubes,
dispersion in 50 ml water is needed to prevent
the pellets from clogging the tube.
2. Immediately shake the syringe for approximately
2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that
the tip has not clogged.
4. Attach the syringe to the tube whilst maintaining
the above position.
5. Shake the syringe and position it with the tip
pointing down. Immediately inject 5 – 10 ml into
the tube. Invert the syringe after injection and
shake (the syringe must be held with the tip
pointing up to avoid clogging of the tip)

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 (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafe@hpra.ie
Malta
ADR Reporting,
The Medicines Authority,
Post-Licensing Directorate,
203 Level 3,
Rue D’Argens,
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Nexium
• Keep this medicine out of the sight and reach
of children.
• Do not store above 30°C.
• Do not use this medicine after the expiry date
which is stated on the carton and bottle
after EXP. The expiry date refers to the last day
of that month.
• Store this medicine in the original package
(blister) or keep the bottle tightly closed in
order to protect from moisture.
• Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Nexium contains
• The active substance is esomeprazole. Nexium
gastro-resistant tablets come in two strengths
containing 20 mg or 40 mg of esomeprazole
(as magnesium trihydrate).
• The other ingredients are glycerol monostearate
40-55, hyprolose, hypromellose, iron oxide
(20 mg reddish-brown, yellow, 40 mg reddish
brown) (E172), magnesium stearate, methacrylic
acid ethyl acrylate copolymer (1:1) dispersion
30 per cent, microcrystalline cellulose,
synthetic paraffin, macrogol, polysorbate 80,
crospovidone, sodium stearyl fumarate, sugar
spheres (sucrose and maize starch), talc,
titanium dioxide (E171), triethyl citrate.
What Nexium looks like and contents of the pack
• Nexium 20 mg gastro-resistant tablets are light
A
pink with an EH on one side and 20 mg on the
other side.
• Nexium 40 mg gastro-resistant tablets are
A
pink with an EI on one side and 40 mg on the
other side.
• Your tablets will come in a blister pack in
wallets and/or cartons containing
20 mg, 40 mg: Bottles of 2, 5, 7, 14, 15, 28, 30,
56, 60, 100, 140(5x28) tablets.
20  mg, 40 mg: Blister packs in wallet and/or
carton of 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1,
56, 60, 90, 98, 100x1, 140 tablets
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for Nexium in the
UK and Ireland are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU,
United Kingdom.
The Marketing Authorisations for Nexium in Malta
are held by AstraZeneca AB, Gartunavagen,
S-151 85, Södertälje, Sweden.
Nexium is released by AstraZeneca UK
Ltd, Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, United Kingdom;
AstraZeneca AB, S-151 85, Södertälje,
Sweden; AstraZeneca GmbH, Wedel, Germany;
Corden Pharma GmbH, Plankstadt, Germany;
AstraZeneca Reims, Reims, France; or
Recipharm Monts, Monts, France.
This medicine is authorised in the Member
states of the EEA under the following names:
Member State

Name of medicinal
product

Austria, Denmark, Finland, Nexium
Greece, Iceland, Ireland,
Italy, The Netherlands,
Norway, Portugal, Sweden,
United Kingdom
Belgium, Luxembourg

Nexiam

France

Inexium

Germany, Spain

Nexium mups

This leaflet was last revised in August 2014.
© AstraZeneca 2014
Nexium is a trade mark of the AstraZeneca group
of companies.
GI 13 0022b
Other sources of information

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 20 mg Tablets
17901/0068
Nexium 40 mg Tablets
17901/0069
This is a service provided
by the Royal National
Institute of Blind People.

6. Turn the syringe with the tip down and
immediately inject another 5 – 10 ml into the
tube. Repeat this procedure until the syringe
is empty.
7. Fill the syringe with 25 ml of water and 5 ml
of air and repeat step 5 if necessary to wash
down any sediment left in the syringe. For
some tubes, 50 ml water is needed.
This leaflet was last revised in August 2014.
© AstraZeneca 2014
Nexium is a trade mark of the AstraZeneca group
of companies.
GI 13 0022b

P033833

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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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