ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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S1211-2 LEAFLET Nexium 20131120

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tell your doctor or pharmacist 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).



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.

3. How to take Nexium



Rifampicin (used for treatment of tuberculosis).

4. Possible side effects



St. John’s wort (Hypericum perforatum) (used to treat
depression).

NEXIUM 20mg TABLETS
NEXIUM 40mg TABLETS
(esomeprazole magnesium trihydrate)
Your medicine is known by any of the above names but will be
referred to as Nexium throughout the following leaflet.
Please read all of this leaflet carefully before you start taking
this medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



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.

In this leaflet:
1. What Nexium is and what it is used for
2. Before you take Nexium

5. How to store Nexium
6. Further 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 and young people aged 12 years and above




‘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.
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.

Adults


Stomach ulcers caused by medicines called NSAIDs (NonSteroidal 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.

2. BEFORE YOU TAKE NEXIUM

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.
Pregnancy and breast-feeding
Before taking Nexium, tell your doctor if you are pregnant or trying
to get pregnant. Ask your doctor or pharmacist for advice before
taking any 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.
Important information about some of the ingredients of Nexium
Nexium gastro-resistant tablets contain sucrose, which is 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 Nexium exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.


Nexium gastro-resistant tablets are not recommended for
children less than 12 years old.



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.

Do not take 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 (e.g.
pantoprazole, lansoprazole, rabeprazole, omeprazole).



You can take your tablets at any time of the day.



You are taking a medicine containing nelfinavir (used to treat
HIV).



You can take your tablets with food or on an empty stomach.



Taking this medicine

Take special care with Nexium

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

Check with your doctor or pharmacist before taking Nexium if:



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.



You have severe liver problems.



If you have trouble swallowing the tablets:

You have severe kidney problems.






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.



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.



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:

Put them into a glass of still (non-fizzy) water. Do not use
any other liquids.

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’).

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.

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).

 The usual doses are given below.
To treat heartburn caused by gastro-oesophageal reflux
disease (GORD):

Using other medicines

Adults and children aged 12 or above:

Please tell your doctor or pharmacist 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.



If your doctor has found that your food pipe (gullet) has been
slightly damaged, the usual dose is one Nexium 40 mg gastroresistant 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.

Do not take Nexium Tablets if you are taking a medicine containing
nelfinavir (used to treat HIV).



The usual 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 usual 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:



Severe liver problems leading to liver failure and inflammation
of the brain.



Adults and young people aged 12 or above: the usual 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.

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.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):


Adults aged 18 and above: the usual 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 (NonSteroidal Anti-Inflammatory Drugs):


 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).

Adults aged 18 and above: the usual 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):


Adults aged 18 and above: the usual 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.

To be used as prolonged treatment after prevention of
rebleeding of ulcers with intravenous Nexium:


Adults aged 18 and above: the usual dose is one Nexium
40 mg tablet once a day for 4 weeks.

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.

4. 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.

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.
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.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE NEXIUM


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Store in the original package in order to protect from moisture.



Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

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.



6. FURTHER INFORMATION

Effects on your stomach or gut: diarrhoea, stomach pain,
constipation, wind (flatulence).

What Nexium contains

 Feeling sick (nausea) or being sick (vomiting).
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).



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 (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.



Each Nexium 20mg gastro-resistant tablet contains 20mg of the
active ingredient, esomeprazole (as the magnesium trihydrate)



Each Nexium 40mg gastro-resistant tablet contains 40mg of the
active ingredient, esomeprazole (as the magnesium trihydrate).



Nexium also contains the following inactive ingredients: glyceryl
monostearate, hyprolose, hypromellose, magnesium stearate,
methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%,
microcrystalline cellulose, paraffin synthetic, macrogol,
polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose
and maize starch microgranules, talc, titanium dioxide (E171)
triethyl citrate, iron oxide reddish-brown (E172). The 20mg
strength also contains yellow iron oxide (E172).
What Nexium looks like and contents of the pack
Nexium 20mg Tablets are light pink oblong film-coated tablets
marked ‘A EH’ on one side and ’20 mg’ on the other.
Nexium 40mg Tablets are pink oblong film-coated tablets marked ‘A
EI’ on one side and ’40 mg’ on the other.
Nexium is available as blister packs containing 14 or 28 tablets.
Product Licence holder



Low levels of sodium in the blood. This may cause weakness,
being sick (vomiting) and cramps.



Feeling agitated, confused or depressed.



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Taste changes.

Manufacturer



Eyesight problems such as blurred vision.

This product is manufactured by either of the below manufacturers-



Suddenly feeling wheezy or short of breath (bronchospasm).



AstraZeneca AB, Sodertalje, Sweden



An inflammation of the inside of the mouth.



AstraZeneca UK Ltd, Macclesfield, United Kingdom



An infection called “thrush” which can affect the gut and is
caused by a fungus.



AstraZeneca GmbH, Wedel, Germany

Liver problems, including jaundice which can cause yellow skin,
dark urine, and tiredness.



Corden Pharma GmbH, Plankstadt, Germany



AstraZeneca Reims, Reims, France



Recipharm Monts, Months, France



Biofabri S.L., Pontevedra, Spain



AstraZeneca AB, Umea, Sweden.




Hair loss (alopecia).



Skin rash on exposure to sunshine.



Joint pains (arthralgia) or muscle pains (myalgia).



Generally feeling unwell and lacking energy.



Increased sweating.

POM

PL No: 19488/1211 Nexium 20mg Tablets
PL No: 19488/1212 Nexium 40mg Tablets

Very rare (affects less than 1 in 10,000 people)

Leaflet revision date: 20 November 2013



Changes in blood count including agranulocytosis (lack of white
blood cells)

Nexium is a registered trade mark of AstraZeneca AB, Sweden.



Aggression.



Seeing, feeling or hearing things that are not there
(hallucinations).

S1211-2 LEAFLET Nexium 20131120



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
Esomeprazole Tablets.



Medicines that are used to thin your blood, such as warfarin.
Your doctor may need to monitor you when you start or stop
taking Esomeprazole Tablets.



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 Esomeprazole Tablets
treatment.

1. What Esomeprazole Tablets are and what they are used for



Rifampicin (used for treatment of tuberculosis).

2. Before you take Esomeprazole Tablets



St. John’s wort (Hypericum perforatum) (used to treat
depression).

S1211-2 LEAFLET Esomeprazole 20131120

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE 20mg GASTRO-RESISTANT TABLETS
ESOMEPRAZOLE 40mg GASTRO-RESISTANT TABLETS
(esomeprazole magnesium)
Your medicine is known by any of the above names but will be
referred to as Nexium throughout the following leaflet.
Please read all of this leaflet carefully before you start taking
this medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



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.

In this leaflet:

3. How to take Esomeprazole Tablets
4. Possible side effects
5. How to store Esomeprazole Tablets
6. Further information

If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Esomeprazole Tablets to treat ulcers
caused by Helicobacter pylori infection, it is very important that you
tell your doctor about any other medicines you are taking.
Pregnancy and breast-feeding

1. WHAT ESOMEPRAZOLE TABLETS ARE AND WHAT THEY
ARE USED FOR
Esomeprazole Tablets contain 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.

Before taking Esomeprazole Tablets, tell your doctor if you are
pregnant or trying to get pregnant. Ask your doctor or pharmacist
for advice before taking any medicine. Your doctor will decide
whether you can take Esomeprazole Tablets during this time.

Esomeprazole Tablets are used to treat the following conditions:

It is not known if Esomeprazole Tablets pass into breast milk.
Therefore, you should not take Esomeprazole Tablets if you are
breastfeeding.

Adults and young people aged 12 years and above

Driving and using machines



‘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.

Esomeprazole Tablets are not likely to affect you being able to drive
or use any tools or machines.

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.

Esomeprazole gastro-resistant tablets contain sucrose, which is 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.



Important information about some of the ingredients of
Esomeprazole Tablets

Adults


Stomach ulcers caused by medicines called NSAIDs (NonSteroidal Anti-Inflammatory Drugs). Esomeprazole Tablets can
also be used to stop stomach ulcers from forming if you are
taking NSAIDs.

3. HOW TO TAKE ESOMEPRAZOLE TABLETS



Too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome).





Esomeprazole gastro-resistant tablets are not recommended for
children less than 12 years old.

Prolonged treatment after prevention of rebleeding of ulcers
with intravenous Esomeprazole Tablets.



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).

2. BEFORE YOU TAKE ESOMEPRAZOLE TABLETS
Do not take Esomeprazole Tablets 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 (e.g.
pantoprazole, lansoprazole, rabeprazole, omeprazole).



You are taking a medicine containing nelfinavir (used to treat
HIV).

Do not take Esomeprazole Tablets if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking
Esomeprazole Tablets.

Always take Esomeprazole Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.



If your doctor has told you to take this medicine as and when
you need it, tell your doctor if your symptoms change.
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




You have severe kidney problems.

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.

You have severe liver problems.



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.



Check with your doctor or pharmacist before taking Esomeprazole
Tablets if:

Put them into a glass of still (non-fizzy) water. Do not use
any other liquids.



Take special care with Esomeprazole Tablets



If you have trouble swallowing the tablets:

Esomeprazole Tablets may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you
start taking Esomeprazole Tablets or while you are taking it,
talk to your doctor straight away:



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’).



You lose a lot of weight for no reason and have problems
swallowing.



You get stomach pain or indigestion.

How much to take



You begin to vomit food or blood.





You pass black stools (blood-stained faeces).

If you have been prescribed Esomeprazole Tablets “on demand”
you should contact your doctor if your symptoms continue or
change in character.
Taking a proton pump inhibitor like Esomeprazole Tablets,
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).

 The usual doses are given below.
To treat heartburn caused by gastro-oesophageal reflux
disease (GORD):
Adults and children aged 12 or above:


If your doctor has found that your food pipe (gullet) has been
slightly damaged, the usual dose is one Esomeprazole 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 usual dose once the gullet has healed is one
Esomeprazole 20 mg gastro-resistant tablet once a day



If your gullet has not been damaged, the usual dose is one
Esomeprazole 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 Esomeprazole 20 mg gastro-resistant tablet each day.



If you have severe liver problems, your doctor may give you a
lower dose.

Using other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines. This includes medicines that
you buy without a prescription. This is because Esomeprazole
Tablets can affect the way some medicines work and some
medicines can have an effect on Esomeprazole Tablets.
Do not take Esomeprazole Tablets if you are taking a medicine
containing nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of the following
medicines:


Atazanavir (used to treat HIV).

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.

To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back:



Severe liver problems leading to liver failure and inflammation
of the brain.



Adults and young people aged 12 or above: the usual dose is
one Esomeprazole 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.

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.

To treat stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):


Adults aged 18 and above: the usual dose is one Esomeprazole
20 mg gastro-resistant tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (NonSteroidal Anti-Inflammatory Drugs):


 Enlarged breasts in men.
Not known (frequency cannot be estimated from the available
data)


If you are on Esomeprazole Tablets 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).

Adults aged 18 and above: the usual dose is one Esomeprazole
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):


Adults aged 18 and above: the usual dose is Esomeprazole
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.

To be used as prolonged treatment after prevention of
rebleeding of ulcers with intravenous Esomeprazole Tablets:


Adults aged 18 and above: the usual dose is one Esomeprazole
40 mg tablet once a day for 4 weeks.

If you take more Esomeprazole Tablets than you should
If you take more Esomeprazole Tablets than prescribed by your
doctor, talk to your doctor or pharmacist straight away.
If you forget to take Esomeprazole Tablets


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.

Esomeprazole Tablets 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.
Reporting of side effects

4. POSSIBLE 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.

Like all medicines, Esomeprazole Tablets can cause side effects,
although not everybody gets them.

By reporting side effects, you can help provide more information on
the safety of this medicine.

If you notice any of the following serious side effects, stop
taking Esomeprazole Tablets and contact a doctor
immediately:

5. HOW TO STORE ESOMEPRAZOLE TABLETS



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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Store in the original package in order to protect from moisture.



Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include:
Common (affects less than 1 in 10 people)

6. FURTHER INFORMATION



Headache.

What Esomeprazole Tablets contain



Effects on your stomach or gut: diarrhoea, stomach pain,
constipation, wind (flatulence).

 Feeling sick (nausea) or being sick (vomiting).
Uncommon (affects less than 1 in 100 people)


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.

Each Esomeprazole 20mg gastro-resistant tablet contains
20mg of the active ingredient, esomeprazole (as the
magnesium trihydrate)



Each Esomeprazole 40mg gastro-resistant tablet contains
40mg of the active ingredient, esomeprazole (as the
magnesium trihydrate).

Swelling of the feet and ankles.







Fracture of the hip, wrist or spine (if Esomeprazole Tablets are
used in high doses and over long duration).
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.



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.



Esomeprazole Tablets also contain the following inactive
ingredients: glyceryl monostearate, hyprolose, hypromellose,
magnesium stearate, methacrylic acid ethyl acrylate copolymer
(1:1) dispersion 30%, microcrystalline cellulose, paraffin
synthetic, macrogol, polysorbate 80, crospovidone, sodium
stearyl fumarate, sucrose and maize starch microgranules, talc,
titanium dioxide (E171) triethyl citrate, iron oxide reddish-brown
(E172). The 20mg strength also contains yellow iron oxide
(E172).
What Esomeprazole Tablets look like and contents of the pack
Esomeprazole 20mg Tablets are light pink oblong film-coated
tablets marked ‘A EH’ on one side and ’20 mg’ on the other.
Esomeprazole 40mg Tablets are pink oblong film-coated tablets
marked ‘A EI’ on one side and ’40 mg’ on the other.
Esomeprazole Tablets are available as blister packs containing 14
or 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by either of the below manufacturers

AstraZeneca AB, Sodertalje, Sweden



AstraZeneca UK Ltd, Macclesfield, United Kingdom



AstraZeneca GmbH, Wedel, Germany



Corden Pharma GmbH, Plankstadt, Germany



Hair loss (alopecia).



AstraZeneca Reims, Reims, France



Skin rash on exposure to sunshine.



Recipharm Monts, Months, France



Joint pains (arthralgia) or muscle pains (myalgia).



Biofabri S.L., Pontevedra, Spain



Generally feeling unwell and lacking energy.



AstraZeneca AB, Umea, Sweden.



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).

POM

PL No: 19488/1211 Esomeprazole 20mg GastroResistant Tablets
PL No: 19488/1212 Esomeprazole 40mg GastroResistant Tablets

Leaflet revision date: 20 November 2013
S1211-2 LEAFLET Esomeprazole 20131120

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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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