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ESOMEPRAZOLE 20MG GASTRO-RESISTANT TABLETS

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Very rare (may affect up to 1 in 10,000 people)

6. Contents of the pack and other information



What Nexium contains

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

PACKAGE LEAFLET: INFORMATION FOR THE USER



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



Aggression.



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



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



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.

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).



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.

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.



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.



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.



If you have ever had a skin reaction after treatment with a
medicine similar to Nexium that reduces stomach acid.



If you are due to have a specific blood test (Chromogranin A).

1. What Nexium is and what it is used for

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

2. What you need to know before you take Nexium



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).

What is in this leaflet:

3. How to take Nexium
4. Possible side effects
5. How to store Nexium



Rash, possibly with pain in the joints.

This product is manufactured by either of the below manufacturers-

6. Contents of the pack and other information



AstraZeneca AB, Sodertalje, Sweden



AstraZeneca UK Ltd, Macclesfield, United Kingdom



AstraZeneca GmbH, Wedel, Germany



Corden Pharma GmbH, Plankstadt, Germany

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.



AstraZeneca Reims, Reims, France

Nexium is used to treat the following conditions:



Recipharm Monts, Months, France

Adults

POM

1. What Nexium is and what it is used for



‘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.

PL: 19488/1211 Nexium 20mg Tablets
PL: 19488/1212 Nexium 40mg Tablets

Leaflet revision date: 14 November 2017



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.

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



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

Nexium® is a registered trade mark of THALES
COMMUNICATIONS & SECURITY SAS, France.



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.

5. How to store Nexium

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Do not take Nexium:

Product Licence holder

Manufacturer

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 in UK via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting
side effects you can help provide more information on the safety of
this medicine.

Your medicine is known by any of the above names but will be
referred to as Nexium throughout the following leaflet.

Nexium is available as blister packs containing 14 or 28 tablets.

Inflammation in the gut (leading to diarrhoea).

Reporting of side effects

NEXIUM® 20mg TABLETS
NEXIUM® 40mg TABLETS
(esomeprazole magnesium)

2. What you need to know before you take Nexium

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:



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.

S1211-2 LEAFLET Nexium 20171114



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.

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.

S1211-2 LEAFLET Nexium 20171114

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).
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 Nexium. Remember to also mention any other
ill-effects like pain in your joints.
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).

The following information is intended for healthcare professionals
only:

2. Immediately shake the syringe for approximately 2 minutes to
disperse the tablet.

Administration through gastric tube

3. Hold the syringe with the tip up and check that the tip has not
clogged.

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.

4. Attach the syringe to the tube whilst maintaining the above
position.



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.







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

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.

The recommended doses are given below.



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

Use in adults aged 18 and above
To treat heartburn caused by gastroesophageal reflux disease
(GERD):

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.

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).



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.

How much to take

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.






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



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.

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.



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):

3. How to take Nexium





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



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)
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.

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.

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.

Common (may affect up to 1 in 10 people)



Benign polyps in the stomach.

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.



Swelling of the feet and ankles.



Disturbed sleep (insomnia).

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.



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).

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’).

Uncommon (may affect up to 1 in 100 people)

Use in 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).

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.

Dose adjustment is not required in the elderly.

Use in adolescents aged 12 or above

Other side effects include:

-

Elderly

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).

These effects are rare, and may affect up to 1 in 1,000 people.

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

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.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

Yellow skin, dark urine and tiredness which can be symptoms
of liver problems.



If you have trouble swallowing the tablets:



The recommended dose is one Nexium 40 mg tablet once a
day for 4 weeks.





The recommended dose is Nexium 40 mg twice a day.



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’.

What to do if you have trouble swallowing the tablets



Prolonged treatment after prevention of re-bleeding of ulcers
with intravenous Nexium:



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

Your doctor will also tell you to take antibiotics for example
amoxicillin and clarithromycin.

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

Sudden wheezing, swelling of your lips, tongue and throat or
body, rash, fainting or difficulties in swallowing (severe allergic
reaction).

Headache.

The recommended dose is one Nexium 20 mg gastro-resistant
tablet twice a day for one week.

The recommended dose is one Nexium 20 mg gastro-resistant
tablet once a day for 4 to 8 weeks.





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


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



Pregnancy, breast-feeding and fertility

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Taking this medicine

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:

4. Possible side effects



Feeling agitated, confused or depressed.

If you take more Nexium than you should



Taste changes.

If you take more Nexium than prescribed by your doctor, talk to your
doctor or pharmacist straight away.



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.

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.

Very rare (may affect up to 1 in 10,000 people)

6. Contents of the pack and other information



What Esomeprazole Tablets contain

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 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).



Rash, possibly with pain in the joints.

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.
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 in UK via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting
side effects you can help provide more information on the safety of
this medicine.



ESOMEPRAZOLE 20mg GASTRO-RESISTANT TABLETS
ESOMEPRAZOLE 40mg GASTRO-RESISTANT TABLETS
(esomeprazole magnesium)

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

Your medicine is known by any of the above names but will be
referred to as Esomeprazole Tablets throughout the following
leaflet.



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).

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.


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.

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.

Esomeprazole 40mg Tablets are pink oblong film-coated tablets
marked ‘A EI’ on one side and ’40 mg’ on the other.

What is in this leaflet:

Esomeprazole Tablets are available as blister packs containing 14
or 28 tablets.

2. What you need to know before you take Esomeprazole Tablets

1. What Esomeprazole Tablets are and what they are used for
3. How to take Esomeprazole Tablets
4. Possible side effects

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



AstraZeneca Reims, Reims, France



Recipharm Monts, Months, France

POM

PL: 19488/1211 Esomeprazole 20mg Gastro-Resistant
Tablets
PL: 19488/1212 Esomeprazole 40mg Gastro-Resistant
Tablets

Leaflet revision date: 14 November 2017



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

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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



5. How to store Esomeprazole Tablets



S1211-2 LEAFLET Esomeprazole 20171114

5. How to store Esomeprazole Tablets

2. What you need to know before you take Esomeprazole
Tablets
Do not take Esomeprazole Tablets:


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 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole
Tablets:


If you have severe liver problems.



If you have severe kidney problems.



If you have ever had a skin reaction after treatment with a
medicine similar to Esomeprazole Tablets that reduces
stomach acid.



If you are due to have a specific blood test (Chromogranin A).

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:

6. Contents of the pack and other information



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

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



You get stomach pain or indigestion.

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.



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.

Esomeprazole Tablets are 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.

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).



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.

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 Tablets. Remember to also
mention any other ill-effects like pain in your joints.



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.

Children under the age of 12 years



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 Esomeprazole Tablets.

Adolescents aged 12 years and above


S1211-2 LEAFLET Esomeprazole 20171114



‘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.

Information on dosing for children aged 1 to 11 years is provided in
Esomeprazole Tablets sachet product information (ask your doctor
or pharmacist if you require further information).
Other medicines and Esomeprazole Tablets
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 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 infection).

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.

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.

Tell your doctor or pharmacist if you are taking any of the following
medicines:



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 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 recommended dose is
one Esomeprazole 20 mg gastro-resistant tablet each day.

The recommended doses are given below.



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

How much to take




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).

Use in adults aged 18 and above



Citalopram, imipramine or clomipramine (used to treat
depression).

To treat heartburn caused by gastroesophageal reflux disease
(GERD):

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



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.



If your doctor has found that your food pipe (gullet) has been
slightly damaged, the recommended 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 recommended 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 recommended 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.



Tacrolimus (organ transplantation).



Rifampicin (used for treatment of tuberculosis).





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

The recommended dose is one Esomeprazole 20 mg gastroresistant tablet twice a day for one week.



Your doctor will also tell you to take antibiotics for example
amoxicillin and clarithromycin.


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
Esomeprazole Tablets during this time. It is not known if
Esomeprazole Tablets passes into breast milk. Therefore, you
should not take Esomeprazole Tablets if you are breastfeeding.
Driving and using machines
Esomeprazole Tablets are 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.
Esomeprazole Tablets contain sucrose
Esomeprazole Tablets contain 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.

The recommended dose is one Esomeprazole 20 mg gastroresistant tablet once a day for 4 to 8 weeks.

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


The recommended dose is one Esomeprazole 20 mg gastroresistant tablet once a day.

To treat too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome):

Other side effects include:
Common (may affect up to 1 in 10 people)

What to do if you have trouble swallowing the 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).
If your doctor has told you to take this medicine as and when
you need it, tell your doctor if your symptoms change.

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)

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’).

Use in children under the age of 12 years

If your doctor has found that your food pipe (gullet) has been
slightly damaged, the recommended 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.

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.



Headache.



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



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



Benign polyps in the stomach.

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 Esomeprazole Tablets are
used in high doses and over long duration).

Esomeprazole 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 Esomeprazole Tablets sachet
product information (ask your doctor or pharmacist if you require
further information).

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.

If you take more Esomeprazole Tablets than you should



Taste changes.

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



Eyesight problems such as blurred vision.



Suddenly feeling wheezy or short of breath (bronchospasm).



An inflammation of the inside of the mouth.



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.

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.

Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.



Hair loss (alopecia).



Skin rash on exposure to sunshine.



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



Generally feeling unwell and lacking energy.



Increased sweating.

If you forget to take Esomeprazole Tablets


To treat heartburn caused by gastroesophageal reflux disease
(GERD):

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.

Dose adjustment is not required in the elderly.

Use in adolescents aged 12 or above



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.

Elderly

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

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’.



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.

3. How to take Esomeprazole Tablets



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



The recommended dose is one Esomeprazole 40 mg tablet
once a day for 4 weeks.

Sudden wheezing, swelling of your lips, tongue and throat or
body, rash, fainting or difficulties in swallowing (severe allergic
reaction).

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

The recommended dose is Esomeprazole 40 mg twice a day.









Prolonged treatment after prevention of re-bleeding of ulcers
with intravenous Esomeprazole Tablets:

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



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

Esomeprazole Tablets with food and drink

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Your doctor will also tell you to take antibiotics for example
amoxicillin and clarithromycin.

Taking this medicine


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

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.



The recommended dose is one Esomeprazole 20 mg gastroresistant tablet twice a day for one week.

4. Possible side effects



If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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