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ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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

5. How to store Nexium



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







Do not store above 30°C.

Aggression.





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

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





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

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).

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.



Muscle weakness.



Severe kidney problems.



Enlarged breasts in men.

S1211-2 LEAFLET Nexium 20150129

PACKAGE LEAFLET: INFORMATION FOR THE USER

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

6. Contents of the pack and other information

®

NEXIUM 20mg TABLETS
®
NEXIUM 40mg TABLETS
(esomeprazole magnesium)
Your medicine is known by any of the above names but will be
referred to as Nexium throughout the following leaflet.
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 Nexium contains
Not known (frequency cannot be estimated from the available
data)



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).





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.
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

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:

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.

2. What you need to know before you take Nexium



You get stomach pain or indigestion.

3. How to take Nexium



You begin to vomit food or blood.

4. Possible side effects



You pass black stools (blood-stained faeces).

5. How to store Nexium

If you have been prescribed Nexium “on demand” you should
contact your doctor if your symptoms continue or change in
character.

1. What Nexium is and what it is used for

6. Contents of the pack and other information

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.

1. What Nexium is and what it is used for

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

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 available as blister packs containing 14 or 28 tablets.

Nexium is used to treat the following conditions:

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).

Adults


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

‘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.

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



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.



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.

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

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



Prolonged treatment after prevention of rebleeding of ulcers
with intravenous Nexium.

This product is manufactured by either of the below manufacturers-

Yellow Card Scheme



AstraZeneca AB, Sodertalje, Sweden

Website: www.mhra.gov.uk/yellowcard



AstraZeneca UK Ltd, Macclesfield, United Kingdom



AstraZeneca GmbH, Wedel, Germany



Corden Pharma GmbH, Plankstadt, Germany



AstraZeneca Reims, Reims, France



Recipharm Monts, Months, France



Biofabri S.L., Pontevedra, Spain

Adolescents aged 12 years and above

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



AstraZeneca AB, Umea, Sweden.





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).

POM

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

Leaflet revision date: 29 January 2015
Nexium is a registered trade mark of AstraZeneca AB, Sweden.



‘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 20150129

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.



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.



Cilostazol (used to treat intermittent claudication – a pain in
your legs when you walk which is caused by an insufficient
blood supply).

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

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.



Adults aged 18 and above



Cisapride (used for indigestion and heartburn).



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.




Digoxin (used for heart problems).







Tacrolimus (organ transplantation).



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

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.

Rifampicin (used for treatment of tuberculosis).





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.

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.

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.

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.

Taking this medicine




To prevent stomach ulcers if you are taking NSAIDs (NonSteroidal 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.

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.










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.

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.

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.

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

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.

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.

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.

Common (may affect up to 1 in 10 people)
Headache.



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

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.



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

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’).



Swelling of the feet and ankles.



Disturbed sleep (insomnia).



Dizziness, tingling feelings such as “pins and needles”, feeling
sleepy.

Children under the age of 12 years



Spinning feeling (vertigo).

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).



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).

-



Uncommon (may affect up to 1 in 100 people)

Older people
Dose adjustment is not required in the elderly.

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.

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





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.



The recommended dose once the gullet has healed is one
Nexium 20 mg gastro-resistant tablet once a day.



Hair loss (alopecia).



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



Skin rash on exposure to sunshine.



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

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



Generally feeling unwell and lacking energy.



Increased sweating.



The recommended doses are given below.

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)

Other side effects include:


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


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

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.

-

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

Adolescents aged 12 or above

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 with food or on an empty stomach.

If you forget to take Nexium

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).

How much to take


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





If you take more Nexium than you should
Nexium contains sucrose

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

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

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

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

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



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

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

4. Possible side effects



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

Pregnancy, breast-feeding and fertility

Driving and using machines






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.

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

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.



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).



Severe kidney problems.







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).



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.

What Esomeprazole Tablets look like and contents of the pack



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.



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 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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



Enlarged breasts in men.

Not known (frequency cannot be estimated from the available
data)

S1211-2 LEAFLET Esomeprazole 20150129

What Esomeprazole Tablets contain

Muscle weakness.



6. Contents of the pack and other information

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:

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.

Esomeprazole Tablets may hide the symptoms of other diseases.

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
5. How to store Esomeprazole Tablets


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



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



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

5. How to store Esomeprazole Tablets



You get stomach pain or indigestion.

6. Contents of the pack and other information



You begin to vomit food or blood.



You pass black stools (blood-stained faeces).



AstraZeneca AB, Sodertalje, Sweden

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



AstraZeneca UK Ltd, Macclesfield, United Kingdom



AstraZeneca GmbH, Wedel, Germany



Corden Pharma GmbH, Plankstadt, Germany



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.

If you have been prescribed Esomeprazole Tablets “on demand”
you should contact your doctor if your symptoms continue or
change in character.

AstraZeneca Reims, Reims, France



Recipharm Monts, Months, France



Biofabri S.L., Pontevedra, Spain



AstraZeneca AB, Umea, Sweden.

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

POM

PL No: 19488/1211 Esomeprazole 20mg GastroResistant Tablets

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

4. Possible side effects

Esomeprazole Tablets are used to treat the following conditions:
Adults


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



3. How to take Esomeprazole Tablets

This product is manufactured by either of the below manufacturersReporting of side effects

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

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:

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



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.

PL No: 19488/1212 Esomeprazole 40mg GastroResistant Tablets
Leaflet revision date: 29 January 2015



‘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 (NonSteroidal Anti-Inflammatory Drugs). Esomeprazole Tablets 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 Esomeprazole Tablets.

S1211-2 LEAFLET Esomeprazole 20150129

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.

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.

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).
Children under the age of 12 years
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).
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).

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.







Phenytoin (used in epilepsy). If you are taking phenytoin, your
doctor will need to monitor you when you start or stop taking
Esomeprazole Tablets.

Adults aged 18 and above

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).



Tacrolimus (organ transplantation).



Rifampicin (used for treatment of tuberculosis).



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



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.



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

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.





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.

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


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

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

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



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

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



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


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.

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

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.
3. How to take Esomeprazole Tablets
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.

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.

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.



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.



Spinning feeling (vertigo).

-

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

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.



Dry mouth.



Changes in blood tests that check how the liver is working.



Skin rash, lumpy rash (hives) and itchy skin.

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’).



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

Rare (may affect up to 1 in 1,000 people)



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):


The recommended 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.

Children under the age of 12 years



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).
Older 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.

If you take more Esomeprazole Tablets than you should



Eyesight problems such as blurred vision.

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



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.

Dose adjustment is not required in the elderly.

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

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.

The recommended dose is one Esomeprazole 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 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.

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.



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.

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



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



The recommended doses are given below.

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)

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



-

Esomeprazole Tablets with food and drink
To treat stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):

If you have trouble swallowing the tablets:
-

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.

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



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





Taking this medicine

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


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’.

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





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.

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

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.

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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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