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ESOMEPRAZOLE 40 MG GASTRO-RESISTANT TABLETS

Active substance(s): ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM / ESOMEPRAZOLE MAGNESIUM AMORPHOUS / ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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180 mm
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- Phenytoin (used in epilepsy). If you are taking phenytoin,
your doctor will need to monitor you when you start or
stop taking Esomeprazole.
- 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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
- Cilostazol (used to treat intermittent claudication – a pain
in your legs when you walk which is caused by an
Read all of this leaflet carefully before you start taking this
insufficient blood supply).
medicine.
- Cisapride (used for indigestion and heartburn). Digoxin
- Keep this leaflet. You may need to read it again.
(used for heart problems).
- If you have any further questions, ask your doctor or
- Methotrexate (a chemotherapy medicine used in high
pharmacist.
doses to treat cancer) – if you are taking a high dose of
- This medicine has been prescribed for you. Do not pass
methotrexate, your doctor may temporarily stop your
it on to others. It may harm them, even if their
Esomeprazole treatment.
symptoms are the same as yours.
- Tacrolimus (organ transplantation).
- If any of the side effects gets serious, or if you notice any
- Rifampicin (used for treatment of tuberculosis).
side effects not listed in this leaflet, please tell your
- St. John’s wort (Hypericum perforatum) (used to treat
doctor or pharmacist.
depression).
In this leaflet
If your doctor has prescribed the antibiotics amoxicillin
and clarithromycin as well as Esomeprazole
1. What Esomeprazole is and what it is used for
Gastro-resistant Tablets to treat ulcers caused by
2. Before you take Esomeprazole
Helicobacter pylori infection, it is very important that you
3. How to take Esomeprazole
tell your doctor about any other medicines you are taking.
4. Possible side effects
Pregnancy, breast-feeding and fertility
5. How to store Esomeprazole
Before taking Esomeprazole tell your doctor if you are
6. Further information
pregnant or breast-feeding or trying to get pregnant. Ask
your doctor or pharmacist for advice before taking any
WHAT ESOMEPRAZOLE IS AND WHAT IT IS
medicine. Your doctor will decide whether you can take
USED FOR
Esomeprazole during this time.
Esomeprazole 20 mg and 40 mg Gastro-resistant Tablets
It is not known if Esomeprazole passes into breast milk.
contains a medicine called esomeprazole. This belongs to a
Therefore, you should not take Esomeprazole if you are
group of medicines called ‘proton pump inhibitors’. They
breast-feeding.
work by reducing the amount of acid that your stomach
Taking Esomeprazole with food and drink
produces.
You can take your tablets with food or on an empty
Esomeprazole is used to treat the following conditions:
stomach.
Adults
Driving and using machines
- ‘Gastroesophageal reflux disease’ (GERD). This is where
Esomeprazole is not likely to affect you being able to drive
acid from the stomach escapes into the gullet (the tube
or use any tools or machines. However, side effects such
which connects your throat to your stomach) causing
as dizziness and blurred vision may uncommonly or rarely
pain, inflammation and heartburn.
occur (see section 4). If affected, you should not drive or
- Ulcers in the stomach or upper part of the gut (intestine)
use machines.
that are infected with bacteria called ’Helicobacter
Esomeprazole Gastro-resistant Tablets contains sucrose
pylori’. If you have this condition, your doctor may also
and lactose
prescribe antibiotics to treat the infection and allow the
Esomeprazole Gastro-resistant Tablets contain sucrose and
ulcer to heal.
lactose, which are types of sugar. If you have been told by
- Stomach ulcers caused by medicines called NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole your doctor that you have an intolerance to some sugars,
can also be used to stop stomach ulcers from forming if talk to your doctor before taking this medicine.
you are taking NSAIDs.
HOW TO TAKE ESOMEPRAZOLE
- Too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome).
Always take Esomeprazole exactly as your doctor has told
- Prolonged treatment after prevention of rebleeding of
you. You should check with your doctor or pharmacist if
ulcers with intravenous esomeprazole.
you are not sure.
Adolescents aged 12 years and above
- Esomeprazole is not recommended for children less
- ‘Gastroesophageal reflux disease’ (GERD). This is where
than 12 years old.
acid from the stomach escapes into the gullet (the tube
- If you are taking this medicine for a long time, your
which connects your throat to your stomach) causing
doctor will want to monitor you (particularly if you are
pain, inflammation and heartburn.
taking it for more than a year).
- Ulcers in the stomach or upper part of the gut (intestine) - If your doctor has told you to take this medicine as and
that are infected with bacteria called ’Helicobacter
when you need it, tell your doctor if your symptoms
pylori’. If you have this condition, your doctor may also
change.
prescribe antibiotics to treat the infection and allow the
How much to take
ulcer to heal.
- Your doctor will tell you how many tablets to take and
BEFORE YOU TAKE ESOMEPRAZOLE
how long to take them for. This will depend on your
condition, how old you are and how well your liver
Do not take Esomeprazole:
works.
- If you are allergic (hypersensitive) to esomeprazole or
- The recommended doses are given below.
any of the other ingredients of this medicine (listed in
Adults aged 18 and above
Section 6: Further information).
To treat heartburn caused by gastroesophageal reflux
- If you are allergic to other proton pump inhibitor
medicines (e.g. pantoprazole, lansoprazole, rabeprazole, disease (GERD):
- If your doctor has found that your food pipe (gullet) has
omeprazole)
been slightly damaged, the recommended dose is one
- If you are taking a medicine containing nelfinavir (used
Esomeprazole 40 mg gastro-resistant tablet once a day
to treat HIV infection ).
for 4 weeks. Your doctor may tell you to take the same
Do not take Esomeprazole if any of the above apply to you.
dose for a further 4 weeks if your gullet has not yet
If you are not sure, talk to your doctor or pharmacist
healed.
before taking Esomeprazole.
- The recommended dose once the gullet has healed is
Take special care with Esomeprazole
one Esomeprazole 20 mg gastro-resistant tablet once a
Check with your doctor or pharmacist before taking
day.
Esomeprazole :
- If your gullet has not been damaged, the recommended
- If you have severe liver problems
dose is one Esomeprazole 20 mg gastro-resistant tablet
- If you have severe kidney problems
each day. Once the condition has been controlled, your
- If you have ever had a skin reaction after treatment with
doctor may tell you to take your medicine as and when
a medicine similar to Esomeprazole that reduces
you need it, up to a maximum of one Esomeprazole
stomach acid.
20 mg gastro-resistant tablet each day.
- If you are due to have a specific blood test
- If you have severe liver problems, your doctor may give
(Chromogranin A).
you a lower dose.
Esomeprazole may hide the symptoms of other diseases.
To treat ulcers caused by Helicobacter pylori infection and
Therefore, if any of the following happen to you before you to stop them coming back:
start taking Esomeprazole or while you are taking it, talk
- The recommended dose is one Esomeprazole 20 mg
to your doctor straight away:
gastro-resistant tablet twice a day for one week.
- You lose a lot of weight for no reason and have
- Your doctor will also tell you to take antibiotics for
problems swallowing.
example amoxicillin and clarithromycin.
- You get stomach pain or indigestion.
To treat stomach ulcers caused by NSAIDs (Non-Steroidal
- You begin to vomit food or blood.
Anti-Inflammatory Drugs):
- You pass black stools (blood-stained faeces).
- The recommended dose is one Esomeprazole 20 mg
If you have been prescribed Esomeprazole “on demand”
gastro-resistant tablet once a day for 4 to 8 weeks.
you should contact your doctor if your symptoms continue
To prevent stomach ulcers if you are taking NSAIDs
or change in character.
(Non-Steroidal Anti-Inflammatory Drugs):
Taking a proton pump inhibitor like Esomeprazole,
- The recommended dose is one Esomeprazole 20 mg
especially over a period of more than one year, may
gastro-resistant tablet once a day.
slightly increase your risk of fracture in the hip, wrist or
To treat too much acid in the stomach caused by a growth
spine. Tell your doctor if you have osteoporosis or if you
in the pancreas (Zollinger-Ellison syndrome):
are taking corticosteroids (which can increase the risk of
- The recommended dose is one Esomeprazole 40 mg
osteoporosis).
gastro-resistant tablet twice a day.
If you get a rash on your skin, especially in areas exposed - Your doctor will adjust the dose depending on your
to the sun tell your doctor as soon as you can, as you may
needs and will also decide how long you need to take
need to stop your treatment with Esomeprazole.
the medicine for. The maximum dose is 80 mg twice a
Remember to also mention any other ill-effects like pain in
day.
your joints.
Prolonged treatment after prevention of rebleeding of
Taking other medicines
ulcers with intravenous Esomeprazole:
The recommended dose is one Esomeprazole 40 mg tablet
Please tell your doctor or pharmacist if you are taking or
once a day for 4 weeks.
have recently taken or might take any other medicines,
This includes medicines that you buy without a
Adolescents aged 12 or above
prescription. This is because Esomeprazole can affect the
To treat heartburn caused by gastroesophageal reflux
way some medicines work and some medicines can have
disease (GERD):
an effect on Esomeprazole.
- If your doctor has found that your food pipe (gullet) has
Do not take Esomeprazole if you are taking a medicine
been slightly damaged, the recommended dose is one
containing nelfinavir (used to treat HIV infection).
Esomeprazole 40 mg gastro-resistant tablet once a day
for 4 weeks. Your doctor may tell you to take the same
Tell your doctor or pharmacist if you are taking any of the
dose for a further 4 weeks if your gullet has not yet
following medicines:
healed.
- Atazanavir (used to treat HIV infection).
- The recommended dose once the gullet has healed is
- Clopidogrel (used to prevent blood clots).
one Esomeprazole 20 mg gastro-resistant tablet once a
- Ketoconazole, itraconazole or voriconazole (used to treat
day.
infections caused by a fungus).
- If your gullet has not been damaged, the recommended
- Erlotinib (used to treat cancer).
dose is one Esomeprazole 20 mg gastro-resistant tablet
- Citalopram, imipramine or clomipramine (used to treat
each day.
depression).
- If you have severe liver problems, your doctor may give
- Diazepam (used to treat anxiety, relax muscles or in
you a lower dose.
epilepsy).

Pharmacode area

Esomeprazole 20 mg
Gastro-resistant Tablets
Esomeprazole 40 mg
Gastro-resistant Tablets

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3

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Pharmacode area

180 x 450 mm Front/Back

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
450 mm
180 mm
N/A
N/A

Colours Used:

Pharmacode area

To treat ulcers caused by Helicobacter pylori infection and
to stop them coming back:
- The recommended 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.
Taking this medicine
- You can take your tablets at any time of the day.
- You can take your tablets with food or on an empty
stomach.
- Swallow your tablets whole with a drink of water. Do not
chew or crush the tablets. This is because the tablets
contain coated pellets which stop the medicine from
being broken down by the acid in your stomach. It is
important not to damage the pellets.
What to do if you have trouble swallowing the tablets
- If you have trouble swallowing the tablets:
• Put them into a glass of still (non-fizzy) water. Do not
use any other liquids.
• Stir until the tablets break up (the mixture will not be
clear). Then drink the mixture straight away or within
30 minutes. Always stir the mixture just before
drinking it.
• To make sure that you have drunk all of the medicine,
rinse the glass very well with half a glass of water and
drink it. The solid pieces contain the medicine - do not
chew or crush them.
- If you cannot swallow at all, the tablet can be mixed with
some water and put into a syringe. It can then be given
to you through a tube directly into your stomach
(‘gastric tube’).
Elderly
Dose adjustment is not required in the elderly.
If you take more Esomeprazole than you should
If you take more Esomeprazole Gastro-resistant Tablets
than prescribed by your doctor, talk to your doctor or
pharmacist straight away.

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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.
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 ESOMEPRAZOLE

Keep out of the reach and sight of children.
Do not use Esomeprazole after the expiry date which is
stated on the carton, bottle and blister after EXP. The expiry
date refers to the last day of that month.
Store in the original package in order to protect from light
and moisture.
Esomeprazole should be used no longer than 100 days
after first opening of the bottle.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

What Esomeprazole 20 mg and 40 mg Gastro-resistant
Tablets contain
- The active substance is esomeprazole. Esomperazole
If you forget to take Esomeprazole
gastro-resistant tablets come in two strengths
If you forget to take a dose, take it as soon as you
containing 20 mg or 40 mg of esomeprazole (as
remember it. However, if it is almost time for your next
esomeprazole magnesium).
dose, skip the missed dose.
Do not take a double dose (two doses at the same time) to - The other ingredients are:
Seal coated sugar spheres: Sugar spheres (sucrose and
make up for a forgotten dose.
maize starch), ethylcellulose, magnesium stearate
POSSIBLE SIDE EFFECTS
Drug coat: Povidone K 90, magnesium oxide, light
(E 530)
Like all medicines, Esomeprazole can cause side effects,
Barrier coat: Povidone, magnesium oxide, light (E 530),
although not everybody gets them.
magnesium stearate
If you notice any of the following serious side effects, stop
Enteric coat: Methacrylic acid - ethyl acrylate copolymer
taking Esomeprazole and contact a doctor immediately:
(1:1) dispersion 30 per cent (contains sodium
- Sudden wheezing, swelling of your lips, tongue and
laurilsulfate and polysorbate 80), diethyl phthalate, talc
throat or body, rash, fainting or difficulties in swallowing
(E 553b)
(severe allergic reaction).
- Reddening of the skin with blisters or peeling. There may
Tablet core: Silicified microcrystalline cellulose
also be severe blisters and bleeding in the lips, eyes,
(microcrystalline cellulose and colloidal anhydrous
mouth, nose and genitals. This could be
silica), starlac (lactose monohydrate and maize starch),
‘Stevens-Johnson syndrome’ or ‘toxic epidermal
copovidone K 28, macrogol 8000, crospovidone, silica
necrolysis’.
colloidal, anhydrous, magnesium stearate
- Yellow skin, dark urine and tiredness which can be
Film coat: Hypromellose (E 464), macrogol 8000, talc
symptoms of liver problems.
(E 553b), titanium dioxide (E 171), silica colloidal,
- If you have an infection with symptoms such as fever
anhydrous, iron oxide red (E172)
with a severely reduced general condition or fever with
Imprint: Opacode S-1-17823 black ink (contains
symptoms of a local infection such as pain in the neck,
propylene glycol, iron oxide black (E172), shellac glaze)
throat or mouth or difficulties in urinating, you must
consult your doctor as soon as possible so that a lack of What Esomeprazole looks like and contents of the pack
white blood cells (agranulocytosis) can be ruled out by a Esomeprazole 20 mg gastro-resistant tablets
blood test. It is important for you to give information
Brick-red coloured, round shape, biconvex, film-coated
about your medication at this time.
tablet, imprinted with “20” on one side and plain on the
other side.
These effects are rare, and may affect up to 1 in 1,000
people.
Esomeprazole 40 mg gastro-resistant tablets
Brick-red coloured, round shape, bevelled edge, biconvex,
Other side effects include:
film-coated tablet, imprinted with “40” on one side and
Common: affects 1 to 10 users in 100
plain on the other side.
- Headache.
- Effects on your stomach or gut: diarrhoea, stomach pain, Blister (Aluminium/Aluminium) or HDPE container (HDPE
container of neck finish and PP closure with induction
constipation, wind (flatulence).
sealing wad and a silica gel canister as desiccant).
- Feeling sick (nausea) or being sick (vomiting).
Pack sizes:
Uncommon: affects 1 to 10 users in 1,000
- Swelling of the feet and ankles.
20 mg, blister: 7, 14, 28, 30, 56, 60, 98, 100 gastro-resistant
- Disturbed sleep (insomnia).
tablets
- Dizziness, tingling feelings such as “pins and needles”,
20 mg, HPDE container: 14, 28, 56, 98, 100 gastro-resistant
feeling sleepy.
tablets
- Spinning feeling (vertigo).
40 mg, blister: 14, 28, 30, 56, 60, 98, 100 gastro-resistant
- Dry mouth.
tablets
- Changes in blood tests that check how the liver is
40 mg, HPDE container: 14, 28, 56, 98, 100 gastro-resistant
working.
tablets
- Skin rash, lumpy rash (hives) and itchy skin
Not all pack sizes may be marketed.
- Fracture of the hip, wrist or spine (if Esomeprazole is

4

180 x 450 mm Front/Back

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Teva UK Limited,
Eastbourne, BN22 9AG, United Kingdom
Manufacturer: Merckle GmbH, Ludwig-Merckle-Strasse 3,
D-89143 Blaubeuren, Germany
This leaflet was last revised in October 2016.
PL 00289/1491 and PL 00289/1492
The following information is intended for healthcare
professionals only:
Administration through gastric tube
1. Put the tablet into an appropriate syringe and fill the
syringe with approximately 25 mL water and
approximately 5 mL air. For some tubes, dispersion in
50 mL water is needed to prevent the pellets from
clogging the tube.
2. Immediately shake the syringe for approximately
2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip
has not clogged.
4. Attach the syringe to the tube whilst maintaining the
above position.
5. Shake the syringe and position it with the tip pointing
down. Immediately inject 5-10 mL into the tube. Invert
the syringe after injection and shake (the syringe must
be held with the tip pointing up to avoid clogging of the
tip).
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.

88292-I
192981.06-GB (TBC)

Pharmacode area

used in high doses and over long duration).
Rare: affects 1 to 10 users in 10,000
- Blood problems such as a reduced number of white cells
or platelets. This can cause weakness, bruising or make
infections more likely.
- Low levels of sodium in the blood. This may cause
weakness, being sick (vomiting) and cramps.
- Feeling agitated, confused or depressed.
- Taste changes.
- Eyesight problems such as blurred vision.
- Suddenly feeling wheezy or short of breath
(bronchospasm).
- An inflammation of the inside of the mouth.
- An infection called “thrush” which can affect the gut and
is caused by a fungus.
- Liver problems, including jaundice which can cause
yellow skin, dark urine, and tiredness.
- Hair loss (alopecia).
- Skin rash on exposure to sunshine.
- Joint pains (arthralgia) or muscle pains (myalgia).
- Generally feeling unwell and lacking energy.
- Increased sweating.
Very rare: affects less than 1 user in 10,000
- 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.
Esomeprazole may in very rare cases affect the white
blood cells leading to immune deficiency.
Not known: frequency cannot be estimated from the
available data
- If you are on Esomeprazole for more than three months
it is possible that the levels of magnesium in your blood
may fall. Low levels of magnesium can be seen as
fatigue, involuntary muscle contractions, disorientation,

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