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ESOMEPRAZOLE 40MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Esomeprazole 20mg and 40mg
Gastro-resistant Capsules
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. see section 4.
• The full name of this medicine is Esomeprazole 20mg
and 40mg Gastro-resistant Capsules but within the
leaflet it will be referred to as Esomeprazole capsules.

What is in this leaflet:
1 What Esomeprazole capsules are and what
they are used for
2 What you need to know before you take
Esomeprazole capsules
3 How to take Esomeprazole capsules
4 Possible side effects
5 How to store Esomeprazole capsules
6 Contents of the pack and other information
1 What Esomeprazole capsules are and what

they are used for

Esomeprazole capsules 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.
Esomeprazole capsules are used to treat the following
conditions:
Adults and adolescents aged 12 years and above
• ‘Gastro-oesophageal reflux disease’ (GORD). This is
where acid from the stomach escapes into the gullet
(the tube which connects your throat to your stomach)
causing pain, inflammation and heartburn
• 
ulcers in the stomach or upper part of the gut
(intestine) that are infected with bacteria called
“Helicobacter pylori”. If you have this condition, your
doctor may also prescribe antibiotics to treat the
infection and allow the ulcer to heal
Adults
• 
stomach ulcers caused by medicines called NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole
capsules 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

2 What you need to know before you take

Esomeprazole capsules

Do not take Esomeprazole capsules if you

• are allergic to esomeprazole or any of the other
ingredients of this medicine (listed in Section 6)
• are allergic to other proton pump inhibitor
medicines (e.g. pantoprazole, lansoprazole, rabeprazole,
omeprazole)
• are taking a medicine containing nelfinavir (used to
treat HIV infection).
Do not take Esomeprazole capsules if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Esomeprazole capsules.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Esomeprazole capsules if you:
• have severe liver problems
• have severe kidney problems
Esomeprazole capsules may hide the symptoms of other
diseases. Therefore, if any of the following happen to
you before you start taking Esomeprazole capsules
or while you are taking it, talk to your doctor straight
away:
• you lose a lot of weight for no reason and have
problems swallowing
• you get stomach pain or indigestion
• you begin to vomit food or blood
• you pass black stools (blood-stained faeces)
If you have been prescribed Esomeprazole capsules “on
demand” you should contact your doctor if your symptoms
continue or change in character.
Talk to your doctor if you experience severe or persistent
diarrhoea; esomeprazole has been associated with a small
increased risk of infectious diarrhoea.
Taking a proton pump inhibitor like Esomperazole Capsules,
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

Esomperazole Capsules should not be used in children
younger than 12 years. More appropriate pharmaceutical
forms of this medicine may be available.

Other medicines and Esomeprazole capsules

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This is
because Esomeprazole capsules can affect the way some
medicines work and some medicines can have an effect on
Esomeprazole capsules.

Do not take Esomeprazole capsules 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 or saquinavir (used to treat HIV infection).
• 
clopidogrel (used to prevent blood clots).
• 
ketoconazole, itraconazole or voriconazole (used to
treat infections caused by a fungus).
• 
erlotinib (used to treat cancer).
• 
citalopram, imipramine or clomipramine (used to
treat depression).
• 
diazepam (used to treat anxiety, relax muscles or in
epilepsy).
• 
phenytoin (used in epilepsy). If you are taking
phenytoin, your doctor will need to monitor you when
you start or stop taking Esomeprazole capsules.
• 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 capsules.
• 
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 capsules 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 Esomeprazole capsules to
treat ulcers caused by Helicobacter pylori infection, it is
very important that you tell your doctor about any other
medicines you are taking.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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
capsules during this time.
It is not known if Esomeprazole capsules passes into breast
milk. Therefore, you should not take Esomeprazole capsules
if you are breast-feeding.

Driving and using machines

Esomeprazole capsules is not likely to affect your ability 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 capsules contain sucrose and
parahydroxybenzoates (E216 and E218)

Esomeprazole capsules contain sugar spheres which
contain sucrose, a type of sugar, propyl-p-hydroxybenzoate
(E216) and methyl-p-hydroxybenzoate (E218):
• If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before
taking this medicine.
• Parahydroxybenzoates may cause allergic reactions
(possibly delayed).

3 How to take Esomeprazole capsules
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 capsules to take and
how long to take them for. This will depend on your
condition, how old you are and how well your liver works.
The recommended doses are given below.
To treat heartburn caused by gastro-oesophageal reflux
disease (GORD):
Adults and adolescents aged 12 years or above:
• If your doctor has found that your food pipe (gullet) has
been slightly damaged, the recommended dose is one
capsule of Esomeprazole 40mg 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 capsule of Esomeprazole 20mg once a day
• If your gullet has not been damaged, the recommended
dose is one capsule Esomeprazole 20mg 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 capsule of Esomeprazole 20mg
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:
Adults and young people aged 12 or above:
• The recommended dose is one capsule of Esomeprazole
20mg twice a day for one week
• Your doctor will also tell you to take antibiotics for
example amoxicillin and clarithromycin
To treat stomach ulcers caused by NSAIDs (NonSteroidal Anti-Inflammatory Drugs):
Adults aged 18 and above:
• The recommended dose is one capsule of Esomeprazole
20mg once a day for 4 to 8 weeks

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AAAH7475

The following information is intended for healthcare professionals only:
Administration through gastric tube
1. Add the contents of a capsule into approximately 25 ml or
50 ml of water. (For some tubes, dispersion in 50 ml water
is needed to prevent the granules from clogging the
tube).
Stir.
2. Draw the suspension into a syringe and add
approximately 5 ml of air.

3. Immediately shake the syringe for approximately
2 minutes to disperse the granules.
4. Hold the syringe with the tip up and check that the tip has
not clogged.
5. Attach the syringe to the tube whilst maintaining the
above position.

Esomeprazole 20mg & 40mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAH7475

dimensions:

print proof no:

4

pharmacode:

origination date: 10.03.15
approved for print/date

min pt size:

190 x 600

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

21.07.15

Technical Approval

revised by:

sa

date sent:

supplier:

Dupnitsa

technically app. date: 12.03.15

10.03.15

Non Printing Colours
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To prevent stomach ulcers if you are taking NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):
Adults aged 18 and above:
• The recommended dose is one capsule of Esomeprazole
20mg once a day.
To treat too much acid in the stomach caused by a
growth in the pancreas (Zollinger-Ellison syndrome):
Adults aged 18 and above:
• The recommended dose is one capsule of Esomeprazole
40mg 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 80mg twice a
day.
To be used as prolonged treatment after prevention of
rebleeding of ulcers with intravenous Esomeprazole:
Adults aged 18 years and above:
-The recommended dose is one capsule of Esomeprazole
40mg once a day for 4 weeks.
Taking this medicine
• You can take your capsules at any time of the day.
• You can take your capsules with food or on an empty
stomach.
• Swallow your capsules whole with a glass of water. Do
not chew or crush the capsules or their contents. This
is because the capsules contain coated granules which
stop the medicine from being broken down by the
acid in your stomach. It is important not to damage the
granules.
What to do if you have trouble swallowing the capsules
• If you have trouble swallowing the capsules:
• Open the capsule carefully above half a glass of still
(non-fizzy) water and empty the content of the capsule
(granules) into the glass. Do not use any other liquids.
• Stir. 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 content of the capsule
can be mixed with some water and put into a syringe.
It can then be given to you through a tube directly into
your stomach (‘gastric tube’).
Children under the age of 12 years
Esomeprazole capsules should not be used in children
younger than 12 years. More appropriate pharmaceutical
forms of this medicine may be available.
Older people
Dose adjustment is not required in the elderly.

If you take more Esomeprazole capsules than you
should

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

Very rare (may affect up to 1 in 10,000 people)
• changes in blood count including agranulocytosis (lack
of white blood cells) (see *below)
• aggression
• seeing, feeling or hearing things that are not there
(hallucinations)
• severe liver problems leading to liver failure and
inflammation of the brain
• muscle weakness
• severe kidney problems
• enlarged breasts in men
Not known (frequency cannot be estimated from the
available data)
• inflammation in the gut (leading to diarrhoea)
• If you are on Esomeprazole capsules 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, 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.
*Esomeprazole capsules 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 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 capsules
• Keep this medicine out of the sight and reach of
children.
• Do not store above 25°C.
• Keep this medicine in the original container (blister) or
keep the container tightly closed (bottle) in order to
protect from moisture.
• Do not use this medicine after the expiry date which is
stated on the carton, bottle or blister foil after ‘EXP’. The
expiry date refers to the last day of that month.
• After opening the bottle, the capsules should be used
within 3 months.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

If you forget to take Esomeprazole capsules

• If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your next
dose, skip the missed dose.
• Do not take a double dose (two doses at the same time)
to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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

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

• sudden wheezing, swelling of your lips, tongue and
throat or body, rash, fainting or difficulties in swallowing
(severe allergic reaction, seen rarely)
• 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 ‘erythema
multiforme’, ‘Stevens-Johnson syndrome’ or ‘toxic
epidermal necrolysis’, seen very rarely
• yellow skin, dark urine and tiredness which can be
symptoms of liver problems, seen rarely.
Other side effects include:
Common (may affect up to 1 in 10 people)
• headache
• effects on your stomach or gut: diarrhoea, stomach pain,
constipation, wind (flatulence)
• feeling sick (nausea) or being sick (vomiting)
Uncommon (may affect up to 1 in 100 people)
• swelling of the feet and ankles
• disturbed sleep (insomnia)
• dizziness, tingling feelings such as “pins and needles”,
feeling sleepy
• spinning feeling (vertigo)
• dry mouth
• changes in blood tests that check how the liver is
working
• skin rash, lumpy rash (hives) and itchy skin
• fracture of the hip, wrist or spine (if Esomeprazole
capsules is used in high doses and over long duration)
Rare (may affect up to 1 in 1,000 people)
• blood problems such as a reduced number of white cells
or platelets. This can cause weakness, bruising or make
infections more likely
• low levels of sodium in the blood. This may cause
weakness, being sick (vomiting) and cramps
• feeling agitated, confused or depressed
• taste changes
• eyesight problems such as blurred vision
• suddenly feeling wheezy or short of breath
(bronchospasm)
• an inflammation of the inside of the mouth
• an infection called “thrush” which can affect the gut and
is caused by a fungus
• hair loss (alopecia)
• skin rash on exposure to sunshine
• joint pains (arthralgia) or muscle pains (myalgia)
• generally feeling unwell and lacking energy
• increased sweating

6 Contents of the pack and other information

What Esomeprazole capsules contain

• The active substance is esomeprazole.
Esomeprazole capsules come in two strengths
containing 20mg or 40mg of esomeprazole (as
magnesium dihydrate).
• The other ingredients are:
Capsule content: sugar spheres (sucrose and maize starch),
hypromellose, dimethicone emulsion 35% (containing
dimethicone, propyl-p-hydroxybenzoate (E216), methylp-hydroxybenzoate (E218), sorbic acid, sodium benzoate,
polyethylene glycol sorbitan monolaureate, octylphenoxy
polyethoxy ethanol and propylene glycol), polysorbate 80,
mannitol, diacetylated monoglycerides, talc, methacrylic
acid-ethyl acrylate copolymer (1:1) dispersion 30 %
(containing copolymer of methacrylic acid and ethyl
acrylate, sodium lauryl sulfate and polysorbate 80, triethyl
citrate and stearoyl macrogolglycerides.
Capsule shell: black iron oxide (E 172), shellac, gelatin,
yellow iron oxide (E 172) and titanium dioxide (E 171).

What Esomeprazole capsules look like and
contents of the pack

• Esomeprazole 20mg capsules have an opaque yellow
cap and an opaque white body. “20mg” is printed in
black both on the cap and on the body.
• Esomeprazole 40mg capsules have an opaque yellow
cap and an opaque yellow body. “40mg” is printed in
black both on the cap and on the body.
• Your capsules will come in packs of 28 capsules
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturers
Famar l’Aigle
Z.I. N°1, Route de Crulai
61300 L’Aigle
France
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in July 2015.

If you would like a
leaflet with larger
text, please contact
01271 385257.

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Actavis, Barnstaple, EX32 8NS, UK

AAAH7475

6. 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).
7. 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.
8. Fill the syringe with 25 ml of water and 5 ml of air and
repeat step 6 if necessary to wash down any sediment left
in the syringe. For some tubes, 50 ml water is needed.
AAAH7475

Esomeprazole 20mg & 40mg capsule leaflet - UK

colours/plates:
1. Black

item no:

AAAH7475

dimensions:

print proof no:

4

pharmacode:

origination date: 10.03.15
approved for print/date

min pt size:

190 x 600

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

21.07.15

Technical Approval

revised by:

sa

date sent:

supplier:

Dupnitsa

technically app. date: 12.03.15

10.03.15

Non Printing Colours
1.
2.
3.

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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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