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ESOMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES HARD

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

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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 and contact a
doctor immediately:
• sudden wheezing, swelling of your lips, tongue and
throat or body, rash, fainting or difficulties in
swallowing (severe allergic reaction)
• reddening of the skin with blisters or peeling. There
may also be severe blisters and bleeding in the lips,
eyes, mouth, nose and genitals. This could be
‘Stevens-Johnson syndrome’ or ‘toxic epidermal
necrolysis’.
• yellow skin, dark urine and tiredness which can be
symptoms of liver problems.
These effects are rare, affecting less than 1 in 1,000
people.
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 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
• 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 (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

What Esomeprazole contains
The active substance is esomeprazole. Esomeprazole
gastro-resistant capsules come in two strengths
containing 20 mg or 40 mg of esomeprazole (as
magnesium dihydrate).
The other ingredients are:
Capsule content
Raw pellets: carrageenan; cellulose, microcrystalline;
mannitol; sodium hydroxide; sodium hydrogen
carbonate
Isolation coat: polyvinylalcohol-PEG copolymer;
sodium hydroxide; talc; titanium dioxide (E171); silica,
colloidal hydrated
Gastro-resistant coat: methacrylic acid-ethyl acrylate
copolymer (1:1); triethyl citrate; talc; titanium dioxide
(E171)
Capsule
Esomeprazole 20 mg gastro-resistant capsules:
Cap: gelatin; titanium dioxide (E171); iron oxide yellow
(E172)
Body: gelatin; titanium dioxide (E171)
Esomeprazole 40 mg gastro-resistant capsules:
Cap: gelatin; iron oxide red (E172); titanium dioxide
(E171); iron oxide yellow (E172)
Body: gelatin; titanium dioxide (E171)
What Esomeprazole looks like and contents of the
pack
Esomeprazole 20 mg gastro-resistant capsules:
Gastro-resistant capsules, hard with a white opaque
body and a light yellow opaque cap containing white
to off-white gastro-resistant pellets.
Esomeprazole 40 mg gastro-resistant capsules:
Gastro-resistant capsules, hard with a white opaque
body and a light orange opaque cap containing white
to off-white gastro-resistant pellets.
Your capsules will come in HDPE plastic bottles with a
desiccant capsule contained in the PP caps or in
aluminium-aluminium blisters. Do not eat the
desiccant capsule.
Pack sizes:
14, 15, 28, 30, 50, 60, 90 and 100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Str. 8-10, 13435 Berlin, Germany
Manufacturer
Medinsa (Laboratorios Medicamentos
Internacionales S.A.)
c/ Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain
Distributed by
Creo Pharma Ltd
Felsted Business Centre
Felsted, Essex CM6 3LY
This leaflet was last revised in 05/2015
CRE-ESOCRE-PIL-122_08
22/06/2015

Important
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4. Possible side effects

6. Contents of the pack and other
information

Typefaces

Do not take Esomeprazole
• 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 if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking Esomeprazole.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Esomeprazole
• if you have severe liver problems.
• if you have severe kidney problems.
Esomeprazole may hide the symptoms of other
diseases. Therefore, if any of the following happen
to you before you start taking Esomeprazole 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 “on
demand” you should contact your doctor if your
symptoms continue or change in character.
Taking a proton pump inhibitor like Esomeprazole,
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 and adolescents
Esomeprazole is not recommended for children less
than 12 years old.
Other medicines and Esomeprazole
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 can affect
the way some medicines work and some medicines
can have an effect on Esomeprazole.
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 (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)

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.
Adults aged 18 and above
To treat heartburn caused by gastro-esophageal
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 capsule
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 capsule
once a day.
• If your gullet has not been damaged, the
recommended dose is one Esomeprazole 20 mg
gastro-resistant capsule 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 capsule 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:
• The recommended dose is one Esomeprazole 20 mg
gastro-resistant capsule 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
(Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is one Esomeprazole 20 mg
gastro-resistant capsule once a day for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is one Esomeprazole
20 mg gastro-resistant capsule 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 one Esomeprazole
40 mg gastro-resistant capsule 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.
Prolonged treatment after prevention of
rebleeding of ulcers with intravenous
esomeprazole:
• The recommended dose is one Esomeprazole 40 mg
gastro-resistant capsule once a day for 4 weeks.
Adolescents aged 12 or above
To treat heartburn caused by gastro-esophageal
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 capsule

• Keep this medicine out of the sight and reach of
children.
• Do not store above 25 °C.
• Store this medicine in the original package (blister)
or keep the bottle tightly closed in order to protect
from moisture.
• Do not use this medicine after the expiry date which
is stated on the carton after “EXP”. The expiry date
refers to the last day of that month.
• 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 protect the environment.

Process
Black

2. What you need to know before you take
Esomeprazole

3. How to take Esomeprazole

5. How to store Esomeprazole

Reason for Draft
New file
Add Creo refs
Aristo logo
New revision date and manu address correction
Text correction
Text revision
Major text revisions
Text revisions

Esomeprazole 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.
Esomeprazole is used to treat the following conditions:
Adults
• ‘Gastro-esophageal 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
(Non-Steroidal Anti-Inflammatory Drugs).
Esomeprazole 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
re-bleeding of ulcers with intravenous
esomeprazole.
Adolescents aged 12 years and above
• ‘Gastro-esophageal 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.

Date
10/09/2014
20/11/2014
08/04/2015
13/04/2015
15/04/2015
20/04/2015
18/06/2005
22/06/2015

1. What Esomeprazole is and what it is
used for

No. of Draft
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What is in this leaflet
1. What Esomeprazole is and what it is used for
2. What you need to know before you take
Esomeprazole
3. How to take Esomeprazole
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information

• 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.
• 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.
• 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 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
to treat ulcers caused by Helicobacter pylori infection, it
is very important that you tell your doctor about any
other medicines you are taking.
Esomeprazole with food and drink
You can take your capsules with food or on an empty
stomach.
Pregnancy and breast-feeding
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 during this time.
It is not known if Esomeprazole passes into breast
milk. Therefore, you should not take Esomeprazole if
you are breastfeeding.
Driving and using machines
Esomeprazole 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 “Possible
side effects”). If affected, you should not drive or use
machines.

10/09/2014
Creo Pharma
UK
CRE-ESOARI-PIL-122

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.

• 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 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 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via Yellow Card Scheme; website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Date
Client
Country
Job No.

Esomeprazole

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 capsule
once a day.
• If your gullet has not been damaged, the
recommended dose is one Esomeprazole 20 mg
gastro-resistant capsule 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:
• The recommended dose is one Esomeprazole 20 mg
gastro-resistant capsule 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 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 drink of water.
Do not chew or crush the capsules. This is because
the capsules 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
capsules
• If you have trouble swallowing the capsules:
◦ Open the capsule and disperse the content in
half a glass of still (non-fizzy) water. 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. The mixture will not be clear.
◦ 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.
Children under the age of 12 years
Esomeprazole is not recommended for children less
than 12 years old.
Older people
Dose adjustment is not required in the elderly.
If you take more Esomeprazole than you should
If you take more Esomeprazole than prescribed by
your doctor, talk to your doctor or pharmacist straight
away.
If you forget to take Esomeprazole
• 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.

Esomeprazole Capsules
20 mg & 40 mg
Aristo Pharma
165 x 450 mm
1

Esomeprazole 20 mg gastro-resistant capsules, hard
Esomeprazole 40 mg gastro-resistant capsules, hard

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Strength
Supplier
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Package leaflet: Information for the patient

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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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