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EMOZUL 40 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Package leaflet:
Information for the patient

Emozul 20 mg
gastro-resistant capsules, hard

Emozul 40 mg
gastro-resistant capsules, hard
Esomeprazole
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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
In this leaflet:
1. What Emozul is and what it is used for
2. What you need to know before you take
Emozul
3. How to take Emozul
4. Possible side effects
5. How to store Emozul
6. Contents of the pack and other information

1. WHAT EMOZUL IS AND WHAT IT IS USED
FOR
Emozul contains a medicine called
esomeprazole magnesium dihydrate. This
belongs to a group of medicines called “proton
pump inhibitors”.They work by reducing the
amount of acid that your stomach produces.
Emozul is used to treat the following
conditions:
Adults and young people 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). Emozul 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 Emozul
Do not take Emozul if:
• You are allergic to esomeprazole or any of
the other ingredients of this medicine (listed
in section 6).
• You are allergic to other proton pump
inhibitor medicines (e.g. pantoprazole,
lansoprazole, rabeprazole, omeprazole).
• You are taking a medicine containing
nelfinavir (used to treat HIV).
Do not take Emozul if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking Emozul.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Emozul if:
• You have severe liver problems.
• You have severe kidney problems.
Emozul may hide the symptoms of other
diseases. Therefore, if any of the following
happen to you before you start taking Emozul
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 Emozul “on
demand” you should contact your doctor
if your symptoms continue or change in
character.
If diarrhoea occurs during the treatment with
Emozul contact your doctor immediately,
as treatment with proton pump inhibitors
may lead to a slightly increased risk of
gastrointestinal infections such as Salmonella
and Campylobacter.
Taking a proton pump inhibitor like Emozul,
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).
Other medicines and Emozul
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you
obtained without a prescription. This is because
Emozul can affect the way some medicines
work and some medicines can have an effect
on Emozul.
Do not take Emozul Capsules if you are taking
a medicine containing nelfinavir (used to treat
HIV).
Tell your doctor or pharmacist if you are taking
any of the following medicines:
































Atazanavir (used to treat HIV).
Ketoconazole, itraconazole or voriconazole
(used to treat infections caused by a fungus).
Digoxin (used to treat heart problems).
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 Emozul.
Medicines that are used to thin your blood,
such as warfarin. Your doctor may need to
monitor you when you start or stop taking
Emozul.
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).
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
Emozul treatment.
Rifampicin (to treat tuberculosis).
St John’s Wort (Hypericum perforatum) (used
to treat depression).

If your doctor has prescribed the antibiotics
amoxicillin and clarithromycin as well as
Emozul to treat ulcers caused by Helicobacter
pylori infection, it is very important that you

tell your doctor if you are taking any other
medicines.
Taking Emozul 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 Emozul during
this time.
It is not known if Emozul passes into breast
milk. Therefore, you should not take Emozul if
you are breastfeeding.
Driving and using machines
Emozul is not likely to affect you being able to
drive or use any tools or machines.
Emozul contains sucrose
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 Emozul
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
• Emozul gastro-resistant capsules are not
recommended for children less than 12 years
old.
• 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.
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 empty the pellets
into half a glass of still (non-fizzy) water.
Do not use any other liquids.
- 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 pellets
can be mixed with some water and put into a

syringe. They can then be given to you
through a tube directly into your stomach
(“gastric tube”).
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 usual doses are given below.
To treat heartburn caused by gastrooesophageal reflux disease (GORD):
Adults and children aged 12 or above:
• If your doctor has found that your food pipe
(gullet) has been slightly damaged, the usual
dose is one Emozul 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 usual dose once the gullet has healed is
one Emozul 20 mg gastro-resistant capsule
once a day.
• If your gullet has not been damaged, the
usual dose is one Emozul 20 mg gastroresistant 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
Emozul 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:
• Adults and young people aged 12 or above:
the usual dose is one Emozul 20 mg gastroresistant 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):
• Adults aged 18 and above: the usual dose is
one Emozul 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):
• Adults aged 18 and above: the usual dose is
one Emozul 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):
• Adults aged 18 and above: the usual dose is
one Emozul 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:
• Adults aged 18 and above: the usual dose
is one Emozul 40 mg capsule once a day for
4 weeks.

and bleeding in the lips, eyes, mouth,
nose and genitals. This could be “StevensJohnson syndrome” or “toxic epidermal
necrolysis”.
• Yellow skin, dark urine and tiredness which
can be symptoms of liver problems.

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

These effects are rare, affecting less than 1 in
1,000 people.

If you forget to take Emozul
• 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.

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).

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 Emozul 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

Other side effects include:

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 Emozul
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.
• 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 Emozul 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.
• Inflammation in the gut (leading to
diarrhoea).
Emozul 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.

Do not be concerned by this list of possible side
effects. You may not get any of them.

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 http://yellowcard.
mhra.gov.uk/
• By reporting side effects you can help
provide more information on the safety of
this medicine.
5. HOW TO STORE EMOZUL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the packaging. The expiry
date refers to the last day of that month.
Blister pack consisting of OPA/Al/PE + DES film/
Al foil
This medicinal product does not require any
special temperature storage conditions.
Store in the original package in order to protect
from moisture.
Blister pack consisting of OPA/Al/PVC/Al foil
Do not store above 30°C.
Store in the original package in order to protect
from moisture.

HDPE container
This medicinal product does not require any
special temperature storage conditions.
Keep the container tightly closed in order to
protect from moisture.
After first opening of the container, the product
should be used within 6 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 protect
the environment.
6. FURTHER INFORMATION
What Emozul contains
• The active substance is esomeprazole.
Each gastro-resistant capsule, hard,
contains 20 mg or 40 mg esomeprazole (as
esomeprazole magnesium dihydrate).
• The other ingredients are sugar spheres
(sucrose and maize starch), povidone,
sodium laurilsulfate, poly(vinyl alcohol),
titanium dioxide (E171), macrogol, talc
(E553b), heavy magnesium carbonate,
polysorbate 80 (E433) and methacrylic acid
– ethyl acrylate copolymer (1:1) dispersion
30 per cent in pellets in the capsule, and
gelatine (E441), titanium dioxide (E171) and
red iron oxide (E172) in the capsule shell.
See section 2 “Emozul contains sucrose”.

What Emozul looks like and contents of the
pack
The body and cap of the 20 mg gastro-resistant
capsules, hard, are slightly pink. The capsules
contain white to almost white pellets.
The body and cap of the 40 mg gastro-resistant
capsules, hard, are off-pink. The capsules
contain white to almost white pellets.
The capsules are available in boxes of 7, 10, 14,
15, 28, 30, 50, 56, 60, 90, 98 and 100 capsules
in blister packs, and boxes of 98 capsules and
a desiccant capsule in HDPE containers. Do
not eat the desiccant capsule provided in the
container.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Ltd.,
5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2,
Ireland
Manufacturer
KRKA, tovarna zdravil, d. d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last revised in July 2013

P0187

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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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