Skip to Content

UK Edition. Click here for US version.

EMOZUL 40MG GASTRO-RESISTANT CAPSULES HARD

PDF options:  View Fullscreen   Download PDF

PDF Transcript

S1671 LEAFLET Emozul 20130306

PACKAGE LEAFLET: INFORMATION FOR THE USER

EMOZUL 40mg
GASTRO-RESISTANT CAPSULES, HARD
(esomeprazole magnesium)
Your medicine is known as Emozul 40mg Gastro-resistant
Capsules, Hard but will be referred to as Emozul throughout the
following leaflet.
Please note that other strength, 20mg is also available for Emozul
Capsules.

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


Atazanavir (used to treat HIV).



Digoxin (used to treat heart problems).



Ketoconazole, itraconazole or voriconazole (used to treat
infections caused by a fungus).



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 or
clopidogrel. Your doctor may need to monitor you when you
start or stop taking Emozul.



Cisapride (used for indigestion and heartburn).



Rifampicin (to treat tuberculosis).



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

Read all of this leaflet carefully before you start taking this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Emozul is and what it is used for
2. Before you take Emozul

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.
Pregnancy and breast-feeding

6. Further information

Before taking Emozul, tell your doctor if you are pregnant or trying
to get pregnant. Ask your doctor or pharmacist for advice before
taking any 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.

1. WHAT EMOZUL IS AND WHAT IT IS USED FOR

Taking Emozul with food and drink

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.

You can take your capsules with food or on an empty stomach.
Driving and using machines

3. How to take Emozul
4. Possible side effects
5. How to store Emozul

Emozul is used to treat the following conditions:


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.



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.

Emozul is not likely to affect you being able to drive or use any tools
or machines.
Important information about some of the ingredients of Emozul
Emozul gastro-resistant capsules contain sucrose, which is 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 EMOZUL
Always take Emozul exactly as your doctor has told you. You
should 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

2. BEFORE YOU TAKE EMOZUL



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

Do not take Emozul if



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



You are allergic (hypersensitive) to esomeprazole or any of the
other ingredients of this medicine (listed in Section 6: Further
information).





You are allergic to other proton pump inhibitor medicines.



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.
Take special care with Emozul

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


-



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).



Then drink the mixture straight away or within 30 minutes.
Always stir the mixture just before drinking it.

-

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:

Open the capsule and empty the pellets into half a glass of
still (non-fizzy) water. Do not use any other liquids.

-

Check with your doctor or pharmacist before taking Emozul if:


If you have trouble swallowing the capsules:

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.

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

 The usual doses are given below.
To treat heartburn caused by gastro osophageal reflux disease
(GORD):

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.

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.

Taking other medicines



Please tell your doctor or pharmacist if you are taking, or have
recently taken, 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.

If your gullet has not been damaged, the usual dose is one
Emozul 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 Emozul 20 mg gastro-resistant capsule each day.



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

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).

Do not take Emozul Capsules if you are taking a medicine
containing nelfinavir (used to treat HIV).

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



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.

Adults aged 18 or above: the usual dose is one Emozul 20 mg
gastro-resistant capsule twice a day for one week.



Your doctor will also tell you to take antibiotics called 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):

 Increased sweating.
Very rare


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



Aggression.

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):



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



Severe liver problems leading to liver failure and inflammation
of the brain.



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.

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.



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.
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.
If you forget to take Emozul


Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.



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.



 Enlarged breasts in men.
Not known (frequency cannot be estimated from the available
data)

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Emozul can cause side effects, although not
everybody gets them.
Side effects are classified into the following groups in order of
frequency:
Very common

Affects more than 1 user in 10

Common

Affects 1 to 10 users in 100

Uncommon

Affects 1 to 10 users in 1,000

Rare

Affects 1 to 10 users in 10,000

Very rare

Affects less than 1 user in 10,000

Not known

Frequency cannot be estimated from available
data
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 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.

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. 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.
5. HOW TO STORE EMOZUL


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



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



Do not use Emozul after the expiry date which is stated on the
blister and the carton after EXP. The expiry date refers to the
last day of that month.



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 Emozul contains


The active substance is esomeprazole. Each gastro-resistant
capsule, hard contains 40 mg esomeprazole (as esomeprazole
magnesium).



The other ingredients are sucrose, maize starch, povidone,
sodium lauryl sulfate, poly(vinyl alcohol), titanium dioxide
(E171), macrogol 3000, macrogol 6000, talc, magnesium
carbonate, polysorbate 80 and methacrylic acid- ethyl acrylate
copolymer (1:1) dispersion in pellets in the capsule, and
gelatine, titanium dioxide (E171) and red iron oxide (E172) in
the capsule shell.

These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include:
Common


Headache.



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

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

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.

What Emozul looks like and contents of the pack



Swelling of the feet and ankles.



Disturbed sleep (insomnia).



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

Emozul capsules are available in blister packs of 28 capsules.



Spinning feeling (vertigo).



Dry mouth.



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



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

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



Musculoskeletal disorders

The body and cap of Emozul capsules is off-pink. The capsules
contain white to almost white pellets.
Product Licence holder

This product is manufactured by KRKA, d. d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

 Fracture of the hip, wrist or spine
Rare

Leaflet revision date: 6 March 2013



Emozul is a registered trademark of KRKA, Slovenia.

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.

POM

PL No: 19488/1671

S1671 LEAFLET Emozul 20130306

S1671 LEAFLET Esomeprazole 20130306

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESOMEPRAZOLE 40mg
GASTRO-RESISTANT CAPSULES, HARD
(esomeprazole magnesium)
Your medicine is known as Esomeprazole 40mg Gastro-resistant
Capsules, Hard but will be referred to as Esomeprazole Capsules
throughout the following leaflet.
Please note that other strength, 20mg is also available for
Esomeprazole Capsules.

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


Atazanavir (used to treat HIV).



Digoxin (used to treat heart problems).



Ketoconazole, itraconazole or voriconazole (used to treat
infections caused by a fungus).



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 or
clopidogrel. Your doctor may need to monitor you when you
start or stop taking Esomeprazole Capsules.



Cisapride (used for indigestion and heartburn).



Rifampicin (to treat tuberculosis).



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

Read all of this leaflet carefully before you start taking this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Esomeprazole Capsules are and what they are used for
2. Before you take Esomeprazole Capsules
3. How to take Esomeprazole Capsules
4. Possible side effects
5. How to store Esomeprazole Capsules
6. Further information
1. WHAT ESOMEPRAZOLE CAPSULES ARE AND WHAT THEY
ARE USED FOR
Esomeprazole Capsules contain 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.
Esomeprazole Capsules are used to treat the following conditions:






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.
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.

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 if you are taking any other medicines.
Pregnancy and breast-feeding
Before taking Esomeprazole Capsules, tell your doctor if you are
pregnant or trying to get pregnant. Ask your doctor or pharmacist
for advice before taking any medicine. Your doctor will decide
whether you can take Esomeprazole Capsules during this time. It is
not known if Esomeprazole Capsules pass into breast milk.
Therefore, you should not take Esomeprazole Capsules if you are
breastfeeding.
Taking Esomeprazole Capsules with food and drink
You can take your capsules with food or on an empty stomach.
Driving and using machines
Esomeprazole Capsules are not likely to affect you being able to
drive or use any tools or machines.
Important information about some of the ingredients of
Esomeprazole Capsules
Esomeprazole gastro-resistant capsules contain sucrose, which is 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 CAPSULES
Always take Esomeprazole Capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist if you are
not sure.


Esomeprazole 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.

2. BEFORE YOU TAKE ESOMEPRAZOLE CAPSULES
Do not take Esomeprazole Capsules if


You are allergic (hypersensitive) to esomeprazole or any of the
other ingredients of this medicine (listed in Section 6: Further
information).



You are allergic to other proton pump inhibitor medicines.



You are taking a medicine containing nelfinavir (used to treat
HIV).

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.

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:

Take special care with Esomeprazole Capsules

-

Check with your doctor or pharmacist before taking Esomeprazole
Capsules if:

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.



You have severe liver problems.



You 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 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.

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

 The usual doses are given below.
To treat heartburn caused by gastro osophageal reflux disease
(GORD):

If diarrhoea occurs during the treatment with Esomeprazole
Capsules 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.

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 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 usual dose once the gullet has healed is one
Esomeprazole 20 mg gastro-resistant capsule once a day.

Taking other medicines



Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines. This includes medicines that
you obtained without a prescription. This is because Esomeprazole
Capsules can affect the way some medicines work and some
medicines can have an effect on Esomeprazole Capsules.

If your gullet has not been damaged, the usual 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.

Taking a proton pump inhibitor like Esomeprazole 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).

Do not take Esomeprazole Capsules if you are taking a medicine
containing nelfinavir (used to treat HIV).

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



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.

Adults aged 18 or above: the usual dose is one Esomeprazole
20 mg gastro-resistant capsule twice a day for one week.



Your doctor will also tell you to take antibiotics called 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 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):

 Increased sweating.
Very rare


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



Aggression.

Adults aged 18 and above: the usual 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):



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



Severe liver problems leading to liver failure and inflammation
of the brain.



Adults aged 18 and above: the usual 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.

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.



Prolonged treatment after prevention of rebleeding of ulcers
with intravenous esomeprazole:


Adults aged 18 and above: the usual dose is one Esomeprazole
40 mg capsule once a day for 4 weeks.
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.
If you forget to take Esomeprazole Capsules


Do not take a double dose (two doses at the same time) to
make up for a forgotten dose.



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.



 Enlarged breasts in men.
Not known (frequency cannot be estimated from the available
data)

If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Esomeprazole Capsules can cause side effects,
although not everybody gets them.
Side effects are classified into the following groups in order of
frequency:
Very common

Affects more than 1 user in 10

Common

Affects 1 to 10 users in 100

Uncommon

Affects 1 to 10 users in 1,000

Rare

Affects 1 to 10 users in 10,000

Very rare

Affects less than 1 user in 10,000

Not known

Frequency cannot be estimated from available
data
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).
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.

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.
Do not be concerned by this list of possible side effects. You may
not get any of them. 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.
5. HOW TO STORE ESOMEPRAZOLE CAPSULES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



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



Do not use Esomeprazole Capsules after the expiry date which
is stated on the blister and the carton after EXP. The expiry
date refers to the last day of that month.



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 Capsules contain


The active substance is esomeprazole. Each gastro-resistant
capsule, hard contains 40 mg esomeprazole (as esomeprazole
magnesium).



The other ingredients are sucrose, maize starch, povidone,
sodium lauryl sulfate, poly(vinyl alcohol), titanium dioxide
(E171), macrogol 3000, macrogol 6000, talc, magnesium
carbonate, polysorbate 80 and methacrylic acid- ethyl acrylate
copolymer (1:1) dispersion in pellets in the capsule, and
gelatine, titanium dioxide (E171) and red iron oxide (E172) in
the capsule shell.

These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include:
Common


Headache.



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

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


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.



Musculoskeletal disorders



Fracture of the hip, wrist or spine

Rare


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.

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.

What Esomeprazole Capsules look like and contents of the
pack
The body and cap of Esomeprazole capsules is off-pink. The
capsules contain white to almost white pellets.
Esomeprazole capsules are available in blister packs of 28
capsules.
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
This product is manufactured by KRKA, d. d., Novo mesto,
Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
POM

PL No: 19488/1671

Leaflet revision date: 6 March 2013
S1671 LEAFLET Esomeprazole 20130306

+ Expand Transcript

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.

Hide