Skip to Content

NEXIUM 20MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Nexium® 20mg gastro-resistant tablets
(esomeprazole)
Your medicine is available using above names, but
will be referred to as Nexium throughout the
remainder of this leaflet.
Your medicine is available in a higher strength.
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.
What is in this leaflet:
1. What Nexium is and what it is used for
2. What you need to know before you take Nexium
3. How to take Nexium
4. Possible side effects
5. How to store Nexium
6. Contents of the pack and other information

1. What Nexium is and what it is used for
Nexium 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.
Nexium is used to treat the following conditions:
Adults
 ‘Gastroesophageal 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).
Nexium 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 Nexium.

2. What you need to know before you take
Nexium
Do not take Nexium:






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 Nexium if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Nexium.









Warnings and precautions
Talk to your doctor or pharmacist before taking
Nexium:
 If you have severe liver problems.
 If you have severe kidney problems.
Nexium may hide the symptoms of other diseases.
Therefore, if any of the following happen to you
before you start taking Nexium 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 Nexium “on demand” you
should contact your doctor if your symptoms continue
or change in character.
Taking a proton pump inhibitor like Nexium, 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
Information on dosing for children aged 1 to 11 years is
provided in Nexium sachet product information (ask
your doctor or pharmacist if you require further
information).

Other medicines and Nexium
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 Nexium can affect the way
some medicines work and some medicines can have an
effect on Nexium.





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 Nexium.
Medicines that are used to thin your blood, such
as warfarin. Your doctor may need to monitor you
when you start or stop taking Nexium.
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 Nexium 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 Nexium to treat ulcers
caused by Helicobacter pylori infection, it is very
important that you tell your doctor about any other
medicines you are taking.

How much to take




Your doctor will tell you how many tablets 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 gastroesophageal
reflux disease (GERD):








Nexium with food and drink

If your doctor has found that your food pipe (gullet)
has been slightly damaged, the recommended dose
is one Nexium 40 mg gastro-resistant tablet 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 Nexium 20 mg gastro-resistant tablet once a
day
If your gullet has not been damaged, the
recommended dose is one Nexium 20 mg gastroresistant tablet 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 Nexium 20 mg gastro-resistant tablet each
day.
If you have severe liver problems, your doctor may
give you a lower dose.

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

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

Pregnancy, breast-feeding and fertility



If you are pregnant, 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 Nexium during this time. It
is not known if Nexium passes into breast milk.
Therefore, you should not take Nexium if you are
breastfeeding.

Driving and using machines
Nexium 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). If affected, you should not
drive or use machines.

Nexium contains sucrose
Nexium contains sugar spheres which contain sucrose,
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.

Do not take Nexium Tablets if you are taking a medicine 3. How to take Nexium
Always take Nexium exactly as your doctor or
containing nelfinavir (used to treat HIV infection).
pharmacist has told you. Check with your doctor or
Tell your doctor or pharmacist if you are taking any of
pharmacist if you are not sure.
Adolescents aged 12 years and above
the following medicines:
 If you are taking this medicine for a long time, your
 ‘Gastroesophageal reflux disease’ (GERD).
 Atazanavir (used to treat HIV infection).
doctor will want to monitor you (particularly if you are
This is where acid from the stomach escapes into the
 Clopidogrel (used to prevent blood clots).
taking it for more than a year).
gullet (the tube which connects your throat to your
 Ketoconazole, itraconazole or voriconazole (used to
 If your doctor has told you to take this medicine as
stomach) causing pain, inflammation and heartburn.
treat infections caused by a fungus).
and when you need it, tell your doctor if your
 Ulcers in the stomach or upper part of the gut
 Erlotinib (used to treat cancer).
symptoms change.
(intestine) that are infected with bacteria called
 Citalopram, imipramine or clomipramine (used to
‘Helicobacter pylori’. If you have this condition, your
treat depression).
doctor may also prescribe antibiotics to treat the
infection and allow the ulcer to heal.



The recommended dose is one Nexium 20 mg
gastro-resistant tablet twice a day for one week.
Your doctor will also tell you to take antibiotics for
example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):


The recommended dose is one Nexium 20 mg
gastro-resistant tablet 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 Nexium 20 mg
gastro-resistant tablet 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 Nexium 40 mg
gastro-resistant tablet 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
re-bleeding of ulcers with intravenous Nexium:


The recommended dose is one Nexium 40 mg tablet
once a day for 4 weeks.

S0363-28-GR-PIL-30.01.2015

Adolescents aged 12 or above
To treat heartburn caused by gastroesophageal
reflux disease (GERD):








If your doctor has found that your food pipe (gullet)
has been slightly damaged, the recommended dose
is one Nexium 40 mg gastro-resistant tablet 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 Nexium 20 mg gastro-resistant tablet once a
day.
If your gullet has not been damaged, the
recommended dose is one Nexium 20 mg
gastro-resistant tablet 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 Nexium 20 mg
gastro-resistant tablet twice a day for one week.
Your doctor will also tell you to take antibiotics for
example amoxicillin and clarithromycin.

Taking this medicine




You can take your tablets at any time of the day.
You can take your tablets with food or on an empty
stomach.
Swallow your tablets whole with a drink of water. Do
not chew or crush the tablets.
This is because the tablets contain coated pellets
which stop the medicine from being broken down by
the acid in your stomach. It is important not to
damage the pellets.

What to do if you have trouble swallowing the
tablets

If you take more Nexium than you should

Rare (may affect up to 1 in 1,000 people)

Reporting of side effects

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



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.

If you forget to take Nexium




If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

If you notice any of the following serious side
effects, stop taking Nexium 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, and may affect up to 1 in
1,000 people.

Other side effects include:
Common (may affect up to 1 in 10 people)



If you have trouble swallowing the tablets:
Put them into a glass of still (non-fizzy) water.
Do not use any other liquids.

Stir until the tablets break up (the mixture will not
be clear). Then drink the mixture straight away or
within 30 minutes. Always stir the mixture just
before drinking it.

To make sure that you have drunk all of the
medicine, rinse the glass very well with half a
glass of water and drink it. The solid pieces
contain the medicine - do not chew or crush them.
 If you cannot swallow at all, the tablet can be mixed
with some water and put into a syringe.
It can then be given to you through a tube directly
into your stomach (‘gastric tube’).



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)

















Possible side effects

Like all medicines, Nexium can cause side effects,
although not everybody gets them.





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.

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 Nexium is used
in high doses and over long duration).








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.

Nexium gastro-resistant tablets are not recommended
for children less than 12 years old. Information on
dosing for children aged 1 to 11 years is provided in
Nexium sachet product information (ask your doctor or
pharmacist if you require further information).

Older people
Dose adjustment is not required in the elderly.











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.

6.

How to store Nexium
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package.
Protect from moisture.
Do not take your tablets after the expiry date (EXP)
shown on the carton, wallet pack or blister foil. 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 that are no longer required.
These measures will help to protect the environment.
If your medicine becomes discoloured or shows any
signs of deterioration, you should seek the advice of
your pharmacist.

Contents of the pack and other
information

What Nexium contains
Each gastro-resistant tablet contains: Esomeprazole
magnesium trihydrate equivalent to esomeprazole
20mg.

The other ingredients are glycerol monostearate
40-55 (Type II), hyprolose, hypromellose, yellow iron
oxide E172, magnesium stearate, microcrystalline
cellulose, macrogol 6000, polysorbate 80,

crospovidone, sodium stearyl fumarate, sugar spheres

(sucrose and maize starch), talc, titanium dioxide

(E171), triethyl citrate, methacrylic acid ethyl acrylate
Not known (frequency cannot be estimated from the copolymer (1:1) dispersion 30 per cent, synthetic
paraffin and reddish-brown iron oxide.
available data)
 If you are on Nexium for more than three months it is
What Nexium looks like and contents of the pack
possible that the levels of magnesium in your blood
• Nexium 20 mg gastro-resistant tablets are light pink
may fall. Low levels of magnesium can be seen as
with an A on one side and 20 mg on the other side.
fatigue, involuntary muscle contractions,
EH
disorientation, convulsions, dizziness or increased
 Your tablets come in a blister pack of 28.
heart rate. If you get any of these symptoms, please
Manufacturer:
tell your doctor promptly. Low levels of magnesium
AstraZeneca UK Ltd, Macclesfield, Cheshire, United
can also lead to a reduction in potassium or calcium
Kingdom.
levels in the blood. Your doctor may decide to
perform regular blood tests to monitor your levels of
Procured from within the EU and repackaged by:
magnesium.
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
 Inflammation in the gut (leading to diarrhoea).
Product Licence Holder: Sam Pharma Ltd, Unit 20
Nexium 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.

Children under the age of 12 years

5.

Garrick Industrial Estate, Irving Way, Hendon, London,
NW9 6AQ.
PL No: 33902/0363
POM
Leaflet revision date: 30/01/2015
Nexium® is a registered trademark of the AstraZeneca
group of companies.

S0363-28-GR-PIL-30.01.2015

The following information is intended for
healthcare professionals only:
Administration through gastric tube
1. Put the tablet into an appropriate syringe and
fill the syringe with approximately 25 ml water and
approximately 5 ml air. For some tubes, dispersion in
50 ml water is needed to prevent the pellets from

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

5. Shake the syringe and position it with the tip
pointing down. Immediately inject 5 – 10 ml into the
tube. Invert the syringe after injection and shake (the
syringe must be held with the tip pointing up to avoid
clogging of the tip)

6. Turn the syringe with the tip down and immediately
inject another 5 – 10 ml into the tube. Repeat this
procedure until the syringe is empty.
7. Fill the syringe with 25 ml of water and 5 ml of air and
repeat step 5 if necessary to wash down any sediment
left in the syringe. For some tubes, 50 ml water is
needed.

Expand view ⇕

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