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NEXIUM 20MG GASTRO-RESISTANT TABLETS

Active substance(s): ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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Ref: 1773/070218/1/F

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
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.

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

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).
* 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).

What Nexium is and what it is used for

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.

Your medicine is called Nexium 20mg gastro-resistant tablets but will be
referred to as Nexium throughout the leaflet. Please note that the leaflet also
contains information about other strength of the medicine, Nexium 40mg.
What is in this leaflet:

1

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.
Adolescents aged 12 years and above
* ‘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.

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.
* If you have ever had a skin reaction after treatment with a medicine similar
to Nexium that reduces stomach acid.
* If you are due to have a specific blood test (Chromogranin A).
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).
If you get a rash on your skin, especially in areas exposed to the sun tell
your doctor as soon as you can, as you may need to stop your treatment
with Nexium. Remember to also mention any other ill-effects like pain in your
joints.
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.
Do not take Nexium Tablets if you are taking a medicine containing nelfinavir
(used to treat HIV infection).

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

3

How to take Nexium

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 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.
Use in adults aged 18 and 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. 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.
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.
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 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.

Ref: 1773/220817/1/B

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
Patient Information Leaflet (continued)
Use in 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 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’).
Use in children under the age of 12 years
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).
Elderly
Dose adjustment is not required in the elderly.
If you take more Nexium than you should
If you take more Nexium than prescribed by your doctor, talk to your doctor
or pharmacist straight away.
If you forget to take Nexium
* 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.

*
*
*
*
*

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 Nexium 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).
* Rash, possibly with pain in the joints.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.

How to store Nexium

5

*
*
*
*
*
*

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 Nexium after the expiry date which is stated on the label
or carton. The expiry date refers to the last day of the month.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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.

6
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
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)
* Headache.
* Effects on your stomach or gut: diarrhoea, stomach pain, constipation,
wind (flatulence).
* Feeling sick (nausea) or being sick (vomiting).
* Benign polyps in the stomach.
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 Nexium is used in high doses and
over long duration).

Contents of the pack and other information

What Nexium contains:
Each gastro-resistant tablet contains: esomeprazole magnesium trihydrate
equivalent to esomeprazole 20mg.
Also contains: glycerol monostearate 40-55, hydroxypropylcellulose,
hypromellose, iron oxide reddish-brown (E 172), iron oxide yellow (E 172),
magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1)
dispersion 30 per cent, cellulose microcrystalline, synthetic paraffin,
macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar
spheres (sucrose and maize starch), talc, titanium dioxide (E 171), triethyl
citrate.
What Nexium looks like and contents of the pack:
Nexium is a light-pink, oblong, biconvex, film-coated tablet engraved 20mg
on one side and A on the other side.
EH

Each blister pack contains 28 Tablets.
Manufacturer and Licence Holder
Manufactured by AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire SK10 2NA, United Kingdom and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1773

Nexium 20mg gastro-resistant
tablets

Nexium is a registered trademark of AstraZeneca AB.
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.

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

Revision date: 07/02/18

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

(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.
Nexium is a registered trademark of AstraZeneca AB.
Revision date: 07/02/18

Ref: 1773/070218/2/F

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
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.

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

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).
* 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).

What Nexium is and what it is used for

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.

Your medicine is called Nexium 20mg gastro-resistant tablets but will be
referred to as Nexium throughout the leaflet. Please note that the leaflet also
contains information about other strength of the medicine, Nexium 40mg.
What is in this leaflet:

1

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.
Adolescents aged 12 years and above
* ‘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.

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.
* If you have ever had a skin reaction after treatment with a medicine similar
to Nexium that reduces stomach acid.
* If you are due to have a specific blood test (Chromogranin A).
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).
If you get a rash on your skin, especially in areas exposed to the sun tell
your doctor as soon as you can, as you may need to stop your treatment
with Nexium. Remember to also mention any other ill-effects like pain in your
joints.
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.
Do not take Nexium Tablets if you are taking a medicine containing nelfinavir
(used to treat HIV infection).

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

3

How to take Nexium

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 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.
Use in adults aged 18 and 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. 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.
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.
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 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.

Ref: 1773/070218/2/B

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
Patient Information Leaflet (continued)
Use in 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 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’).
Use in children under the age of 12 years
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).
Elderly
Dose adjustment is not required in the elderly.
If you take more Nexium than you should
If you take more Nexium than prescribed by your doctor, talk to your doctor
or pharmacist straight away.
If you forget to take Nexium
* 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.

*
*
*
*
*

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 Nexium 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).
* Rash, possibly with pain in the joints.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

*
*
*
*
*
*

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 Nexium after the expiry date which is stated on the label
or carton. The expiry date refers to the last day of the month.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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.

6
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
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.

How to store Nexium

Contents of the pack and other information

What Nexium contains:
Each gastro-resistant tablet contains: esomeprazole magnesium trihydrate
equivalent to esomeprazole 20mg.
Also contains: glycerol monostearate 40-55, hydroxypropylcellulose,
hypromellose, iron oxide reddish-brown (E 172), iron oxide yellow (E 172),
magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1)
dispersion 30 per cent, cellulose microcrystalline, synthetic paraffin,
macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar
spheres (sucrose and maize starch), talc, titanium dioxide (E 171), triethyl
citrate.
What Nexium looks like and contents of the pack:
Nexium is a light-pink, oblong, biconvex, film-coated tablet engraved 20mg
on one side and A on the other side.
EH

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).
* Benign polyps in the stomach.

Each blister pach contains 28 Tablets.

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

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

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.

Revision date: 07/02/18

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.

Manufacturer and Licence Holder
Manufactured by Corden Pharma GmbH, Otto-Hahn-Strasse 68723,
Plankstadt, Germany and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1773

Nexium 20mg gastro-resistant
tablets

Nexium is a registered trademark of AstraZeneca AB.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Nexium is a registered trademark of AstraZeneca AB.
Revision date: 07/02/18

Ref: 1773/070218/3/F

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
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.

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

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).
* 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).

What Nexium is and what it is used for

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.

Your medicine is called Nexium 20mg gastro-resistant tablets but will be
referred to as Nexium throughout the leaflet. Please note that the leaflet also
contains information about other strength of the medicine, Nexium 40mg.
What is in this leaflet:

1

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.
Adolescents aged 12 years and above
* ‘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.

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.
* If you have ever had a skin reaction after treatment with a medicine similar
to Nexium that reduces stomach acid.
* If you are due to have a specific blood test (Chromogranin A).
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).
If you get a rash on your skin, especially in areas exposed to the sun tell
your doctor as soon as you can, as you may need to stop your treatment
with Nexium. Remember to also mention any other ill-effects like pain in your
joints.
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.
Do not take Nexium Tablets if you are taking a medicine containing nelfinavir
(used to treat HIV infection).

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

3

How to take Nexium

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 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.
Use in adults aged 18 and 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. 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.
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.
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 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.

Ref: 1773/220817/3/B

®

Nexium 20mg gastro-resistant tablets
(esomeprazole magnesium)
Patient Information Leaflet (continued)
Use in 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 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’).
Use in children under the age of 12 years
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).
Elderly
Dose adjustment is not required in the elderly.
If you take more Nexium than you should
If you take more Nexium than prescribed by your doctor, talk to your doctor
or pharmacist straight away.
If you forget to take Nexium
* 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.

*
*
*
*
*

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 Nexium 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).
* Rash, possibly with pain in the joints.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5

*
*
*
*
*
*

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 Nexium after the expiry date which is stated on the label
or carton. The expiry date refers to the last day of the month.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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.

6
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
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.

How to store Nexium

Contents of the pack and other information

What Nexium contains:
Each gastro-resistant tablet contains: esomeprazole magnesium trihydrate
equivalent to esomeprazole 20mg.
Also contains: glycerol monostearate 40-55, hydroxypropylcellulose,
hypromellose, iron oxide reddish-brown (E 172), iron oxide yellow (E 172),
magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1)
dispersion 30 per cent, cellulose microcrystalline, synthetic paraffin,
macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar
spheres (sucrose and maize starch), talc, titanium dioxide (E 171), triethyl
citrate.
What Nexium looks like and contents of the pack:
Nexium is a light-pink, oblong, biconvex, film-coated tablet engraved 20mg
on one side and A on the other side.
EH

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).
* Benign polyps in the stomach.

Each blister pack contains 28 Tablets.

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

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

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.

Revision date: 07/02/18

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.

Manufacturer and Licence Holder
Manufactured by AstraZeneca AB, S-151 85, Sodertalje, Sweden and is
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/1773

Nexium 20mg gastro-resistant
tablets

Nexium is a registered trademark of AstraZeneca AB.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Nexium is a registered trademark of AstraZeneca AB.
Revision date: 07/02/18

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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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