ESOMEPRAZOLE 40MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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Nexium® 40mg Tablets
Esomeprazole 40mg Gastro-resistant Tablets
(esomeprazole magnesium)
Your medicine is known by one of the above names, but will be referred to
as Nexium throughout this:
Patient Information Leaflet
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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Nexium is and what it is used for
2) Before you take Nexium
3) How to take Nexium
4) Possible side effects
5) How to store Nexium
6) Further 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 and young people aged 12 years and above
 ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from
the stomach escapes into the gullet (the tube which connects your throat
to your stomach) causing pain, inflammation and heartburn.
 Ulcers in the stomach or upper part of the gut (intestine) that are infected
with bacteria called ‘Helicobacter pylori’. If you have this condition, your
doctor may also prescribe antibiotics to treat the infection and allow the
ulcer to heal.
Adults
 Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal AntiInflammatory 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) Before you take Nexium
Do not take Nexium 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 (e.g.
pantoprazole, lanzoprazole, rabeprazole, omeprazole).
 You are taking a medicine containing nelfinavir (used to treat HIV).
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.
Take special care with Nexium
Check with your doctor or pharmacist before taking Nexium if:
 You have severe liver problems.
 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.
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, 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.
Using other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, 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).
Tell your doctor or pharmacist if you are taking any of the following
medicines:
 Atazanavir (used to treat HIV).
 Ketoconazole, itraconazole or voriconazole (used to treat infections
caused by a fungus).
 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.
 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.
Pregnancy and breast-feeding
Before taking Nexium, 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 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.
Important information about some of the ingredients of Nexium
Nexium gastro-resistant tablets 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 Nexium
Always take Nexium exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
 Nexium gastro-resistant tablets are not recommended for children less
than 12 years old.
 If you are taking this medicine for a long time, your doctor will want to
monitor you (particularly if you are taking it for more than a year).
 If your doctor has told you to take this medicine as and when you need it,
tell your doctor if your symptoms change.
Taking this medicine
 You can take your 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’).
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 usual doses are given below.
To treat heartburn caused by gastro-oesophageal reflux disease
(GORD):
Adults and children aged 12 or above:
 If your doctor has found that your food pipe (gullet) has been slightly
damaged, the usual dose is one 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 usual dose once the gullet has healed is one Nexium 20 mg gastroresistant tablet once a day
 If your gullet has not been damaged, the usual 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:
 Adults and young people aged 12 or above: the usual 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 AntiInflammatory Drugs):
 Adults aged 18 and above: the usual dose is one Nexium 20 mg gastroresistant tablet once a day for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs):
 Adults aged 18 and above: the usual dose is one Nexium 20 mg gastroresistant tablet once a day.
To treat too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome):
 Adults aged 18 and above: the usual dose is Nexium 40 mg 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.
To be used as prolonged treatment after prevention of rebleeding of
ulcers with intravenous Nexium:
 Adults aged 18 and above: the usual dose is one Nexium 40 mg tablet
once a day for 4 weeks.
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.

4) Possible side effects
Like all medicines, Nexium 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, affecting less than 1 in 1,000 people.
Other side effects include:
Common (affects less than 1 in 10 people)
 Headache.
 Effects on your stomach or gut: diarrhoea, stomach pain, constipation,
wind (flatulence).
 Feeling sick (nausea) or being sick (vomiting).

Very rare (affects less than 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.
 Low levels of magnesium in the blood. This may cause weakness, being
sick (vomiting), cramps, tremor and arrhythmias (heart rhythm
disturbances). If you have very low levels of magnesium, you may also
have low levels of calcium in your blood.
Not known (frequency cannot be estimated from the available data)
 Inflammation in the gut (leading to diarrhoea).
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.
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, 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.
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 Nexium
Keep all medicines out of the sight and reach of children.
 Do not take Nexium after the expiry date printed on the carton or blister
strip label. The expiry date refers to the last day of the month.
 Do not store above 30°C. Store in the original package.
 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) Further information
What Nexium contains:
Each gastro-resistant tablet contains 44.5mg of esomeprazole magnesium
trihydrate equivalent to 40mg of the active ingredient esomeprazole as
enteric coated pellets.

Uncommon (affects less than 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.
 Musculoskeletal disorders
 Fracture of the hip, wrist or spine

Each gastro-resistant tablet also contains glycerol monostearate 40-55,
Hydroxypropylcellulose, hypromellose, reddish-brown iron oxide (E172),
magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1)
dispersion 30 per cent, microcrystalline cellulose, synthetic paraffin,
macrogol 6000, polysorbate 80, crospovidone, sodium stearyl fumarate,
sugar spheres (sucrose and maize starch), talc, titanium dioxide (E171)
and triethyl citrate.

Rare (affects less than 1 in 1,000 people)
 Blood problems such as a reduced number of white cells or platelets.
This can cause weakness, bruising or make infections more likely.
 Low levels of sodium in the blood. This may cause weakness, being sick
(vomiting) and cramps.
 Feeling agitated, confused or depressed.
 Taste changes.
 Eyesight problems such as blurred vision.
 Suddenly feeling wheezy or short of breath (bronchospasm).
 An inflammation of the inside of the mouth.
 An infection called “thrush” which can affect the gut and is caused by a
fungus.
 Liver problems, including jaundice which can cause yellow skin, dark
urine, and tiredness.
 Hair loss (alopecia).
 Skin rash on exposure to sunshine.
 Joint pains (arthralgia) or muscle pains (myalgia).
 Generally feeling unwell and lacking energy.
 Increased sweating.

Nexium tablets are available as two wallets containing 2 x 7 calendar
blister strips – total of 28 tablets in a carton.

What Nexium looks like and contents of the pack
The tablets are pink, oval, film-coated, marked ‘A EI’ on one side and
‘40mg’ on the other.

PL 10383/1364

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Recipharm Monts, 18 route de
Montbazon, 37260, Monts, France. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 26.07.2012
Nexium® is a registered trade mark of AstraZeneca AB, Sweden.

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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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