NEXIUM 20MG TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Nexium 20mg 40mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/2026 2028

DATE OF PROOF:

23/01/13

DATE:

PROOF HISTORY:
v.4 - waymade - 23/01/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2012

Pg 4

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 tablets
Nexium tablets should not be stored above 30°C. Store in the original package.
Do not take a tablet out of the blister foil until you are ready to take it.
Do not use after the expiry date printed on the carton or blister label or wallet pack. The expiry date refers
to the last day of that month.
If your doctor tells you to stop taking your medicine, please take it back to the pharmacist for safe
disposal. Only keep your medicine if your doctor tells you to.
If the tablets show any visible signs of deterioration, you should seek the advice of your pharmacist who
will advise you what to do.
Keep all medicines out of the sight and reach of children.
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.

Patient Information Leaflet

This product is available as the above names but throughout this leaflet these products will be collectively
referred to as Nexium tablets.
Please 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 tablets are and what they are used for
2. Before you take Nexium tablets
3. How to take Nexium tablets
4. Possible side effects
5. How to store Nexium tablets
6. Further information

6. Further information
Each Nexium 20mg tablet contains 22.3 mg of esomeprazole magnesium trihydrate equivalent to 20mg
esomeprazole as the active ingredient. They are oval shaped, light pink, gastro-resistant tablets marked
‘A EH’ on one side, and ‘20mg’ on the other side.
Each Nexium 40mg tablet contains 44.5mg of esomeprazole magnesium trihydrate equivalent to 40mg
esomeprazole as the active ingredient. They are a dark pink, oval, gastro-resistant tablet, which is marked
‘A EI’ on one side, and ‘40mg’ on the other side.
Nexium tablets also contain the following: glyceryl monostearate, hydroxypropyl cellulose, microcrystalline
cellulose, synthetic paraffin, sodium stearyl fumarate, methacrylic acid-ethyl acrylate copolymer,
magnesium stearate, macrogol 6000, polysorbate 80, crospovidone, sugar spheres (sucrose and maize
starch), triethyl citrate, reddish-brown iron oxide (E172), yellow iron oxide (E172), titanium dioxide
(E171), talc and hypromellose.
Nexium tablets are available as blister packs of 7, 14 and 28 tablets.
POM

PL: 6464/2026 Nexium 20mg tablets
PL: 6464/2028 Nexium 40mg tablets

These products are manufactured by AstraZeneca AB, S-151 85, Sodertalje, Sweden and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 23.1.2013
Nexium is a registered trademark of AstraZeneca AB

Pg 1

NEXIUM® 20mg TABLETS
NEXIUM® 40mg TABLETS
(esomeprazole magnesium)

Nexium tablets 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.

1. What Nexium tablets are and what they are used for
Nexium tablets contain 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 tablets are used to treat the following conditions:
Adults and young people aged 12 years and above

‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into
the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and
heartburn.

Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called
‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat
the infection and allow the ulcer to heal.
Adults




Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Nexium tablets 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 tablets
Do not take Nexium tablets 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, lansoprazole
rabeprazole, omeprazole).

You are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Nexium tablets if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Nexium tablets.
Take special care with Nexium tablets
Check with your doctor or pharmacist before taking Nexium tablets if:

You have severe liver problems.

You have severe kidney problems.
Nexium tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to
you before you start taking Nexium tablets or while you are taking them, 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 tablets “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).
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 tablets can affect the way some medicines work and some medicines can have
an effect on Nexium tablets.
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).
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Nexium 20mg 40mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/2026 2028

DATE OF PROOF:

23/01/13

DATE:

PROOF HISTORY:
v.4 - waymade - 23/01/13

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED JULY 2012

Pg 2



Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you
when you start or stop taking Nexium tablets.

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 tablets.

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 tablets 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 tablets, 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
tablets during this time.
It is not known if Nexium passes into breast milk. Therefore, you should not take Nexium tablets if you are
breastfeeding.
Driving and using machines
Nexium tablets are not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Nexium tablets
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 tablets
Always take Nexium tablets 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 gastro-resistant 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 Anti-Inflammatory Drugs):

Adults aged 18 and above: the usual 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):

Adults aged 18 and above: the usual dose is one Nexium 20 mg gastro-resistant tablet once a
day.

Pg 3

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

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 tablets can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Nexium tablets 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).
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.

Fracture of the hip, wrist or spine (if Nexium is used in high doses and over long duration).
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.
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.
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).

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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