NEXIUM 10 MG GASTRO-RESISTANT GRANULES FOR ORAL SUSPENSION SACHET

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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PS00722

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nexium 10 mg gastro-resistant granules for oral suspension, sachet
Esomeprazole

Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What 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. These work by reducing the amount
of acid that your stomach produces.
Nexium is used to treat the following conditions:
Children over 1 year of age
Nexium is used to treat a condition called “gastro-oesophageal reflux disease”.
• This is where acid from the stomach escapes into the gullet (oesophagus)
causing pain, inflammation and heartburn. Heartburn is a burning feeling
rising from the stomach or lower chest up towards the neck.
• In children, the symptoms of the condition can include the return of
stomach contents into the mouth (regurgitation), being sick (vomiting) and
poor weight gain.

• 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.
Taking Nexium gastro-resistant granules with food and drink
Nexium gastro-resistant granules can be taken with or without food.
Pregnancy and breast-feeding
Before taking Nexium, ask your doctor or pharmacist for advice if you are
pregnant or trying to become pregnant. Your doctor will assess whether you can
take Nexium during this time. Nexium should not be used during breast-feeding.
Driving and using machines
Nexium is not likely to affect you being able to drive or use tools or machines.
Important information about some of the ingredients of Nexium
Nexium contains sucrose and glucose which both are types of sugars. Careful
oral hygiene and regular tooth brushing are therefore important.
If you have been told by your doctor, that you have an intolerance to some
sugars, contact your doctor before taking Nexium.
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.
Your medicine comes as granules in individual sachets. Each sachet contains
10 mg of esomeprazole. Your doctor will tell you how many sachets to take
each day and when to take them. He or she will also tell you how long you
should take them for.

2. BEFORE YOU TAKE NEXIUM
Do not take Nexium
• if you are allergic (hypersensitive) to esomeprazole or other similar
proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole,
omeprazole), or any other ingredients in Nexium gastro-resistant granules
• if you are taking a medicine containing nelfinavir (used to treat HIV).

• Empty the contents of the sachet or sachets into a glass containing some
water. Do not use fizzy (carbonated) water. The amount of water depends
on the number of sachets that your doctor has told you to take at one time.
• Use 15 millilitres (ml) of water (3 teaspoonfuls) for each sachet. This
means that you will need 15 ml for one sachet and 30 ml for two sachets.
• Stir the granules in the water.
• Leave the mixture for a few minutes until it has thickened.
• Stir again and drink the mixture. The granules must not be chewed or crushed.
Do not leave the mixture to stand for more than 30 minutes before you drink it.
• If anything remains in the glass, add some more water, stir and drink it
immediately.

Take special care with Nexium
• if you have liver problems, you should talk to your doctor as he or she
might want to prescribe a lower dose.
• if you have kidney problems, you should discuss this with your doctor.

Nexium gastro-resistant granules can be taken with or without food.
If you are being fed using a feeding (gastric) tube, your doctor or nurse can
give you Nexium through your tube. Information for your doctor or nurse is
provided at the end of this leaflet.

Nexium may hide the symptoms of other diseases. Therefore, if any of the
following happen to you while you are taking Nexium, you should talk to
your doctor immediately:
• You lose a lot of weight for no reason.
• You get stomach pain or indigestion.
• You begin to vomit repeatedly.
• You have problems swallowing.
• You vomit blood or pass black (blood-stained) motions (faeces).

Children
• Nexium is not recommended for children younger than 1 year.
• Children aged between 1 and 11 years may take Nexium to treat
gastro-oesophageal reflux disease. The usual dose is one sachet (10 mg)
or two sachets (20 mg) once daily. The dose for children is based on the
child’s weight and the doctor will decide the correct dose.
• Children aged 4 years and older may take Nexium to treat ulcers caused
by Helicobacter pylori infection and to stop them coming back. The dose
for children is based on the child’s weight and your doctor will decide the
correct dose. The doctor will also prescribe two antibiotics for your child.

Children over 4 years of age
• Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your
child has this condition, your doctor may also prescribe antibiotics to treat
the infection and allow the ulcer to heal.

If you have been prescribed Nexium “on demand” you should contact your
doctor if the symptoms are persistent or change character. “On demand”
treatment has not been investigated in children and is therefore not
recommended in this patient group.
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken,
any other medicines including medicines obtained without a prescription.
Nexium can affect the way some other medicines work and some medicines
can have an effect on Nexium.
In particular, tell your doctor or pharmacist if you are taking any of the
following medicines:
• Atazanavir (used to treat HIV). Do not take Nexium if you are taking nelfinavir.
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused
by a fungus).
• Erlotinib (used to treat cancer).
• Diazepam (used to treat anxiety or relax muscles).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Phenytoin (used in epilepsy).
• Warfarin or coumarin (medicines called anticoagulants that are used to thin
your blood).
• 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.

Adults and young people aged 12 and older
The usual dose is two sachets (20 mg) or four sachets (40 mg) once daily.
Older people
There is no need to alter the dose if you are elderly.
People with liver or kidney problems
• For people with severe liver problems, the maximum daily dose of Nexium
is two sachets (20 mg). For children 1-11 years with severe liver problems,
a maximum dose of 10 mg should not be exceeded.
• There are no special dosage restrictions for people with kidney problems.
However, if you have severe kidney problems your doctor may decide to
carry out regular tests.
If you take more Nexium than you should
If you have taken more Nexium than prescribed by your doctor, seek medical
advice.
If you forget to take Nexium
If you forget to take a dose, take it as soon as you remember. If it is almost
time to take the next dose, wait until then. Do not take a double dose to make
up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nexium can cause side effects, although not everybody
gets them.
Allergic reactions
A severe allergic reaction (anaphylaxis) is a rare side effect, affecting less
than 1 in 1,000 people taking Nexium. You may notice sudden wheezing,
swelling of your face or body, rash, fainting or difficulties in swallowing. If this
happens to you, stop taking Nexium and contact a doctor immediately.

Other side effects include:
Common (affects less than 1 in 10 people)
• Headache.
• Effects on your stomach or gut: stomach pain, constipation, diarrhoea,
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.
• Low levels of sodium in the blood.
• 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.
• Hepatitis with our without jaundice
• 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).
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.
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
This medicinal product does not require any special storage conditions.
• Keep out of the reach and sight of children.
• Do not use Nexium after the expiry date which is stated on the carton and
sachet. The expiry date refers to the last day of the month.
• The reconstituted suspension should be used within 30 minutes.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Nexium gastro-resistant granules for oral suspension contains
The active substance is esomeprazole. Each sachet contains 10 mg of
esomeprazole (as magnesium
trihydrate).The other ingredients are:
Esomeprazole granules:
Glycerol monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Methacrylic acid – ethyl acrylate copolymer (1:1) 30% dispersion
Polysorbate 80
Sugar spheres (sucrose and maize starch)
Talc
Triethyl citrate

Excipient granules:
Citric acid anhydrous (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E172)
Xanthan gum
What Nexium looks like and contents of the pack
Each sachet of Nexium contains pale yellow fine granules. Brownish granules
may be visible.
The oral suspension is a thick yellow liquid containing suspended pellets.
Each carton contains 28 sachets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is AstraZeneca UK Limited, Horizon Place,
600 Capability Green, Luton, Bedfordshire, LU1 3LU, United Kingdom.
Nexium is manufactured by AstraZeneca AB, S-151 85 Södertälje, Sweden.

To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Reference number
Nexium Sachet 10 mg
17901/0253
This is a service provided by the Royal National
Institute of Blind People.
This medicine is authorised in the Member States of the EEA under the
following names: Nexium, Nexiam, Inexium.
Austria (AT)
Belgium (BE)
Cyprus (CY)
Czech Republic (CZ)
Denmark (DK)
Finland (FI)
France (FR)
Germany (DE)
Greece (EL)
Hungary (HU)
Iceland (IS)
Ireland (IE)
Latvia (LV)
Lithuania (LT)
Luxembourg (LU)
The Netherlands (NL)
Norway (NO)
Poland (PL)
Portugal (PT)
Romania (RO)
Slovakia (SK)
Slovenia (SL)
Spain (ES)
United Kingdom (UK)

Nexium
Nexiam
Nexium
Nexium
Nexium
Nexium
Inexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexiam
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium
Nexium

Leaflet prepared: July 2012
GI 12 0149a
© AstraZeneca 2012
Nexium is a trademark of the AstraZeneca group of companies.
<-----------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only:
Administration information for patients with a nasogastric or gastric
tube in place:
1. For a 10 mg dose, add the contents of a 10 mg sachet into 15 ml of water.
2. For a 20 mg dose, add the contents of two 10 mg sachets into 30 ml of water.
3. Stir.
4. Leave for a few minutes to thicken.
5. Stir again.
6. Draw the suspension into a syringe.
7. Inject through the enteric tube, French size 6 or larger, into the stomach
within 30 minutes after reconstitution.
8. Refill the syringe with 15 ml water for a 10 mg dose and 30 ml for a
20 mg dose.
9. Shake and flush any remaining contents from the enteric tube into the
stomach.
Any unused suspension should be discarded.
Leaflet prepared: July 2012
GI 12 0149a
© AstraZeneca 2012
Nexium is a trademark of the AstraZeneca group of companies.

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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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