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NEXIUM 10 MG GRANULES

Active substance(s): ESOMEPRAZOLE

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Patient Information Leaflet

Nexium® 10 mg granules
(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
symptoms 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.
The name of your medicine is Nexium 10 mg granules, but
will be referred to as Nexium throughout the remainder of
the leaflet.
What is in this leaflet:
1. What Nexium is and what it is used for
2. What you need to know before you take Nexium
3. How to take Nexium
4. Possible side effects
5. How to store Nexium
6. Contents of the pack and other information
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1. What Nexium is and what it is used for
Nexium contains a substance 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.

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).

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.

Nexium is used to treat the following conditions:

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.

It is not known if Nexium passes into breast milk. Therefore
you should not take Nexium if you are breast-feeding.

Children over 1 year of age
Nexium is used to treat a condition called
“gastroesophageal reflux disease” (GERD).
• This is where acid from the stomach escapes into the
gullet (esophagus) 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.
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.
2. What you need to know before you take Nexium
Do not take Nexium:
• If you are allergic to esomeprazole or other similar
proton pump inhibitors (e.g. pantoprazole,
lansoprazole, rabeprazole, omeprazole), or any other
ingredients of this medicine (listed in section 6).
• 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 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 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).
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.

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 if you are taking nelfinavir (used to
treat HIV infection).
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).
• 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.
• Tacrolimus (organ transplantation).
• Rifampicin (used for treatment of tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat
depression).
If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Nexium to treat ulcers caused by
Helicobacter pylori infection, it is very important that you tell
your doctor about any other medicines you are taking.
Nexium gastro-resistant granules with food and drink
Nexium gastro-resistant granules can be taken with or
without food.

Driving and using machines
Nexium is not likely to affect you being able to drive or use
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 and glucose
Nexium contains sucrose and glucose which are both 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 this medicine exactly as your doctor has told
you. 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. He or she
will also tell you how long you should take them for.
• 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 teaspoonful’s) 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.
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.
The recommended doses are given below:
Use in children aged 1 to 11 years
• Nexium is not recommended for children younger than
1 year.
To treat gastroesophageal reflux disease (GERD)
• The recommended 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.

Use in children aged 4 years and older
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.
Use in adults and adolescents
Nexium oral suspension may also be used by patients
having difficulty swallowing dispersed Nexium gastroresistant tablets. Information on dosing for patients from the
age of 12 years is in Nexium gastro-resistant tablet product
information (ask your doctor or pharmacist if you require
further information).
Elderly
There is no need to alter the dose if you are elderly.
People with liver 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.
People with kidney problems
• 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, this medicine 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 (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).
Rare (may affect up to 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 or 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 (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.

Manufactured by: AstraZeneca AB Gartunavagen SE-151 85
Södertälje, Sweden. Procured from within the EU. Product
Licence holder: Quadrant Pharmaceuticals Ltd. Lynstock
House, Lynstock Way, Lostock, Bolton
BL6 4SA. Repackaged by Maxearn Ltd. Bolton BL6 4SA.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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.

Leaflet prepared: 21st November 2017

5. How to store Nexium
This medicinal product does not require any special
storage conditions.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and sachet after EXP. The expiry date
refers to the last day of that month.
The reconstituted suspension should be used within 30
minutes.
Do not throw away any medicines 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. Contents of the pack and other information
Each sachet contains pale yellow fine granules. Brownish
granules may be visible.
Each sachet contains esomeprazole magnesium trihydrate,
corresponding to esomeprazole 10 mg.
Also contains: 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 and Triethyl citrate.
Excipient granules:
Citric acid anhydrous (for pH adjustment), Crospovidone,
Glucose, Hydroxypropyl cellulose, Yellow iron oxide
(E172), and Xanthan gum.

PL 20774/1440

Nexium 10 mg granules

POM

Nexium is a trademark of the AstraZeneca AB

Blind or partially sighted? Is this
leaflet hard to see or read?
Contact Quadrant
Pharmaceuticals – 01204
473081
PP2/1440/V2

<--------------------------------------------------->
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.

Each carton contains 28 sachets.
Any unused suspension should be discarded.

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