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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
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.
Nexium is used to treat the following conditions:
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.

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).
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.

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).

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.

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.

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.

Warnings and precautions

If you have liver problems, talk to your doctor as he or she might
want to prescribe a lower dose.

If you have kidney problems, discuss this with your doctor.
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).
< -------------------------------------------------------------->

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

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.
PP1/1440/V2



The recommended dose is:
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.





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.
Adults and young people aged 12 and older
Nexium oral suspension may also be used by patients having difficulty
swallowing dispersed Nexium gastro-resistant 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).
Older people
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).
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 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 (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).
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, 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.
By reporting side effects, you can help provide more information on the
safety of this medicine.
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.
Each carton contains 28 sachets.
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.
PL 20774/1440

Nexium 10 mg granules

POM

Nexium is a trademark of the AstraZeneca AB
th

Leaflet prepared: 5 October 2015
PP1/1440/V2

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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.

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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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