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NEXIUM 10MG GRANULES

Active substance(s): ESOMEPRAZOLE / ESOMEPRAZOLE

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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.

Package Leaflet: Information for the user

Nexium® 10mg Granules

Leaflet reference: NEXI10mg

(esomeprazole magnesium)
“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).

Your medicine is available using the above name but will be referred to as
Nexium® throughout the following leaflet.
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.

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.

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®

PL 16378/0593

Revision date: 20.02.2017

®

3. How to take Nexium®

Nexium 10mg Granules

4. Possible side effects
Revision date: 20.02.2017

5. How to store Nexium®

Leaflet reference: NEXI10mg

6. Contents of the pack and other information
1. WHAT NEXIUM ® IS AND WHAT IT IS USED FOR

POM

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.

Nexium® is a trademark of AstraZeneca AB.

Nexium® gastro-resistant granules with food and drink
Nexium® gastro-resistant granules can be taken with or without food.
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.
It is not known if Nexium® passes into breast milk. Therefore, you should
not take Nexium® if you are breast-feeding.

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®.

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

Nexium® contains sucrose and glucose

 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).
If you have been prescribed Nexium® “on demand” you should contact
your doctor if the symptoms are persistent or change character.

4

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.

1

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 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.
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.

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:

The recommended dose is:

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Very rare (may affect up to 1 in 10,000 people)

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).

 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.

Children aged 4 years and older
To treat ulcers caused by Helicobacter pylori infection and to stop them
coming back.

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.

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.

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).

Adults and young people aged 12 and older

• 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.

Keep out of the sight and reach of children.

The reconstituted suspension should be used within 30 minutes.

• 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.

• Nexium® is not recommended for children younger than 1 year.
To treat gastroesophageal reflux disease (GERD)

This medicinal product does not require any special storage conditions.

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).

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.

Children aged 1 to 11 years

5. HOW TO STORE NEXIUM ®

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.

What Nexium® contains
Each sachet contains esomeprazole magnesium trihydrate,
corresponding to esomeprazole 10 mg.
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 and Triethyl citrate.
Excipient granules: Citric acid anhydrous (for pH adjustment),
Crospovidone, Glucose, Hydroxypropyl cellulose, Yellow iron oxide
(E172) and 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.
Each carton contains 28 sachets.
Product Licence Holder and Manufacturer:
Manufactured by AstraZeneca AB, SE-151 85 Södertälje, Sweden.
Procured from within the EU and repackaged by Product Licence Holder:
Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB,
UK.
PL 16378/0593

Nexium® 10mg Granules

Revision date: 20.02.2017
Leaflet reference: NEXI10mg
POM

Nexium® is a trademark of AstraZeneca AB.

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).

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.

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 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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse,
Tel: 020 8896 9054
for help.

Reporting of side effects
4. POSSIBLE SIDE EFFECTS

If you get any side effects, talk to your doctor or pharmacist. 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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

2

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Expand Transcript

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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