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NEXIUM 10MG GASTRO-RESISTANT GRANULES FOR ORAL SUSPENSION SACHET

Active substance(s): ESOMEPRAZOLE / ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

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Ref: 1659/051217/1/F

Nexium 10mg Gastro-resistant granules for oral suspension, sachet
(esomeprazole magnesium)
Patient Information 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.
Your medicine is called Nexium 10mg Gastro-resistant granules for oral
suspension, sachet but will be referred to as Nexium throughout 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.

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 a 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.

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.
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.
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 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.

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).

The recommended doses are given below:

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.

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.

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.

Use in children aged 4 years and older

Do not take Nexium if you are taking nelfinavir (used to treat HIV infection).

Use in children aged 1 to 11 years
* Nexium is not recommended for children younger than 1 year.

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 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).

Ref: 1659/051217/1/B

Nexium 10mg Gastro-resistant granules for oral suspension, sachet
(esomeprazole)
Patient Information Leaflet (continued)
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

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed on 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.

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 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.

5

How to store Nexium

Keep out of the sight and reach of children.
Do not use Nexium after the expiry date which is stated on the
sachet label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist (chemist) for safe disposal. Only keep this
medicine if your doctor tells you to.
If the granules becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell you
what to do.
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.
6

Contents of the pack and other information

What Nexium contain:
Each sachet contains esomeprazole magnesium trihydrate, corresponding to
esomeprazole 10mg.
Also contains glycerol monosterate 40-55, hydroxypropyl cellulose,
hypromellose magnesium stearate, polysorbate 80, sugar spheres, (sucrose,
corn starch), talc, triethyl citrate, citric acid anhydrous, crospovidone,
glucose, yellow iron oxide (E172), xanthan gum.
What Nexium look like and contents of the pack
Nexium is a pale yellow fine granules, brownish granules may be visible.
Each pack contains 28 Sachets.
Manufacturer and Licence Holder
Manufactured by Astrazeneca AB Gärtunavägen SE-151 85 Södertälje,
Sweden and procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1659

Nexium 10mg Gastro-resistant granules
for oral suspension, sachet

Nexium is a registered trademark of AstraZenca AB.
Revision date: 05/12/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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.
Nexium is a registered trademark of AstraZenca AB.
Revision date: 05/12/17

+ 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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