NEXIUM 40MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Nexium 40mg gastro-resistant tablets
(esomeprazole)
Your medicine is available using above names, but
will be referred to as Nexium throughout the
remainder of this leaflet.
Your medicine is available in a higher strength.
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‟. They work by reducing the amount
of acid that your stomach produces.
Nexium is used to treat the following conditions:
Adults and young people aged 12 years and above
 „Gastro-oesophageal reflux disease‟ (GORD). This
is where acid from the stomach escapes into the
gullet (the tube which connects your throat to your
stomach) causing pain, inflammation and heartburn.
 Ulcers in the stomach or upper part of the gut
(intestine) that are infected with bacteria called
‘Helicobacter pylori’. If you have this condition,
your doctor may also prescribe antibiotics to treat
the infection and allow the ulcer to heal.
Adults
 Stomach ulcers caused by medicines called
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Nexium can also be used to stop stomach ulcers
from forming if you are taking NSAIDs.
 Too much acid in the stomach caused by a growth
in the pancreas (Zollinger-Ellison syndrome).
 Prolonged treatment after prevention of rebleeding
of ulcers with intravenous Nexium.

2. Before you take Nexium
Do not take Nexium if


You are allergic (hypersensitive) to esomeprazole
or any of the other ingredients of this medicine
(listed in Section 6: Further information).



You are allergic to other proton pump inhibitor
medicines (e.g. pantoprazole, lansoprazole,
rabeprazole, omeprazole).
 You are taking a medicine containing nelfinavir
(used to treat HIV).
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.

Take special care with Nexium
Check with your doctor or pharmacist before taking
Nexium if:
 You have severe liver problems.
 You have severe kidney problems.
Nexium may hide the symptoms of other diseases.
Therefore, if any of the following happen to you
before you start taking Nexium or while you are
taking it, talk to your doctor straight away:
 You lose a lot of weight for no reason and have
problems swallowing.
 You get stomach pain or indigestion.
 You begin to vomit food or blood.
 You pass black stools (blood-stained faeces).
If you have been prescribed Nexium “on demand” you
should contact your doctor if your symptoms continue
or change in character.
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).

Using other medicines
Please tell your doctor or pharmacist if you are
taking, or have recently taken, 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 Tablets if you are taking a
medicine containing nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of
the following medicines:
 Atazanavir (used to treat HIV).
 Clopidogrel (used to prevent blood clots).
 Ketoconazole, itraconazole or voriconazole (used to
treat infections caused by a fungus).
 Erlotinib (used to treat cancer).
 Citalopram, imipramine or clomipramine (used to
treat depression).
 Diazepam (used to treat anxiety, relax muscles or
in epilepsy).
 Phenytoin (used in epilepsy). If you are taking
phenytoin, your doctor will need to monitor you
when you start or stop taking Nexium.
 Medicines that are used to thin your blood, such
as warfarin. Your doctor may need to monitor you
when you start or stop taking Nexium.











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.

Pregnancy and breast-feeding
Before taking Nexium, tell your doctor if you are
pregnant or trying to get pregnant . Ask your doctor
or pharmacist for advice before taking any 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
breastfeeding.

Driving and using machines
Nexium is not likely to affect you being able to drive
or use any tools or machines.

Important information about some of the
ingredients of Nexium
Nexium gastro-resistant tablets contain sucrose,
which is a type of sugar. If you have been told by your
doctor that you have an intolerance to some sugars,
talk to your doctor before taking this medicine.

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.
 Nexium gastro-resistant tablets are not
recommended for children less than 12 years old.
 If you are taking this medicine for a long time, your
doctor will want to monitor you (particularly if you
are taking it for more than a year).
 If your doctor has told you to take this medicine
as and when you need it, tell your doctor if your
symptoms change.

damage the pellets.

What to do if you have trouble swallowing the
tablets




How much to take







You can take your tablets at any time of the day.
You can take your tablets with food or on an empty
stomach.
Swallow your tablets whole with a drink of water. Do
not chew or crush the tablets.
This is because the tablets contain coated pellets
which stop the medicine from being broken down by
the acid in your stomach. It is important not to

Your doctor will tell you how many tablets to take
and how long to take them for. This will depend on
your condition, how old you are and how well your
liver works.
The usual doses are given below.

To treat heartburn caused by gastrooesophageal reflux disease (GORD):
Adults and children aged 12 or above:
 If your doctor has found that your food pipe (gullet)
has been slightly damaged, the usual dose is one
Nexium 40 mg gastro-resistant tablet once a day for
4 weeks. Your doctor may tell you to take the same
dose for a further 4 weeks if your gullet has not yet
healed.
 The usual dose once the gullet has healed is one
Nexium 20 mg gastro-resistant tablet once a day
 If your gullet has not been damaged, the usual dose
is one Nexium 20 mg gastro-resistant tablet
each day. Once the condition has been controlled,
your doctor may tell you to take your medicine as
and when you need it, up to a maximum of one
Nexium 20 mg gastro-resistant tablet each day.
 If you have severe liver problems, your doctor may
give you a lower dose.

To treat ulcers caused by Helicobacter pylori
infection and to stop them coming back:




Taking this medicine


If you have trouble swallowing the tablets:

Put them into a glass of still (non-fizzy) water.
Do not use any other liquids.

Stir until the tablets break up (the mixture will
not be clear). Then drink the mixture straight
away or within 30 minutes. Always stir the
mixture just before drinking it.

To make sure that you have drunk all of the
medicine, rinse the glass very well with half
a glass of water and drink it. The solid pieces
contain the medicine - do not chew or crush
them.
If you cannot swallow at all, the tablet can be
mixed with some water and put into a syringe.
It can then be given to you through a tube directly
into your stomach („gastric tube‟).

Adults and young people aged 12 or above: the usual
dose is one Nexium 20 mg gastro-resistant tablet
twice a day for one week.
Your doctor will also tell you to take antibiotics for
example amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):


Adults aged 18 and above: the usual dose is one
Nexium 20 mg gastro-resistant tablet once a day
for 4 to 8 weeks.
S0364-28-GR-PIL-07.10.2013

To prevent stomach ulcers if you are taking
NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

Uncommon (affects less than 1 in 100 people)





Adults aged 18 and above: the usual dose is one
Nexium 20 mg gastro-resistant tablet once a day.

To treat too much acid in the stomach caused
by a growth in the pancreas (Zollinger-Ellison
syndrome):



Adults aged 18 and above: the usual dose is
Nexium 40 mg twice a day.
Your doctor will adjust the dose depending on your
needs and will also decide how long you need
to take the medicine for. The maximum dose is
80 mg twice a day.

To be used as prolonged treatment after
prevention of rebleeding of ulcers with
intravenous Nexium:


If you take more Nexium than prescribed by your
doctor, talk to your doctor or pharmacist straight away.

If you forget to take Nexium



4.









If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your
next dose, skip the missed dose.
Do not take a double dose (two doses at the same
time) to make up for a forgotten dose.

Possible side effects

Like all medicines, Nexium can cause side effects,
although not everybody gets them.
If you notice any of the following serious side
effects, stop taking Nexium and contact a doctor
immediately:
 Sudden wheezing, swelling of your lips, tongue
and throat or body, rash, fainting or difficulties in
swallowing (severe allergic reaction).
 Reddening of the skin with blisters or peeling.
There may also be severe blisters and bleeding
in the lips, eyes, mouth, nose and genitals. This
could be „Stevens-Johnson syndrome‟ or „toxic
epidermal necrolysis‟.
 Yellow skin, dark urine and tiredness which can be
symptoms of liver problems.


























Other side effects include:







Headache.
Effects on your stomach or gut: diarrhoea,
stomach pain, constipation, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).

Blood problems such as a reduced number
of white cells or platelets. This can cause
weakness, bruising or make infections more
likely.
Low levels of sodium in the blood. This may
cause weakness, being sick (vomiting) and
cramps.
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.
Liver problems, including jaundice which can
cause yellow skin, dark urine, and tiredness.
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)

These effects are rare, affecting less than 1 in
1,000 people.

Common (affects less than 1 in 10 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)

Adults aged 18 and above: the usual dose is one
Nexium 40 mg tablet once a day for 4 weeks.

If you take more Nexium than you should







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.










6.

How to store Nexium
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package.
Protect from moisture.
Do not take your tablets after the expiry date (EXP)
shown on the carton, wallet pack or blister foil. The
expiry date refers to the last day of that month.
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.
If your medicine becomes discoloured or shows any
signs of deterioration, you should seek the advice of
your pharmacist.

Further information

What Nexium contains
Each gastro-resistant tablet contains: Esomeprazole
magnesium trihydrate equivalent to esomeprazole
40mg.

The other ingredients are glycerol monostearate
40-50 (Type II), hyprolose, hypromellose, iron oxide
reddish-brown E172, magnesium stearate, methacrylic
acid ethyl acrylate copolymer (1:1) dispersion 30 per
cent, microcrystalline cellulose, paraffin synthetic,
macrogol 6000, polysorbate 80, crospovidone, sodium
stearyl fumarate, sugar spheres (sucrose and maize
starch), talc, titanium dioxide (E171) and triethyl citrate,.

What Nexium looks like and contents of the pack
• Nexium 40 mg gastro-resistant tablets are
Pink, oblong, biconvex film-coated tablets engraved 40
mg on one side and with an A on the other.
EI


Your tablets come in a blister pack of 28.

Manufacturer:
AstraZeneca AB, Sweden.
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon, London,
NW9 6AQ.
PL No: 33902/0364
POM
Leaflet revision date: 07/10/2013
Nexium® is a registered trademark of the AstraZeneca
group of companies.
S0364-28-GR-PIL-07.10.2013

Expand view ⇕

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.

Hide
(web3)