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AXAGON 40MG TABLETS

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Nexium® 40 mg Tablets / Axagon 40mg Tablets/ /Esomeprazole 40mg gastro-resistant Tablets
(esomeprazole magnesium)
PATIENT INFORMATION LEAFLET
This product is available as the above but will be referred to as Nexium tablets throughout the remainder of the leaflet.
What you should know about Nexium 40 mg Tablets.
Please read this leaflet carefully before you take your medicine. Keep this leaflet in a safe place, you may wish to read it again.
If you have any further questions or are unsure about anything to do with your medicine please ask your doctor or pharmacist
(chemist).
Remember this medicine is only for you. Only a doctor can prescribe it. Never give it to anyone else even if their symptoms are similar
to yours.
What is in your medicine?
Nexium tablets are gastro-resistant. This means that the coated pellets in your tablet are resistant to the acid in your stomach.
Each gastro-resistant tablet contains the active ingredient esomeprazole.
Nexium tablets contain 40 mg of the active ingredient esomeprazole (as magnesium trihydrate).
40 mg tablets are pink, oblong, film-coated tablets with an A and EI on one side and 40 mg on the other side.
Each tablet also contains: Glyceryl monostearate 40-55, hyprolose, hypromellose, iron oxide (reddish-brown, yellow) (E 172),
magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) (Ph. Eur.) dispersion 30 per cent, microcrystalline cellulose,
synthetic paraffin, macrogol, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and maize starch), talc,
titanium dioxide (E 171), triethyl citrate.
Nexium tablets come in blister packs containing 14 or 28 tablets.
Nexium tablets contain a type of drug called a ‘proton pump inhibitor’. It reduces the production of acid in your stomach.
Who has made your medicine?
Nexium Tablets are manufactured by AstraZeneca AB, Gartunavagen, Sodertalje, Sweden. Procured from within the EU.
Product Licence holder: S.C.A.C. Ltd, Unit 2A, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP, United Kingdom. Repackaged
by Cross Healthcare Ltd, Unit 2A, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP, United Kingdom.Licensed2U Limited, Unit 6,
Sugarswell Business Park, Shenington, Banbury, Oxon OX15 6HW
PL 31349/005730984/0048

Nexium 40 mg Tablets
Axagon 40mg Tablets
Esomeprazole 40mg gastro-resistant Tablets

POM

What is your medicine used for?
Nexium tablets are used for treating the following conditions:

Heartburn with or without inflammation of the gullet (oesophagus) caused by acid from the stomach escaping into the
gullet. Nexium tablets reduce acid production and help the healing of the gullet by reducing the pain and inflammation.

Ulcers in the upper part of the intestine or stomach infected with bacteria called Helicobacter pylori. Nexium tablets and
the appropriate antibiotics get rid of the infection, which causes the ulcer to heal and prevents the infection and ulcer from
re-appearing.

Healing of stomach ulcers that have been caused by taking non-steroidal anti-inflammatory drugs (NSAIDs), such as
those used in the treatment of arthritis.

To stop stomach ulcers forming, if you are at risk of developing them whilst taking non-steroidal anti-inflammatory drugs
(NSAIDs), such as those used in the treatment of arthritis.

To treat excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
Before taking your medicine
Do not take Nexium tablets:

if you have a known allergy to any of the ingredients in Nexium tablets

if you have a known allergy to any other proton pump inhibitors (medicines used to treat your ulcer-like symptoms)

if you are taking atazanavir (a medicine used to treat HIV).
Take special care and tell your doctor if any of the following apply to you:

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

Are you pregnant, think you might be pregnant, or considering becoming pregnant?













COA

Are you breast-feeding?
Do you have any liver problems?
Do you have severe kidney problems?
Have you recently suffered any unintentional weight loss?
Have you recently been vomiting frequently?
Have you experienced pain or difficulty when swallowing?
Have you recently vomited blood or dark particles that look like coffee-grounds?
Have you passed black tarry stools?
If you think you may have a stomach ulcer, please tell your doctor before taking this medicine.
If you will be taking this medicine for an extended period (particularly if it is more than a year) your doctor will
want to monitor you.
If you are taking this medicine as ‘on demand’ therapy (you take your medicine as and when you require it), you
should tell your doctor if your symptoms change.

Tell your doctor if you are taking any of the following medicines:

Ketoconazole, itraconazole or voriconazole (drugs used to treat fungal infections)

citalopram, imipramine, clomipramine (drugs used to treat depression)

diazepam (drug used to treat insomnia or anxiety)

phenytoin (drug used to treat epilepsy) – if you are being treated with phenytoin your doctor should monitor you
when you start or stop taking Nexium tablets

warfarin (anticoagulant used to prevent blood clotting) – if you are being treated with warfarin your doctor should
monitor you when you start or stop taking Nexium tablets.
If your doctor has prescribed Nexium tablets, Amoxycillin and Clarithromycin to get rid of your Helicobacter
pylori in order to heal your ulcer, it is essential that you tell your doctor about any other medicines you are taking.
Make sure that you have told your doctor about any other medicines that you are taking, including those you have bought
without a prescription.
Taking your medicine
Nexium tablets can be taken by adults, adolescents (12 to 18 years) and the elderly. Nexium tablets should not be taken by
children younger than 12 years. You may take your tablets at any time of the day. You can take your tablets with food or on an
empty stomach. The tablets should not be chewed or crushed, they should be swallowed whole, with a drink of water. If you
have difficulty swallowing, the tablets can also be put into a glass of still water. No other liquids should be used. Stir until the
tablets break up (the mixture will not be clear). Drink straight away or at least within 30 minutes. Always stir just before drinking.
To ensure that you have taken all of the medicine, rinse the glass thoroughly with half a glass of water and drink. The solid
pieces contain the medicine, they should never be chewed or crushed.
If you cannot swallow at all, the tablet can be mixed with some water and can be put into a syringe and given to you through a
gastric tube (a tube passed down your throat and into your stomach).
How to open your Nexium tablets 40 mg blister pack
• Always push your tablet through the blister foil.
• Hold the blister pack with its flat side down.
• Push the tablet from the back as shown.
Your doctor will tell you how many tablets to take, and when to take them. The strength of tablet you take and the length of time
you take them for will depend on what condition you are suffering from. The dosages below are those usually recommended.
Treatment for heartburn
For adults, adolescents and the elderly, Nexium 40 mg should be taken once a day for 4 weeks. An additional 4 weeks
treatment may be required dependent on whether your symptoms persist, or to allow healing. If you have severe liver problems
you will be limited to 20 mg daily. To prevent your symptoms returning, your doctor may tell you to continue taking your Nexium
20 mg once each day. For adults and the elderly only, your doctor may tell you to take your medicine as and when you require
it in order to control your symptoms, up to a maximum of one Nexium 20 mg tablet each day.
Healing of ulcers caused by infection with bacteria called Helicobacter pylori and to prevent your ulcer coming back
Adults (including the elderly), Nexium 20 mg should be taken twice a day. Your doctor will also tell you to take the following
antibiotics: Amoxycillin and Clarithromycin. The treatment time is 1 week.
Healing of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs)
Adults (including the elderly) and adolescents, Nexium 20 mg should be taken once daily for 4–8 weeks.
Prevention of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs)

Adults (including the elderly), Nexium 20 mg should be taken once daily. Follow the directions for taking your medicine very carefully
and if you are unsure about anything, ask your doctor.
Treatment for excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome)
Adults (including the elderly), Nexium 40 mg should be taken once daily, your doctor will adjust the dose according to your needs and
also decide how long you should take the medicine.
What happens if you take too many?
If you take more than the recommended number of tablets, contact your doctor or pharmacist (chemist) straight away.
What to do if you forget to take a dose?
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed
dose, just take the next dose on time.
After taking your medicine – possible side effects
As with all medicines, as well as benefits, Nexium tablets may sometimes cause side effects. These are usually mild and go away
when you stop taking this medicine. Do not be alarmed by this list of side effects, as you may not experience any of them.
If you experience any of the following side effects, you should stop taking Nexium tablets and tell your doctor immediately or go to the
casualty department of your nearest hospital:
• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing
• hives
• low blood pressure, fainting or collapse.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Nexium tablets. You may
need urgent medical attention or hospitalisation. These very serious side effects are rare (experienced by less than 1 in 1000, but
more than 1 in 10,000 patients).
You should also tell your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the
following side effects:
• signs of frequent infections, such as sore throat or fever or mouth or throat ulcers
• bruising or bleeding easily or bleeding from the nose or gums
• difficulty in breathing
• urinary problems e.g. less urine than is normal for you or blood in your urine
• jaundice (yellow colouration of the skin, eyes or nail beds and greenish-yellow colour of the urine).
These are serious side effects. You may need urgent medical attention. These serious side effects are rare or very rare (experienced
by less than 1 in 10,000 patients).
More common (experienced by less than 1 in 10, but more than 1 in 100 patients) side effects are a headache, stomach ache,
diarrhoea, wind, feeling sick or being sick, or constipation. Or less commonly (less than 1 in 100, but more than 1 in 1000 patients),
you may have a skin rash, itchy skin, allergic skin reactions (such as swelling and hives), a feeling of dizziness or spinning, a dry
mouth, difficulty sleeping, swollen limbs, pins and needles, blood tests which show changes in the way your liver is working, or you
may feel very sleepy.
Rarely, you may experience agitation (restlessness), tiredness, confusion, depression, blurred vision, taste disorders, muscle or joint
pain, sensitivity to light, thinning of the hair, increased sweating, low blood sodium (salt) which may make you feel nauseous or weak,
swelling and soreness in the mouth or a yeast infection of the gut (which may cause an upset stomach or pain in your gut).
Very rarely you may experience hallucinations or become aggressive, or you may have muscle weakness, kidney problems, liver
failure, or larger breasts (if you are male). Cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have also been
reported very rarely (a serious illness with blistering of the skin, mouth, eyes and genitals). If you have previously had liver disease
you may very rarely get encephalopathy (a brain disease).
If you suffer from any of these side effects, or if you get any other unusual or unexpected symptoms, talk to your doctor or pharmacist
(chemist).

Storing your medicine
• Do not take your tablets after the expiry date shown on the carton, wallet pack or blister foil.
• Keep your medicine in a safe place where children cannot reach or see it.
• Do not store above 30°C.
• Keep this medicine in the original package.
• Remember to return any unused tablets to your pharmacist (chemist).
• If the tablets become discoloured or show 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 no
longer required. These measures will help to protect the environment.
Important:
This medicine is for your use only. It can only be prescribed by a doctor. Never give it to anyone else it may harm them,
even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist who has access to additional information.
Nexium Tablets
26.08.200812.11.2010
Nexium is a registered trademark of AstraZeneca AB.

Nexium Tablets
(esomeprazole magnesium)
Your doctor has prescribed your medicine for treatment of
Reflux Disease (heartburn)
or Peptic ulcers infected with Helicobacter pylori (Hp)
Q. What is a peptic ulcer?
A. A peptic ulcer is a break (hole) in the lining of the stomach
(gastric ulcer) or the upper part of the intestine (duodenal ulcer).
Q. What is Helicobacter pylori (H. pylori)?
A. H. pylori are bacteria (bugs) which live in the protective
lining of the gut and have been recognised as an important
cause of many peptic ulcers. It is unknown as to why some
people are infected with Hp and others are not.
Q. What causes a peptic ulcer?
A. Usually there is a balance between the protection
of the lining of the stomach or duodenum and the attack from acid.
Peptic ulcers form when there is either too much acid or not
enough protection.
Because Hp is involved in peptic ulcers, treatment to
eradicate the bug should ensure that peptic ulcers are
unlikely to return once they are healed.
Q. What is Reflux Disease?
A. When digestive juices containing acid rise into the
gullet (oesophagus) this is called reflux. The gullet, unlike the
stomach, does not have a protective lining,
so when it is exposed to the acid it may become inflamed
and painful.
This leads to symptoms such as heartburn.

How can I help myself?
Reflux Disease

Do not eat just
before going to
bed

Do not wear tight
clothing

Lose weight if
needed

Raise the head of
the bed by 20cm

Reflux and Peptic Ulcer Disease

Stop smoking

avoid caffeine, alcohol,
hot spicy food and fatty
or fried food

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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