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Esomeprazole GxP

contains the active ingredient esomeprazole (as magnesium)
CONSUMER MEDICINE INFORMATION

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Esomeprazole GxP. It does not contain all the information that is known about Esomeprazole GxP. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Esomeprazole GxP is used for

Reflux Oesophagitis:
Esomeprazole GxP is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus).
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
Esomeprazole GxP is also taken to help stop reflux oesophagitis coming back or relapsing.
Upper gastrointestinal symptoms associated with non-steroidal anti- inflammatory drugs (NSAIDs) therapy
Esomeprazole GxP is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation.
Esomeprazole GxP is also taken to help heal and prevent ulcers caused by NSAIDs.
Peptic Ulcers Associated with Helicobacter pylori Infection:
Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach.
Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach.
If you have a peptic ulcer, your doctor will prescribe Esomeprazole GxP with antibiotics. When Esomeprazole GxP and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics.
Zollinger-Ellison Syndrome:
Esomeprazole GxP is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease.
Bleeding Peptic Ulcers:
When peptic ulcers become severe enough, they start to bleed. You may receive treatment injected into your veins initially. This treatment may be followed with
Esomeprazole GxP tablets or granules prescribed by your doctor
for a longer period of time. This is to help your ulcer/s to heal.
How Esomeprazole GxP works
Esomeprazole GxP is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. This does not stop food being digested in the normal way.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Ask your doctor if you want more information. Your doctor may have prescribed Esomeprazole GxP for another reason.
There is no evidence that Esomeprazole GxP is addictive.

Before you take Esomeprazole GxP

When you must not take it

Do not take Esomeprazole GxP if you have an allergy to:
esomeprazole or any ingredient listed at the end of this leaflet
any medicines containing a proton-pump inhibitor
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
add any other specific reactions listed in the PI.
Do not take ESOMEPRAZOLE GXP if you are also taking atazanavir or cilostazol.
Please check with your doctor or pharmacist if you are taking these medicines. These medicines will be affected by Esomeprazole GxP.
Esomeprazole GxP is not approved for use in children younger than 1 year of age.
There is no specific information about use in children younger than 1 year of age, so Esomeprazole GxP is not recommended in these patients.
Do not take Esomeprazole GxP after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

You must tell your doctor if you have:
allergies to any other medicines, foods, dyes or preservatives.
any problems with your liver
severe kidney problems
any other medical conditions
Do not take Esomeprazole GxP if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.
It is not known if it is safe for you to take Esomeprazole GxP while you are pregnant. It may affect your baby. It is not known if your baby can take in Esomeprazole GxP from breast milk if you are breastfeeding.

Taking other medicines

Do not take Esomeprazole GxP if you are taking the following medicines:
atazanavir, a medicine used to treat Human Immunodeficiency Virus (HIV)
cilostazol, a medicine used to treat intermittent claudication.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Esomeprazole GxP. These include:
medicines used to treat fungal infections such as ketoconazole, itraconazole and voriconazole
cisapride
diazepam, a medicine used to treat anxiety and some other conditions
phenytoin, a medicine used to treat epilepsy
medicines used to treat depression such as citalopram, clomipramine and imipramine
St John's wort, a herbal remedy used to treat mood disorders
medicines used to treat bacterial infections such as clarithromycin and rifampicin
warfarin, a medicine used to prevent blood clots
medicines for HIV treatment such as nelfinavir
digoxin, a medicine used to treat heart conditions
methotrexate, a medicine used to treat arthritis and some types of cancer
erlotinib or related medicines used to treat cancer
These medicines may be affected by Esomeprazole GxP or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor can tell you what to do if you are taking any other medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Esomeprazole GxP.
If you have not told your doctor about any of these things, tell them before you take Esomeprazole GxP.

How to take Esomeprazole GxP

Follow all directions given to you by your doctor and pharmacist carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the directions on the label, ask your doctor or pharmacist for help.

How to take it

Esomeprazole GxP is available as tablets and as granules for suspension in sachets.
Esomeprazole GxP Tablets
Take one Esomeprazole GxP tablet each day, unless your doctor has told you otherwise.
The dose of Esomeprazole GxP tablets is usually 20 mg or 40 mg a day depending on what condition you are being treated for and how severe it is.
Swallow Esomeprazole GxP tablets whole with a glass of water. Do not crush or chew the tablets.
If the tablets are chewed or crushed they will not work properly.
If you have difficulty swallowing the tablets:
1) Place the tablet in half a glass of non-carbonated water. Mineral water or other liquids are not suitable.
2) Gently mix the tablet and water by stirring, taking care not to crush the tablet.
3) Stir until the tablet dissolves into little pellets.
4) Drink the liquid with the pellets immediately, or within 30 minutes. Do not chew the pellets.
5) Rinse the glass with half a glass of water and drink.
If you cannot swallow at all, follow steps 1-3 above to disperse the tablets and administer the liquid and pellets through a gastric tube.
Take Esomeprazole GxP at about the same time each day.
Keeping a regular time for taking Esomeprazole GxP will help to remind you to take it.
Keep taking Esomeprazole GxP for as long as your doctor recommends. In most patients, Esomeprazole GxP relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking Esomeprazole GxP for as long as your doctor tells you to.
Esomeprazole GxP can be taken with food or on an empty stomach.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, and then go back to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Esomeprazole GxP. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include (list symptoms as per PI).

While you are taking Esomeprazole GxP

Things you must do

Take Esomeprazole GxP exactly as your doctor has prescribed.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Esomeprazole GxP.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Esomeprazole GxP.
Tell your doctor if you become pregnant while you are taking Esomeprazole GxP.
Tell your doctor if your symptoms return.
Although Esomeprazole GxP can heal ulcers successfully, it may not prevent them recurring at a later date.
If you need to have any medical tests while you are taking Esomeprazole GxP, tell your doctor. It may affect the results of some tests.

Things you must not do

Do not take it to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Esomeprazole GxP.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea or vomiting
constipation
diarrhoea
headache
wind
stomach pain
skin rash, itchy skin
dizziness
dry mouth
These side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
blurred vision
mood changes, confusion or depression
muscle pain or weakness, joint pain
increase in breast size (males)
increased sweating
changes in sleep patterns
fever
increased bruising
"pins and needles"
hair loss
tremor
blood in the urine
These side effects may require medical attention.
If you notice any of the following happen, tell your doctor immediately or go to Accident and Emergency at the nearest hospital:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin
signs of liver inflammation including yellowing of the skin or eyes, feeling generally unwell, nausea, vomiting, loss of appetite
These are very serious side effects. You may need urgent medical treatment or hospitalisation.
Occasionally, Esomeprazole GxP may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.
Tell your doctor if you think you have any of these effects or notice anything else that is making you feel unwell.
Some people may get other side effects while taking Esomeprazole GxP.
Other problems are more likely to arise from the condition itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
pain or indigestion during treatment with Esomeprazole GxP
you begin to vomit blood or food
you pass black (blood-stained) motions

After taking Esomeprazole GxP

Storage

Keep your Esomeprazole GxP in the blister pack until it is time to take them.
If you take Esomeprazole GxP out of the blister pack it will not keep well.
Keep it in a cool, dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Esomeprazole GxP or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets you have left over.

Product description

What it looks like

Esomeprazole GxP 20 mg are light pink, oblong, biconvex, film coated tablets debossed with '20' on one side and 'CE' on the other side.
Esomeprazole GxP 40 mg are pink, oblong, biconvex, film coated tablets debossed '40' on one side and 'CE' on the other side.

Ingredients

Each Esomeprazole GxP tablet contains esomeprazole magnesium as the active ingredient equivalent to esomeprazole 20mg or 40mg;
plus,
Sugar spheres (Non-pareil seeds 40-50, ARTG 108808)
Hydroxypropylcellulose
Crospovidone
Confectioner's sugar (sucrose and maize starch)
Magnesium oxide light
Purified talc
Macrogol 6000
Methacrylic acid ethyl acrylate copolymer
Glyceryl monostearate
Macrogol 400
Polysorbate 80
Hypromellose phthalate
Acetone
Microcrystalline cellulose
Iron oxide red
Povidone
Pregelatinised maize starch
Silicon dioxide
Lactose
Opadry Pink 03B848893 (ARTG108603) (20mg)
Opadry Pink 03B54193 (ARTG 108604) (40mg)
Esomeprazole GxP tablets are available in blister packs of 30 tablets. The tablets are gluten free.

Supplier

Esomeprazole GxP is distributed in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
Australian registration numbers:
AUST R 205831
AUST R 205845
This leaflet was prepared on
11/09/2015
Esomeprazole GxP_cmi\Sep2015