ESOMEPRAZOLE APOTEX
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Esomeprazole magnesium dihydrate
Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about ESOMEPRAZOLE APOTEX. It does not contain all the information that is known about ESOMEPRAZOLE APOTEX.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ESOMEPRAZOLE APOTEX against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What ESOMEPRAZOLE APOTEX is used for

Reflux Oesophagitis

ESOMEPRAZOLE APOTEX 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 APOTEX 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 APOTEX 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 APOTEX 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 APOTEX with antibiotics. When ESOMEPRAZOLE APOTEX 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 APOTEX 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 APOTEX tablets or granules prescribed by your doctor for a longer period of time. This is to help your ulcer/s to heal.

How ESOMEPRAZOLE APOTEX works

ESOMEPRAZOLE APOTEX 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 APOTEX for another reason. There is no evidence that ESOMEPRAZOLE APOTEX is addictive

Before you take ESOMEPRAZOLE APOTEX

When you must not take it

Do not take Esomeprazole Apotex 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 APOTEX 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 APOTEX.
ESOMEPRAZOLE APOTEX 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 APOTEX is not recommended in these patients.
Do not take ESOMEPRAZOLE APOTEX 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
been diagnosed with osteoporosis
Do not take ESOMEPRAZOLE APOTEX 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 APOTEX while you are pregnant.
It may affect your baby.
It is not known if your baby can take in ESOMEPRAZOLE APOTEX from breast milk if you are breastfeeding.

Taking other medicines

Do not take ESOMEPRAZOLE APOTEX if you are taking the following medicines:
atazanavir, and nelfinavir, medicines used to treat viral infections such as 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 APOTEX. These include:
ketoconazole, itraconazole and voriconazole medicines used to treat fungal infections
diazepam , a medicine used to treat anxiety and some other conditions
phenytoin , a medicine used to treat epilepsy or fits
citalopram, clomipramine and imipramine medicines used to treat depression
St John's wort - a herbal remedy used to treat mood disorders
clarithromycin and rifampicin medicines used to treat bacterial infections
warfarin and clopidogrel - medicines used to prevent blood clots
digoxin, a medicine used to treat heart conditions
methotrexate, a medicine used to treat arthritis and some types of cancer
tacrolimus and mycophenolate mofetil - a medicine used to assist in organ transplants
erlotinib or related medicines used to treat cancer.
These medicines may be affected by ESOMEPRAZOLE APOTEX 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 APOTEX.
If you have not told your doctor about any of these things, tell them before you take ESOMEPRAZOLE APOTEX.

How to take ESOMEPRAZOLE APOTEX

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

How much to take

The dose of ESOMEPRAZOLE APOTEX 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 APOTEX 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.
Keeping a regular time for taking
ESOMEPRAZOLE APOTEX will help to remind you to take it.
Keep taking ESOMEPRAZOLE APOTEX for as long as your doctor recommends.
In most patients, ESOMEPRAZOLE APOTEX relieves symptoms rapidly and healing is usually complete within 4 weeks.
Continue taking ESOMEPRAZOLE APOTEX for as long as your doctor tells you to.
ESOMEPRAZOLE APOTEX can be taken with food or on an empty stomach

How to take it

ESOMEPRAZOLE APOTEX is available as tablets
Take one ESOMEPRAZOLE APOTEX tablet each day, unless your doctor has told you otherwise.

If you forget to take it

If it is less than 'x' hours before 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)

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too many ESOMEPRAZOLE APOTEX. Do this even if there are no signs of discomfort or poisoning

While you are using ESOMEPRAZOLE APOTEX

Things you must do

Take ESOMEPRAZOLE APOTEX 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 APOTEX.
Tell all doctors, dentists and pharmacists who are treating you that you are taking ESOMEPRAZOLE APOTEX.
Tell your doctor if you become pregnant while you are taking ESOMEPRAZOLE APOTEX.
Tell your doctor if your symptoms return.
Although ESOMEPRAZOLE APOTEX 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 APOTEX, 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 APOTEX.
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
Benign polyps in the stomach.
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 APOTEX 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 APOTEX.
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 APOTEX
you begin to vomit blood or food
you pass black (blood - stained) motions.

After using ESOMEPRAZOLE APOTEX

Storage

Keep your ESOMEPRAZOLE APOTEX in the blister pack until it is time to take them.
If you take ESOMEPRAZOLE APOTEX 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 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 APOTEX 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 APOTEX 20 mg tablet: light pink, elliptically shaped, biconvex, enteric coated tablet.
ESOMEPRAZOLE APOTEX 40 mg tablet: pink, elliptically shaped, biconvex, enteric-coated tablet.
ESOMEPRAZOLE APOTEX tablets are available in blister packs of 30 tablets.
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains esomeprazole magnesium dihydrate equal to 20mg or 40 mg base
It also contains the following inactive ingredients:
methacrylic acid polymer
purified talc
triethyl citrate
hypromellose
sucrose
maize starch
magnesium stearate
hydroxypropyl cellulose
glyceryl monostearate
polysorbate 80
microcrystalline cellulose
povidone
macrogol 6000
crospovidone
sodium stearylfumarate
titanium dioxide
macrogol 400
iron oxide red and iron oxide yellow.

Australian Registration Numbers

ESOMEPRAZOLE APOTEX 20mg Tablets (Blister pack): AUST R 210849.
ESOMEPRAZOLE APOTEX 40mg Tablets (Blister pack): AUST R 210843.

Sponsor

Medis PharmaPty Ltd
Suite 1002, 53 Walker Street,
North Sydney, NSW 2060,

Distributor

APOTEX Pty Ltd
Level 5, 117 Harrington Street
The Rocks NSW 2000
This leaflet was prepared in Aug 2017.

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