Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking MAXOR HEARTBURN RELIEF?
MAXOR HEARTBURN RELIEF contains the active ingredient omeprazole. MAXOR HEARTBURN
RELIEF is used for the relief of heartburn and stomach acid complaints due to gastro-oesophageal
reflux disease (GORD).
For more information, see Section
1. Why am I taking MAXOR HEARTBURN RELIEF? in the full CMI.
2. What should I know before I take MAXOR HEARTBURN RELIEF?
Do not take if you have ever had an allergic reaction to omeprazole or any of the
ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take MAXOR HEARTBURN RELIEF? in the full CMI.
3. What if I am taking other medicines?
4. How do I take MAXOR HEARTBURN RELIEF?
Take one MAXOR HEARTBURN RELIEF capsule at the same time each day unless your doctor
has told you otherwise.
Swallow the capsules whole with a glass of water. Do not crush or chew the capsules.
5. What should I know while taking MAXOR HEARTBURN RELIEF?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking MAXOR HEARTBURN
RELIEF.
Tell your doctor or pharmacist if you become pregnant while you are taking MAXOR HEARTBURN
RELIEF.
MAXOR HEARTBURN RELIEF should be taken for at least 7 days, and up to 14 days.
Tell your doctor or pharmacist if your symptoms return.
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Things you should not do
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Do not take MAXOR HEARTBURN RELIEF to treat any other complaints unless your doctor
tells you to.
You should not take it for more than 14 days unless directed by a doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how MAXOR
HEARTBURN RELIEF affects you.
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Drinking alcohol
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Tell your doctor or pharmacist if you drink alcohol.
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Looking after your medicine
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Keep it in a cool, dry place where the temperature stays below 25°C.
Keep your MAXOR HEARTBURN RELIEF in the blister pack until it is time to take them.
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6. Are there any side effects?
Mild side effects: constipation, nausea or vomiting, diarrhoea, wind, stomach pain, headache, dizziness,
skin rash, itchy skin, dry or sore mouth.
Serious side effects (Call your doctor straight away, or go straight to the Emergency
Department): swelling of the face, lips, mouth, tongue or throat, shortness of breath or difficulty
in breathing, skin reaction (which may include rash, itching, redness, blistering
or peeling of the skin) especially in sun-exposed areas with joint pain, ulcers, blisters
or bleeding of the lips, eyes, mouth, nose and genitals, blood in the urine, swelling
of hands, feet or ankles, yellowing of the skin or eyes, feeling generally unwell,
nausea, vomiting, loss of appetite.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
omeprazole
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MAXOR HEARTBURN RELIEF. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using MAXOR HEARTBURN RELIEF.
Where to find information in this leaflet:
1. Why am I taking MAXOR HEARTBURN RELIEF?
MAXOR HEARTBURN RELIEF contains the active ingredient omeprazole. MAXOR HEARTBURN RELIEF belongs to a group of medicines called proton pump inhibitors.
It works by reducing 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.
MAXOR HEARTBURN RELIEF is used for the relief of heartburn and stomach acid complaints
due to gastro-oesophageal reflux disease (GORD).
This can be caused by "washing back" (reflux) of food and acid from the stomach into
the oesophagus (food pipe).
Reflux can cause a burning feeling in the chest rising up to the throat, also known
as heartburn.
Who should use MAXOR HEARTBURN RELIEF
MAXOR HEARTBURN RELIEF is recommended for:
adults 18 years of age and over who suffer from heartburn at least 2 times a week.
MAXOR HEARTBURN RELIEF is not the right medicine for you if you suffer heartburn only
occasionally (one episode of heartburn a week or less), or if you want immediate relief
of heartburn.
Your doctor may have prescribed MAXOR HEARTBURN RELIEF for another reason. Ask your doctor if you have any questions about why MAXOR HEARTBURN RELIEF has been
prescribed for you.
MAXOR HEARTBURN RELIEF is not recommended for use in children, as there is no experience
with MAXOR HEARTBURN RELIEF capsules in children.
MAXOR HEARTBURN RELIEF is available only from your pharmacist or doctor. It can be
purchased directly from your local pharmacy without a doctor's prescription.
There is no evidence that MAXOR HEARTBURN RELIEF is addictive.
2. What should I know before I take MAXOR HEARTBURN RELIEF?
Warnings
Do not use MAXOR HEARTBURN RELIEF if:
you are allergic to omeprazole, or any of the ingredients listed at the end of this
leaflet
you are allergic to any medicines containing a proton pump inhibitor
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include rash, itching or hives on
the skin; fever; shortness of breath, wheezing or difficulty breathing; swelling of
the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or
breathing or swelling of other parts of the body.
you are also taking cilostazol, a medicine used to treat cramping pain and weakness
in legs. Please check with your doctor or pharmacist if you are taking cilostazol.
The medicine will be affected by MAXOR HEARTBURN RELIEF
Do not give MAXOR HEARTBURN RELIEF to children and adolescents under 18 years of age.
Do not take this medicine after the 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.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor or pharmacist if you have:
allergies to any other medicines, foods, dyes or preservatives
had to take other medication for indigestion or heartburn continuously for four or
more weeks in order to control your symptoms
recently (within the last two weeks) finished a course of MAXOR HEARTBURN RELIEF or
a similar medicine
any problems with your liver
been diagnosed with osteoporosis
any other medical conditions
take any medicines for any other condition
ever had a skin reaction after treatment with a medicine similar to MAXOR HEARTBURN
RELIEF that reduces stomach acid.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take MAXOR HEARTBURN RELIEF if you are pregnant or breastfeeding unless your
doctor says so. Ask your doctor about the risks and benefits involved.
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
It is not known if it is safe for you to take MAXOR HEARTBURN RELIEF while you are
pregnant. It may affect your baby.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
It is not known if your baby can take in MAXOR HEARTBURN RELIEF from breast milk if
you are breastfeeding.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking MAXOR HEARTBURN RELIEF.
If you have suffered from frequent heartburn/indigestion symptoms for some time you
should see your doctor.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not take MAXOR HEARTBURN RELIEF if you are taking the following medicine:
cilostazol - a medicine used to treat intermittent claudication such as cramping pain
and weakness in legs.
Some medicines may interfere with MAXOR HEARTBURN RELIEF and affect how it works.
phenytoin - a medicine used to treat epilepsy or fits
warfarin and clopidogrel - medicines used to prevent blood clots
digoxin - a medicine used to treat heart conditions
diazepam - a medicine used to treat anxiety and some other conditions
St John’s Wort - a herbal remedy used to treat mood disorders
ketoconazole, itraconazole or voriconazole - medicines used to treat certain fungal
infections
clarithromycin or rifampicin - medicines used to treat bacterial infections
atazanavir or nelfinavir - medicines used to treat viral infections such as HIV
tacrolimus and mycophenolate mofetil - medicines used to assist in organ transplants
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 MAXOR HEARTBURN RELIEF or may affect how well it
works. You may need different amounts of your medicines, or you may need to take different
medicines. Your doctor can tell you what to do if you are taking any other medicines.
If you have not told your doctor about any of the above, tell them before you start
taking MAXOR HEARTBURN RELIEF.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MAXOR HEARTBURN RELIEF.
4. How do I take MAXOR HEARTBURN RELIEF?
How much to take
The required dose is one MAXOR HEARTBURN RELIEF capsule a day (every 24 hours)
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this leaflet or the instructions on the carton
If you do not understand the instructions on the carton, ask your doctor or pharmacist
for help
Do not exceed the recommended dosage.
When to take MAXOR HEARTBURN RELIEF
MAXOR HEARTBURN RELIEF should be taken at the same time each day.
Keeping a regular time for taking MAXOR HEARTBURN RELIEF will help to remind you to
take it.
How to take it
Swallow the capsules whole with a glass of water with or without food
Do not crush or chew the capsules
If the granules in the capsules are crushed or chewed they will not work properly.
How long to take it for
MAXOR HEARTBURN RELIEF should be taken for at least 7 days, and up to 14 days.
You should not take it for more than 14 days unless directed by a doctor.
Tell your doctor if your symptoms return. You may need further treatment with omeprazole.
If you forget to take MAXOR HEARTBURN RELIEF
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your capsules as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much MAXOR HEARTBURN RELIEF
If you think that you or anyone else may have taken too much MAXOR HEARTBURN RELIEF,
urgent medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include nausea, vomiting, dizziness, stomach pain, diarrhoea,
headache and confusion.
5. What should I know while taking MAXOR HEARTBURN RELIEF?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking MAXOR HEARTBURN RELIEF
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine
If you become pregnant while taking MAXOR HEARTBURN RELIEF, tell your doctor or pharmacist
immediately
If you need to have any medical tests while you are taking MAXOR HEARTBURN RELIEF,
tell your doctor. It may affect the results of some tests.
Remind any doctor, dentist or pharmacist you visit that you are taking MAXOR HEARTBURN
RELIEF.
Things you should not do
Do not take MAXOR HEARTBURN RELIEF to treat any other complaints unless your doctor
or pharmacist tells you to
Do not give your medicine to anyone else, even if they have the same condition as
you.
Things that may help your condition
Some self-help actions suggested below may help your condition. Talk to your doctor
or pharmacist about these and ask for more information.
Alcohol - your doctor or pharmacist may advise you to limit your alcohol intake
Aspirin and similar medicines used to treat, for example, arthritis, period pain or
headache - these medicines may irritate the stomach and may make your condition worse.
Your doctor or pharmacist can suggest other medicines you may take
Caffeine - your doctor or pharmacist may advise you to limit the number of drinks
you take which contain caffeine, such as coffee, tea, cocoa and cola drinks because
they contain ingredients that may irritate the stomach
Eating habits - consider eating smaller quantities at regular meal times. Do not skip
meals. Eat slowly and chew your food carefully. Try not to rush at meal times
Smoking - your doctor or pharmacist is likely to advise you to stop smoking or at
least cut down the number of cigarettes you smoke. Ask for advice on how they can
help you do this
Weight - if you are overweight, your doctor or pharmacist may suggest that you lose
some weight to help your condition.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MAXOR
HEARTBURN RELIEF affects you.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
Keep your capsules in the blister pack, until it is time to take them. If you take
the capsules out of the blister, they may not keep well.
Keep your capsules in a cool, dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
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.
Getting rid of any unwanted medicine
If your doctor or pharmacist tells you to stop taking this medicine or if you no longer
need it or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking MAXOR HEARTBURN RELIEF.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. If you do experience any side effects, most of them are minor and temporary.
However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
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Less serious side effects
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What to do
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These side effects are usually mild and short-lived.
constipation
diarrhoea
nausea (feeling sick) or vomiting
headache
skin rash, itchy skin
wind
stomach pain
dizziness
dry or sore mouth
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Serious side effects
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Serious side effects
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What to do
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These are serious side effects which may require medical attention. Serious side effects
are rare.
muscle pain or weakness, joint pain
tingling or numbness of the hands or feet, pins and needles
changes in sleep patterns
mood changes, confusion or depression
blurred vision
increase in breast size (males)
fever
increased bruising or bleeding
increased sweating
hair loss
tremor
signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers
worsening of acid related symptoms as a result of stopping your heartburn medicine
pain or indigestion which occurs during treatment with MAXOR HEARTBURN RELIEF
vomiting blood or food
passing black or blood-stained motions
treatment > 3 month possibly decrease magnesium blood levels resulting in fatigue,
involuntary muscle contractions, disorientation, convulsions, dizziness or increased
heart rate
low magnesium blood levels may cause decrease of potassium or calcium levels in blood
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Tell your doctor immediately if you notice any of these serious side effects.
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These are very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
Shortness of breath or difficulty in breathing
severe skin reaction which may include rash, itching, redness, blistering and peeling
of the skin
ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
blood in the urine
swelling of hands, feet or ankles
signs of liver inflammation including yellowing of the skin or eyes, feeling generally
unwell, nausea, vomiting, loss of appetite.
skin reaction, especially in sun-exposed areas, with joint pain
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Occasionally, MAXOR HEARTBURN RELIEF may be associated with changes in your liver
or blood, which may require your doctor to do certain blood tests.
When taking MAXOR HEARTBURN RELIEF, inflammation in your kidney may occur. Signs and
symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity
reactions such as fever, rash, and joint stiffness. You should report such signs to
the treating physician.
Some health problems may arise from the condition being treated itself, rather than
the treatment. For this reason, contact your doctor immediately if you notice any
of the following:
pain or indigestion which occurs during treatment with MAXOR HEARTBURN RELIEF
vomiting blood or food
passing black or blood-stained motions.
Tell your doctor if your reflux symptoms return after you stop taking MAXOR HEARTBURN
RELIEF.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What MAXOR HEARTBURN RELIEF contains
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Active ingredient
(main ingredient)
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Omeprazole
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Other ingredients
(inactive ingredients)
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sucrose
maize starch
hypromellose
purified talc
dibasic sodium phosphate dihydrate
methacrylic acid copolymer
triethyl citrate
gelatin
purified water
iron oxide black
iron oxide red
erythrosine
titanium dioxide
TekPrint SW-9008 Black Ink
(ARTG PI No: 2328)
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Potential allergens
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Sugars and trace quantities of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What MAXOR HEARTBURN RELIEF looks like
MAXOR HEARTBURN RELIEF omeprazole 20 mg enteric capsule: Opaque pink cap and opaque
white body capsule #2, printed G/OE20 containing white to slightly beige spherical
pellets (AUST R 180913).
MAXOR HEARTBURN RELIEF is available in packs of 14 enteric capsules.
Who distributes MAXOR HEARTBURN RELIEF
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2023.
MAXOR® is a Viatris company trade mark
MAXOR HEARTBURN RELIEF_cmi\Oct23/00