Contains the active ingredient omeprazole
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine. It does not contain
all the available information. It does not take the place of talking to your doctor
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
this medicine 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 this medicine is used for
Omeprazole is used to treat the symptoms of reflux oesophagitis or reflux disease.
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
Omeprazole is also taken to help stop reflux oesophagitis coming back or relapsing.
Omeprazole is used to treat peptic ulcers. 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.
These ulcers can be caused by too much acid being made in the stomach.
Omeprazole is also used to help stop gastric or duodenal ulcers coming back.
Peptic Ulcers Associated with Helicobacter pylori Infection
Most people who have a peptic ulcer also have a bacterium called Helicobacter pylori
in their stomach.
When omeprazole is taken with antibiotics, they work to kill the bacterium and let
your ulcer heal. You may need further treatment with antibiotics.
Peptic Ulcers Associated with Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
Some peptic ulcers are caused by taking medicines called non-steroidal anti-inflammatory
drugs (NSAIDs), a type of medicine used to treat pain or inflammation. Omeprazole
is used to heal and prevent ulcers associated with NSAIDs.
Omeprazole is 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.
How it works
Omeprazole belongs to a group of medicines called proton-pump inhibitors.
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
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor's prescription
Before you take this medicine
When you must not take it
Do not take omeprazole if you have an allergy to:
any medicine containing omeprazole
any of the ingredients listed at the end of this leaflet
any medicine 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
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy. Your doctor can
discuss with you the risks and benefits involved.
Do not breastfeed if you are taking this medicine.
It is not known whether omeprazole passes into breast milk and there is a possibility
that your baby may be affected. Your doctor can discuss with you the risks and benefits
Do not take this medicine if you are also taking cilostazol.
Cilostazol will be affected by omeprazole. Please check with your doctor or pharmacist
if you are unsure.
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.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
any problems with your liver
an osteoporosis diagnosis
if you have ever had a skin reaction after treatment with a medicine similar to omeprazole
that reduces stomach acid
any other medical conditions
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Do not take this medicine if you are taking the following medicine:
cilostazol, used to treat intermittent claudication
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and this one may interfere with each other. These include:
cilostazol, used to treat intermittent claudication
phenytoin, used to treat epilepsy or fits
warfarin and clopidogrel, used to prevent blood clots
digoxin, used to treat heart conditions
diazepam, used to treat anxiety and some other conditions
St John’s Wort, a herbal remedy used to treat mood disorders
ketoconazole, itraconazole or voriconazole, used to treat fungal infections
clarithromycin or rifampicin, antibiotics used to treat infections
atazanavir or nelfinavir, used to treat viral infections such as HIV
tacrolimus and mycophenolate mofetil, immunosuppressants used to assist in organ transplants
methotrexate, used to treat arthritis and some types of cancer
erlotinib or related medicines used to treat cancer
These medicines may be affected by omeprazole 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 and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
If you have not told your doctor about any of these medicines, tell them before you
take this medicine.
How to take this medicine
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 label, ask your doctor or pharmacist
How much to take
The dose for omeprazole varies from patient to patient. Your doctor will decide the
right dose for you.
How to take it
Swallow the capsules with a glass of water.
Do not crush or chew the capsules.
If the granules or pellets contained in the capsules are crushed or chewed, they will
not work properly.
When to take it
Take this medicine at the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
Omeprazole can be taken with food or on an empty stomach.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
If you are taking omeprazole to heal an ulcer or to treat reflux disease, you will
usually need to take omeprazole for 4 to 8 weeks.
It is very important that you take the full course of omeprazole as prescribed by
your doctor so that your condition is properly treated.
If you are taking omeprazole to stop an ulcer from coming back or to treat other conditions,
your doctor will tell you how long you need to take the capsules.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
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 of this medicine. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking this medicine
Things you must do
Take this medicine exactly as your doctor has prescribed.
If you are about to start any new medicine, remind your doctor and pharmacist that
you are taking this medicine.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
If you become pregnant or start to breastfeed while taking this medicine, tell your
Tell your doctor if your symptoms return.
Although omeprazole can heal ulcers successfully, it may not prevent them recurring
at a later date.
If you are about to have any medical tests, tell your doctor that you are taking this
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you
Do not give your medicine to anyone else, even if they have the same condition as
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly or change the dose, your condition may worsen or you
may have unwanted side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
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
skin rash or itchy skin
dry or sore mouth
These side effects are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
muscle pain or weakness, or joint pain
pins and needles sensation
changes in sleep patterns
mood changes, confusion or depression
increase in breast size (males)
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
skin reaction which may include rash, itching, redness, blistering or peeling of the
ulcers, blisters or bleeding of the lips, eyes, mouth, nose and genitals
blood in urine
swelling of feet, hands and ankles
signs of liver inflammation including yellowing of the skin or eyes, feeling generally
unwell, nausea, vomiting or loss of appetite
symptoms of an allergic reaction including cough, shortness of breath, wheezing or
difficulty breathing; swelling of the face, lips, tongue, throat or other parts of
the body; rash, itching or hives on the skin
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects, such as changes in your liver or blood, or lower levels
of Vitamin B12, can only be found when your doctor does tests from time to time to
check your progress.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
pain or indigestion that occurs during treatment with omeprazole
you begin to vomit blood or food
you pass black (blood-stained) motions
Tell your doctor if your symptoms return or become worse after you have stopped this
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store this medicine or any other medicine in the bathroom or near a sink. Do
not leave it on a window sill or in the car.
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.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What APO-Omeprazole Capsules looks like
APO-OMEPRAZOLE has an opaque yellow cap and body No. 2 hard gelatin capsule containing
enteric coated off-white spherical microgranules. AUST R 149518. AUST R 167316.
Each bottle or carton (in blisters) contains 30 capsules.
Each capsule contains 20 mg of omeprazole as the active ingredient.
It also contains the following inactive ingredients:
sodium lauryl sulfate
dibasic sodium phosphate
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was last updated in