NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
APO-OMEPRAZOLE
Contains the active ingredient omeprazole
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about omeprazole. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO- Omeprazole. It contains the active ingredient omeprazole.
It is used to treat:
Reflux Oesophagitis
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 as heartburn.
Omeprazole is also used to help stop reflux oesophagitis coming back or relapsing.
Peptic Ulcers
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 peptic or duodenal ulcers coming back.
Peptic Ulcers Associated with Helicobacter pylori Infection
Helicobacter pylori is a bacteria that often occurs in the stomach together with peptic ulcers.
When omeprazole is taken together with an antibiotic, they work together to kill the bacteria 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, swelling or inflammation, including arthritis and joint pain.
Omeprazole is used to treat and help to prevent ulcers developing, which are associated with long-term use of NSAIDs.
Zollinger-Ellison Syndrome
Omeprazole 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
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 way.
There is no evidence that this medicine is addictive.
Use in children
This medicine should not be used in children.
Before you take this medicine
When you must not take it
Do not take Omeprazole if you have an allergy to:
omeprazole or any ingredient 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.
Do not take Omeprazole if you are also taking cilostazol.
Please check with your doctor or pharmacist if you are taking cilostazol. This medicine will be affected by Omeprazole.
Do not take Omeprazole 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.
If you are not sure whether you should take this medicine, talk to your doctor.
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
any other medical conditions
been diagnosed with osteoporosis
if you have ever had a skin reaction after treatment with a medicine similar to Omeprazole that reduces stomach acid
Do not take Omeprazole 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 Omeprazole while you are pregnant. It may affect your baby.
It is not known if your baby can take in Omeprazole from breast milk if you are breastfeeding.
Taking other medicines
Do not take Omeprazole if you are taking the following medicine:
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 Omeprazole tablets. These include:
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, voriconazole – medicines used to treat fungal infection
clarithromycin or rifampicin – medicines used to treat infections
atazanavir and 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 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 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 this medicine.
If you have not told your doctor about any of these things, tell them before you take Omeprazole.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take.
The usual dose is 20 mg once a day. The dose may vary from 10 mg to 40 mg a day depending on what condition you are being treated for and how severe it is. This may also depend whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
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 and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
How long to take it for
In most patients, omeprazole relieves symptoms rapidly and healing is usually complete within 4 weeks. Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. 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 missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
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 Omeprazole exactly as your doctor has prescribed.
If you are about to start any new medicine, remind your doctor and pharmacist that you are taking Omeprazole.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Omeprazole.
Tell your doctor if you become pregnant while you are taking Omeprazole.
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 need to have any medical tests while you are taking Omeprazole, tell your doctor.
It may affect the results of some tests.
Things you must not do
Do not take Omeprazole to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
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.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking omeprazole or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
constipation
nausea/vomiting
flatulence (wind)
stomach pain
diarrhoea
headache
skin rash, itchy skin
dizziness
dry or sore mouth
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
muscle pain, joint pain or weakness
“pins and needles” (tingling or numbness) in the hands and feet
changes in sleep patterns
increased sweating
hair loss
tremor
mood changes, confusion or depression
increase in breast size (males)
fever, vomiting and abdominal cramps accompanied by diarrhoea with or without blood or mucous
increased bruising, or bleeding more easily
disturbance in hearing.
Blurred vision
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.
swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in breathing
shortness of breath or difficulty in breathing
skin reaction, which may include rash, itching, redness, blistering or peeling of the skin
swelling of feet, hands and ankles
ulcers, blisters of bleeding of the lips, eyes, mouth, nose and genitals
blood in urine
signs of liver inflammation including yellowing of the skin or eyes, generally feeling unwell, nausea, vomiting, loss of appetite
skin reaction, especially in sun-exposed areas, with joint pain
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Occasionally, Omeprazole may be associated with changes in your liver or blood, which may require your doctor to do certain blood tests.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some people. 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 reflux symptoms return
Storage and disposal
Storage
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 will stay below 25°C.
Do not store your 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 this medicine 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
Product description
What APO-Omeprazole looks like
20 mg omeprazole is a red brown, oblong, enteric coated tablet.
Ingredients
Each tablet contains 20 mg of omeprazole as the active ingredient.
It also contains the following inactive ingredients:
ascorbyl palmitate
microcrystalline cellulose
crospovidone
magnesium stearate
povidone
lactose monohydrate
hypromellose phthalate
triacetin
purified talc
iron oxide red
iron oxide black
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Omeprazole is available in:
Blister packs and bottles of 30 tablets.
Not all pack types may be available.
Australian Registration Numbers
APO-Omeprazole 20 mg tablet (blister pack): AUST R 243812.
APO-Omeprazole 20 mg tablet (bottles): AUST R 243813.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie ParkNSW2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in August 2020
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