Contains the active ingredient, pantoprazole (as sodium sesquihydrate)
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 . It does
not contain all the information that is known about
. 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.
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What APO-Pantoprazole Heartburn Relief is used for
The name of your medicine is APO-Pantoprazole Heartburn Relief. It contains the active ingredient, pantoprazole (as sodium
sesquihydrate).
APO-Pantoprazole Heartburn Relief is also used to treat reflux oesophagitis or reflux disease. This can be caused by "washing
back" (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus.
Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.
Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you. Your doctor
or pharmacist may have recommended this medicine for another reason.
APO-Pantoprazole Heartburn Relief is a "Pharmacist Only Medicine". It is available without a doctor's prescription, but your
pharmacist's advice is required.
There is no evidence that this medicine is addictive.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before you take APO-Pantoprazole Heartburn Relief
When you must not take it
Do not take APO-Pantoprazole Heartburn Relief if you are lactose-intolerant. The tablets contain lactose.
Do not take this medicine if you have had an allergic reaction to APO-Pantoprazole Heartburn Relief or any of the ingredients
listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling
of the face, lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain; or rash, itching or
hives on the skin.
Do not take APO-Pantoprazole Heartburn Relief if you have severe liver disease or cirrhosis
Do not take APO-Pantoprazole Heartburn Relief in combination with antibiotics or any other medicine if:
you are allergic to any of the antibiotics or medicines your doctor may prescribe with APO-Pantoprazole Heartburn Relief
you have moderate to severe liver or kidney disease.
Do not take APO-Pantoprazole Heartburn Relief in combination with atazanavir (an anti-viral medication).
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
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:
1.
You have allergies to:
pantoprazole
any other ingredients listed at the end of this leaflet
any other substances, such as foods, preservatives or dyes.
2.
You have or have had any medical conditions
3.
You plan to become pregnant or breast-feed.
Your doctor will discuss the risks and benefits of taking APO-Pantoprazole Heartburn Relief during pregnancy or while breast-feeding.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist 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 be affected by APO-Pantoprazole Heartburn Relief, or may affect how well it works. These may include medicines
used to prevent blood clots (anticoagulants) and medicines whose activity depend on the acidity of the stomach e.g. ketoconazole.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines
to be careful with or avoid while taking APO-Pantoprazole Heartburn Relief.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
The usual dose is one tablet per day.
How to take it
Swallow your tablets whole with a little water with or without food.
Do not crush or chew the tablets. APO-Pantoprazole Heartburn Relief tablets have a special coating to protect them from the
acidic contents of your stomach. For APO-Pantoprazole Heartburn Relief to work effectively, this coating must not be broken.
When to take it
Take it at about the same time each day.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
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 for 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 have trouble remembering 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 (Tel: 13 11 26 for Australia) for advice, or go to the
Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much APO-Pantoprazole
Heartburn Relief.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking APO-Pantoprazole Heartburn Relief
Things you must do
Use APO-Pantoprazole Heartburn Relief exactly as your doctor has prescribed.
Tell your doctor immediately if you become pregnant while you are taking APO-Pantoprazole Heartburn Relief.
Tell all doctors, dentists and pharmacists who are treating you that you are taking APO-Pantoprazole Heartburn Relief.
If you take APO-Pantoprazole Heartburn Relief for a long period of time, e.g. over 1 year, you will need to see your doctor
regularly so that he/she can monitor your condition.
Tell your doctor if you do not feel better while taking APO-Pantoprazole Heartburn Relief. Your doctor may recommend further
examination.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how APO-Pantoprazole Heartburn Relief affects you.
Things that may help your condition
Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and
for more information.
Alcohol - your doctor may advise you to limit your alcohol intake.
Aspirin and many other medicines used to treat arthritis, period pain, headaches - these medicines may irritate the stomach
and may make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.
Caffeine - your doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and
cola drinks, because they contain ingredients that may irritate your stomach.
Eating habits - eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
Smoking - your doctor may advise you to stop smoking or at least cut down.
Weight - your doctor may suggest losing some weight to help your condition.
Side effects of APO-Pantoprazole Heartburn Relief
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking APO-Pantoprazole Heartburn
Relief, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet.
Like other medicines, APO-Pantoprazole Heartburn Relief can cause some side effects. If they occur, most are likely to be
minor and temporary. However, some may be serious and need medical attention.Your doctor has weighed the risks of using this
medicine against the benefits they expect it will have for you.
Ask your doctor or pharmacist to answer any questions you may have.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
headache
dizziness
diarrhoea
nausea or vomiting
stomach pain
excessive gas in the stomach or bowel
indigestion
constipation
dry mouth
metallic taste
weakness or tiredness
increased sweating
blurred vision
skin problems, such as itchiness and rash.
These are the more common side effects of APO-Pantoprazole Heartburn Relief. Some of these side effects may be due to the
combination of other medicines you are taking with APO-Pantoprazole Heartburn Relief.
Tell your doctor as soon as possible if you notice any of the following:
nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured
urine
skin problems such as itchiness and rash, or swelling, blistering or peeling of the skin
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
frequent infections such as fever, severe chills, sore throat or mouth ulcers
chest pain
shortness of breath
high blood pressure
swelling of the legs
bleeding or bruising more easily than normal
depression, confusion or anxiety.
These may be serious side effects and you may need urgent medical attention. Serious side effects are rare.
Other side effects not listed above may occur in some people. Tell your doctor if you notice anything that is making you feel
unwell when you are taking, or soon after you have finished taking APO-Pantoprazole Heartburn Relief.
Ask your doctor or pharmacist if you do not understand some of the information in this list.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take them.
If you take the tablets out of their original packaging they 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 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist
what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist
is the best person to give you advice on the treatment of your condition.
Product description
What APO-Pantoprazole Heartburn Relief looks like
The tablets are available in 20 mg strength. The tablets have an acid-resistant coating called an enteric coating.
The tablets are yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "20" on the other side.
Available in blister packs of 7 and 14 tablets.
Ingredients
The active ingredient in the tablets is pantoprazole (as sodium sesquihydrate).
The tablets also contain the following as inactive ingredients: lactose anhydrous, crospovidone, cellulose-microcrystalline,
magnesium stearate, hypromellose, macrogol 8000, anhydrous sodium carbonate, methacrylic acid copolymer, triethyl citrate,
talc-purified, titanium dioxide and iron oxide yellow.
This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.
Australian Registration Numbers
APO-Pantoprazole Heartburn Relief 20 mg tablets (blisters): AUST R 156332.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia
This leaflet was prepared in:
November 2009.