Contains the active ingredient, pantoprazole (as sodium sesquihydrate)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine
This leaflet answers some common questions about pantoprazole. 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 APOTEX-Pantoprazole It contains the active ingredient, pantoprazole (as sodium sesquihydrate).
This medicine belongs to a group of medicines called proton pump inhibitors (PPIs). PPIs work by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place.
Ulcers
It is used to treat and help heal duodenal and gastric 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 of the stomach. These can be caused in part by too much acid being made in the stomach.
Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. When pantoprazole is taken with antibiotics the combination therapy will kill the Helicobacter pylori and let your ulcer heal.
Pantoprazole may also be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (inflammation of the joints).
Reflux disease
Pantoprazole 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.
Pantoprazole is also used to prevent reflux oesophagitis from coming back.
Zollinger-Ellison syndrome
Pantoprazole is used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
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 this medicine
When you must not take it
Do not take APOTEX-Pantoprazole if you:
are lactose-intolerant.
The tablets contain lactose.
have had an allergic reaction to pantoprazole 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 pantoprazole if you have severe liver disease or cirrhosis.
Do not take pantoprazole in combination with antibiotics or any other medicine if:
you are allergic to any of the antibiotics or medicines your doctor may prescribe with pantoprazole
you have moderate to severe liver or kidney disease.
Do not take pantoprazole in combination with atazanavir (anti-viral medications).
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 especially the following:
a bone fracture of the hip, wrist or spine (mainly a risk in people who take high doses of PPIs or use them long term (a year or longer))
kidney disease.
3. You plan to become pregnant or breast-feed.
Your doctor will discuss the risks and benefits of taking pantoprazole during pregnancy or while breast-feeding.
4. Tell your doctor if you have any of the following symptoms:
unintentional weight loss
repeated vomiting
vomiting blood
difficulty or pain when swallowing
you look pale and feel weak
you notice blood in your stools
Your doctor may need to perform some additional tests before you take this medicine.
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 and pantoprazole may interfere with each other. These include:
warfarin and phenprocoumon - medicines used to prevent blood clots (anticoagulants)
atazanavir, - medicines used to treat viral infections such as HIV
ketoconazole, itraconazole, posaconazole - medicines used to treat fungal infection
methotrexate - a medicine used to treat arthritis and some types of cancer
erlotinib or related medicines used to treat cancer
tacrolimus, mycophenolate mofetil - medicines used to suppress the immune system
fluvoxamine - a medicine used to treat anxiety and depression.
These medicines may be affected by pantoprazole, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines.
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 pantoprazole.
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.
However, if your doctor also prescribes antibiotics in combination with this medicine for the treatment of duodenal ulcers, the dose is two per day. The first tablet should be taken in the morning and the second tablet should be taken before the evening meal for 7 days.
Your doctor will prescribe the dose that is right for you.
The dose and frequency of pantoprazole that your doctor prescribes for you depends on your medical condition. Your doctor may change the dose as your condition changes.
How to take it
Swallow your tablets whole with a little water with or without food.
Do not crush or chew the tablets. APOTEX-Pantoprazole tablets have a special coating to protect them from the acidic contents of your stomach. For the tablets to work effectively, this coating must not be broken.
If you are taking other medicines, like antibiotics, in combination with pantoprazole therapy, follow the instructions for the use of each medicine carefully.
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 go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much pantoprazole.
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
Use pantoprazole exactly as your doctor has prescribed.
Tell your doctor immediately if you become pregnant while you are taking pantoprazole.
Tell all doctors, dentists and pharmacists who are treating you that you are taking pantoprazole.
If you take pantoprazole 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 pantoprazole. 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 pantoprazole 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.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking pantoprazole.
Like other medicines, pantoprazole 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 or body temperature
blurred vision
skin problems, such as itchiness and rash
These are the more common side effects of pantoprazole. Some of these side effects may be due to the combination of other medicines you are taking with pantoprazole.
Tell your doctor as soon as possible if you notice any of the following:
unusual tiredness or weakness
nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine
blood in the urine
increased or decreased need to urinate
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 pantoprazole.
Ask your doctor or pharmacist if you do not understand some of the information in this list.
Storage and disposal
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.
New Formulation
Keep your medicine in a cool dry place where the temperature will stay below 30°C.
Old Formulation
Keep your medicine in a cool dry place where the temperature will stay below 25°C. Protect from light and moisture.
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.
Product description
What APOTEX-Pantoprazole looks like
The tablets are available as 20 mg and 40 mg strengths. The tablets have an acid-resistant coating called an enteric coating.
20 mg tablets
Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "20" on the other side.
Blister pack of 30 tablets.
40 mg tablets
Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "40" on the other side.
Blister pack of 5 and 30 tablets.
*Not all strengths and/or pack sizes may be available.
Ingredients
The active ingredient in the tablets is pantoprazole (as sodium sesquihydrate).
The tablets also contain the following as inactive ingredients:
anhydrous lactose
crospovidone
microcrystalline cellulose
magnesium stearate
hypromellose
macrogol 8000
anhydrous sodium carbonate
methacrylic acid copolymer
triethyl citrate
purified talc
titanium dioxide
iron oxide yellow.
This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.
