Pantoprazole enteric-coated tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about OZPAN (Pantoprazole enteric-coated tablets 20/40 mg).
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking pantoprazole against the benefits it is expected to 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 OZPAN is used for
The name of your medicine is OZPAN. It contains the active ingredient pantoprazole.
OZPAN 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.
OZPAN 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).
OZPAN 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.
OZPAN is also used to prevent reflux oesophagitis from coming back.
OZPAN 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.
Your doctor may have prescribed OZPAN for another reason. Ask your doctor if you have any questions about why OZPAN has been prescribed for you.
How OZPAN works
OZPAN belongs to a group of medicines called proton pump inhibitors (PPIs).
OZPAN works by decreasing the amount of acid the stomach makes to give relief from the symptoms and allow healing to take place.
There is no evidence that OZPAN is addictive.
This medicine is available only with a doctor's prescription.
Before you take OZPAN
When you must not take it
Do not take OZPAN if:
- you have an allergy to:
- any of the ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
- you have severe liver disease or cirrhosis
Do not take OZPAN if the packaging is torn or shows signs of tampering.
Do not take OZPAN after the expiry date (EXP) printed on the pack has passed.
Do not take OZPAN in combination with any other medicine if:
- you are allergic to any of the medicines your doctor may prescribe with OZPAN
- you have moderate to severe liver or kidney disease
Do not take OZPAN in combination with atazanavir (an anti-viral medication).
OZPAN should not be given to children. Safety and effectiveness of OZPAN in children have not been established.
If you are not sure whether you should start taking OZPAN, talk to your doctor.
Before you start to take it
You must tell your doctor if:
- you have any allergies to:
- any of the ingredients listed at the end of this leaflet
- any other medicines, or any other substances, such as foods, preservatives or dyes.
- you are pregnant, intend to become pregnant, are breast-feeding or intend to breast-feed.
Your doctor will discuss the risks and benefits of taking OZPAN during pregnancy or while breast-feeding.
- you have or have had any other medical conditions.
If you have not told your doctor about any of the above, tell them before you take OZPAN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by OZPAN, 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.
You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
How to take OZPAN
How much to take
The usual dose is one tablet per day.
The dose and frequency of OZPAN that your doctor prescribes for you depends on your medical condition. Your doctor may change the dose as your condition changes.
How and when to take it
Swallow your tablets whole with a little water with or without food.
Do not crush or chew the tablets. OZPAN tablets have a special coating to protect them from the acidic contents of your stomach. For OZPAN to work effectively, this coating must not be broken.
How long to take it
Your doctor will tell you how long to take your tablets.
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 it 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 Poisons Information Centre for advice – the telephone number in Australia is 13 11 26 or go to Accident and Emergency (Casualty) at your nearest hospital, if you think that you or anyone else may have taken too much OZPAN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.
While you are taking OZPAN
Things you must do
Use OZPAN exactly as your doctor has prescribed.
Tell your doctor immediately if you become pregnant while you are taking OZPAN.
Tell all doctors, dentists and pharmacists who are treating you that you are taking OZPAN.
If you take OZPAN 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 OZPAN. Your doctor may recommend further examination.
Things you must not do
Do not give OZPAN to anyone else, even if they have the same symptoms as you.
Do not use OZPAN to treat any other complaints unless your doctor tells you to.
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
- 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.
Tell your doctor as soon as possible if you have any problems while taking OZPAN, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet.
Like other medicines, OZPAN 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.
Ask your doctor or pharmacist any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- nausea or vomiting
- stomach pain
- excessive gas in the stomach or bowel
- 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 pantoprazole . Some of these side effects may be due to the combination of other medicines you are taking with OZPAN.
Tell your doctor immediately 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.
- 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, OZPAN.
Ask your doctor or pharmacist if you do not understand some of the information in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking OZPAN
Keep your tablets in their blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep OZPAN tablets in a cool dry place where the temperature stays below 25°C.
Do not store OZPAN or any other medicines in a bathroom or near a sink. Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep OZPAN where children cannot reach it. A locked cupboard at least one-and-a-half meters above the ground, is a good place to store medicines.
If your doctor tells you to stop taking OZPAN or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
What OZPAN looks like
OZPAN 20 mg and 40 mg tablets are available in packs of 30 tablets.
OZPAN 20 mg are yellow, enteric-coated, oval-shaped, biconvex tablets imprinted with ‘II’ in black ink on one side and plain on other side.
OZPAN 40 mg are yellow, enteric-coated, oval-shaped, biconvex tablets imprinted with ‘IV’ in black ink on one side and plain on other side.
- OZPAN 20 mg tablets contains pantoprazole sodium equivalent to 20 mg of pantoprazole.
- OZPAN 40 mg tablets contains pantoprazole sodium equivalent to 40 mg of pantoprazole.
OZPAN contains the following inactive ingredients: sodium carbonate anhydrous, mannitol, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose, calcium stearate, Opadry 02H52369 yellow, methacrylic acid – ethyl acrylate copolymer (1:1) , triethyl citrate, sodium lauryl sulfate, titanium dioxide, yellow iron oxide, purified talc, Opacode S-1-17823 black.
Australian Registration Numbers
OZPAN 20 mg tablets: AUST R 151290
OZPAN 40 mg tablets: AUST R 151291
OZPAN tablets are supplied in Australia by:
Ranbaxy Australia Pty. Ltd
Suite 4.02, Building D, Level 4
12 – 24 Talavera Road
North Ryde, NSW 2113
This leaflet was prepared in July 2010.
Published by MIMS November 2010