SALPRAZ™ contains the active ingredient pantoprazole Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SALPRAZ.
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 SALPRAZ 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 SALPRAZ is used for
The name of your medicine is SALPRAZ.
It contains the active ingredient called pantoprazole.
Ulcers: SALPRAZ 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. SALPRAZ may be used to prevent ulcers associated with the use of nonsteroidal 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: SALPRAZ is 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.
Zollinger-Ellison syndrome: SALPRAZ 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.
Other uses: Ask your doctor if you have any questions about why SALPRAZ has been prescribed for you. Your doctor may have prescribed it for another reason.
How SALPRAZ works
SALPRAZ belongs to a group of medicines called proton pump inhibitors (PPIs). SALPRAZ 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 SALPRAZ is addictive.
This medicine is available only with a doctor's prescription.
Before you take SALPRAZ
When you must not take it
Do not take SALPRAZ if you have an allergy to:
• any medicine containing pantoprazole
• 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 or other parts of the body
• rash, itching or hives on the skin.
Do not take SALPRAZ if you have severe liver disease or cirrhosis.
Do not take SALPRAZ if the packaging is torn or shows signs of tampering. If it is damaged, return it to your pharmacist for disposal.
Do not take SALPRAZ after the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date it may have no effect at all, or worse, an unexpected effect.
Do not take SALPRAZ in combination with antibiotics or any other medicine if:
• you are allergic to any of the antibiotics or medicines your doctor may prescribe with SALPRAZ
• you have moderate to severe liver or kidney disease.
SALPRAZ should not be given to children. Safety and effectiveness of SALPRAZ in children have not been established.
If you are not sure whether you should start taking SALPRAZ alone or in combination with antibiotics, talk to your doctor.
Before you start to take it
You must tell your doctor if:
1. 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.
2. you are pregnant, intend to become pregnant, are breastfeeding or intend to breast-feed. Your doctor will discuss the risks and benefits of taking SALPRAZ during pregnancy or while breastfeeding.
3. 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 SALPRAZ.
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 SALPRAZ, 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 SALPRAZ
How much to take
The usual dose is one tablet per day. Your doctor will prescribe the dose that is right for you. The dose and frequency of SALPRAZ 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. SALPRAZ tablets have a special coating to protect them form the acidic contents of your stomach. For SALPRAZ to work effectively, this coating must not be broken.
How long to take it
You 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 (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much SALPRAZ. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking SALPRAZ
Things you must do
Use SALPRAZ exactly as your doctor has prescribed. If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking SALPRAZ.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking SALPRAZ. If you take SALPRAZ 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 immediately if you become pregnant while you are taking SALPRAZ. Tell your doctor if you do not feel better while taking SALPRAZ. Your doctor may recommend further examination.
Things you must not do
Do not give SALPRAZ to anyone else, even if they have the same symptoms as you.
Do not take SALPRAZ 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 limit your alcohol intake.
SALPRAZ™ 2 • 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 Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SALPRAZ, even if you do not think the problems are connected with the medicine or they are not listed in this leaflet.
Like other medicines, SALPRAZ 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.
Do not be alarmed by the following list of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor or pharmacist 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 SALPRAZ. Some of these side effects may be due to the combination of other medicines you are taking with SALPRAZ.
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.
Tell your doctor if you notice anything that is making you feel unwell when you are taking, or soon after you have finished taking SALPRAZ. Other side effects not listed above may also occur in some people.
After taking SALPRAZ
Keep your tablets in their original container until it is time to take them. If you take the tablet out of the bottle or the blister pack they may not keep well. Keep SALPRAZ in a cool dry place where the temperature stays below 25°C. Do not store SALPRAZ 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 SALPRAZ where young 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 SALPRAZ or the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.
What it looks like
SALPRAZ is available as 20 mg and 40 mg tablets. The tablets have an acid-resistant coating called an enteric coating. The 20 mg tablets are yellow to ochre and elongated shape. The 40 mg tablets are yellow to ochre and elongated shape. The 20 mg and 40 mg tablets are available in blister packs of 30 tablets.
Ingredients The active ingredient in SALPRAZ tablets is pantoprazole. SALPRAZ 40 mg tablets contain the equivalent of 40 mg pantoprazole and; SALPRAZ 20 mg tablets contain the equivalent of 20 mg pantoprazole. SALPRAZ tablets also contain the following inactive ingredients: cellulose-microcrystalline, lactose, croscarmellose sodium, silicacolloidal anhydrous, magnesium stearate (vegetable), Eudragit L30D-55, triethyl citrate and talc. The 20mg tablets contain OPADRY II complete film coating system 85F32081 Yellow as the coating agents, while 40mg tablets contain OPADRY II complete film coating system 85F32029 Yellow. SALPRAZ does not contain gluten, sucrose, tartrazine or any other azo dyes.
SALPRAZ is supplied by:
Alphapharm Pty Limited
(ACN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
Phone: 1800 028 365
Australian registration numbers:
Salpraz 20 mg tablets in blister packs
- AUST R 163888
Salpraz 40 mg tablets in blister packs
- AUST R 163886
This leaflet was prepared on 30 November 2009.