2. What should I know before I take SALPRAZ?
Do not take if you have ever had an allergic reaction to pantoprazole or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Tell your doctor
if you have severe liver disease or cirrhosis.
3. What if I am taking other medicines?
Some medicines may interfere with SALPRAZ and affect how it works.
4. How do I take SALPRAZ?
Swallow SALPRAZ tablets whole with a little water with or without food. Do not crush
or chew the tablets.
5. What should I know while taking SALPRAZ?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking SALPRAZ.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
|
|
Things you should not do
|
Do not take SALPRAZ to treat any other complaints unless your doctor tells you to.
Do not give SALPRAZ to anyone else, even if they have the same symptoms as you.
|
|
Driving or using machines
|
Do not drive or operate machinery if SALPRAZ affects your ability to concentrate and
react.
|
|
Drinking alcohol
|
Your doctor may advise you to limit your alcohol intake to help your condition.
|
|
Looking after your medicine
|
Keep SALPRAZ in a cool, dry place where the temperature stays below 30°C.
|
6. Are there any side effects?
Headache, dizziness, diarrhoea, nausea or vomiting, stomach pain, excessive gas in
stomach or bowel, indigestion, constipation, sore breasts, dry mouth, taste disturbances,
metallic taste, weakness/ tiredness, trouble sleeping. Increased sweating/body temperature,
blurred vision, skin problems, unusual tiredness or weakness, tingling or numbness,
blood in urine, increased or decreased need to urinate, frequent infections, chest
pain, high blood pressure, irregular heartbeat, water retention, swelling, bleeding/bruising
more easily than normal, depression, confusion or anxiety, bone fracture of hip, wrist
or spine, seizures, abnormal or fast heartbeat, jerking/shaking movements or muscle
cramps, severe and/or persistent diarrhoea. Signs of liver inflammation including
yellowing of skin/eyes, nausea, vomiting, loss of appetite, feeling unwell, fever,
itching and dark coloured urine; severe skin problems such as itchiness, redness,
rash with swelling, blistering or peeling of skin or rash when exposed to sun, possibly
with pain in joints and general fever; swelling of face, lips, mouth, tongue or throat
which may cause difficulty swallowing or breathing; shortness of breath, wheezing
or difficulty breathing; black stools; vomiting blood.
Active ingredient(s): pantoprazole (as sodium sesquihydrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking SALPRAZ. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking SALPRAZ.
Where to find information in this leaflet:
1. Why am I taking SALPRAZ?
SALPRAZ contains the active ingredient pantoprazole (as sodium sesquihydrate). 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.
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.
Most people who have a peptic ulcer also have bacteria called Helicobacter pylori
in their stomach. When SALPRAZ is taken with antibiotics the combination therapy will
kill the Helicobacter pylori and let your ulcer heal.
SALPRAZ 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
SALPRAZ 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.
SALPRAZ is also used to prevent reflux oesophagitis from coming back.
Zollinger-Ellison syndrome
SALPRAZ is also 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.
SALPRAZ is not addictive.
2. What should I know before I take SALPRAZ?
Warnings
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 symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing or swallowing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Always check the ingredients to make sure you can take this medicine.
you have severe liver disease or cirrhosis.
after the expiry date printed on the pack or if the packaging is damaged or shows
signs of tampering. If it has expired or is damaged return it to your pharmacist for
disposal.
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
Do not take SALPRAZ in combination with atazanavir or nelfinavir (anti-viral medications).
Check with your doctor if you:
you have any allergies to any other medicines, foods, preservatives or dyes
have reduced body stores or risk factors for reduced vitamin B12, as pantoprazole
may lead to a reduced
absorption of vitamin B12
have or have had any other medical conditions
take any medicines for any other condition
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 SALPRAZ.
If you have not told your doctor about any of the above, tell them before you take
SALPRAZ.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if it is safe for you to take SALPRAZ while you are pregnant. It may
affect your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if your baby can take in SALPRAZ from breast milk if you are breastfeeding.
Your doctor can discuss the risks and benefits involved.
Children
Do not give SALPRAZ to children under 5 years of age.
There is not enough information to recommend the use of this medicine for children
under the age of 5 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not take SALPRAZ in combination with atazanavir or nelfinavir (anti-viral medications).
Some medicines may interfere with SALPRAZ and affect how it works. These include:
warfarin, phenprocoumon - medicines used to prevent blood clots (anticoagulants)
atazanavir, nelfinavir – 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 SALPRAZ or may affect how well it works. You may
need to take different amounts of your medicine or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking SALPRAZ
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SALPRAZ.
4. How do I take SALPRAZ?
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
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.
The usual dose is 40 mg per day.
However, if your doctor also prescribes antibiotics in combination with SALPRAZ for
the treatment of duodenal ulcers, the dose of SALPRAZ is 80 mg per day. The first
40 mg dose should be taken in the morning and the second 40 mg dose should be taken
before the evening meal for 7 days.
Your doctor will prescribe the dose that is right for you.
In children over 5 years of age, the dose of SALPRAZ for reflux oesophagitis or reflux
disease is based on weight and may be 20 mg or 40 mg per day, depending on the condition
being treated.
SALPRAZ should not be taken for longer than 8 weeks.
When to take SALPRAZ
SALPRAZ should be taken around the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
If you are taking other medicines, like antibiotics, in combination with SALPRAZ therapy,
follow the instructions for the use of each medicine carefully.
How to take SALPRAZ
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 from the acidic contents of
your stomach.
For SALPRAZ to work effectively, this coating must not be broken.
How long to take SALPRAZ
Continue taking your medicine for as long as your doctor or pharmacist tells you.
If you forget to take SALPRAZ
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 you missed. This may increase the chance of getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you take too much SALPRAZ
If you think that you or anyone else has taken too much SALPRAZ, urgent medical attention
maybe needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking SALPRAZ?
Things you should do
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 treat you that you are taking
SALPRAZ.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
SALPRAZ.
If you become pregnant while you are taking SALPRAZ, tell your doctor or pharmacist
immediately.
If you are about to have any blood tests, tell your doctor that you are taking SALPRAZ. It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Tell your doctor if your reflux symptoms return after you stop taking this medicine. The symptoms of reflux may return after stopping this medicine suddenly, especially
if you have taken it for a while.
Things you should not do
Do not take SALPRAZ to treat any other complaints unless your doctor tells you to.
Do not give SALPRAZ to anyone else, even if they have the same symptoms as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SALPRAZ
affects you. This medicine is not expected to affect your ability to drive a car or operate machinery.
However, do not drive a car or operate machinery if you
experience side effects such as dizziness or blurred vision.
Things that may help your condition
Some self-help measures suggested below may help your condition. Your doctor or pharmacist
can give you more information about these measures.
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.
Looking after your medicine
Keep your tablets in their blister pack until it is time to take them.
Keep SALPRAZ where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it. A locked
cupboard at least one-and-a-half metres above the
ground, is a good place to store medicines.
When to discard your medicine
If your doctor tells you to stop taking this medicine or if the medicines have passed
their expiry date, ask your pharmacist what to do with any tablets or granules that
are left over.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
This medicine helps most people with peptic ulcers or reflux disease, but it may have
unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SALPRAZ contains
|
Active ingredient
(main ingredient)
|
Pantoprazole (as sodium
Sesquihydrate) 20 mg and 40 mg
|
|
Other ingredients
(inactive ingredients)
|
Sodium carbonate
Calcium stearate
Mannitol
Povidone
Crospovidone
Hypromellose
Macrogol 6000
Methacrylic acid- ethyl acrylate copolymer (1:1)
Triethyl citrate
Purified talc
OPADRY AMB Aqueous Moisture Barrier Coating System 80W52172 Yellow
Carnauba wax
Purified water
|
|
Potential allergens
|
contains traces of soya bean products
|
Do not take this medicine if you are allergic to any of these ingredients.
What SALPRAZ 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 and 40 mg tablets are yellow coloured, oval, biconvex enteric coated tablets
plain on both sides.
The 20 mg and 40 mg tablets are available in packs of 30 tablets.
SALPRAZ 20 mg tablets - AUST R 330563
SALPRAZ 40 mg tablets - AUST R 330562
Who distributes SALPRAZ
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in September 2025.
SALPRAZ® is a Viatris company trade mark
SALPRAZ_cmi\Sept25/00