2. What should I know before I use SOMAC Heartburn Relief?
Do not use 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 pharmacist or 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 pharmacist or doctor if you have severe liver disease or cirrhosis.
For more information, see Section
2. What should I know before I use SOMAC Heartburn Relief? in the full CMI.
3. What if I am taking other medicines?
4. How do I use SOMAC Heartburn Relief?
Take one SOMAC Heartburn Relief tablet every day (once every 24 hours) for at least
seven days, and up to 14 days. Swallow SOMAC Heartburn Relief tablets whole with a
little water with or without food. Do not crush or chew the tablets. More instructions
can be found in Section
4. How do I use SOMAC Heartburn Relief? in the full CMI.
5. What should I know while using SOMAC Heartburn Relief?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using SOMAC Heartburn
Relief.
Tell your pharmacist or doctor if you are pregnant, or plan to become pregnant or
are breastfeeding.
|
|
Things you should not do
|
Do not stop using SOMAC Heartburn Relief without talking to your pharmacist or doctor
first.
Do not use SOMAC Heartburn Relief to treat any other complaints unless your pharmacist
or doctor tells you to.
Do not give SOMAC to anyone else, even if they have the same symptoms as you.
|
|
Driving or using machines
|
Do not drive or operate machinery if SOMAC Heartburn Relief affects your ability to
concentrate and react.
|
|
Drinking alcohol
|
Your pharmacist or doctor may advise you to limit your alcohol intake to help your
condition.
|
|
Looking after your medicine
|
Keep SOMAC Heartburn Relief 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.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
pantoprazole sodium sesquihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SOMAC Heartburn Relief. It
does not take the place of talking to your doctor or pharmacist. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using SOMAC Heartburn Relief.
Where to find information in this leaflet:
1. Why am I using SOMAC Heartburn Relief?
SOMAC Heartburn Relief contains the active ingredient pantoprazole sodium sesquihydrate.
SOMAC Heartburn Relief belongs to a group of medicines called proton pump inhibitors
(PPIs). SOMAC Heartburn Relief works by decreasing the amount of acid the stomach
makes, to give relief from the symptoms.
Reflux disease
SOMAC Heartburn Relief is used for lasting symptomatic relief of frequent heartburn
and stomach acid complaints due to gastro-oesophageal reflux disease (GORD).
These symptoms 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.
Frequent heartburn is when you have heartburn for two or more days a week. Heartburn
that occurs frequently is a typical symptom of GORD.
SOMAC Heartburn Relief is not the right medicine for you if you suffer heartburn only
occasionally (one episode of heartburn a week or less), or if you want immediate relief
of heartburn.
SOMAC Heartburn Relief will start to suppress acid within a few hours, however it
is not intended to provide instant symptom relief. For effective, lasting relief,
you should take a full course of SOMAC Heartburn Relief (see ‘How do I use SOMAC Heartburn
Relief?' below).
2. What should I know before I use SOMAC Heartburn Relief?
Warnings
Do not take SOMAC Heartburn Relief if:
you are allergic to pantoprazole sodium sesquihydrate, or any of the ingredients listed
at the end of this leaflet.
you are allergic to any medicines containing proton pump inhibitors.
always check the ingredients to make sure you can use this medicine.
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.
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 SOMAC Heartburn Relief in combination with atazanavir or nelfinavir (anti-viral
medications).
Do not give SOMAC Heartburn Relief to children or adolescents under 18 years of age.
There is not enough information to recommend the use of this medicine for children
and adolescents under the age of 18 years.
Check with your doctor if you:
you have any allergies to any other medicines, foods, preservatives or dyes
have jaundice, liver problems or anaemia
a feeling of weakness or you look pale
previously taken heartburn / indigestion medications continuously for 4 or more weeks
persisting heartburn symptoms despite taking SOMAC Heartburn Relief (or other similar
medicines) continuously for 2 weeks, or your symptoms have recently changed
been told by your doctor that you have a stomach ulcer, or gastrointestinal surgery
is planned
heartburn/ indigestion symptoms for the first time and you are over 40 years of age
a scheduled endoscopy (investigation of your stomach lining performed by a specialist)
have reduced body stores or risk factors for reduced vitamin B12, (pantoprazole may
lead to a reduced
absorption of vitamin B12)
have 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 SOMAC Heartburn
Relief.
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
Check with your doctor if you are pregnant or intend to become pregnant. It is not known if it is safe for you to take SOMAC Heartburn Relief 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 SOMAC Heartburn Relief from breast milk if
you are breastfeeding.
Ask your doctor about the risks and benefits involved.
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 SOMAC Heartburn Relief in combination with atazanavir or nelfinavir (anti-viral
medications).
Some medicines and SOMAC Heartburn Relief may interfere with each other. 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 SOMAC Heartburn Relief or may affect how well it
works. You may need to use 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 SOMAC Heartburn Relief.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SOMAC Heartburn Relief.
4. How do I use SOMAC Heartburn Relief?
The directions for use are included on the Medicine Information panel on the pack.
If you do not understand the instructions, ask your doctor or pharmacist for help.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Take one SOMAC Heartburn Relief tablet every day (once every 24 hours).
When to take SOMAC Heartburn Relief
Take SOMAC Heartburn Relief 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.
How to take SOMAC Heartburn Relief
Swallow your tablets whole with a little water with or without food.
Do not crush or chew the tablets. SOMAC Heartburn Relief tablets have a special coating to protect them from the acidic
contents of your stomach. For SOMAC Heartburn Relief to work effectively, this coating
must not be broken.
How long to take SOMAC Heartburn Relief
For effective, lasting relief, take SOMAC Heartburn Relief strictly according to the
directions on your pack.
SOMAC Heartburn Relief tablets should be taken for at least seven days, and up to
14 days.
If you purchased the pack containing 7 days' supply and you need to take it for longer
than 7 days, ask your pharmacist for advice.
Do not take beyond 14 days without consulting your doctor.
SOMAC Heartburn Relief is not intended to provide instant relief from your heartburn/
indigestion symptoms.
If you are not sure, ask your pharmacist or doctor how to take your medicine.
If you forget to take SOMAC Heartburn Relief
SOMAC Heartburn Relief should be used regularly at the same time each day.
If you miss your dose at the usual time, take it as soon as you remember, and then
go back to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
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 SOMAC Heartburn Relief
If you think that you have taken too much SOMAC Heartburn Relief, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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 using SOMAC Heartburn Relief?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking SOMAC Heartburn Relief.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
SOMAC Heartburn Relief.
If you are going to have surgery, tell the surgeon that you are taking SOMAC Heartburn
Relief.
If you become pregnant while you are taking SOMAC Heartburn Relief, tell your doctor
or pharmacist immediately.
If you are about to have any blood tests, tell your doctor or pharmacist that you
are taking SOMAC Heartburn Relief. 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 or pharmacist if you do not feel better while taking SOMAC Heartburn
Relief. If your symptoms recur within 2 weeks of completing your course, consult your
doctor. Further investigation may be recommended.
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 use SOMAC Heartburn Relief to treat any other complaints unless your doctor
tells you to.
Do not give SOMAC Heartburn Relief 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 SOMAC
Heartburn Relief
affects you. A small number of patients have felt dizzy or had problems with their vision after
taking SOMAC Heartburn Relief.
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 until it is time to take them.
Follow the instructions on the carton on how to take care of your medicine properly.
Keep SOMAC Heartburn Relief in a cool, dry place where the temperature stays below
30°C.
Do not store it or any other medicines in the bathroom, near a sink or windowsill.
Do not leave it in the car. 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 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 use 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.
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 available over-the-counter without a doctor's prescription.
SOMAC Heartburn Relief is available as a 20 mg tablet. The tablets have an acid-resistant
coating called an enteric coating.
What SOMAC Heartburn Relief contains
|
Active ingredient
(main ingredient)
|
pantoprazole sodium sesquihydrate
|
|
Other ingredients
(inactive ingredients)
|
sodium carbonate
mannitol
crospovidone
povidone
calcium stearate
hypromellose
titanium dioxide
iron oxide yellow
propylene glycol
methacrylic acid copolymer
polysorbate 80
sodium lauryl sulfate
triethyl citrate
opacode brown S-1-16530 printing ink
|
Do not take this medicine if you are allergic to any of these ingredients.
Somac Heartburn Relief tablets do not contain gluten, lactose, sucrose, tartrazine
or other azo dyes.
What SOMAC Heartburn Relief looks like
SOMAC Heartburn Relief 20 mg tablets - yellow and oval shaped, marked with 'P20' on
one side. SOMAC Heartburn Relief 20 mg tablets are available in blister packs of 7
and 14 tablets.
Pharmacy Only Medicine (7 tablets) – AUST R 234279
Pharmacist Only Medicine (14 tablets) AUST R 154252
Who distributes SOMAC Heartburn Relief
Takeda Pharmaceuticals Australia Pty Ltd
Level 39
225 George Street
Sydney NSW 2000
Australia
Telephone: 1800 012 612
This leaflet was prepared in July 2025.
TAKEDA and the TAKEDA Logo are registered trademarks of Takeda Pharmaceutical Company
Limited
SOMAC Heartburn Relief is a registered trademark of Takeda GmbH