pantoprazole sodium sesquihydrate
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Somac.
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 final page.
More recent information on the medicine may be available. You should ensure that you
speak to your pharmacist or doctor to obtain the most up to date information on this
medicine.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Somac 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 Somac is used for
Ulcers
Somac 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 Somac is taken with antibiotics the combination therapy will
kill the Helicobacter pylori and let your ulcer heal.
Somac 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
Somac 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.
Somac is also used to prevent reflux oesophagitis from coming back.
Zollinger-Ellison syndrome
Somac 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.
This medicine belongs to a group of medicines called proton pump inhibitors (PPIs).
This medicine works by decreasing the amount of acid the stomach makes, to give relief
from the symptoms and allow healing to take place.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed it for another purpose.
This medicine is not addictive. This medicine is available only with a doctor’s prescription.
This medicine is not expected to affect your ability to drive a car or operate machinery.
However, do not drive a car or operate machines if you experience side effects such
as dizziness or blurred vision.
Somac should not be given 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.
Before you take Somac
When you must not take it
Do not take Somac 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 include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.
Do not take this medicine if you have severe liver disease or cirrhosis.
Do not take Somac in combination with antibiotics or any other medicine if:
you are allergic to any of the antibiotics or medicines your doctor may prescribe
with Somac
you have moderate to severe liver or kidney disease
Do not take Somac in combination with atazanavir or nelfinavir (anti-viral medications).
Do not take it 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.
Before you start to take it
Tell your doctor or pharmacist if you have any allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor if you have or have had any other medical conditions.
Tell your doctor if you are pregnant, intend to become pregnant, or are breast-feeding.
Your doctor can discuss the risks and benefits involved. If you have not told your
doctor about any of the above, tell them before you take Somac.
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.
Taking other medicines
Tell your doctor 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 Somac 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, 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.
How to take Somac
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 on the box/bottle, ask your doctor or pharmacist
for help.
How much to take
The usual dose is 40 mg per day.
However, if your doctor also prescribes antibiotics in combination with Somac for
the treatment of duodenal ulcers, the dose of Somac is 80 mg per day. The first 40
mg dose should be taken in the morning and the second 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 Somac for reflux oesophagitis or reflux
disease is based on weight and may be 20 mg or 40 mg, depending on the condition being
treated. Somac should not be taken for longer than 8 weeks.
The dose and frequency of Somac 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.
If you are using Somac granules, take it half an hour before a meal without chewing
or crushing the granules. Take the granules in apple juice, orange juice or water
as follows:
2. sprinkle intact granules into a small volume of apple juice, pulp-free orange juice,
or water (at least 15 mL). Alternatively, a tablespoon may be used
3. mix briefly just before drinking
5. to ensure that you have taken all the medicine, rinse the container thoroughly once
or twice with apple juice, orange juice or water to remove any remaining granules
and drink immediately
You can also take the granules in applesauce as follows:
2. sprinkle intact granules on a teaspoon of applesauce.
3. swallow within 10 minutes of preparation
Somac granules are intended for people who have difficulty swallowing tablets including
those who require a nasogastric tube.
When to take it
Take Somac at about 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 Somac therapy,
follow the instructions for the use of each medicine carefully.
Do not crush or chew the tablets or granules. Somac tablets and granules have a special
coating to protect them from the acidic contents of your stomach. For Somac to work
effectively, this coating must not be broken.
How long to take it
Continue taking your medicine for as long as your doctor or pharmacist tells you.
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 getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone Australia
13 11 26 or New Zealand 0800 764 766), or go to Accident and Emergency at your nearest
hospital, if you or anyone else may have taken too much Somac. Do this even if there
are no signs of discomfort or poisoning.
Urgent medical attention may be needed.
While you are taking Somac
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Somac.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon that you are taking this medicine.
If you become pregnant while you are taking this medicine, tell your doctor or pharmacist
immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
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 must not do
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Do not give this medicine to anyone else, even if they have the same symptoms as you.
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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Somac.
It helps most people peptic ulcers or reflux disease, but it may have unwanted side
effects in a few people.
All medicines have some unwanted side effects. Sometimes they are serious, but most
of the time they are not. You may need medical attention if you get some of the side-effects.
Ask your doctor or pharmacist any questions you may have.
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
trouble sleeping
These are the more common side effects of Somac.
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
blood in the urine
increased or decreased need to urinate
severe skin problems such as itchiness, redness, rash with swelling, blistering or
peeling of the skin or rash when exposed to the sun, possibly with pain in the joints
and general fever
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
water retention, swelling
bleeding or bruising more easily than normal
depression, confusion or anxiety
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))
symptoms such as seizures, abnormal or fast heartbeat, jerking/shaking movements or
muscle cramps. These can be a sign of low magnesium, calcium or potassium levels in
your blood
severe and/or persistent diarrhoea, because this medicine has been associated with
a small increase in infectious diarrhoea
The above list includes serious side effects that may require medical attention. Serious
side effects are rare.
Tell your doctor if you notice anything else that is making you feel unwell. Other
side effects not listed above may occur in some people.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
After taking Somac
Storage
Keep your tablets in their blister or bottle, and granules in their sachet pack until
it is time to take them.
If you take the tablets or granules out of the blister, bottle or sachet pack they
may not keep well.
Keep the medicine in a cool dry place where the temperature stays below 25°C (granules)
or 30°C (tablets).
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 children cannot reach it.
A locked cupboard at least one-and-a-half metres (5 feet) above the ground, is a good
place to store medicines.
Disposal
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.
Product description
What it looks like
Somac comes in 20 mg and 40 mg tablets, and 40 mg granules.
Somac 20 mg tablets - yellow and oval shaped, marked with 'P20' on one side.
Somac 40 mg tablets - yellow and oval shaped, marked with 'P40' on one side.
Somac 40 mg granules – pale yellowish to dark brownish in colour.
Somac 40 mg tablets are available in blister packs of 5 and 30 tablets and bottle
packs of 30 tablets.
Somac 20 mg tablets are available in blister packs of 30 tablets.
Somac 40 mg granules are available in single aluminium foil sachets in packs of 5
and 30 sachets.
Ingredients
Tablets
Somac 40 mg tablets contain the equivalent of 40 mg pantoprazole and Somac 20 mg tablets
contain the equivalent of 20 mg pantoprazole. Somac tablets also contain:
sodium carbonate anhydrous
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
Granules
Somac 40 mg granules contain the equivalent of 40 mg pantoprazole.
Somac granules also contain:
microcrystalline cellulose
sodium carbonate anhydrous
crospovidone
hypromellose
polysorbate 80
povidone
titanium dioxide
iron oxide yellow
EUDRAGIT L30D-55
triethyl citrate
purified talc
Somac tablets and granules do not contain gluten, lactose, sucrose, tartrazine or
other azo dyes.
Supplier
Somac tablets and granules are supplied in Australia by:
Takeda Pharmaceuticals Australia Pty Ltd
Level 39
225 George Street
Sydney NSW 2000
Australia
Telephone: 1800 012 612
The Australian Registration Number(s) are as follows:
Somac tablets (blister packs)
40 mg - AUST R 69792
20 mg - AUST R 70829
Somac tablets (bottle packs)
40 mg - AUST R 69791
Somac granules
40 mg - AUST R 148005
SOMAC® is a registered trademark of Takeda GmbH
This leaflet was prepared in August 2022