Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about PENTASA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
Please read this leaflet before you
start using PENTASA.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using PENTASA
against the benefits they expect it
will have for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What PENTASA is
This medicine is used to treat Crohn's
disease and ulcerative colitis,
diseases associated with
inflammation, ulcers and sores in the
bowel causing bleeding, stomach
pain, and diarrhoea.
The active ingredient in PENTASA
is mesalazine. It is an anti-
inflammatory agent, similar to
aspirin, and is thought to work by
reducing inflammation in the bowel.
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.
There is no evidence that PENTASA
It is available only with a doctor's
It is not expected to affect your
ability to drive a car or operate
Before you take
When you must not take it
Do not take PENTASA if you have
an allergy to:
any medicine containing
mesalazine or aspirin-like
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
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin.
Do not take PENTASA if you have
a severe kidney or liver problem.
Do not take PENTASA after the
expiry date printed on the pack or
if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return
it to your pharmacist for disposal.
Do not give PENTASA to a child
12 years old or under.
The safety and effectiveness of
PENTASA in this age group have not
Before you start to take it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any of the following
a known allergy to PENTASA,
sulfasalazine or aspirin-like
medicines, or any of the
ingredients listed at the end of
a kidney or liver problem
a bleeding disorder
a history of asthma.
Tell your doctor if you are
pregnant or plan to become
pregnant or are breast-feeding.
Your doctor can discuss with you the
risks and benefits involved.
PENTASA should be used with
caution during pregnancy and breast-
feeding and only if the potential
benefits outweigh the possible risks
in the opinion of the doctor. The
underlying condition itself
(inflammatory bowel disease) may
increase risks for the pregnancy
If you have not told your doctor
about any of the above, tell
him/her before you start using
Taking other medicines
Tell your doctor or pharmacist if
you are using any other medicines,
including any that you get without
a prescription from your
pharmacy, supermarket or health
There is no information available on
interactions between PENTASA and
other medicines. However,
mesalazine belongs to a group of
medicines called salicylates that may
interfere with the following types of
anti-coagulants, used to thin
blood or stop blood clots (e.g.
glucocorticoids, used to treat
inflammation, swelling or
allergies (e.g. prednisolone)
sulphonylureas, used to lower
blood sugar and treat diabetes
(e.g. glibenclamide, glipizide)
methotrexate, used to treat some
kinds of cancers and arthritis
probenicid or sulfinpyrazone,
used to treat gout
spirinolactone or frusemide, used
to increase the amount of urine
produced, and to lower blood
rifampicin, used to treat
azathioprine, used to suppress the
mercaptopurine and thioguanine,
used to treat leukaemia.
Ask your doctor or pharmacist if you
are unsure about taking any of these
Your doctor and pharmacist have
more information on medicines to be
careful with or avoid while taking
How to take PENTASA
Follow all directions given to you
by your doctor or pharmacist
They may differ from the
information contained in this leaflet.
If you do not understand the
instructions on the packaging, ask
your doctor or pharmacist for
How much to take
For active ulcerative colitis, take up
to 4 g PENTASA once a day or in
For long term treatment of ulcerative
colitis, take 2 g PENTASA once a
day or in divided doses.
For active Crohn's disease, take up to
4 g PENTASA daily in divided
For long term treatment of Crohn's
disease, take up to 4 g PENTASA
daily in divided doses.
For some conditions, your doctor
may prescribe a different dose.
How to take it
Tear or cut to open the sachet along
the dotted line.
Empty the contents (granules) of the
sachet onto the tongue and wash
down with water or juice.
Swallow the PENTASA granules
whole without chewing or crushing.
When to take it
Take your medicine the same time
each day. This will help you
remember when to take it.
You can take PENTASA with or
How long to take it
Continue using your medicine for
as long as your doctor tells you.
This medicine helps to control your
condition, but does not cure it. It is
important to keep using your
medicine even if you feel well.
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
Otherwise, take it as soon as you
remember, and then go back to
taking PENTASA as you would
If you are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering to
take PENTASA, ask your pharmacist
for some hints.
If you take too much
Immediately telephone your doctor
or the Poisons Information Centre
(telephone 13 11 26) for advice, or
go to Accident and Emergency at
the nearest hospital, if you think
that you or anyone else may have
used too much PENTASA. Do this
even if there are no signs of
discomfort or poisoning.
You may need urgent medical
While you are taking
Things you must do
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are taking PENTASA.
Have all blood tests recommended
by your doctor.
PENTASA may cause kidney, liver
or blood problems in a few people.
You should have regular blood tests
to check your kidney function.
Tell any other doctors, dentists,
and pharmacists who treat you
that you are using this medicine.
If you are going to have surgery,
tell the surgeon or anaesthetist that
you are using this medicine.
It may affect other medicines used
If you become pregnant while
using this medicine, tell your
Things you must not do
Do not take PENTASA to treat any
other complaints unless your
doctor tells you to.
Do not give your medicine to
anyone else, even if they have the
same condition as you.
Do not stop using your medicine or
lower the dosage without checking
with your doctor.
If you stop taking it suddenly, your
condition may worsen.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking
This medicine helps most people 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 experience some of the side
Do not be alarmed by the following
lists of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor or pharmacist if
you notice any of the following and
they worry you:
abdominal or stomach pain
flatulence (stomach discomfort or
fullness, relieved by passing
nausea (feeling sick)
mild skin rash.
The above list includes the more
common side effects of your
medicine (affecting between 1 in 10
and 1 in 100 patients). They are
usually mild and short-lived.
Tell your doctor as soon as possible
if you notice any of the following:
bruising easily, unusual bleeding
(e.g. nosebleeds), signs of
infection such as fever, chills,
sore throat and mouth ulcers
muscle aches and pains
painful or swollen joints
severe upper stomach pain,
nausea and vomiting
changes in kidney
function/kidney disease, and or
numbness, tingling or weakness
of the arms and legs
yellowing of the skin or eyes,
dark coloured urine
hair loss (this is reversible)
worsening of your condition.
The above list includes serious side
effects which may require medical
attention. Serious side effects are
usually rare or very rare (affecting
less than 1 in 1,000 patients).
If you notice any of the following,
tell your doctor immediately or go
to Accident and Emergency at
your nearest hospital:
sudden signs of allergic reactions
such as rash, itching or hives,
shortness of breath, wheezing,
coughing, or swelling of limbs,
face, lips, mouth, tongue or throat
which may cause difficulty
swallowing or breathing
severe stomach cramps and/or
pain, bloody diarrhoea, fever,
severe headache and skin rash
rash with severe blisters and
bleeding of the eyes, mouth, lips,
nose and genitals e.g. erythema
multiforme or Stevens-Johnson
reactions (a disease affecting the
skin, joints and kidneys with
symptoms such as joint pain,
fever and skin rash)
chest pain and/or pain behind the
breast bone sometimes spreading
to the neck and shoulders, or with
The above list includes very serious
side effects, which may need urgent
medical attention or hospitalisation.
These side effects are usually rare or
very rare (affecting less than 1 in
Other very rare side effects that
have been reported with
changes in kidney function
changes in liver function e.g.
raised liver enzymes
changes in the blood e.g. a
decrease in the number of
red/white blood cells, and/or
low sperm count (this is
As a precaution, your doctor may do
blood tests to check if there are any
changes in your blood, kidney or
Very rare side effects occur in less
than 1 in 10,000 patients.
Other side effects not listed above
may also occur in some people.
Tell your doctor or pharmacist if
you notice anything that is making
you feel unwell.
After taking PENTASA
Keep your PENTASA in the
packaging until it is time to take
your next dose.
If you take PENTASA out of the
packaging it may not keep well.
Keep your PENTASA in a cool dry
place where the temperature stays
Do not store PENTASA or any
other medicine in the bathroom or
near a sink. Do not leave it on a
window sill or in the car.
Heat and dampness can damage
Keep PENTASA where children
cannot reach it.
A locked cupboard at least one-and-
a-half metres above the ground is a
good place to store medicines.
If your doctor tells you to stop
taking PENTASA or the expiry
date has passed, ask your
pharmacist what to do with any
granules that are left over.
What it looks like
PENTASA Sachets contain short and
cylindrical (or tube) shaped granules
that are white-grey to pale white
brown in colour.
PENTASA 1 g Sachets are supplied
in packs of 30 and 120.
PENTASA 2 g Sachets are supplied
in packs of 15 and 60.
PENTASA 4 g Sachets are supplied
in packs of 8 and 30.
Not all pack sizes are being
distributed in Australia.
PENTASA Sachets contain 1 g , 2 g
or 4 g of mesalazine as the active
ingredient, as well as the following
This medicine does not contain
sucrose, gluten, tartrazine or any
other azo dyes.
PENTASA Sachets are supplied in
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073, Australia
AUST R 161063 - PENTASA
mesalazine 1 g prolonged release
AUST R 161064 - PENTASA
mesalazine 2 g prolonged release
AUST R 216259 - PENTASA
mesalazine 4 g prolonged release
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