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 pharmacist.
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 used for
This medicine is used to treat ulcerative proctosigmoiditis and/or left-sided ulcerative
colitis. These are conditions with inflammation, ulcers and sores in the rectum (back
passage) and in the large bowel next to the rectum causing bleeding, stomach pain,
The active ingredient in this medicine is mesalazine. It is an anti-inflammatory agent,
similar to aspirin and is thought to work by helping to reduce inflammation in the
large bowel and rectum.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
There is no evidence that PENTASA is addictive.
It is available only with a doctor's prescription.
It is not expected to affect your ability to drive a car or operate machinery.
Before you use PENTASA
When you must not use it
Do not use PENTASA if you have an allergy to:
any medicine containing mesalazine or aspirin-like medicines
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 use PENTASA if you have a severe kidney or liver problem.
Do not use this medicine 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 been established.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
a known allergy to PENTASA, sulfasalazine or aspirin-like medicines, or any of the
ingredients listed at the end of this leaflet
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 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 food
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 medicines:
anti-coagulants, used to thin blood or stop blood clots (e.g. warfarin)
glucocorticoids, used to treat inflammation, swelling or allergies (e.g. prednisolone)
sulphonylureas, used to lower blood sugar and treat diabetes (e.g. glibenclamide,
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 pressure
rifampicin, used to treat tuberculosis
azathioprine, used to suppress the immune system
mercaptopurine and thioguanine, used to treat leukaemia.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to use PENTASA
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If possible, go to the toilet and empty your bowels before using an enema. The enema
will work better if the bowel has been emptied.
Insert the contents of the enema in the rectum (back passage). Keep lying down for
5 to 10 minutes.
Detailed instructions for use are available in the pack.
Do not swallow the enema.
You may experience a little discomfort and a feeling of urgency to empty your bowels
immediately after inserting the enema. This is normal and expected due to the inflammation
present within the bowel. Try to resist this urge to empty your bowels for as long
as possible. This feeling will subside as treatment continues and the inflammation
Even if you retain just a portion of the enema, it is a step in the right direction.
If you do not understand the instructions on the packaging, ask your doctor or pharmacist
How much to use
Use as directed by your doctor.
Usual dose: the contents of one enema (1g) inserted into the rectum at bedtime.
How long to use 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 use it
If it is almost time for your next enema, skip the one you missed and use your next
enema when you are meant to.
Otherwise, use it as soon as you remember and then go back to using your medicine
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 are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some
If you use too much (overdose) or swallow the medicine
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, particularly if the
medicine has been taken by mouth. Do this even if there are no signs of discomfort
You may need urgent medical attention.
While you are using PENTASA
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 and liver function.
Tell any other doctors, dentists, and pharmacists who treat you that you are using
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Things you must not do
Do not use 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
Do not stop using your medicine or lower the dosage without checking with your doctor.
If you stop using it suddenly, your condition may worsen.
Things you must be careful of
PENTASA enemas may stain clothing, fabrics or other surfaces.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are using PENTASA.
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 get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
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:
abdominal or stomach pain
flatulence (stomach discomfort or fullness, relieved by passing wind)
nausea (feeling sick)
mild skin rash
discomfort, pain or itching in the anus or rectum, or feeling that you need to have
a bowel movement, during or after inserting the medicine.
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), or 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 urine discolouration
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.
Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
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
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 on the skin, 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 with severe blisters and bleeding of the eyes, mouth, lips, nose and genitals
e.g. erythema multiforme or Stevens-Johnson Syndrome (SJS)
lupus erythematosus-like 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 fever.
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are usually rare or very rare (affecting less
than 1 in 1,000 patients).
Other very rare side effects that have been reported with PENTASA include:
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 reversible).
As a precaution, your doctor may do blood tests to check if there are any changes
in your blood, kidney or liver function.
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 using PENTASA
Keep your enema in the packaging until it is time to use it.
If you take the enema out of the packaging it may not keep well.
Keep your enemas in a cool dry place where the temperature stays below 25°C.
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 destroy some medicines.
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 using this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
What it looks like
PENTASA Enemas are supplied in packs of 7.
Each enema is in the form of a transparent plastic bottle containing a white to slightly
yellow suspension. Each bottle is protected by an aluminium foil bag. The aluminium
foil bag protects the contents of the enema from light.
PENTASA Enemas contain 1 g mesalazine as the active ingredient, as well as the following
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
PENTASA Enema is supplied in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073, Australia.
AUST R 98033 - PENTASA mesalazine 1 g enema bottle.
This leaflet was prepared in
PENTASA® is a registered trademark of Ferring B.V.
® = Registered trademark