General Information
Consumer Medicine Information
tablets and
EN tablets
What is in this leaflet
Please read this leaflet carefully before you
start taking Salazopyrin tablets or Salazopyrin EN
tablets. This leaflet answers some common
questions about Salazopyrin (when this name is
used it will refer to both the plain and EN
tablets unless specified).
It does not
contain all the available information and does not
take the place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your Doctor has weighed the risks of you
taking Salazopyrin against the benefits this
medicine is expected to have for you.
Use
Salazopyrin as instructed and follow the advice
given in this leaflet.
If you have any
concerns about taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet
with your medicine. You may need to read it again.
What Salazopyrin is used for
Salazopyrin belongs to a group of medicines
called anti-inflammatory medicines and is used to
treat and manage Ulcerative Colitis and Crohn's
disease which are diseases of the bowel.
Salazopyrin EN tablets are also used to treat
rheumatoid arthritis, which is a painful joint
disease.
Salazopyrin is available only with
a doctor's prescription.
There is no
evidence that Salazopyrin is addictive.
Before you take Salazopyrin
Some
information is provided below. However, always
talk to your doctor if you have concerns or
questions about your treatment.
When you
must not take Salazopyrin
Do not take
Salazopyrin if you have an allergy to:
sulfur-
containing medicines eg. sulfonamides; some oral
hypoglycaemics (diabetes medicine) eg. glipizide;
thiazide diuretics eg. Chorothiazide
salicylates eg. aspirin
any of the
ingredients of Salazopyrin which are listed under
the heading, "Product Description", at the end of
this leaflet.
Symptoms of an allergic
reaction to Salazopyrin may include skin rash and
itching, breathlessness and anaphylactic reactions
(major allergic reactions).
If you are not
sure if you have or have had an allergic reaction
to Salazopyrin, check with your doctor.
Do
not take Salazopyrin if:
you have kidney or
liver problems
you have any form of blood
disorder
you have any form of intestinal or
urinary obstruction
you have porphyria (rare
disease of blood pigments)
If you are not
sure about any of the above, ask your doctor.
the packaging is torn or shows signs of
tampering or the tablets do not look quite right.
the expiry date (Exp.) on the carton has
passed.
If you take this medicine after the
expiry date has passed, it may not work as well.
Do not give Salazopyrin to children under
two years of age.
Do not use Salazopyrin to
treat any other complaints unless your doctor says
to.
See your Doctor for a check up before
you start to take Salazopyrin.
Before you
start taking Salazopyrin
Tell your doctor
if you:
are pregnant or trying to become
pregnant.
are breast feeding or plan to
breast-feed.
Your doctor will discuss the
possible risks and benefits of taking Salazopyrin
during pregnancy and breast-feeding.
are
allergic to any other medicines or any other
substances such as foods, preservatives or dyes
have a glucose-6-phosphate dehydrogenase (G-6-
P) deficiency. This is a rare blood disorder which
means that your body cannot get rid of some
medicines.
have bronchial asthma (wheezing or
shortness of breath)
Taking other
medicines
Tell your Doctor if you are
taking any other medicines, including medicines
you buy without a prescription from a pharmacy,
supermarket or health food shop.
There may
be interference between Salazopyrin and some other
medicines including:
oral medicines used to
prevent blood clots eg. warfarin
methotrexate,
a medicine used to treat arthritis and some
cancers
medicines to lower blood sugar or
control diabetes
mercaptopurine and
azathioprine, medicines used to treat some cancers
antacids, medicines that help to control
heartburn or symptoms of indigestion
digoxin,
a medicine used to treat heart failure
oxyphenbutazone, phenylbutazone, indomethacin
and sulfinpyrazone which are medicines used to
treat arthritis and gout
salicylates
oxacillin and penicillins, which are types of
antibiotics
certain local anaesthetics
medicines used to make the urine more acidic
iron tablets
These medicines may be
affected by Salazopyrin or may affect how well it
works. You may need different amounts of your
medicine or you may need to take different
medicines.
Your doctor or pharmacist has
more information on medicines to be careful with
or to avoid while taking Salazopyrin.
How
to take Salazopyrin
How to take
Salazopyrin
Your doctor will tell you how
to take Salazopyrin. The directions your doctor
gives you should be strictly followed. The
directions given to you by your doctor may differ
from the information contained in this leaflet.
You may be given a different dosage depending on
your condition and how you react to this medicine.
Salazopyrin should be swallowed after
meals with water.
It is important to
maintain adequate fluid intake while taking
Salazopyrin.
Do not crush, break or chew
Salzopyrin EN tablets.
How much to take and
when to take it
Inflammatory Bowel
Disease
Salazopyrin tablets should be taken
after meals in evenly spaced doses over each 24
hour period.
Adults: The usual initial dose
is 2 to 4 tablets, four times a day. The usual
maintenance dose is 4 tablets a day.
Children: Your doctor will determine the
proper dose, taking into account the age and
weight of the child.
Rheumatoid
Arthritis
Adults: The usual dose is 2
Salazopyrin EN tablets, two to three times a day.
It is usual to start taking Salazopyrin EN tablets
at a lower dose and gradually increase. Your
doctor will advise whether you should do this and
how to do this.
At present there is no dose
recommendation for treating rheumatoid arthritis
in children.
How long to take
Salazopyrin
Continue taking Salazopyrin for
as long as your doctor recommends.
If you
forget to take it
If you forget to take
your Salazopyrin, take your next dose at the
normal time it is due.
Do not try to make
up for missed doses by taking more than one dose
at a time because this may increase the chance of
you getting an unwanted side effect.
If you
have trouble remembering when to take your
medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons
Information Centre (telephone 13 11 26) for
advice, or go to Accident and Emergency (Casualty)
at your nearest hospital if you think you or
anyone else may have taken too much Salazopyrin.
Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical
attention. Keep telephone numbers for these
places/services handy. Have the Salazopyrin bottle
or this leaflet available to give details if
needed.
The symptoms of taking too many
Salazopyrin tablets may include stomach discomfort
and other effects listed under the heading "Side
effects" in this leaflet.
While taking
Salazopyrin
Things you must do
Advise your doctor immediately if you notice
any unusual symptoms.
Ensure you drink
plenty of fluids while on Salazopyrin.
Tell
your doctor if you become pregnant while taking
Salazopyrin.
If you are about to start
taking any new medicines, tell your doctor or
pharmacist that you are taking Salazopyrin.
Tell all doctors, dentists and pharmacists who
are treating you that you are taking Salazopyrin.
Ensure that you keep all doctor's
appointments for check-ups and any tests that your
doctor may order for you while you are taking
Salazopyrin.
Protect your skin when you are
in the sun, especially between 10am and 3pm.
Salazopyrin may cause your skin to be more
sensitive to sunlight than it is normally. If
outdoors, wear protective clothing and use a 15+
sunscreen. If your skin does appear to be burning,
tell your doctor immediately. Exposure to sunlight
may cause a skin rash, itching, redness or a
severe sunburn.
Things you must not do
Do not stop taking Salazopyrin or change the
dose without first checking with your doctor.
Do not give Salazopyrin to anyone else even if
they have the same condition as you.
Side
Effects
Check with your doctor as soon as
possible if you have any concerns while taking
Salazopyrin, even if you do not think the concerns
are connected with the medicine or are not listed
in this leaflet. All medicines can have side
effects and Salazopyrin may have unwanted side
effects in a few people. Sometimes they are
serious, most of the time they are not. You may
need medical treatment if you get some of the side
effects.
Do not be alarmed by this list of
possible side effects. You may not experience any
of them.
Ask your doctor or pharmacist to
answer any questions you may have.
Tell
your doctor if you notice any of the following and
they worry you:
nausea and vomiting
loss
of appetite
raised temperature
fever
redness and itchiness of the skin
diarrhoea
stomach pains
swelling of
the liver
headache
dizziness
abnormal
change in sense of smell or taste
insomnia
depression
convulsions
ringing in the
ears
hallucinations
yellow skin
allergic reactions
skin rash
dermatitis
loss of hair
increased
sensitivity to light
breathlessness
cough
If these effects do not go away
or they are worrying to you, tell your doctor.
If you get a sore throat, fever, pallor, rash
and yellow skin tell your doctor immediately. This
may mean that you have a serious blood disorder
and need urgent medical care.
Salazopyrin
can also cause:
blood cell changes, low
sperm count (which is reversible), pancreatitis
(swelling of the pancreas), stomatitis (swelling
in the mouth), impaired folic acid absorption,
peripheral neuropathy and neuritis (which cause
tingling, burning or numbness in the hands or
feet), kidney changes and lung complications.
This is not a complete list of all possible
side effects. Some people may get other side-
effects while taking Salazopyrin.
It is
very important to tell your doctor immediately if
you notice any side-effects while taking
Salazopyrin.
After treatment with
Salazopyrin
Storage
Keep your
tablets where children cannot reach them. Your
Salazopyrin tablets should be stored in their
original container in a cool, dry place where the
temperature stays below 25 °C.
If you take
your tablets out of their bottle, they may not
keep as well. Make sure the container is well
closed after use.
Do not store Salazopyrin
or any other medicine in a bathroom or near a
sink. Do not leave them in the car or on window
sills. Heat and dampness can destroy medicines.
Disposal
If your doctor tells you
to stop taking Salazopyrin, or the tablets have
passed their expiry date, ask your pharmacist what
to do with any tablets left over.
Product
Description
What Salazopyrin looks like
Salazopyrin tablets are yellow, round, scored
and marked '101' on one side and 'KPh' on the
other side. They come in plastic bottles
containing 100 tablets.
Salazopyrin EN
tablets are enteric coated 500mg tablets. They are
yellow, oval, and marked with '102' on one side
and 'KPh' on the other side. Salazopyrin EN 500mg
tablets come in plastic bottles containing 100
tablets.
Identification
Salazopyrin
tablets can be identified by an Australian
Register number which is found on the bottle
label:
500 mg tablets: AUST R 14486 500 mg
EN tablets: AUST R 14485 Ingredients
The
active ingredient in each tablet is sulfasalazine.
Each tablet contains 500mg sulfasalazine.
Salazopyrin tablets also contain:
silica, magnesium stearate, maize starch.
Salazopyrin EN tablets also contain: silica,
magnesium stearate, maize starch, cellacephate,
propylene glycol, white beeswax, carnauba wax,
glyceryl monostearate, macrogol 20000 and talc.
Salazopyrin tablets do not contain lactose,
sucrose, or tartrazine. Supplier
Salazopyrin is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422
348
38-42 Wharf Road
West Ryde NSW
2114
Australia
Toll Free Number: 1800 675
229
This leaflet was revised in March
2006
© Pfizer Australia Pty Ltd
®
Registered trademark