Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking SALAZOPYRIN?
SALAZOPYRIN contains the active ingredient sulfasalazine. SALAZOPYRIN is used to treat
and manage ulcerative colitis and Crohn's disease which are inflammatory bowel diseases.
Salazopyrin EN tablets are also used to treat rheumatoid arthritis, which is a painful
joint disease.
For more information, see Section
1. Why am I using SALAZOPYRIN? in the full CMI.
2. What should I know before I take SALAZOPYRIN?
Do not take if you have ever had an allergic reaction to sulfasalazine, sulfur-containing
medicines, some oral sugar-controlling medicines, some diuretics (thiazide diuretics)
salicylates, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take SALAZOPYRIN? in the full CMI.
3. What if I am taking other medicines?
4. How do I take SALAZOPYRIN?
Your doctor will tell you how many tablets you need to take each day. This may depend
on your age, your condition and whether or not you are taking any other medicines.
Continue taking SALAZOPYRIN for as long as your doctor recommends.
SALAZOPYRIN should be swallowed whole after meals with a full glass of water, taken
at evenly spaced intervals over a 24 hour period.
Do not crush, break or chew SALAZOPYRIN EN tablets
5. What should I know while taking SALAZOPYRIN?
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Things you should do
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Remind any doctor or dentist you visit that you are using SALAZOPYRIN.
Drink plenty of fluids while on SALAZOPYRIN.
Protect your skin when you are in the sun, especially between 10am and 3pm.
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Things you should not do
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Do not take SALAZOPYRIN to treat any other complaints unless your doctor tells you
to.
Do not stop taking SALAZOPYRIN or change the dose without first checking with your
doctor.
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Driving or using machines
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SALAZOPYRIN may cause dizziness or hallucinations in some people. Be careful before
you drive or use any machines or tools until you know how SALAZOPYRIN affects you.
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Looking after your medicine
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Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 25°C.
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6. Are there any side effects?
Common side effects include nausea or vomiting, diarrhoea and cold and flu symptoms.
More serious side effects may be severe allergic reactions, serious skin infections
or reactions or liver disease.
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):
Sulfasalazine
Full Consumer Medicine Information (CMI)
"SALAZOPYRIN" will be used in this leaflet to refer to the "plain" and "EN" tablets
unless specified otherwise.
This leaflet provides important information about using SALAZOPYRIN. 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 SALAZOPYRIN.
Where to find information in this leaflet:
1. Why am I taking SALAZOPYRIN?
SALAZOPYRIN contains the active ingredient sulfasalazine. It has a number of effects in the body. It suppresses the immune system and is an
anti- inflammatory medicine.
SALAZOPYRIN is used to treat and manage ulcerative colitis and Crohn's disease which
are inflammatory bowel diseases.
SALAZOPYRIN EN tablets are also used to treat rheumatoid arthritis, which is a painful
joint disease.
SALAZOPYRIN EN tablets help prevent damage to your joints. It works to slowly reduce
the swelling and stiffness in your joints. It is usually given when a group of medicines
known as non-steroidal anti-inflammatory drugs (NSAIDs) are not working.
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.
This medicine is available only with a doctor’s prescription.
There is no evidence that SALAZOPYRIN is addictive.
2. What should I know before I take SALAZOPYRIN?
Warnings
Do not take SALAZOPYRIN if:
sulfasalazine
sulfur-containing medicines e.g. sulfonamides;
some oral sugar-controlling medicines for diabetes (hypoglycaemics) e.g. glipizide;
medicines knows as thiazide diuretics e.g. chlorothiazide
medicines known as salicylates e.g. aspirin
any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can take 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.
2. If you have the following medical conditions
kidney or liver problems
any form of blood disorder
any form of intestinal or urinary obstruction
porphyria (rare disease of blood pigments).
3. If the packaging is torn or shows signs of tampering or the tablets do not look quite
right
4. If the expiry date (Exp.) on the carton has passed.
Do not give SALAZOPYRIN to children under two years of age.
Check with your doctor if you:
have any other medical conditions, including if you:
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)
have a history of recurring or chronic infections.
are allergic to any other medicines or any other substances such as foods, preservatives
or dyes
take any medicines for any other condition
Your doctor will send you to have blood tests to help assess your liver and kidney
function and the levels of various cells in your bloodstream before you start treatment
with SALAZOPYRIN. You may also have a urine test to monitor your kidney function.
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?
If you have any of the above, tell your doctor before you start taking SALAZOPYRIN.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks and benefits of taking SALAZOPYRIN during
pregnancy and breast-feeding.
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.
Some medicines may interfere with SALAZOPYRIN and affect how it works. These include:
oral medicines used to prevent blood clots e.g. 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: medicines used to treat minor relief of pain e.g. aspirin
oxacillin and penicillins, which are types of antibiotics
certain local anaesthetics
medicines used to make the urine more acidic
iron tablets
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SALAZOPYRIN.
4. How do I take SALAZOPYRIN?
How much to take and when
Your doctor will tell you how many tablets you need to take each day. This may depend
on your age, your condition and whether or not you are taking any other medicines.
Continue taking SALAZOPYRIN for as long as your doctor recommends.
Inflammatory Bowel Disease
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 ENtablets, 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.
SALAZOPYRIN EN is not recommended for treating rheumatoid arthritis in children.
How to take SALAZOPYRIN
SALAZOPYRIN should be swallowed whole after meals with a full glass of water.
SALAZOPYRIN tablets are usually taken at evenly spaced intervals over a 24 hour period.
It is important to maintain adequate fluid intake while taking SALAZOPYRIN.
Do not crush, break or chew SALAZOPYRIN EN tablets.
If you forget to take SALAZOPYRIN
SALAZOPYRIN should be taken regularly at the same time each day. If you miss your
dose at the usual time, take your next dose at the normal time it’s due.
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.
If you take too much SALAZOPYRIN
If you think that you have taken too much SALAZOPYRIN, 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.
The symptoms of taking too many SALAZOPYRIN tablets may include stomach discomfort
and other effects listed under the heading "Side effects" in this leaflet.
5. What should I know while taking SALAZOPYRIN?
Things you should do
Drink plenty of fluids while on 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 sunscreen. If your skin does appear to be
burning, tell your doctor immediately. Exposure to sunlight may cause a skin rash,
itching, redness or severe sunburn.
Tell all doctors, dentists,pharmacists and specialists who are treating you that you
are taking SALAZOPYRIN.
Make sure 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.
Call your doctor straight away if you:
notice any unusual symptoms.
become pregnant while taking SALAZOPYRIN.
Remind any doctor or dentist you visit that you are using SALAZOPYRIN.
Things you should not do
Do not take SALAZOPYRIN to treat any other complaints unless your doctor tells you
to.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SALAZOPYRIN
affects you.
SALAZOPYRIN may cause dizziness or hallucinations in some people. If you have any
of these symptoms, do not drive, operate machinery or do anything else that could
be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 25°C; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
If you take your tablets out of their bottle, they may not keep as well. Make sure
the container is closed after use.
Do not take this medicine after the expiry date.
Keep it where young children cannot reach it.
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.
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.
Serious side effects
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Serious side effects
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What to do
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Breathing and chest related problems
breathlessness
chest pain
palpitations
Skin symptoms
redness and itchiness of the skin
signs of serious skin infections such as rash or mucosal lesions
dermatitis (dry, itchy skin)
Other
convulsions
allergic reactions
swelling of the face
loss of hair
signs of liver disease such as yellowing of skin and eyes and dark coloured urine
severe pain in the loins or pain on urination
Sore throat, fever, pale appearance, rash and yellow skin
Tell your doctor immediately. This may mean that you have a serious blood disorder
and need urgent medical care.
Side-effects seen via blood tests
blood cell changes
reversible low sperm count
swelling of the pancreas
swelling in the mouth
impaired folic acid absorption
peripheral neuropathy and neuritis (which cause tingling, burning or numbness in the
hands or feet)
changes in kidney function and lung complications.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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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 only available with a doctor's prescription.
What SALAZOPYRIN contains
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Active ingredient
(main ingredient)
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Sulfasalazine 500 mg per tablet
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Other ingredients
(inactive ingredients)
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SALAZOPYRIN:
colloidal anhydrous silica
magnesium stearate
maize starch
SALAZOPYRIN EN:
colloidal anhydrous silica
magnesium stearate
maize starch
cellacefate
propylene glycol
white beeswax
carnauba wax
glyceryl monostearate
macrogol 20000
povidone
purified talc
SALAZOPYRIN tablets do not contain lactose, sucrose, or tartrazine.
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Do not take this medicine if you are allergic to any of these ingredients.
What SALAZOPYRIN looks like
SALAZOPYRIN tablets are yellow-orange, round and scored tablets, marked with '101'
on one side and 'KPh' on the other side. They come in plastic bottles containing 100
tablets (AUST R 14486).
SALAZOPYRIN EN tablets are enteric coated 500mg tablets. They are yellow-orange, elliptical
convex tablets, marked with '102' on one side and 'KPh' on the other side. Salazopyrin
EN 500 mg tablets come in plastic bottles containing 100 tablets (AUST R 14485).
Who distributes SALAZOPYRIN
In Australia:
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in March 2023.