Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you start taking Pyralin EN. This leaflet answers some common questions about Pyralin EN. 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 Pyralin EN against the benefits this medicine is expected to have for you.
Use Pyralin EN 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 Pyralin EN is used for
Pyralin EN 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.
Pyralin EN is also used to treat rheumatoid arthritis which is a painful joint disease.
This medicine is available only with a doctor's prescription.
There is no evidence that Pyralin EN is addictive.
Before you take Pyralin EN
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 Pyralin EN
Do not take Pyralin EN 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 Pyralin EN which are listed under the heading, "Product Description", at the end of this leaflet.
Symptoms of an allergic reaction to Pyralin EN 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 Pyralin EN, check with your doctor.
Do not take Pyralin EN 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 Pyralin EN to children under two years of age.
Do not use Pyralin EN to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else.
See your Doctor for a check up before you start to take Pyralin EN.
Before you start to take Pyralin EN.
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 Pyralin EN 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 Pyralin EN 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
oxacillin and penicillins, which are types of antibiotics
certain local anaesthetics
medicines used to make the urine more acidic
These medicines may be affected by Pyralin EN 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 Pyralin EN.
How to take Pyralin EN
How to take it
Your doctor will tell you how to take your Pyralin EN tablets. 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.
Pyralin EN should be swallowed after meals with water.
It is important to maintain adequate fluid intake while taking Pyralin EN.
Do not crush,break or chew these enteric-coated tablets.
How much to take and when to take it
Inflammatory Bowel Disease
Pyralin EN 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.
Adults: The usual dose is 2 tablets, two to three times a day.
It is usual to start taking Pyralin EN 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 it
Continue taking Pyralin EN for as long as your doctor recommends. If you forget to take it
If you forget to take your Pyralin EN 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 at your nearest hospital if you think you or anyone else may have taken too much Pyralin EN. 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 Pyralin EN bottle or this leaflet available to give details if needed.
The symptoms of taking too many Pyralin EN tablets may include stomach discomfort and other effects listed under the heading "Side effects" in this leaflet.
While you are taking Pyralin EN
Things you must do
Advise your doctor immediately if you notice any unusual symptoms. Ensure you drink plenty of fluids while on Pyralin EN. Tell your doctor if you become pregnant while taking Pyralin EN. If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking Pyralin EN. Tell all doctors, dentists and pharmacists who are treating you that you are taking Pyralin EN. 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 Pyralin EN. Protect your skin when you are in the sun, especially between 10am and 3pm. Pyralin EN 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 Pyralin EN or change the dose without first checking with your doctor.
Do not give Pyralin EN to anyone else even if they have the same condition as you.
Check with your doctor as soon as possible if you have any concerns while taking Pyralin EN, 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 Pyralin EN 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
redness and itchiness of the skin
swelling of the liver
abnormal change in sense of smell or taste
ringing in the ears
loss of hair
increased sensitivity to light
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.
Pyralin EN 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 Pyralin EN. It is very important to tell your doctor immediately if you notice any side-effects while taking Pyralin EN. After treatment with Pyralin EN Storage
Keep your tablets where children cannot reach them Your Pyralin EN 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 Pyralin EN 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.
If your doctor tells you to stop taking Pyralin EN, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.
What it looks like
Pyralin EN tablets are enteric coated 500mg tablets. They are yellow, oval, and marked with '102' on one side and 'KPh' on the other side.
Pyralin EN 500mg tablets come in plastic bottles containing 100 tablets.
Pyralin EN tablets can be identified by an Australian Register number which is found on the bottle label:
500 mg EN tablets: AUST R 58398 Ingredients
The active ingredient in each tablet is sulfasalazine. Each tablet contains 500mg sulfasalazine.
Pyralin EN tablets also contain: silica, magnesium stearate, maize starch, cellacephate, propylene glycol, white beeswax, carnauba wax, glyceryl monostearate, macrogol 20000 and talc.
Pyralin EN tablets do not contain lactose, sucrose, or tartrazine.
Pyralin EN is supplied in Australia by:-
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229
This leaflet was revised in March 2006.
© Pfizer Australia Pty Ltd
® Registered trademark