Pyralin EN

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Sulfasalazine

Disponible depuis:

Pfizer Australia Pty Ltd

classe:

Medicine Registered

Notice patient

PYRALIN
®
 EN TABLETS

_Sulfasalazine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
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.
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
_WHAT PYRALIN DOES_
Pyralin EN is used to treat and
manage ulcerative colitis and Crohn's
disease which are inflammatory
bowel diseases.
Pyralin EN is also used to treat
rheumatoid arthritis which is a
painful joint disease.
Pyralin EN helps 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.
_HOW PYRALIN EN WORKS_
The active substance in Pyralin EN is
sulfasalazine. It has a number of
effects in the body. It is an
immunosuppressive and an anti-
inflammatory medicine.
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 Pyralin EN
is addictive.
BEFORE YOU TAKE
PYRALIN EN
_WHEN YOU MUST NOT TAKE_
_PYRALIN EN_
DO NOT TAKE PYRALIN EN IF YOU HAVE
AN ALLERGY TO:
•
sulfasalazine
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
sulfasalazine 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.
If you are not sure if you have or
have had an allergic reaction to
Pyralin EN, check

Résumé des caractéristiques du produit

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PRODUCT INFORMATION 
PYRALIN

 EN (SULFASALAZINE) 
NAME OF THE MEDICINE 
PYRALIN EN (sulfasalazine) 500 mg enteric coated tablets. 
The structural formula of sulfasalazine is shown below: 

Chemical Name: 
2-Hydroxy-5-[2-[4-(pyridin-2-
ylsulphamoyl)phenyl]diazenyl]benzoic acid

Molecular Formula: 
C
18
H
14
N
4
O
5
S 
Molecular Weight: 
398.4 
CAS Registry Number: 
599-79-1. 
DESCRIPTION 
Sulfasalazine is a bright yellow or brownish-yellow, fine powder.
 It is practically insoluble in 
water, very slightly soluble in ethanol (96 percent),
practically insoluble in methylene 
chloride.  It dissolves in dilute solutions of alkali hydroxides. 
PYRALIN  EN  enteric  coated  tablets  contain  500  mg  of  sulfasalazine  and  the  following 
inactive  ingredients:  starch-maize,  silica-colloidal  anhydrous,  magnesium  stearate, 
cellacephate,  propylene  glycol,  beeswax-white,  carnauba  wax,  macrogol  20000,  glyceryl 
monostearate, and talc-purified. 
PHARMACOLOGY 
PHARMACODYNAMICS 
Sulfasalazine  has,  among  others,  an  immunosuppressive  effect  and  has  shown  affinity  to 
connective tissue.  It has also been shown to have a wide range of effects in other biological 
systems.  It is, however, difficult to judge the clinical relevance of its various pharmacological 
actions since the aetiology of rheumatoid arthritis is largely unknown.  Moreover, the mode of 
action of sulfasalazine in the treatment of ulcerative colitis is also not known.  A
metabolite of 
the  drug  may  have  an  inhibitory  effect  on  an  antigen-antibody  process  occurring  in  the 
Version: pfppyrat10913 
Supersedes: pfppyrat10413 

 Page 2 of 13 
intestinal wall and the salicylate component may act as an anti-inflammatory�