PYRALIN EN Sulfasalazine 500mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sulfasalazine, Quantity: 500 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: white beeswax; propylene glycol; magnesium stearate; colloidal anhydrous silica; cellacefate; purified talc; macrogol 20000; povidone; Carnauba Wax; maize starch; glyceryl monostearate

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ulcerative Colitis and Crohn's Disease: Adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. For the management of severe, acute attacks of ulcerative colitis, rectal and systemic corticosteroid therapy appears to be clinically superior to sulfasalazine, but sulfasalazine may be more effective than corticosteroids in reducing the number of relapses in patients on maintenance therapy. In the treatment of active Crohn's disease, especially in patients with colonic involvement. Rheumatoid Arthritis: Pyralin EN tablets are indicated for rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (NSAIDs).

Product summary:

Visual Identification: Yellow-orange, elliptical convex enteric coated tablets marked with 'KPh' on one side and 102 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1997-02-27

Patient Information leaflet

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
•
sulfur-containing medicines e.g.
sulfonamides; some oral
hypoglycaemics (diabetes
medicine) e.g. glipizide; thiazide
diuretics e.g. chlorothiazide
•
salicylates e.g. aspirin
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other

Summary of Product characteristics

Version: pfppyrat10919
Supersedes: pfppyrat10913
Page 1 of 15
AUSTRALIAN
PRODUCT
INFORMATION
–
PYRALIN® EN (SULFASALAZINE)
1.
NAME OF THE MEDICINE
Sulfasalazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PYRALIN EN enteric coated tablets contain 500 mg of sulfasalazine
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
PYRALIN EN (sulfasalazine) 500 mg enteric coated tablets
Yellow-orange, elliptical convex, enteric coated tablets; marked with
`KPh' on the one side and
`102' on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ULCERATIVE COLITIS AND CROHN'S DISEASE
Adjunct in the treatment of ulcerative colitis with the usual
supportive and dietary measures.
For the management of severe, acute attacks of ulcerative colitis,
rectal and systemic
corticosteroid therapy appears to be clinically superior to
sulfasalazine, but sulfasalazine may
be more effective than corticosteroids in reducing the number of
relapses in patients on
maintenance therapy.
In the treatment of active Crohn's disease, especially in patients
with colonic involvement.
RHEUMATOID ARTHRITIS
PYRALIN EN tablets are indicated for rheumatoid arthritis which has
failed to respond to non-
steroidal anti-inflammatory drugs (NSAIDs).
_ _
4.2 DOSE AND METHOD OF ADMINISTRATION
INFLAMMATORY BOWEL DISEASE
_ORAL:_
PYRALIN EN tablets (enteric coated) should be given preferably after
meals in evenly
divided doses over a 24 hour period with no more than 8 hours between
overnight doses. The
enteric coated tablets should not be crushed or broken.
_ _
_ _
Version: pfppyrat10919
Supersedes: pfppyrat10913
Page 2 of 15
_INITIAL DOSAGE _
Adults: 1 to 2 g four times daily.
Children: 40 to 60 mg/kg bodyweight daily in three to six divided
doses.
_MAINTENANCE DOSAGE _
Adults: 2 g daily in four divided doses.
Children: 40 mg/kg bodyweight daily in four divided doses. The daily
maintenance dose
should be continued unless contraindicated by side effects.
RHEUMATOID ARTHRITIS
_ORAL_
: Two PYRALIN EN tablets, two