Salazopyrin-EN

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sulfasalazine 500mg (Sulfasalazine 500 mg added as 535 mg sulfasalazine with povidone)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Sulfasalazine 500 mg (Added as 535mg sulphasalazine coated with povidone)

Dosage:

500 mg

Pharmaceutical form:

Enteric coated tablet

Composition:

Active: Sulfasalazine 500mg (Sulfasalazine 500 mg added as 535 mg sulfasalazine with povidone) Excipient: Carnauba wax Cellacefate Colloidal silicon dioxide Macrogol 20000 Magnesium stearate Povidone Propylene glycol Purified talc Self-emulsifying glyceryl monostearate Starch White beeswax

Units in package:

Bottle, plastic, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Recipharm Uppsala AB

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 Salazopyrin EN tablets are indicated for rheumatoid arthritis which has failed to respond to nonsteroidal anti-inflammatory drugs (NSAIDs).

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

SALAZOPYRIN
®
1
SALAZOPYRIN®
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?
Some medicines may interfere with SALAZOPYRIN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
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
More instructions can be found in Section 4. How do I take
SALAZOPYRIN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING SALAZOPYRIN?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using SALAZOPYR

Summary of Product characteristics

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Supersedes: pfdsalab10913
Page 1 of 14
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
Sulfasalazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salazopyrin tablet: Each tablet contains 500 mg sulfasalazine.
Salazopyrin-EN enteric coated tablet: Each tablet contains 500 mg
sulfasalazine.
EXCIPIENT(S) WITH KNOWN EFFECT
Salazopyrin-EN tablets contain:
•
Propylene glycol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Salazopyrin 500 mg tablet: Yellow-orange, round, scored tablets;
marked with `KPh' on the
one side and `101' on the other side.
Salazopyrin-EN 500 mg enteric coated tablet: 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
Salazopyrin EN tablets are indicated for rheumatoid arthritis which
has failed to respond to
non-steroidal anti-inflammatory drugs (NSAIDs).
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Supersedes: pfdsalab10913
Page 2 of 14
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The dosage of sulfasalazine should be individually adjusted according
to the patient’s
tolerance and response to the treatment.
_INFLAMMATORY BOWEL DISEASE _
Salazopyrin or Salazopyrin EN (enteric coated) tablets 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.
Initial Dosage
_Adults_
: 1 to 2 g four