Sulfasalazine 500mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulfasalazine

Available from:

Kent Pharma (UK) Ltd

ATC code:

A07EC01

INN (International Name):

Sulfasalazine

Dosage:

500mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050100

Patient Information leaflet

_S1295 LEAFLET Salazopyrin 20191107_
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALAZOPYRIN
® EN 500MG TABLETS
(SULFASALAZINE)
Your medicine is called Salazopyrin EN 500mg Tablets but will be
referred to as Salazopyrin EN-tabs throughout the following leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Salazopyrin EN-tabs are and what they are used for
2.
Before you take Salazopyrin EN-tabs
3.
How to take Salazopyrin EN-tabs
4.
Possible side effects
5.
How to store Salazopyrin EN-tabs
6.
Further information
1.
WHAT SALAZOPYRIN EN-TABS ARE AND WHAT THEY
ARE USED FOR
The active substance in Salazopyrin EN-tabs is sulfasalazine which
is an anti-inflammatory drug and belongs to a group of medicines
called aminosalicylates.
Your doctor may give you Salazopyrin EN-tabs to treat and manage
inflammatory bowel disease or to treat rheumatoid arthritis.
INFLAMMATORY BOWEL DISEASE
The main forms of inflammatory bowel disease are Ulcerative
Colitis and Crohn’s disease. Although the diseases have some
features in common, there are some important differences.
Ulcerative Colitis is an inflammatory disease which affects only the
large bowel (colon and back passage). The lining of the bowel
becomes inflamed (red and swollen) and symptoms include
abdominal pain and diarrhoea (which may contain blood and
mucus). Salazopyrin EN-tabs are used to control the flare-ups of
ulcerative colitis. They may also be used at lower doses to prevent
more flare-ups of ulcerative colitis.
Crohn’s disease is an inflammatory disease which may affect any
part of the digestive system from the mouth to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SULAZINE EC
Sulfasalazine 500 mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg Sulfasalazine
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant Tablets
Oval-shaped, orange, bi-convex tablets engraved ‘SULAZINE EC’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Induction and maintenance of remission of ulcerative colitis;
treatment of
active Crohn’s disease
2.
Treatment of rheumatoid arthritis which has failed to respond to non-
steroidal anti-inflammatory drugs (NSAIDs)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gastro-resistant tablets should be used where there is
gastro-intestinal intolerance of
plain tablets. They should not be crushed or broken.
The dose is adjusted according to the severity of the disease and the
patient’s
tolerance to the drug, as detailed below.
1. Ulcerative colitis:
Adults and Elderly:
•
_Severe attacks: _
2-4 tablets four times a day, which may be given in conjunction with
steroids as
part of an intensive management regime. Rapid passage of the tablets
may reduce
the effect of the drug.
Night-time interval between doses should not exceed 8 hours.
When remission occurs, maintenance therapy should be commenced.
•
_Moderate attacks: _
2-4 tablets four times a day may be given in conjunction with steroids
•
_Mild attacks: _
2 tablets four times a day with or without steroids
•
_Maintenance therapy: _
With induction of remission gradually reduce dose to 4 tablets per
day. The
dosage should be continued indefinitely to avoid relapse, since
discontinuation
even several years after an acute attack is associated with a
four-fold increase in
risk of relapse.
Children over 2 years:
Adjust the dose in proportion to bodyweight
•
Acute attack or relapse: 40-60 mg/kg per day
•
Maintenance therapy: 20-30 mg/kg per day
Sulfasalazine suspension may provide a more flexible dosage form.
2. Crohn’s disease
In active Crohn�