Salazopyrin® EN Tabs 500 mg Gastro-resistant tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Sulfasalazine

제공처:

Pfizer Healthcare Ireland

ATC 코드:

A07EC; A07EC01

INN (International Name):

Sulfasalazine

복용량:

500 milligram(s)

약제 형태:

Gastro-resistant tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Aminosalicylic acid and similar agents; sulfasalazine

승인 상태:

Marketed

승인 날짜:

1977-04-01

환자 정보 전단

Page 1 of 8
2022-0082309
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALAZOPYRIN
® EN-TABS 500 MG
Gastro-resistant tablets
sulfasalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• 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 only. Do not pass it on
to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Salazopyrin EN-tabs are and what they are used for
2. What you need to know 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. Contents of the pack and other 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
inflammation caused by
rheumatoid arthritis or 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 the anus, but i

제품 특성 요약

Health Products Regulatory Authority
13 June 2023
CRN00DKZ7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salazopyrin® EN Tabs 500 mg Gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of sulfasalazine
Excipient with known effect:
Salazopyrin En-Tabs 500mg contains 5 mg propylene glycol in each
tablet.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Orange/Yellow, oval-shaped tablets with ‘KPh’ imprinted on one
side and ‘102’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of remission of ulcerative colitis;
treatment of active Crohn’s disease.
Treatment of rheumatoid arthritis which has failed to respond to
non-steroidal and anti-inflammatory drugs (NSAIDs).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Salazopyrin EN-Tabs 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 of the drug, as detailed below.
(a) Ulcerative Colitis
ADULTS AND THE ELDERLY
_Severe attacks_: 2 to 4 tablets, four times a day, 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.
The night-time interval between doses should not exceed 8 hours.
_Moderate attacks_: 2 to 4 tablets, four times per day may be given in
conjunction with steroids.
_Mild attacks_: 2 tablets, four times per day, may be taken with or
without steroids.
_Maintenance Therapy_: With induction of remission, reduce the dose
gradually to 4 tablets per day. This dosage should be
continued indefinitely, since discontinuance even several years after
an acute attack is associated with a four-fold increase in
relapse.
PAEDIATRIC POPULATION
The dose is reduced in proportion to body weight.
_Acute attack or relapse_: 40-60 mg/kg/per day.
_Maintenance Dosage_: 2