SALAZOPYRIN EN 500 Milligram Tablets Gastro-Resistant

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

SULFASALAZINE

Dostupné z:

Pfizer Limited

ATC kód:

A07EC01

INN (Medzinárodný Name):

SULFASALAZINE

Dávkovanie:

500 Milligram

Forma lieku:

Tablets Gastro-Resistant

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Aminosalicylic acid and similar agents

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2012-04-05

Príbalový leták

14:04
2016‑0009776B
296442
Kemwell ‑ Uppsala
As Supplied
5.5 pt
Ireland
03
Label‑Leafsert
FPO
B11
Covers: 47 x 157 mm
Covers 1 + Base 1 + Text 24 = 26 Pages
PAR‑2016‑0009776
PROFILE
BLACK
PMS 134
BRAILLE
BARCODE Nº
PHARMA CODE
SUPPLIER Nº
DATE:
14 DEC 2016
TIME:
PERIGORD Nº
SUPPLIER
SMALLEST
BODY TEXT
SIZE
MARKET
PROOF Nº
COMPONENT
DRAWING Nº
DIMENSIONS
NOTES
PAR NUMBER
COLOURS
PRINTING
NON-PRINTING
BRAILLE:
salazopyrin
en-tabs
#500 mg
Each gastro-resistant tablet contains
Sulfasalazine 500 mg.
Use as directed by a doctor.
Oral use.
TO BE SWALLOWED WHOLE, NOT CHEWED
OR BROKEN.
Do not store above 25
o
C. Keep the
container tightly closed.
Read the leaflet before use.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
MA Holder: Pfizer Limited, Ramsgate
Road, Sandwich, Kent, CT13 9NJ, UK
PA 19/84/1
Peel back for package leaflet.
Salazopyrin
®
En-Tabs 500 mg
Gastro-resistant tablets
500 mg
Sulfasalazine
112 Enteric-coated tablets
2016‑0009776B
FPO
1
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.
2
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
3
1. What Salazopyrin EN-tabs are and what they are
used for
The active substance in Salazopyrin EN-tabs is sulfasalazine which i

Súhrn charakteristických

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 sulphasalazine.
For a 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_: 20-30 mg/kg per day.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___