SALAZOPYRIN 500 Milligram Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

SULFASALAZINE

Mevcut itibaren:

Pfizer Limited

ATC kodu:

A07EC01

INN (International Adı):

SULFASALAZINE

Doz:

500 Milligram

Farmasötik formu:

Tablets

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Aminosalicylic acid and similar agents

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2012-04-05

Bilgilendirme broşürü

13:48
2016‑0009776A
296441
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
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
PMS 277
BRAILLE:
salazopyrin
#500 mg
tablets
Each 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 19/84/2
Peel back for package leaflet.
Salazopyrin
®
500 mg Tablets
500 mg
Sulfasalazine
112 Tablets
2016‑0009776A
FPO
1
Package leaflet: Information for the user
Salazopyrin
®
500 mg 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.
2
What is in this leaflet:
1. What Salazopyrin Tablets are and what they are used for
2. What you need to know before you take Salazopyrin Tablets
3. How to take Salazopyrin Tablets
4. Possible side effects
5. How to store Salazopyrin Tablets
6. Contents of the pack and other information
3
1. What Salazopyrin Tablets are and what they are
used for
The active substance in Salazopyrin Tablets is sulfasalazine which is
an anti‑inflammatory drug
and belongs to a group of medicines called aminosalicylates.
Your doc

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salazopyrin® 500 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of sulfasalazine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Orange/Yellow, round tablet with ‘KPh’ imprinted on one side and
‘101’ 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 anti-inflammatory drugs (NSAIDs).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is adjusted according to the severity of the disease and
the patient’s tolerance to the drug, as detailed below.
ELDERLY PATIENTS:
No special precautions are necessary.
A) ULCERATIVE COLITIS, CROHN’S DISEASE
Adults:
_Severe attack:_ 2-4 tablets, four times a day, may be given in
conjunction with steroids as part of an intensive
management regime.
Rapid passage of the tablet may reduce the effect of the drug.
Night-time interval between doses should not exceed eight hours.
_Moderate attack:_ 2-4 tablets, four times a day may be given in
conjunction with 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 four-fold
increase in risk of relapse.
PAEDIATRIC POPULATION:
The dose is reduced in proportion to body weight.
_Acute attack or relapse:_
40-60 mg/kg/per day.
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