SALAZOPYRIN EN TABLET 500MG

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

SULPHASALAZINE

Dostopno od:

PFIZER (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

SULPHASALAZINE

Enote v paketu:

100Tablet Tablets

Izdeluje:

Recipharm Uppsala AB

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SALAZOPYRIN EN
® TABLETS
Sulfasalazine
(500 mg)
WHAT IS IN THIS LEAFLET
1.
What SALAZOPYRIN EN is used for
2.
How SALAZOPYRIN EN works
3.
Before you use SALAZOPYRIN EN
4.
How to use SALAZOPYRIN EN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
SALAZOPYRIN EN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT SALAZOPYRIN EN IS USED FOR
SALAZOPYRIN EN tablets are used to
treat and manage inflammatory bowel
disease or to treat rheumatoid arthritis (a
painful joint disease).
The main forms of inflammatory bowel
disease are ulcerative colitis and Crohn’s
disease.
Ulcerative colitis is an inflammatory
disease which affects only the large
bowel (colon and back passage). Crohn’s
disease is an inflammatory disease which
may affect any part of the digestive
system from the mouth to the anus, but it
most commonly affects the last part of
the small bowel and the first part of the
large bowel.
HOW SALAZOPYRIN EN WORKS
The active substance in SALAZOPYRIN
EN is sulfasalazine. It has a number of
effects in the body. It is an
immunosuppressive (suppresses
overactivity of the immune system) and
an anti-inflammatory medicine.
BEFORE YOU USE SALAZOPYRIN EN
-
_When you must not use it _
Do not take SALAZOPYRIN EN if
you
- are allergic (hypersensitive) to
sulfasalazine or any of the ingredients
of SALAZOPYRIN EN tablets;
- are allergic (hypersensitive) to
salicylates (e.g. aspirin) or
sulfonamides (e.g. a certain type of
antibiotic);
- have a disease known as porphyria (a
rare blood pigment disorder).
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
for advice before taking this medicine.
Your doctor will discuss the possible
risks and benefits of taking
SALAZOPYRIN EN during pregnancy
and breast-feeding.
SALAZOPYRIN EN are found in low
levels in breast milk. Caution should be
used, particularly if breastfe

Lastnosti izdelka

Pfizer confidential
2
PFIZER
SALAZOPYRIN EN ®
sulfasalazine
1. NAME OF THE MEDICINAL PRODUCT
Salazopyrin EN
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: sulfasalazine.
Each coated gastro -resistant tablet for oral administration contains 500 mg of sulfasalazine.
3. PHARMACEUTICAL FORM
Salazopyrin EN coated tablet is a yellow -orange, elliptical, convex, enteric -coated tablet with
the letter KPh on one face, and the product code “102” on the other.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Ulcerative colitis
In the treatment of mild to moderate ulcerative co litis and as adjunctive therapy in severe
ulcerative colitis. For maintenance of remission in ulcerative colitis.
Crohn`s Disease
In the treatment of active Crohn`s disease especially in patients with colonic involvement.
Rheumatoid arthritis
4.2 Posology and Method of Administration
The dosage should be adjusted according to the patient’s response to treatment and tolerance
to the drug. The tablets should be taken at regular intervals during the day, preferably in
connection with meals.
Patients not previously treated with Salazopyrin EN tabs are recommended to increase the
dose gradually during the first few weeks. The use of enteric coated tablets will reduce the
incidence of gastrointestinal side effects. The enteric coated tablets should not be crushed or
broken.
Inflammatory bowel diseases
Adults
Acute attacks and severe attacks:
2- 4 tablets 3 -4 times a day may be given in conjunction with steroids as part of an intensive
management regime.
Moderate and mild attacks:
2 tablets 3 -4 times a day.