SALOFALK 250MG GASTRO-RESISTANT TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

LOSAN PHARMA GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SALOFALK
® GASTRO-RESISTANT TABLETS
Mesalazine 250 mg / 500 mg
1
WHAT IS IN THIS LEAFLET
1.
What Salofalk tablets are used for
2.
How Salofalk tablets work
3.
Before you use Salofalk tablets
4.
How to use Salofalk tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Salofalk
tablets
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SALOFALK TABLETS ARE USED FOR
Salofalk tablets are used for
-
the treatment of acute episodes and
prevention of further episodes of an
inflammatory disease of the large
intestine (colon and rectum) known by
doctors as ulcerative colitis.
-
the treatment of acute episodes of
Crohn’s disease (an inflammatory
bowel disease).
HOW SALOFALK TABLETS WORK
Salofalk tablets contain the active
substance mesalazine, an anti-
inflammatory agent used to treat
inflammatory bowel disease.
BEFORE YOU USE SALOFALK TABLETS
-
_When you must not use it _
-
if you are or have been told you
are allergic (hypersensitive) to
salicylic acid, to salicylates such as
Aspirin or to any of the other
ingredients of Salofalk
tablets
(these are listed in section
“Product description”).
-
if you have a serious liver and/or
kidney disease.
_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 or pharmacist
for advice before using this medicine.
_ _
You should only use Salofalk tablets
during pregnancy if your doctor tells you
to.
You should also only use Salofalk
tablets during breastfeeding if your
doctor tells you to, as this medicine may
pass into breast milk.
-
_Before you start to use it _
Before you start taking this medicine, you
should tell your doctor
-
if you have a history of problems with
your lungs, particularly if you suffer
from
BRONCHIAL
ASTHMA
-
if you have a history of
HYPERSENSITIVITY
to mesalazine, to
salicylates (e.g. sulphasalazine) or any
other ingredients of
Salofalk
tablets
(these are

Ciri produk

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Salofalk
®
250mg gastro-resistant tablets
Mesalazine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 250 mg mesalazine.
Excipient with known effect: sodium carbonate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablets
Appearance: round, light yellow to ochre, gastro-resistant tablets,
matt with smooth surface; not
scored.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
For the treatment of acute episodes and the maintenance of remission
of ulcerative colitis
-
For the treatment of acute episodes of Crohn’s disease
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
For the treatment of chronic inflammatory bowel disease (Crohn’s
disease, ulcerative colitis) both
Salofalk 250mg gastro-resistant tablets and Salofalk 500mg
gastro-resistant tablets are available.
At a dosage recommendation above 1.5 g mesalazine daily, Salofalk
500mg should preferably be
used.
Depending upon the clinical requirements in individual cases, the
following daily doses are
recommended
2
CROHN’S DISEASE
ULCERATIVE COLITIS
Acute episode
Acute episode
Prevention of recurrence/
long-term treatment
Mesalazine
(active
substance)
1.5 g - 4.5 g
1.5 g - 3.0 g
1.5 g
Salofalk 250mg
tablets
3 x 2
to
3 x 6
3 x 2
to
3 x 4
3 x 2
_Children _
There is only limited documentation for an effect in children (age
6-18 years).
_Children 6 years of age and older _
ACTIVE DISEASE
: To be determined individually, starting with 30-50 mg/kg/day in
divided doses.
Maximum dose: 75 mg/kg/day. The total dose should not exceed the
maximum adult dose.
MAINTENANCE TREATMENT (ULCERATIVE COLITIS):
To be determined individually, starting with 15-30
mg/kg/day in divided doses. The total dose should not exceed the
recommended adult dose.
It is generally recommended that half the adult dose may be given to
children up to a body
weight of 40 kg; and the normal adult dose to those above 40 kg.
Method of administration
Salo