Salofalk 1.5g Gastro-resistant Prolonged Release Granules

国家: 马来西亚

语言: 英文

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

有效成分:

MESALAZINE

可用日期:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN（国际名称）:

MESALAZINE

每包单位数:

35sachet Sachets; 100sachet Sachets

厂商:

LOSAN PHARMA GMBH

资料单张

SALOFALK® GASTRO-RESISTANT PROLONGED-RELEASE
GRANULES
Mesalazine 500mg / 1000mg / 1.5g / 3g
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Salofalk
®
gastro-resistant
prolonged-release granules are used
for
2.
How Salofalk
®
granules work
3.
Before you use Salofalk
®
granules
4.
How to use Salofalk
®
granules
5.
While you are using them
6.
Side effects
7.
Storage and Disposal of Salofalk
®
granules
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SALOFALK
® GRANULES ARE USED FOR
Salofalk
®
granules are used for:
−
the treatment of acute episodes
and prevention of further
episodes (recurrence) of an
inflammatory
disease of the large
intestine (colon), known by
doctors as ulcerative colitis.
HOW SALOFALK
® GRANULES WORK
Salofalk
®
granules contain the active
substance mesalazine, an anti-
inflammatory agent used to
treat
inflammatory bowel disease.
BEFORE YOU USE SALOFALK
® GRANULES
-
_When you must not use them _
−
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
®
granules
(these are listed in section
“Product description”).
−
if you have a serious liver and/or
kidney disease.
-
_Pregnancy and lactation _
Ask your doctor or pharmacist for advice
before taking any medicine.
You should only use Salofalk
®
granules
during pregnancy if your doctor tells you
to.
You should also only use Salofalk
granules during breastfeeding if your
doctor tells you to, as this medicine may
pass into breast milk.
_ _
-
_Before you start use them _
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. sulfasalazine) or
any other ingredients of Salofalk
®
granules (these are listed in
section “Product description”).
−
i