Salofalk 500mg Gastro-resistant Prolonged Release Granules

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

MESALAZINE

থেকে পাওয়া:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (International Name):

MESALAZINE

প্যাকেজ ইউনিট:

100sachet Sachets; 300sachet Sachets; 50sachet Sachets

Manufactured by:

LOSAN PHARMA GMBH

তথ্য লিফলেট

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 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
mesalazine, salicylic acid,
salicylates such as Aspirin or any of
the other ingredients of this
medicine.
-
if you have a serious liver and/or
kidney disease.
_Pregnancy and breast-feeding: _
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
granules
during pregnancy if your doctor tells you
to.
You should only use Salofalk granules
during breast-feeding 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 ALLERGY TO
SULPHASALAZINE
, a substance related
to mesalazine.
-
if you suffer with problems of your
LIVER.
-
if you suffer with problems of your
KIDNEY.
-
if you have ever developed a severe
skin rash or skin peeling

পণ্য বৈশিষ্ট্য

spcpalmy-sagall-en4-aug21
1
PACKAGE INSERT
1
NAME OF THE MEDICINAL PRODUCT
Salofalk
®
500mg gastro-resistant prolonged-release granules
Salofalk
®
1000mg gastro-resistant prolonged-release granules
Salofalk
®
1.5g gastro-resistant prolonged-release granules
Salofalk
®
3g gastro-resistant prolonged-release granules
Mesalazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Salofalk 500mg granules contains 500 mg mesalazine.
Each sachet of Salofalk 1000mg granules contains 1000 mg mesalazine.
Each sachet of Salofalk 1.5g granules contains 1.5 g mesalazine.
Each sachet of Salofalk 3g granules contains 3 g mesalazine.
Excipients with known effect:
Each sachet of Salofalk 500mg granules contains 1.0 mg aspartame and
0.02 mg sucrose.
Each sachet of Salofalk 1000mg granules contains 2.0 mg aspartame and
0.04 mg sucrose.
Each sachet of Salofalk 1.5g granules contains 3.0 mg aspartame and
0.06 mg sucrose.
Each sachet of Salofalk 3g granules contains 6.0 mg aspartame and 0.12
mg sucrose.
WARNING
Unsuitable for phenylketonurics
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant prolonged-release granules
Description: stick-formed or round, greyish white granules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of acute episodes and the maintenance of remission
of ulcerative colitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and the elderly
_ _
_For the treatment of acute episodes of ulcerative colitis _
Once daily, 1 sachet of Salofalk 3g granules, 1-2 sachets of Salofalk
1.5g granules, 3 sachets of
Salofalk 1000mg granules or 3 sachets of Salofalk 500mg granules
(equivalent to 1.5-3.0 g
spcpalmy-sagall-en4-aug21
2
mesalazine daily) preferably to be taken in the morning according to
the individual clinical
requirement.
It is also possible to take the prescribed daily dose in three divided
doses (1 sachet of Salofalk
500mg granules 3 times daily or 1 sachet of Salofalk 1000mg granules 3
times daily), if this is
more convenient to the patien