SALOFALK 500MG GASTRO-RESISTANT TABLETS

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

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

זמין מ:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (שם בינלאומי):

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

יחידות באריזה:

100Tablet Tablets

תוצרת:

LOSAN PHARMA GMBH

עלון מידע

_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

מאפייני מוצר

1 NAME OF MEDICINAL PRODUCT
Salofalk ® 500mg
gastro-resistant tablets
Mesalazine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 500 mg mesalazine.
Excipients with known effect: sodium carbonate and croscarmellose sodium\
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Appearance: butter-yellow to ochre enteried-coated oblong formed tablets,
lustreless with smooth surface, no cracking perceptible.
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
Depending upon the clinical requirements in individual cases, the follow\
ing daily
doses are recommended:
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
® 500mg
tablets 3 x 1
to
3 x 3 3 x 1
to
3 x 2 3 x 1
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 no\
t
exceed the recommended adult dose.
It is generally recommended that half the adult dose may be given to chi\
ldren up
to a body weight of 40 kg; and the normal adult dose to those above 40 k\
g.
Method of administration
Salofalk � 500mg tablets should be taken in the morning, at midday and in the
evening, 1 hour before meals. They should be swallowed whole, not chewed\
,
and taken with plenty of uid.
Treatment with Salofalk
� 500mg tablets should be administered regularly and
consistently, both in the