FAZIM 100MG CAPSULE

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

CLOFAZIMINE

Pieejams no:

ZULAT PHARMACY SDN. BHD.

SNN (starptautisko nepatentēto nosaukumu):

CLOFAZIMINE

Vienības iepakojumā:

100Capsule Capsules

Ražojis:

LARK LABORATORIES (INDIA) LIMITED

Lietošanas instrukcija

FAZIM CAPSULE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
Clofazimine (50mg, 100mg)
WHAT IS IN THIS LEAFLET
1.
What FAZIM CAPSULE is used for
2.
How FAZIM CAPSULE works
3.
Before you use FAZIM CAPSULE
4.
How to use FAZIM CAPSULE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of FAZIM
CAPSULE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FAZIM CAPSULE IS USED FOR
FAZIM CAPSULE is used together with
other medicines to treat some forms of
leprosy.
Combination with other medicines e.g.,
with rifampicin or dapsone is necessary
to
prevent
the
development
of
drug
resistance.
HOW FAZIM CAPSULE WORKS
Fazim Capsule contains active ingredient
clofazimine
which
is
an
anti-
mycobacterial
medicine
that
stops
the
growth
of
mycobacteria
in
the
body
and/or eventually kills them.
BEFORE YOU USE FAZIM CAPSULE
_When you must not use it _
_ _
Do not use FAZIM CAPSULE if:
•
you are allergic (hypersensitive) to
Clofazimine
or
any
of
the
other
ingredients.
_Pregnancy and lactation _
_ _
Please consult your doctor or pharmacist
if
you
are
pregnant,
planning
for
pregnancy or breast-feeding before using
any medicine
Do not take FAZIM CAPSULE if you
are pregnant, trying to get pregnant or
think
you
may
be
pregnant,
unless
instructed by your doctor.
Skin
discoloration
of
your
baby
may
occur
if
FAZIM
CAPSULE
capsules
were used during pregnancy
Clofazimine
is
secreted
into
the
breastmilk
and
skin
discoloration
may
occur
in
the
infant.
Therefore,
breastfeeding is not recommended during
treatment with FAZIM CAPSULE.
-
_Before you start use it _
_ _
Talk to your doctor or pharmacist before
using Clofazimine you have or history
of:
•
stomach or bowel problems
•
depression
-
_Taking other medicines _
_ _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket, or health food
shop.
HOW TO USE FAZIM CAPSULE
_How much to use: _
_ _
Follow all directions given to you
by
your
doctor
and
pharmac

Produkta apraksts

FAZIM CAPSULE
(CLOFAZIMINE 50MG AND 100MG)
COMPOSITION:
_Fazim 50mg:_
Each capsule contains:
Clofazimine 50mg
_Fazim 100mg: _
Each capsule contains:
Clofazimine 100mg
DOSAGE FORM
Capsule
PRODUCT DESCRIPTION
50mg & 100mg:
Hard gelatine capsules having scarlet colour cap and body containing
Brick Red colour
powder, stripped in Alu/pvc blister.
PHARMACODYNAMICS
Clofazimine exerts a slow bactericidal effect on Mycobacterium leprae
(Hansen's bacillus).
Clofazimine inhibits mycobacterial growth and binds preferentially to
mycobacterial DNA.
Clofazimine also exerts anti-inflammatory properties in controlling
erythema nodosum leprous
reactions. However, its precise mechanisms of action are unknown.
PHARMACOKINETICS
Clofazimine has a variable absorption rate in leprosy patients,
ranging from 45%-62% after
oral administration. The average serum concentrations in leprosy
patients treated with 100 mg
and 300 mg daily were 0.7 μg/mL and 1.0 μg/mL, respectively. After
ingestion of a single dose
of 300 mg, elimination of unchanged Clofazimine and its metabolites in
a 24-hour urine
collection was negligible. Clofazimine is retained in the human body
for a long time. The half-
life of Clofazimine following repeated oral doses is estimated to be
at least 70 days. Part of the
ingested drug recovered from the feces may represent excretion via the
bile. A small amount
is also eliminated in the sputum, sebum, and sweat.
Clofazimine is highly lipophilic and tends to be deposited
predominantly in fatty tissue and in
cells of the reticuloendothelial system. It is taken up by macrophages
throughout the body. In
autopsies performed on leprosy patients, clofazimine crystals were
found predominantly in the
mesenteric lymph nodes, adrenals, subcutaneous fat, liver, bile, gall
bladder, spleen, small
intestine, muscles, bones, and skin.
INDICATION
Clofazimine employed in combination with dapsone and rifampicin,
serves as treatment for
multibacillary forms of leprosy, such as lepromatous (LL), borderline
lepromatous (BL), and
midborderline (BB