RIAMET TABLET

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

ARTEMETHER; LUMEFANTRINE

Tilgjengelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

ARTEMETHER; LUMEFANTRINE

Enheter i pakken:

24Tablet Tablets

Produsert av:

NOVARTIS SAGLIK

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RIAMET ®
TABLET
Artemether/Lumefantrine
(20mg/120mg)
1
WHAT IS IN THIS LEAFLET
1.
What Riamet is used for
2.
How Riamet works
3.
Before you use Riamet
4.
How to use Riamet
5.
While you are using Riamet
6.
Side effects
7.
Storage and Disposal of Riamet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT RIAMET IS USED FOR
Riamet is used to treat adults, infants
and children with malaria infections
caused by
_Plasmodium falciparum_
(a
type of malaria parasite) or with mixed
infections
that
include
_Plasmodium _
_falciparum_
.
Riamet
is
also
recommended
for
malaria
infections
acquired
in
areas
where
malaria
parasites
may
be
resistant
to
other
anti-malarial
medicines.
Most tourists and business travellers,
who are considered to be non-immune
will
be
able to
get prompt
medical
attention
if
malaria
is
suspected.
However, a small number of people at
risk
of
infection
may
be
unable
to
obtain such care within 24 hours of the
onset of symptoms, particularly if they
are in an isolated location far from
medical services. In such cases, they
are given Riamet by their doctor for
self-administration.
(“stand-by
emergency treatment”).
HOW RIAMET WORKS
Riamet
belongs
to
the
group
of
medicines known as anti-malarials, i.e.
medicines used to treat certain types of
malaria
infections.
It
destroys
the
malaria
parasites
(tiny
organisms
consisting of a single cell that are found
inside the red blood cells).
BEFORE YOU USE RIAMET
It is important to tell your doctor if you
have other medical problems or if you
are taking other medicines.
Follow
all
the
doctor’s
instructions
carefully. They may differ from the
general information contained in this
leaflet.
_When you must not use it _
Do not take Riamet

If you are allergic
(hypersensitive) to
artemether, lumefantrine, or any of
the other ingredients of the Riamet
tablets listed at the end of this leaflet.
If you think you may be allergic, ask
your doctor for advice.

Preparatomtale

Novartis
Page 2
Malaysian Package Leaflet
02-Jul-2018
Riamet
RIAMET

Antimalarial, artemisinins and derivatives
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Yellow, round and flat tablet with bevelled edges and score on one
side. Imprint: one side
“N/C”, other side “CG”.
ACTIVE SUBSTANCES
Artemether and lumefantrine.
Artemether
is
a
semisynthetic
chiral
acetal
derivative
from
artemisinin,
a
bicyclic
sesquiterpene lactone endoperoxide isolated from the plant
_Artemisia annua_
.
Lumefantrine is a racemic mixture of a synthetic fluorene derivative.
One tablet contains 20 mg artemether and 120 mg lumefantrine.
EXCIPIENTS
Cellulose
microcrystalline,
croscarmellose
sodium,
hypromellose,
magnesium
stearate,
polysorbate 80 and silica colloidal anhydrous.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Riamet
is
fixed
combination
of
artemether
and
lumefantrine
which
acts
as
blood
schizontocide. It is indicated for:
Treatment, including stand-by emergency treatment of adults and
children with infections due
to
_Plasmodium falciparum_
or mixed infections including
_P. falciparum_
. Because Riamet is
effective against both drug-sensitive and drug-resistant
_P. falciparum_
it is also recommended
for malaria infections acquired in areas where the parasites may be
resistant to other
antimalarials.
Stand-by emergency treatment:
Most tourists and business travellers, considered to be non-immune,
will be able to obtain
prompt medical attention if malaria is suspected. However, a minority
at risk of infection may
be unable to obtain such care within 24 hours of the onset of
symptoms, particularly if they
are in an isolated location far from medical services. In such cases,
prescribers are advised to
issue Riamet to be carried by the traveller for self-administration
(“stand-by emergency
treatment”).
Consideration
should
be
given
to
official
guidance
regarding
the
appropriate
use
of
antimalarial agents.
Novartis
Page 3
Malaysian Package Leaflet
02-Jul-2018
Riamet
DOSAGE REGIMEN AND ADMINISTRATIO