RILUTEK TABLETS 50MG

国: マレーシア

言語: 英語

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

有効成分:

RILUZOLE

から入手可能:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN（国際名）:

RILUZOLE

パッケージ内のユニット:

56 Tablets

製:

Opella Healthcare International SAS

情報リーフレット

_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
RILUTEK
® TABLET
_ _
Riluzole (50 mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Rilutek is used for
2. How Rilutek works
3. Before you use Rilutek
4. How to use Rilutek
5. While you are using it
6. Side effects
7. Storage and Disposal of Rilutek
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT RILUTEK IS USED FOR
- Rilutek is used to treat people with
amyotrophic lateral sclerosis (ALS),
which can cause muscle degeneration
leading to muscle weakness. It is a
form of Motor Neurone Disease.
Please consult your doctor for more
information about ALS and the
reason why this medicine has been
prescribed for you
HOW RILUTEK WORKS
The active substance in Rilutek is
riluzole which acts on the nervous
system.
- ALS is a form of motor neurone
disease where attacks of the nerve
cells responsible for sending
instruction to the muscles lead to
weakness, muscle waste and
paralysis.
- The destruction of nerve cells in
motor neurone disease may be caused
by too much glutamate (a chemical
messenger) in the brain and spinal
cord. Rilutek stops the release of
glutamate and this may help in
preventing the nerve cells being
damaged.
BEFORE YOU USE RILUTEK
_When you must not use it _
Do not take Rilutek
• if you are allergic (hypersensitive) to
riluzole or any of the other
ingredients of Rilutek,
• if you have any liver disease or
increased blood levels of some
enzymes of the liver (transaminases),
• if you are pregnant or breast-feeding.
_Before you start to use it _
Take special care with RILUTEK
Tell your doctor:
• if you have any liver problems:
yellowing of your skin or the white
of your eyes (jaundice), itching all
over, feeling sick, being sick
• if your kidneys are not working very
well
• if you have any fever: it may be due
to a low number of white blood cells
which can cause an increased risk of
infection
• the use of Rilutek is not
recommended in children because
there is no information available in
this popu

製品の特徴

RILUTEK 50 MG FILM-COATED TABLETS
Riluzole
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of riluzole
PHARMACEUTICAL FORM
Film-coated tablet
The tablets are capsule-shaped, white and engraved with “RPR 202”
on one side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
RILUTEK is indicated to extend life or the time to mechanical
ventilation for patients with
amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that RILUTEK extends survival for
patients with ALS (see
section
_Pharmacodynamic properties_
). Survival was defined as patients who were alive, not
intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that RILUTEK exerts a therapeutic effect on motor
function, lung function,
fasciculations, muscle strength and motor symptoms. RILUTEK has not
been shown to be
effective in the late stages of ALS.
Safety and efficacy of RILUTEK has only been studied in ALS.
Therefore, RILUTEK should not
be used in patients with any other form of motor neurone disease.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with RILUTEK should only be initiated by specialist
physicians with experience in the
management of motor neurone diseases.
The recommended daily dose in adults or elderly is 100 mg (50 mg every
12 hours).
No significant increased benefit can be expected from higher daily
doses.
Special populations
Children: RILUTEK is not recommended for use in children, due to a
lack of data on the safety
and efficacy of riluzole in any neurodegenerative diseases occurring
in children or adolescents.
Patients with impaired renal function: RILUTEK is not recommended for
use in patients with
impaired renal function, as studies at repeated doses have not been
conducted in this population
(see section
_Special Warnings and Precautions for use_
).
Elderly: based on pharmacokinetic data, there are no special
instructions for the use of RILUTEK
in this population.
Patients with impaired hepatic function: (see section
_Contratindications, Special Warnings, and