RILUZOLE WINTHROP riluzole 50mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Riluzole

Tilgjengelig fra:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Riluzole

Informasjon til brukeren

RILUZOLE WINTHROP
®
_riluzole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Riluzole Winthrop.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT RILUZOLE
WINTHROP IS USED FOR
The brand name of your medicine is
Riluzole Winthrop. The active
ingredient in the medicine is called
riluzole.
Riluzole Winthrop is used to treat
people with amyotrophic lateral
sclerosis, which can cause muscle
degeneration leading to muscle
weakness. It is a form of Motor
Neurone Disease.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with
a doctor's prescription.
It is important to remember that you
may not feel any different when you
take Riluzole Winthrop. The benefits
of using Riluzole Winthrop may not
be noticeable to you. You should not
stop taking Riluzole Winthrop
without speaking to your doctor first.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE RILUZOLE WINTHROP IF
YOU:
•
HAVE LIVER DISEASE
•
ARE PREGNANT OR INTEND TO
BECOME PREGNANT
•
ARE BREASTFEEDING OR INTEND TO
BREASTFEED
DO NOT TAKE THIS MEDICINE IF YOU
ARE ALLERGIC TO RILUZOLE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT GIVE THIS MEDICINE TO A
CHILD.
There is no experience with the use
of this medicine in children.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If you take it after the expiry date has
passed, it may not work as well.
DO NOT USE IT IF THE PACKAGING IS
DAMAGED OR SHOWS SIGNS OF
TAMPERING.
_BEFORE

Preparatomtale

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PRODUCT INFORMATION
RILUZOLE WINTHROP
® (RILUZOLE) TABLETS
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Riluzole
CHEMICAL STRUCTURE
Molecular formula: C
8
H
5
F
3
N
2
OS
Molecular weight: 234.20
CAS NUMBER
1744-22-5
DESCRIPTION
Riluzole Winthrop is a film-coated tablet containing riluzole, a
benzothiazole. Chemical name: 2-
amino-6-trifluoromethoxybenzothiazole.
The tablet also contains anhydrous calcium hydrogen phosphate;
microcrystalline cellulose;
anhydrous colloidal silica; magnesium stearate and croscarmellose
sodium as excipients. The
tablet coating contains hypromellose; macrogol 6000 and titanium
dioxide.
Riluzole is a white to slightly yellow, fine crystalline,
non-hygroscopic powder. It is very slightly
soluble in water and 0.1N sodium hydroxide, sparingly soluble in 0.1N
hydrochloric acid; and very
soluble in methanol, acetone, acetonitrile, dichloromethane and
dimethyl sulfoxide.
PHARMACOLOGY
PHARMACODYNAMICS
The aetiology and pathogenesis of amyotrophic lateral sclerosis (ALS)
are not known, although a
number of hypotheses have been advanced. One hypothesis is that motor
neurones made
vulnerable through either genetic predisposition or environmental
factors, are injured by glutamate.
In some cases of familial ALS, enzyme superoxide dismutase has been
found to be defective.
The mechanism of action of riluzole has not been completely elucidated
but evidence to date
suggests that it may involve inactivation of voltage dependent sodium
channels and impairment of
glutamatergic neurotransmission.
There are no validated animal models of ALS in which to test riluzole.
Riluzole has been shown to
cross the
blood brain barrier
and to possess
neuroprotective properties in various
_in vivo _
experimental models of neuronal injury known to involve excitotoxic
mechanisms, such as cerebral
ischemia. _ In vitro_, riluzole protects cultured rat motorneurones
from the excitotoxic effects of
glutamic acid and prevents the death of cortical neurones induced by