PHARMACOR RILUZOLE riluzole 50mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
riluzole, Quantity: 50 mg
Available from:
Pharmacor Pty Ltd
INN (International Name):
Riluzole
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: magnesium stearate; hypromellose; microcrystalline cellulose; calcium phosphate; croscarmellose sodium; colloidal anhydrous silica; purified water; titanium dioxide; macrogol 400
Administration route:
Oral
Units in package:
56's blister pack (4 x 14's blister), 14's blister pack (1 x 14's blister)
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS)
Product summary:
Visual Identification: White to off-white coloured, capsule shaped film coated tablet, debossed with 'RIL' on one side and '50' on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2014-06-04
Patient Information leaflet
1 PHARMACOR RILUZOLE VER-02 MARCH 2018
PHARMACOR RILUZOLE
_riluzole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
Pharmacor
Riluzole.
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 PHARMACOR
RILUZOLE IS USED FOR
The brand name of your medicine is
Pharmacor
Riluzole.
The
active
ingredient in the medicine is called
riluzole.
Pharmacor Riluzole 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
Pharmacor
Riluzole.
The
benefits of using Pharmacor Riluzole
may not be noticeable to you. You
should
not
stop
taking
Pharmacor
Riluzole
without
speaking
to
your
doctor first.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PHARMACOR RILUZOLE 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
DAMAG
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Summary of Product characteristics
PHARMACOR RILUZOLE VER-02 MARCH 2018 1
PRODUCT
INFORMATION
PHARMACOR RILUZOLE
(RILUZOLE) T
ABLETS
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Riluzole
CHEMICAL STRUCTURE
CAS 1744-22-5
DESCRIPTION
Pharmacor Riluzole is a tablet containing riluzole, a benzothiazole.
Chemical name: 2-amino-6-
trifluoromethoxybenzothiazole.
The
tablet
also
contains
dibasic
calcium
phosphate
dihydrate;
croscarmellose
sodium,
hypromellose,
microcrystalline
cellulose,
colloidal
silicon
dioxide,
magnesium
stearate,
as
excipients. The tablet coating contains opadry white Y-1-7000H and
purified water.
Riluzole is a white to slightly yellow, fine crystalline,
non-hygroscopic powder.
I t
i s
freely
soluble in acetonitrile, in alcohol and in methylene chloride; very
slightly soluble in hexane and
water.
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
anoxia. In healthy volunteers
at therapeutic doses, r iluzole has been shown to protect to some
extent against the hypobaric
hypoxia induced at an equivalent altitude of 5000 m. Als
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