RILUCOR riluzole 50mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

riluzole, Quantity: 50 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Riluzole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium phosphate; microcrystalline cellulose; hypromellose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; purified water; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

14's blister pack (1 x 14's blister), 56's blister pack (4 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:

Licence status A

Authorization date:

2014-06-04

Patient Information leaflet

1 RILUCOR VER-02 MARCH 2018
RILUCOR
_riluzole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rilucor.
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 RILUCOR IS USED
FOR
The brand name of your medicine is
Rilucor. The active ingredient in the
medicine is called riluzole.
Rilucor 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 Rilucor. The benefits of using
Rilucor may not be noticeable to you.
You should not stop taking Rilucor
without speaking to your doctor first.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE RILUCOR 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 YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU ARE ALLERGIC
TO ANY OF T

Summary of Product characteristics

RILUCOR VER-02 MARCH 2018 1
PRODUCT
INFORMATION
RILUCOR
(RILUZOLE) T
ABLETS
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Riluzole
CHEMICAL STRUCTURE
CAS 1744-22-5
DESCRIPTION
Rilucor
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. Also, riluzole
moderately reduces th