RILUZOLE SANDOZ riluzole 50mg film-coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

riluzole, Quantity: 50 mg

Tilgjengelig fra:

Sandoz Pty Ltd

INN (International Name):

Riluzole

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: calcium hydrogen phosphate; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 6000

Administreringsrute:

Oral

Enheter i pakken:

56 Film-coated tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

RILUZOLE is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Produkt oppsummering:

Visual Identification: white, capsule shaped tablet, debossed with the text "RLZ" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2012-03-08

Informasjon til brukeren

RILUZOLE SANDOZ
®
1
RILUZOLE SANDOZ
®
_riluzole film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Riluzole Sandoz.
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 THE MEDICINE.
You may need to read it again.
WHAT RILUZOLE
SANDOZ IS USED
FOR
This medicine 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.
It contains the active ingredient
riluzole.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
RILUZOLE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
riluzole, the active ingredient, or
to any of the other ingredient(s)
listed at the end of this leaflet
under Product Description
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE LIVER DISEASE.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
The active ingredient in Riluzole
Sandoz may pass into breast milk and
there is a possibility that your baby
may be affected.
DO NOT GIVE THIS MEDICINE TO A
CHILD.
Safety and effectiveness in children
have not been established.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY

Preparatomtale

190401-Riluzole Sandoz-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
RILUZOLE SANDOZ (RILUZOLE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Riluzole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Riluzole Sandoz 50 mg film-coated tablet contains 50 mg riluzole,
a benzothiazole.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Riluzole Sandoz 50 mg Film-coated tablets: white, capsule shaped,
debossed with the text
‘RLZ’ on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Riluzole is indicated for the treatment of patients with amyotrophic
lateral sclerosis (ALS).
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults _
The recommended daily dose in adults or elderly is 100 mg (50 mg every
12 hours). No
significant increase in benefit can be expected from higher daily
doses.
_Children _
The safety and effectiveness of riluzole in any neurodegenerative
process occurring in children
or adolescents have not been established.
METHOD OF ADMINISTRATION
Due to the reduction in absorption observed when administered with
high fat meals, Riluzole
Sandoz should not be taken with a fat containing meal.
DOSAGE ADJUSTMENT IN:

renal impairment
See Sections 4.3 Contraindications and 4.4 Special warnings and
precautions for use.

hepatic impairment
See Section 4.4 Special warnings and precautions for use.
4.3.
C
ONTRAINDICATIONS
Patients who have a history of severe hypersensitivity reactions to
riluzole or any of the tablet
components.
Patients who have a hepatic disease or hepatic impairment (baseline
transaminases greater than
3 times the upper limit of normal).
190401-Riluzole Sandoz-pi
Page 2 of 13
Patients who are pregnant or lactating.
4.4.
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
NEUTROPENIA
There have been three reports (3/5000) of marked neutropenia where
absolute neutrophil count
was less than 500/mm
3
. Refer to Section 4.8 Adverse effects (Undesirable effects)).
Patients
should be warned to report any febrile illness to their physicians.
The repor