Apo-Riluzole

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Riluzole 50mg

Tilgængelig fra:

Apotex NZ Ltd

INN (International Name):

Riluzole 50 mg

Dosering:

50 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Riluzole 50mg Excipient: Calcium hydrogen phosphate dihydrate Croscarmellose sodium Hypromellose Macrogol 8000 Magnesium stearate Microcrystalline cellulose Purified talc Purified water Titanium dioxide

Recept type:

Prescription

Fremstillet af:

Apotex Pharmachem India Pvt. Ltd.

Terapeutiske indikationer:

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

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, white opaque PVC film with aluminium foil - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 75cc round, white, opaque HDPE, blue PP child-resistant caps - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 75cc round, white, opaque HDPE, blue or white PP caps - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 200cc round, white, opaque HDPE, blue or white PP caps - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Autorisation dato:

2014-01-24

Indlægsseddel

APO-RILUZOLE TABLETS
1
APO-RILUZOLE TABLETS
_Contains the active ingredient riluzole_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 (AUSTRALIA
ONLY)_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about riluzole. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Riluzole. It contains the active
ingredient Riluzole.
It 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.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
It is important to remember that you
may not feel any different when you
take riluzole. The benefits of using
riluzole may not be noticeable to
you.
You should not stop taking riluzole
without speaking to your doctor first
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICIN

Produktets egenskaber

NEW ZEALAND DATA SHEET
APO-RILUZOLE
RILUZOLE USP 50MG FILM-COATED TABLETS
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 13
PRESENTATION
APO-RILUZOLE 50mg are white to off white coloured, film coated,
capsule shaped, biconvex
tablets engraved "APO" on one side and "RI-50" on the other side. Each
tablet typically
weighs 190mg.
INDICATIONS
Riluzole is indicated for the treatment of patients with amyotrophic
lateral sclerosis (ALS).
DOSAGE AND ADMINISTRATION
The recommended daily dose in adults or elderly is 100mg (50mg every
12 hours). No
significant increase in benefit can be expected from higher daily
doses.
Due to the reduction in absorption observed when administered with
high fat meals, APO-
RILUZOLE should not be taken with a fat containing meal.
CHILDREN:
the
safety
and
effectiveness
of
riluzole
in
any
neurodegenerative
process
occurring in children or adolescents have not been established.
PATIENTS WITH IMPAIRED RENAL FUNCTION: see Warnings section.
PATIENTS WITH IMPAIRED HEPATIC FUNCTION: see Contraindications and
Warnings sections.
MAXIMUM TOLERATED DAILY DOSE
Recommended daily dose in adults or elderly is 100mg (50mg every 12
hours).
CONTRAINDICATIONS
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).
Patients who are pregnant or lactating.
WARNINGS AND PRECAUTIONS
Liver impairment:
Riluzole is contraindicated in patients with hepatic disease or
hepatic impairment (baseline
transaminases greater than 3 times the upper limit of normal).
Riluzole should be prescribed with care in patients with a history of
abnormal liver function,
or in patients with slightly elevated serum transaminase (ALT/SGPT;
AST/SGOT up to 3
times
the
ULN),
bilirubin
and/or
gamma-glutamyl
transferase
(GGT)
levels.
Baseline
APO-RILUZOLE
RILUZOLE USP 50MG FILM-COATED TABLETS
Please refer to Medsafe webs