REMLEAS™ hard capsules 40mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Valbenazine tosylate

Boleh didapati daripada:

Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

Valbenazine tosylate

Unit dalam pakej:

30 Capsules

Dikeluarkan oleh:

PATHEON FRANCE S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
REMLEAS
® HARD CAPSULES 40MG
_ _
Valbenazine (40mg)
Page
1
of
2
WHAT IS IN THIS LEAFLET
1.
What REMLEAS is used for
2.
How REMLEAS works
3.
Before you use REMLEAS
4.
How to use REMLEAS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
REMLEAS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REMLEAS IS USED FOR
REMLEAS is used to treat adults with
movements
in
the
face,
tongue,
or
other
body
parts
that
cannot
be
controlled (tardive dyskinesia).
HOW REMLEAS WORKS
REMLEAS
contains
valbenazine
which is in a class of drug called
vesicular
monoamine
transporter
2
(VMAT2) inhibitors. The mechanism
of
action
of
valbenazine
in
the
treatment
of
tardive
dyskinesia
is
unknown,
but
it
is
thought
that
it
works
by
changing
the
activity
of
certain natural substances in the brain.
BEFORE YOU USE REMLEAS
_- When you must not use it _
_ _
Do not take this medicine if you have
an allergy to:
•
valbenazine, the active ingredient
•
any of the other ingredients listed
at the end of this leaflet
_- Before you start to use it _
Before you take REMLEAS, tell your
doctor or pharmacist if you:
•
have liver problems
•
have
heart
disease
that
is
not
stable,
have
heart
failure
or
recently had a heart attack
•
have an irregular heart rhythm or
heartbeat
•
are pregnant or plan to become
pregnant
•
are
breastfeeding
or
plan
to
breastfeed
_- Taking other medicines _
Tell your doctor or pharmacist if you
are
taking
any
other
medicines,
including any that you get without a
prescription
from
your
pharmacy,
supermarket or health food shop.
Do not start any new medicines while
taking REMLEAS without talking to
your doctor or pharmacist.
HOW TO USE REMLEAS
Follow all directions given to you by
your doctor and pharmacist carefully.
The directions may differ from the
information contained in this leaflet.
_- How much to use _
Always take REMLEAS exactly as
your doctor told you.
_- When to use it _
Take REMLEAS as directed

Ciri produk

1
REMLEAS
®
Valbenazine tosylate
1.
NAME OF THE MEDICINAL PRODUCT
REMLEAS
®
hard
capsules 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
(INN: valbenazine)
Each hard capsule contains valbenazine tosylate corresponding to 40 mg
valbenazine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule for oral use, with a white opaque cap and body, axially
printed with ‘VBZ’ over ‘40’ in
black ink, on both the cap and body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REMLEAS is a vesicular monoamine transporter 2 (VMAT2) inhibitor
indicated for the treatment of
adults with tardive dyskinesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The initial dosage for REMLEAS is 40 mg once daily. After one week,
increase the dose to the
recommended dosage of 80 mg once daily. Continuation of 40 mg once
daily may be considered for
some patients.
Administer REMLEAS orally with or without food
_[see Pharmacokinetic properties (5.2)]_
.
Special population
_Pediatric Use _
Safety and effectiveness of REMLEAS have not been established in
pediatric patients.
_Geriatric Use _
No dose adjustment is required for elderly patients. In 3 randomized,
placebo-controlled studies of
REMLEAS, 16% were 65 years and older. The safety and effectiveness
were similar in patients older
than 65 years compared to younger patients.
_CYP2D6 Poor Metabolizers _
Dosage reduction
of
REMLEAS
is
recommended
for
known
CYP2D6
poor metabolizers.
The
recommended dosage for known CYP2D6 poor metabolizers is REMLEAS 40 mg
once daily.
Increased exposure (C
max
and AUC) to valbenazine’s active metabolite is anticipated in CYP2D6
poor
metabolizers. Increased exposure of active metabolite may increase the
risk of exposure-related
adverse reactions
_ [see_
_Pharmacokinetic properties (5.2)]_
.
_Dose adjustments due to interactions _
Coadministration with Strong CYP3A4 Inducers
Concomitant use of strong CYP3A4 inducers with REMLEAS is not
recommended
_[see Interactions _
_with other medicinal products and other for