Abstral 400 microgram sublingual tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FENTANYL CITRATE

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

FENTANYL CITRATE

Unit dalam pakej:

1 x 10's tablet Tablets; 3 x 10'stablet Tablets

Dikeluarkan oleh:

Aesica Queenborough Limited

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
ABSTRAL SUBLINGUAL TABLETS
Fentanyl Citrate (100, 200 and 400 microgram)
1
WHAT IS IN THIS LEAFLET
1.
What Abstral is used for
2.
How Abstral works
3.
Before you use Abstral
4.
How to use Abstral
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Abstral
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ABSTRAL IS USED FOR
Abstral is a treatment for adults WHO
MUST ALREADY REGULARLY TAKING STRONG
PAIN-RELIEVING
MEDICINE
(OPIODS)
for
their persistent cancer pain, but require
treatment for their breakthrough pain. If
you are not sure, talk to your doctor.
Breakthrough pain is pain which occurs
suddenly, even though you have taken
or used your usual opioid pain-relieving
medicine
HOW ABSTRAL WORKS
The
active
substance
in
Abstal
sublingual tablets is fentanyl. Fentanyl
belongs
to
a
group
of
strong
pain-
relieving medicines called opioids.
Abstral
should
be
used
sublingually,
which means that the tablet should be
placed
under
the
tongue
where
it
is
dissolves
rapidly
in
order
to
allow
fentanyl
to
be
absorbed
across
the
lining
of
the
mouth.
Once
absorbed,
fentanyl starts to work to relieve pain.
BEFORE YOU USE ABSTRAL
- When you must not use it
Do not take Abstral

if you are allergic to fentanyl or
any of the other ingredients of this
medicine (listed in section Inactive
ingredients).

if
you
have
severe
breathing
problems.

If
you
are
not
regularly
using
prescribed
opioid
medicine
(e.g
codeine, fentanyl, hydromorphone,
morphine,
oxycodone,
pethidine),
every day on a regular schedule,
for at least a week, to control your
persistent
pain.
If
you
have
not
been
using
these
medicines
you
must
not
use
Abstral
because
it
may increase the risk that breathing
could
become
dangerously
slow
and/or shallow, or even stop.

If you suffer from short-term pain
other than breakthrough pain.

if
you
are
being
treated
with
medicines
containing
sodium
oxybate
Talk
to
your
doctor
or
pharmacist
b

Ciri produk

PACKAGE INSERT
ABSTRAL®
SUBLINGUAL TABLETS
FENTANYL (AS CITRATE)
1.
NAME OF THE MEDICINAL PRODUCT
Abstral 100 microgram sublingual tablets
Abstral 200 microgram sublingual tablets
Abstral 400 microgram sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains:
100 micrograms fentanyl (as citrate)
200 micrograms fentanyl (as citrate)
400 micrograms fentanyl (as citrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
100 microgram sublingual tablet is a white round tablet
200 microgram sublingual tablet is a white oval-shaped tablet
400 microgram sublingual tablet is a white diamond-shaped tablet
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Management of breakthrough pain in adult patients using opioid therapy
for chronic cancer
pain.
Breakthrough
pain
is
a
transient
exacerbation
of
otherwise
controlled
chronic
background pain.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Abstral should only be administered to patients who are considered
tolerant to their
opioid therapy for persistent cancer pain. Patients can be considered
opioid tolerant if
they take at least 60 mg of oral morphine daily, at least 25
micrograms of transdermal
fentanyl
per
hour,
at
least
30
mg
of
oxycodone
daily,
at
least
8
mg
of
oral
hydromorphone daily or an equianalgesic dose of another opioid for a
week or longer.
Method of administration:
Abstral sublingual tablets should be administered directly under the
tongue at the
deepest part.
Abstral sublingual tablets should not be swallowed, but allowed to
completely dissolve in the sublingual cavity without chewing or
sucking. Patients
should be advised not to eat or drink anything until the sublingual
tablet is completely
dissolved.
In patients who have a dry mouth water may be used to moisten the
buccal mucosa
before taking Abstral.
Dose titration:
The object of dose titration is to identify an optimal maintenance
dose for ongoing
treatment of breakthrough pain episodes. This optimal dose should
provide adequa