LOCOA 40MG TRANSDERMAL PATCH

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

Esflurbiprofen

Sẵn có từ:

HOE PHARMACEUTICALS SDN. BHD.

INN (Tên quốc tế):

Esflurbiprofen

Các đơn vị trong gói:

7 patches x 10 pouches (70 patches) Units

Sản xuất bởi:

Tokuhon Corporation

Tờ rơi thông tin

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LOCOA
® 40MG TRANSDERMAL PATCH
Esflurbiprofen (40mg)
WHAT IS IN THIS LEAFLET
1.
What LOCOA
®
is used for
2.
How LOCOA
®
works
3.
Before you use LOCOA
®
4.
How to use LOCOA
®
5.
While
you
are
using
LOCOA
®
6.
Side effects
7.
Storage
and
Disposal
of
LOCOA
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT LOCOA
® IS USED FOR
LOCOA
®
is used to relieve pain
and
inflammation
caused
by
osteoarthritis
(wear
and
tear
arthritis)
in
which
the
joints
become painful and stiff.
HOW LOCOA
® WORKS
LOCOA
®
suppresses production of
prostaglandin, a cause of pain and
inflammation, to relieve pain and
inflammation.
BEFORE YOU USE LOCOA
®
_ _
-
_When you must not use it _
Do not use LOCOA
®
:

Patients
with
stomach
ulcer,
severe blood disorder, bleeding or
any
type
of
blood
clotting
disorder, severe liver and kidney
disease, severe heart disease, or
extremely high blood pressure.
_ _

Patients with a history of allergic
to the components of LOCOA
®
or flurbiprofen.
_ _

Patients with current or previous
aspirin-induced
asthma
(asthmatic
attacks
induced
by
nonsteroidal
anti-inflammatory
analgesics
and
other
relevant
drugs).
_ _

Patients
who
are
taking
medicines
for
infections
(antibiotics)
of
the
quinolone
group such as enoxacin hydrate,
lomefloxacin,
norfloxacin,
or
prulifloxacin.
_ _

Women
in
the
last
3
months
(third trimester) of pregnancy.
_ _
Pregnancy and breast-feeding:

In the first 6 months of pregnancy,
breast-feeding or if you want to
become
pregnant,
LOCOA
®
should be used only after talking
to your doctor.

Taking LOCOA
®
at 20 weeks of
pregnancy
or
later
may
harm
your
unborn
baby.
Kidney
impairment and decreased urine
output in the unborn baby as well
as low amount of fluid in the
womb
have
been
reported
in
pregnant
women
after
use
of
other
non-steroidal
anti-
inflammatory
drugs
(NSAIDs).
Your doctor may need to monitor
the amount of fluid in your womb
around your

Đặc tính sản phẩm

1
1.
NAME OF THE MEDICINAL PRODUCT
LOCOA 40mg transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 × 14 cm patch contains 40mg of esflurbiprofen.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal Patch
The patch consists of a colorless to light yellow transparent adhesive
plaster base and has characteristic
aroma, in which the adhesive plaster base is spread on a backing
layer, and the surface of the adhesive
plaster base is covered with a liner.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of pain and inflammation associated with osteoarthritis_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
LOCOA should be applied to the affected area once daily in adults. Do
not use more than 2 patches at
once.
Do not use more than 2 patches per day, since LOCOA is a topical patch
with improved transdermal
absorption and enhanced penetration of esflurbiprofen, the active
ingredient, into the affected tissue.
Also, the safety of LOCOA has been examined for up to 2 patches per
day in clinical studies. The use
of LOCOA with any other anti-inflammatory agent with expected systemic
effects should be avoided
wherever possible. If such use is deemed necessary, it should be
limited to a minimal level and the
condition of the patient should be carefully monitored.
_ELDERLY _
Since elderly patients are more susceptible to adverse reactions,
their condition should be carefully
monitored during use of LOCOA.
_ _
_PAEDIATRIC POPULATION _
Safety has not been established in low-birth-weight babies, neonates,
nursing infants, infants and
children. [Clinical studies have only been performed in adults and
there is no experience in the use for
the above patients.]
_ _
Method of administration
LOCOA is administered topically by attaching the patch to the skin of
the affected area.
LOCOA cannot be applied to the skin wounds, open injuries, mucous
membrane or to the area of
eczema or rash. If 2 patches are used at a time, the entire sticky
side needs to be in direct contact
with