LOXOTOP PAP 100mg Patch

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Loxoprofen sodium hydrate

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

Loxoprofen sodium hydrate

Unit dalam pakej:

5 Pieces; 10 Sachets

Dikeluarkan oleh:

Lead Chemical Co., Ltd. Hisagane Plant

Risalah maklumat

LOXOTOP
PAP 100MG PATCH
Loxoprofen Sodium (100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_LOXOTOP PAP 100mg Patch _
is used for
2.
How
_LOXOTOP PAP 100mg_
_Patch_
works
3.
Before you use
_LOXOTOP PAP _
_100mg Patch_
4.
How to use
_LOXOTOP PAP 100mg _
_Patch _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_LOXOTOP _
_PAP 100mg Patch_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _LOXOTOP PAP 100MG PATCH_ IS
USED FOR
It is usually used to treat osteoarthritis,
muscle pain, swelling/pain after an
injury.
HOW _LOXOTOP PAP 100MG_ _PATCH_
WORKS
This medicine permeates from the skin,
suppresses prostaglandin formation that
causes inflammation, and acts to ease
swelling/pain induced by inflammation.
BEFORE YOU USE _LOXOTOP PAP 100MG _
_PATCH _
-
_When you must not use it _
_ _
If you have previously experienced any
allergic reactions (itch, rash, etc.) to any
medicines.
If you have: aspirin-induced asthma or
its history.
_Pregnancy and lactation _
Do not use
_LOXOTOP PAP 100mg _
_Patch_
if you are pregnant, trying to get
pregnant or think you may be pregnant.
Do not use
_LOXOTOP PAP 100mg_
_Patch_
if you are breast-feeding. Ask your
doctor or pharmacist for advice before
taking any medicine.
-
_Taking other medicines _
_ _
Tell your doctor or pharmacist if you
are taking any other medicines,
including any that you buy without a
prescription from a pharmacy,
supermarket or health food shop.
HOW TO USE _LOXOTOP PAP 100MG _
_PATCH _
-
_How much to use _
_ _
In general, apply to the affected area
once daily. This preparation contains
100 mg of the active ingredient in one
sheet.
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the
label, ask your doctor or pharmacist
for help.
-
_When to use it _
_ _
Use as directed by your doctor or
pharmacist.
-
_How long

Ciri produk

LOXOPROFEN SODIUM
HYDRATE
_________________________________________
Containing Loxoprofen Sodium Hydrate
(
JP
)
113
.
4mg
(
100mg as Anhydride
)
LOXOTOP PAP 100MG PATCH
FOR EXTERNAL USE ONLY
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
GENERIC NAME
Loxoprofen Sodium Hydrate
(
JAN
) /
Loxoprofen
(
INN
)
CHEMICAL NAME
Monosodium 2
-
{ 4
- [(
2
-
oxocyclopentyl
)
methyl
]
phenyl} propanoate dihydrate
MOLECULAR FORMULA C
15
H
17
NaO
3

2H
2
O
MOLECULAR WEIGHT 304
.
31
STRUCTURAL FORMULA
DESCRIPTION
Loxoprofen sodium hydrate occurs as a white to yellowish white,
crystal or crystalline powder
.
It is very
soluble in water and in methanol, freely soluble in ethanol
(
95
),
and practically insoluble in diethyl ether
.
A solution of loxoprofen sodium hydrate (1 in 20) does not show
optical rotation.
QUANTITATIVE COMPOSITION
LOXOTOP PAP 100MG PATCH
A patch containing 113
.
4mg
(
100mg as anhydride
)
of loxoprofen sodium hydrate in 10g of ointment
(
a
sheet of 140 cm
2
).
PHARMACEUTICAL FORM
LOXOTOP PAP 100MG PATCH
Patch preparation comprising ointment, uniformly spread over a support
with the surface of the ointment
covered by a liner
.
The ointment surface is white to pale yellow in color
.
The ointment has a fragrance of
mentha oil
.
CLINICAL PARTICULARS
1
.
THERAPEUTIC INDICATIONS
LOXOTOP PAP 100mg Patch is indicated for anti-inflammation and pain
relief in the following diseases and
symptoms: Osteoarthritis, myalgia, posttraumatic swelling and pain.
2
.
POSOLOGY AND METHOD OF ADMINISTRATION
LOXOTOP PAP 100mg Patch should be applied once daily to the affected
area.
3
.
CONTRAINDICATIONS
LOXOTOP PAP 100mg Patch is contraindicated in the following patients
.
•
Patients with a history of hypersensitivity to any ingredients of
LOXOTOP PAP 100mg Patch
•
Patients with or with a history of aspirin
-
induced asthma
(
induction of asthmatic attack with
nonsteroidal anti
-
inflammatory
-
analgesics, etc
.) [
May induce an aspirin
-
induced asthmatic attack
.]
4
.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE