POCIN H EAR DROPS

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE; HYDROCORTISONE

Tersedia dari:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Internasional):

NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE; HYDROCORTISONE

Unit dalam paket:

5ml x 12 BOTTLE

Diproduksi oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
POCIN H EAR DROPS
Polymyxin B Sulphate / Neomycin Sulphate / Hydrocortisone (10000u /
3400u / 10mg)
WHAT IS IN THE LEAFLET
1.
What Pocin H is used for
2.
How Pocin H works
3.
Before you use Pocin H
4.
How to use Pocin H
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Pocin H
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT POCIN H IS USED FOR
Pocin
H
is
used
to
treat
external
ear
canal
infections
and
infections
of
cavity
(middle ear) after ear operation
(mastoidectomy).
Your
doctor
may
have
prescribed Pocin H for another
reason. Ask your doctor if you
have any questions about why
Pocin
H
has
been prescribed
for you.
HOW POCIN H WORKS
Pocin
H
contains
the
active
ingredients,
Polymyxin
B
sulphate,
Neomycin
sulphate
and Hydrocortisone.
Polymyxin
B
and
Neomycin
are antibiotics which helps to
clear
up
infections.
Hydrocortisone
is
a
corticosteroid
which
helps
to
relieve
inflammation
and
redness.
BEFORE YOU USE POCIN H
-
_When you must not take it _
You must not use Pocin H if
you have allergic reactions to
Polymyxin
B
sulphate,
Neomycin
sulphate,
Hydrocortisone or to any of the
ingredients listed at the end of
this leaflet.
Do not use Pocin H if you are
sensitive
to
one
type
of
aminoglycoside
or
polymyxin
as you may as well be sensitive
to
other
types
of
aminoglycoside or polymyxin.
Do not use this medicine if you
have:
•
Bacterial
infection
of
middle ear
•
Viral infection of ear
•
Fungal infection of ear
•
Perforated eardrum
Do not use Pocin H after the
expiry date printed on the pack.
If you use this medicine after
the expiry date has passed, it
may not work as well.
Do
not
use
Pocin
H
if
the
packaging
is
torn
or
shows
signs of tampering.
-
_Before you start to use it _
Tell your doctor if you have
any
allergies
to
any
other
medicines,
foods
or
preservatives.
Tell
your
doctor
if
you
are
pregnant,
plan
to
become
pregnant or breast-feeding.
-
_Taking other medicines _
Tell your doctor or ph

Karakteristik produk

Pocin H ear drops should not be used in patients with a sensitivity to
aminoglycside,
polymyxins or sulphates. The use of Pocin H ear drops are also
contraindicated in
bullous
myringitis,
herpes
simplex,
herpes
zoster
oticus,
tubercular
or
fungal
infections of the ear, vaccinia, varicella, or other viral disease of
the ear, chronic otitis
media or perforated eardrum.
Patients sensitive to one aminoglycoside or polymyxin may be sensitive
to other
aminoglycosides or polymyxins also.
Risk of sensitization in relation to thiomersal and other
preservatives.
Co-treatment with CYP3A inhibitors, including cobicistat-containing
products, is
expected to increase the risk of systemic side-effects. The
combination should be
avoided unless the benefit outweighs the increased risk of systemic
corticosteroid
side-effects, in which case patients should be monitored for systemic
corticosteroid
side-effects.
There
is
no
relevant
information
available
for
neomycin,
polymyxin
B
and
hydrocortisone.
_Pregnancy/Reproduction_
Topical corticosteroids have been shown to be teratogenic in rabbits
when applied at
concentration of 0.5% on days 6 to 18 of gestation and in mice when
applied at a
concentration of 15% on days 10 to 13 of gestation.
(FDA Pregnancy Category C)
No breast-feeding, paediatric and geriatric specific problems have
been reported to date.
5ml x 12 bottles
Store in a dry place below 30°C.
For external use only.
Discard contents 4 weeks after opening.
Keep out of reach of children.
_Jauhi daripada kanak-kanak._
Shelf life : Please refer to outer package.
_Product Registration Holder:_
DUOPHARMA MANUFACTURING (BANGI) SDN. BHD.
Lot No. 2, 4, 6, 8, & 10, Jalan P/7, Section 13, Bangi Industrial
Estate,
43650 Bandar Baru Bangi, Selangor, Malaysia.
_Manufacturer:_
DUOPHARMA MANUFACTURING (BANGI) SDN. BHD.
Lot No. 2 & 4, Jalan P/7, Section 13, Bangi Industrial Estate,
43650 Bandar Baru Bangi, Selangor, Malaysia.
DESCRIPTION
POCIN H EAR DROPS
POCIN H EAR DROPS
PRECAUTIONS
TOXICOLOGY
A white to off-white, homogenous suspension.
Ea