ORAFLAM PVP-Iodine ANTISEPTIC GARGLE AND MOUTHWASH 1%WV

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Povidone-Iodine

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

Povidone-Iodine

Unit dalam pakej:

60 ml; 100 ml; 200 ml; 500 ml

Dikeluarkan oleh:

PAHANG PHARMACY SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ORAFLAM PVP-IODINE 1%W/V ANTISEPTIC
GARGLE AND MOUTHWASH
Povidone 1% w/v Povidone Iodine equivalent to 0.1%w/v available Iodine
1
WHAT IS IN THIS LEAFLET
1. What ORAFLAM is used for
2. How ORAFLAM works
3. Before you use ORAFLAM
4. How to use ORAFLAM
_ _
5. While you are using it
6. Side effects
7. Storage and Disposal of
ORAFLAM
_ _
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT ORAFLAM IS USED FOR
ORAFLAM is used for the relief,
prevention and treatment of painful
infection of the mouth and pharynx
e.g.

pharyngitis (inflammation of the
pharynx),

oral moniliasis (infection of the
mouth and throat),

tonsillitis (inflammation of the
tonsils),

aphthous ulcers (small, shallow
lesions that develop on the soft
tissues in your mouth or at the
base of your gums),

stomatitis (inflammation of the
mucous
membrane
of
the
mouth),

gingivitis (inflammation of the
gums)

other inflammatory conditions.
For oral hygiene prior to and after
oral and dental surgery.
For minor irritation of the mouth and
throat.
Helps to reduce or eliminate mouth
odour.
HOW ORAFLAM WORKS
ORAFLAM
contains
povidone-
iodine,
which
has
broad
spectrum
germicidal activity. The germicidal
activity is maintained in the presence
of blood, pus, serum and necrotic
tissue. Povidone Iodine kills bacteria,
viruses, fungi, spores and protozoa.
BEFORE YOU USE ORAFLAM
-
_When you must not use it _

Do not take ORAFLAM if you
have hypersensitivity to Povidone
Iodine.

Avoid using people with thyroid
disorder

Avoid using ORAFLAM in large
areas of broken skin.

If
you
are
pregnant
or
breastfeeding, please consult your
doctor or healthcare professional
before taking this product.
_ _
-
_Before you start use it _
If
possible,
consult
a
doctor
or
pharmacist.
-
_Taking other medicines _

Use
with
concurrent
lithium
therapy
has
been
shown
to
exhibit
additive
hypothyroidic
effects.

Absorption
of
iodine
from
povidone iodine through

Ciri produk

ORAFLAM PVP-IODINE 1% W/V ANTISEPTIC GARGLE AND MOUTHWASH
COMPOSITION:
Contains Povidone Iodine 1% w/v equivalent to 0.1%w/v available iodine
DESCRIPTION:
Reddish brown solution with odor of Iodine
PHARMACODYNAMICS:
ORAFLAM PVP-Iodine ANTISEPTIC GARGLE AND MOUTHWASH contains
povidone-iodine, which
has broad spectrum germicidal activity. The germicidal activity is
maintained in the presence of
blood, pus, serum and necrotic tissue.
Povidone Iodine kills bacteria, viruses, fungi, spores and protozoa.
PHARMACOKINETICS:
Not Applicable
INDICATIONS:

For the relief, prevention and treatment of painful infection of the
mouth and pharynx
e.g. pharyngitis, oral moniliasis, tonsillitis, aphthous ulcers,
stomatitis, gingivitis and other
inflammatory conditions.

For oral hygiene prior to and after oral and dental surgery.

For minor irritation of the mouth and throat.

Helps to reduce or eliminate mouth odour.
DOSAGE AND ADMINISTRATION:
Use full strength or diluted with an equal volume of water. Gargle or
rinse for at least 30 seconds.
Repeat every 6 hours or as directed.
CONTRAINDICATIONS:
Hypersensitivity to povidone-Iodine. People with thyroid disorder.
Application to a large areas of
broken skin should be avoided.
WARNING AND PRECAUTION:
For External use only. Do not swallow.
Discontinue use in rare case of local sensitivity.
INTERACTIONS:
Use with concurrent lithium therapy has been shown to exhibit additive
hypothyroidic effects.
Absorption of iodine from povidone iodine through either intact skin
or broken skin may interfere
with thyroid function tests.
PREGNANCY AND LACTATION:
Iodine freely crosses the placenta and is secreted in breast milk.
Povidone Iodine should not be
used during pregnancy.
ADVERSE EFFECTS:
Local irritation, skin burns and sensitivity reactions have been
reported rarely.
Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock
have been reported
uncommonly with products containing povidone-iodine or povidone.
Excess iodine can produce goitre and hypothyroidism or
hypert