ClariClear Nasal Spray 0.05%

Negara: Malaysia

Bahasa: Inggris

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

Beli Sekarang

Selebaran informasi Selebaran informasi (PIL)
05-07-2022
Karakteristik produk Karakteristik produk (SPC)
31-01-2024

Bahan aktif:

Oxymetazoline Hydrochloride

Tersedia dari:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Nama Internasional):

Oxymetazoline Hydrochloride

Unit dalam paket:

20 ml; 15 ml

Diproduksi oleh:

Delpharm Montreal Inc.

Selebaran informasi

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CLARICLEAR
_® _
Nasal Spray 0.05%
Oxymetazoline
Hydrochloride
0.05%w/v
1
WHAT IS IN THIS LEAFLET
1.
What
_CLARICLEAR _
is used for
2.
How
_CLARICLEAR _
works
3.
Before you use
_CLARICLEAR_
4.
How to use
_CLARICLEAR_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_CLARICLEAR_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _CLARICLEAR _IS USED
FOR
_CLARICLEAR _
is indicated
for the symptomatic relief of
nasal and
nasopharyngeal congestion due to the
common cold, sinusitis, hay fever or
other upper respiratory allergies.
HOW _CLARICLEAR _WORKS
_CLARICLEAR _
contains the active
substance oxymetazoline
hydrochloride. It constricts the
arteriolar network within the nasal
mucosa producing a prolonged
decongestant effect.
BEFORE YOU USE _CLARICLEAR _
-
_When you must not use it_
•
If you are allergic to any of the
ingredients
•
If you have heart or blood vessel
disease
•
If you have an overactive thyroid
•
If you are a man with prostate
problems
-
_Before you start to use it_
Talk to your doctor or pharmacist
before taking
_CLARICLEAR_
Do not exceed the recommended
dosage and it may cause rebound
congestion if used for longer than
three days.
-
_Taking other medicines_
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained without
a prescription.
If you are taking:
•
Medicines for depression (e.g.
tricyclic antidepressants,
maprotiline, monoamine oxidase
inhibitors)
HOW TO USE _CLARICLEAR _
Check the seal is not broken
before first use. If it is, do not use
the medicine.
-
_How much to use_
For adults and children six years of
age and older: two or three sprays
into each nostril.
-
_When to use it_
Twice daily, morning and evening
-
_How long to use it_
Do not use it more than 3 days
unless your doctor tells you to.
-
_If you forget to use it_
Use it as soon as you remember,
unless is very near to the next dose.
                                
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Karakteristik produk

                                44 mm
180 mm
17,5 mm
238 mm
52,5 mm
Inside margins 5 mm
16/08/19
NPI017289
31000425
86984636
A
TR1659161
Philip Ives
G=1; O=0; R=0; - PI - 16/08/19 13:36:04
N/A
N/A
1011101(220)
N/A
N/A
Famar Montreal (ex Bayer Pointe Claire) [CA]
CCL Montréal
White Paper
1
DIG
Process Black
Colours
DESCRIPTION: Each ml
of
AFRIN Nasal
Spray contains 0.5mg (0.05%) oxymetazoline
hydrochloride. Benzalkonium chloride is used as preservative.
Other inactive ingredients include sodium hydroxide, sodium dihydrogen
phosphate dihydrate,
disodium edetate, propylene glycol, hydrochloric acid and purified
water.
Appearance: Clear, colourless solution with a slight odour, free from
foreign matter.
ACTIONS:
The sympathomimetic action of
oxymetazoline hydrochloride constricts the arteriolar
network within the nasal mucosa producing a prolonged decongestant
effect.
PHARMACODYNAMIC PROPERTIES: Oxymetazoline hydrochloride is a
sympathomimetic agent
with exerts a local
vasoconstriction action in the nasal
mucosa, reducing nasal
congestion. Clinical
studies have shown that
oxymetazoline acts within a few minutes and its effect
can last
up to 12
hours following treatment.
INDICATION AND USAGE: AFRIN Nasal
Spray 0.05% is indicated for the symptomatic relief of
nasal and nasopharyngeal
congestion due to the common cold,
sinusitis,
hay fever
or
other
upper respiratory allergies.
It is also recommended for office use on a nasal tampon to facilitate
intranasal examination or before
nasal surgery.
DOSAGE AND ADMINISTRATION:
FOR
ADULTS AND CHILDREN SIX YEARS OF
AGE AND OLDER:
AFRIN Nasal Spray 0.05% - Two or three sprays into each nostril twice
daily, morning and evening.
With the head upright, place the spray nozzle into the nostril without
completely occluding the nostril.
During each administration,
the patient
should bend his head slightly forward and squeeze bottle
quickly and firmly to spray the recommended number of sprays in each
nostril.
DRUG INTERACTIONS: If
significant
systemic absorption of
oxymetazoline occurs,
concomitant
use of
tricyclic
ant
                                
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