Strepsils Max Pro Direct 8.75mg Spray

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLURBIPROFEN

Boleh didapati daripada:

RB (HEALTH) MALAYSIA SDN BHD

INN (Nama Antarabangsa):

FLURBIPROFEN

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
STREPSILS MAX PRO DIRECT 8.75MG SPRAY
Flurbiprofen (8.7480mg/0.540ml)
_____________________________________________________________________________________________
_____________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET:
1.
What
Strepsils
Max
Pro
Direct
8.75mg Spray is used for
2.
How
Strepsils
Max
Pro
Direct
8.75mg Spray works
3.
Before you use Strepsils Max Pro
Direct 8.75mg Spray
4.
How
to
use
Strepsils
Max
Pro
Direct 8.75mg Spray
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Strepsils
Max Pro Direct 8.75mg Spray
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision
11.
Serial Number
WHAT
STREPSILS
MAX
PRO
DIRECT
8.75MG SPRAY IS USED FOR
Strepsils Max Pro Direct 8.75mg Spray
is
indicated
for
the
short
term
symptomatic relief of acute sore throat in
adults.
HOW STREPSILS MAX PRO DIRECT 8.75MG
SPRAY WORKS
The active ingredient (which makes the
medicine
work)
is
flurbiprofen.
It
belongs to a group of medicines called
non-steroidal
anti-inflammatory
drugs
(NSAIDs).
These
medicines
provide
relief
by
changing
how
the
body
responds to pain and high temperature.
BEFORE
YOU
USE
STREPSILS
MAX
PRO
DIRECT 8.75MG SPRAY
_-When you must not use it: _
Do not take Strepsils Max Pro Direct
8.75mg Spray if you
-
If you are allergic to flurbiprofen or to
any of the excipients
-
have had a previous allergic reaction
after
taking
Non-Steroidal
Anti-
Inflammatory
Drugs
(NSAIDs)
or
aspirin
(acetylsalicylic
acid);
e.g.
asthma,
wheezing,
itching,
runny
nose, skin rashes, swelling
-
If you have (or have had two or more
episodes
of)
a
stomach
ulcer
or
bleeding of the stomach
-
If
you
have
a
history
of
gastro-
intestinal
bleeding
or
perforation
related to previous NSAID therapy
-
During
the
last
three
months
of
pregnancy
-
If you have severe liver, kidney or
heart failure
-
Or give to children and adolescents
below 18 years.
_Pregnancy and lactation _
Do not take t

Ciri produk

STREPSILS MAX PRO DIRECT SPRAY
Flurbiprofen 8.75mg
Product Description :
Oromucosal spray, solution. Clear, colourless to slightly yellow solution.
The active ingredient is flurbiprofen.
The other ingredients are: Betadex, Disodium phosphate dodecahydra te, Citric acid monohydrate, Methyl
parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide, Mint flavour, Cherry
flavour, N,2,3 -Trimethyl -2-isopropylbutanamide, Saccharin sodium, Hydroxypropyl betadex and Purified water.
Pharmacod ynamics
Flurbiprofen is a propionic acid derivative NSAID w hich acts through inhibition of prostaglandin synthesis. In
humans flurbiprofen has potent analgesic, a ntipyretic and anti -inflammatory properties and the 8.75 mg dose
dissolved in arti ficial saliv a has been shown to reduce prostaglandin synthesis in cultured human respiratory cells.
According to studies using the whole blood assay, flurbiprofen is a mixed COX -1/COX -2 inhibitor with some
selectivity towards COX -1. Pre -clinical studies suggest that t he R ( -) enantiomer of flur biprofen and related NSAIDs
may act on the central nervous system; the suggested mechanism is by inhibition of induced COX -2 at the level of
the spinal cord.
A single dose of flurbiprofen 8.75 mg delivered locally to the throat a s three sprays has been demonstrated to relieve
sore throat, including swollen and inflamed sore throats through a significant change in the severity of throat
soreness a rea under the change (AUC) from baseline curve (mean difference (standard deviation)) for active
treatment ver sus placebo from 0 to 2 hours ( -1.82 (1.35) vs -1.13 (1.14)), 0 to 3 hours ( -2.01 (1.405) vs -1.31
(1.233)) and 0 to 6 hours ( -2.14 (1.551) vs -1.50 (1.385). Signific ant differences in the AUC from baseline curve
from 0 – 6 hours co mpared to placebo were also s een for other qualities of sore throat including pain intensity ( -
22.50 (17.894) vs -15.64 ( 16.413)), difficulty swallowing (-22.50 (18.260) vs -16.01 (15.451)), swollen throat ( -
20.97 ( 18.897) vs