Flegesic Gel 5% ww

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diethylamine salicylate

Boleh didapati daripada:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (Nama Antarabangsa):

Diethylamine salicylate

Unit dalam pakej:

100 gm; 50 gm

Dikeluarkan oleh:

FARMALABOR

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
FLEGESIC GEL 5% W/W
_ _
Diethylamine salicylate (50 mg/g)
1
WHAT IS IN THIS LEAFLET
1.
What Flegesic Gel is used for
2.
How it works
3.
Before you use Flegesic Gel
4.
How to use Flegesic Gel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Flegesic
Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FLEGESIC GEL IS USED FOR
To relieve muscular problems
including pain, stiffness and
inflammation of muscles/joints of the
lower back; general bruises, sprains
and strains.
HOW FLEGESIC GEL WORKS
Diethylamine salicylate has
painkilling properties and anti-
inflammatory action.
BEFORE YOU USE FLEGESIC GEL
_- When you must not use it _
Hypersensitivity to the active
substances or to any of the excipients
and children under 12 years.
_- Before you start to use it _
This product is for external use only.
Do not apply to nose, mouth,
wounds, burns or inflamed skin.
_- Taking other medicines _
Please inform the doctor or
pharmacist if taking other medicines.
HOW TO USE FLEGESIC GEL
_- How much to use _
Apply one to three times daily, gently
massage onto affected area.
_- When to use it _
Please follow the advice of the doctor
or pharmacist.
_- How long to use it _
Continue using Flegesic Gel for as
long as doctor recommends.
_ _
_- If you forget to use it _
If you forget to use this medicine, use
it as soon as you remember. Then
continue using it at your usual time.
_ _
_- If you use too much (overdose) _
It is advisable for you to inform your
doctor if you did apply Flegesic Gel
too much.
WHILE YOU ARE USING IT
_- Things you must do _
Inform your doctor of all the
medications you are taking.
_- Things you must not do _
Do not apply to nose, mouth, open
wounds, burns or inflamed skin.
Do not use for more than 7 days.
_ _
_- Things to be careful of _
Avoids contact with eyes, nose and
mouth.
SIDE EFFECTS
Like all medicines, Flegesic Gel can
cause side effects, although not
everybody gets them.
Flegesic Ge

Ciri produk

FLEGESIC GEL 5% W/W
Diethylamine salicylate
COMPOSITION:
1g of gel contains 50 mg of diethylamine salicylate.
PRODUCT DESCRIPTION:
Transparent, homogeneous and yellowish coloured gel.
PHARMACODYNAMIC:
Diethylamine salicylate has analgesic properties and anti-inflammatory
action.
The action mechanism of salicylates is based on their ability to
inhibit prostaglandin synthesis (pro-inflammatory mediators) from
arachidonic acid by inhibiting the cyclooxygenase enzyme (COX).
Diethylamine salicylate is a non-selective COX inhibitor.
PHARMACOKINETIC:
Diethylamine salicylate is a salicylic acid salt that penetrates into
the skin by ion-pair association (i.e., the compound is spread on
the viable skin in the form of diethylamine cation and salicylate
anion).
In an in vivo comparison with other salicylates, diethylamine
salicylate demonstrated a lower absorption rate, a lower elimination
rate and a lower flow through the skin. This effect is desired in a
formulation for topical application since it allows the drug to be
absorbed slowly, with relief of local discomfort and minimum systemic
effects.
In the same study, increased levels of diethylamine salicylate have
been found in the stratum corneum and viable skin, when
compared with other studied compounds (salicylic acid,
buthylsalicylate and salicylamine).
In a study with human skin, salicylic acid reached a concentration
peak on the dermis, skin tissue and fascia after 2 hours.
Animal and human studies suggest that the distribution of salicylates
for subcutaneous tissues is mainly done by direct penetration
(passive diffusion) in the tissues under the application area, up to
the superficial muscle level, with a penetration depth of 3-4 mm.
Biotransformation of salicylates occurs in many tissues, but
especially in hepatic endoplasmic reticulum and mitochondria. The
three main salicylate metabolites are: salicyluric acid (glycine
conjugate), ether or phenol gluconoride and ester or acyl
glucuronide.
Salicylates are excreted in the urine mainly as free salicylic acid,
sali