ALMIRAL GEL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

25gm mcg/mL

Dikeluarkan oleh:

MEDOCHEMIE LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
ALMIRAL 1% GEL
Diclofenac diethylamine (1% W/W)
1
WHAT IS IN THIS LEAFLET
1.
What ALMIRAL is used for
2.
How ALMIRAL works
3.
Before you use ALMIRAL
4.
How to use ALMIRAL
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ALMIRAL
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ALMIRAL IS USED FOR
ALMIRAL
gel
is
indicated
for
external
treatment
of
pain,
inflammation
and
swelling
for
muscles
and
joints.
For
topical
use
only.
HOW ALMIRAL WORKS
ALMIRAL
is
a
group
of
medicine
called
“non-steroidal
anti-
inflammatory
drug” (NSAID)
which
works by reducing inflammation and
pain in the body.
BEFORE YOU USE ALMIRAL
_-When you must not use it_
You should not use ALMIRAL:
-
if
you
have
allergic
reaction
to
diclofenac or to any of the other
components
of
ALMIRAL
gel
based mentioned.
-
if you have hypersensitivity to any
other medicine from the NSAID or
acetylsalicylic acid (aspirin) group
-
if
you
are
at
last
trimester
of
pregnancy
-
if you are less than 12 years old
_ _
_-Before you start to use it _
Always wash your hands before and
after applying ALMIRAL cream.
-
Do not continue treatment if you
have skin rash, itching or redness
after applying the gel.
-
Do not touch your eye until you
have
washed
your
hands
after
application.
-
Do not apply ALMIRAL gel to
skin
with
wounds
or
open
injuries.
-
You
may
use
non-occlusive
bandages
together
with
almiral
gel
but
not
airtight
occlusive
dressing
-
If
you
have
been told
by
your
doctor
that
you
have
stomach
ulcer,
inflamed
intestine
or
weaken liver or kidney, contact
your
doctor
before
starting
this
treatment.
_Pregnancy and Breastfeeding: _
If you are pregnant or breast-feeding,
or think you may be pregnant or are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
using this medicine. Use of diclofenac
in late pregnancy should be avoided.
Consult your doctor before you use
ALMIRAL if you are breastfeeding.
_-Taking other medicines _

Ciri produk

SPCDICLGEL6.0-CY
1
ALMIRAL GEL – PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Almiral 1% gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of gel contains 10 mg diclofenac sodium as diclofenac
diethylamine.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
Colourless, transparent, smooth, homogeneous gel with a characteristic
peppermint odour.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the external treatment of pain, inflammation and swelling in the
following situations:
-
injuries of the tendons, ligaments, muscles and joints, e.g. sprains,
bruises, strains and back pain after sport or
accidents
-
localized forms of soft tissue rheumatism such as tendinitis (tennis
elbow), shoulder hand syndrome, bursitis,
periarthropathies
-
for the symptomatic treatment of osteoarthritis of small and medium
sized joints located close to the skin such as
the finger joints or knee joints
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For cutaneous use only.
Patients should consult their doctor if the condition does not improve
or worsens within 7 days of starting treatment.
For adults and adolescents aged 12 years and over.
This medicine should be applied over the affected area 3 or 4 times
daily and rubbed gently into the skin. The amount
needed depends on the size of the painful area: 2 g to 4 g Almiral gel
(a quantity ranging in size from a cherry to a
walnut) is sufficient to treat an area of about 400-800 cm². After
application, the hands should be washed, unless they
are the site being treated.
The duration of treatment depends on the indication and clinical
response. The product should not be used for more
than 14 days. Almiral gel can also be used as an adjunctive therapy
with other pharmaceutical forms of Almiral gel.
Elderly patients (over 65 years of age)
The usual adult dosage may be used.
Children (under 12 years of age)
The use and safety of Almiral gel in children under 12 years
systematically and is not recom