DICLOTROY (Diclofenac Diethylamine Topical Solution 4.64% wv)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC DIETHYLAMINE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC DIETHYLAMINE

Unit dalam pakej:

30 ml

Dikeluarkan oleh:

Troikaa Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DICLOTROY (DICLOFENAC DIETHYLAMINE
TOPICAL SOLUTION 4.64% W/V)
Diclofenac Diethylamine (46.40mg)
WHAT IS IN THIS LEAFLET
1.
What Diclotroy is used for
2.
How Diclotroy works
3.
Before you use Diclotroy
4.
How to use Diclotroy
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Diclotroy
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT DICLOTROY IS USED FOR
Diclotroy
is
used
to
relieve
pain
and
swelling in a number of painful conditions
such as low back pain or pain following
sprain, strain and blunt trauma to tendons,
ligaments, muscles and joints.
HOW DICLOTROY WORKS
Diclotroy contains the active substance
diclofenac which belongs to a group of
medicines
called
non-steroidal
anti-
inflammatory drugs. It acts by inhibiting
the
prostaglandin
synthesis
responsible
for pain.
BEFORE YOU USE DICLOTROY
-
_When you must not use it _
_ _
Do not use Diclotroy:
•
If you are allergic (hypersensitive) to
diclofenac or other medicine used to
relieve pain and inflammation such as
ibuprofen or acetylsalicylic acid.
•
In the last trimester of pregnancy
•
If you are below 14 years of age
-
_Before you start use it _
_ _
Tell your pharmacist or doctor if you are
using any other painkillers.
PREGNANCY
You
must
tell
your
doctor
if
you
are
pregnant, think you may be pregnant or
plan to get pregnant. Do not use Diclotroy
if you are pregnant especially during the
last 3 months of pregnancy as it could
harm unborn child or cause problems at
delivery.
Diclotroy should be used with caution and
only if clearly necessary during the first 6
months of pregnancy.
LACTATION
Tell your doctor if you are breast-feeding
or about to start breast-feeding. Do not
use it if you are breast-feeding. Ask your
doctor, health-care provider or pharmacist
for advice before taking any medicine.
-
_Taking other medicines _
Please tell a doctor or pharmacist if you
are taking, or have recently taken, any
other
medicines,
including
medicines
o

Ciri produk

FRONT
DICLOTROY
Prescribing Information
Diclofenac Diethylamine Topical Solution 4.64% w/v
INDICATIONS:
Use in pediatric population is not recommended as data related to
safety and efficacy is not
available.
Geriatric Use:
DOSAGE AND ADMINISTRATION:
Pediatric Use:
No overall difference in effectiveness or safety is expected between
elderly and younger
patients, but greater sensitivity to the effect of NSAIDs in some
older individuals cannot be ruled
• Low backache, sprain and strain
DESCRIPTION:
DICLOTROY is indicated for the symptomatic relief of mild to moderate
pain and inflammation
associated with:
DICLOTROY (Diclofenac Diethylamine
Solution 4
% w/v) is Clear, Colourless to
Topical
.64
yellow coloured solution filled in 30 ml frosted cobalt blue moulded
vial USP type-I and sealed
with spray pump crimp on covered with pump ring and actuator. Each
pump strokes contains 0.1
ml which is equivalent to 4 mg of diclofenac sodium
• blunt trauma of the tendons, ligaments, muscles and joints
The treatment may be discontinued when the symptoms (pain and/or
swelling) have subsided.
Patient should be advised to ensure that the site of application is
clean and dry before applying
DICLOTROY. Before using DICLOTROY for the first time, prime the pump
by spraying it into the
air 2-3 times. On the affected area, 4 pump strokes (0.4 ml equivalent
to 16 mg of diclofenac
sodium) should be applied 4 times a day at regular intervals. Number
of the pump strokes to be
applied may be higher or lower depending on the area to be treated.
The maximum single dose of
7 pump strokes and the maximum daily dose of 30 pump strokes (120 mg
of diclofenac sodium)
should not be exceeded. It should be sprayed from a distance of 6-8
inches from the site of
application.
DICLOTROY is a non-aqueous solution, hence the spray pattern will not
be like the spray pattern
of aqueous solutions or aerosol sprays. The prime purpose of the spray
system is to ensure
accurate dosing with each metered dose spray, which delivers 0.1 ml of
solution. After applying