RHUMANOL CREAMAGEL

Country: Malaysia

Language: English

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

Active ingredient:

DICLOFENAC DIETHYLAMMONIUM

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

DICLOFENAC DIETHYLAMMONIUM

Units in package:

20gm mcg/mL

Manufactured by:

T.O. CHEMICALS (1979) LTD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
RHUMANOL CREAMAGEL
_ _
Diclofenac diethylammonium 1.17g (equivalent to diclofenac sodium 1.00
g)
WHAT IS IN THIS LEAFLET
1.
What RHUMANOL is used for
2.
How it works
3.
Before you use it
4.
How to use RHUMANOL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
RHUMANOL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RHUMANOL IS USED FOR
RHUMANOL
is
used
for
the
treatment
of
muscle
inflammatory
conditions such as muscle sprain and
strain, tendonitis (inflammation of the
tendon) and soft tissue injuries. This
preparation is recommended for short
term treatment of up to two weeks.
HOW RHUMANOL WORKS
RHUMANOL
contains
diclofenac
sodium, which belongs to a class of
painkillers
known
as
Non-Steroidal
Anti-inflammatory Drugs (NSAIDs).
It works by blocking the production of
some
body
substances
that
cause
inflammation, pain, and swelling in
the muscle and soft tissues.
BEFORE YOU USE RHUMANOL
_- When you must not use it _
Do not use RHUMANOL:
• If you are allergic or hypersensitive
to diclofenac, propylene glycol or any
of the other ingredients listed at the
end of this leaflet.
•
If
you
have
experienced
hypersensitivity
reactions
such
as
symptoms of asthma, allergic rhinitis
(inflammation
of
the
nasal
mucous
membrane)
or
urticaria
(itching
or
hives), to aspirin (medication used to
reduce fever, reduce pain and prevent
blood clot) or other non-steroidal anti-
inflammatory drugs (NSAIDs).
Do not use this medicine if any of the
above condition applies to you. If you
are not sure, get advice from your
doctor or pharmacist.
_ _
_- Before you start to use it _
Tell your doctor if you:
•
Have
allergies
to
any
other
medicines,
food,
preservatives
or
dyes.
•
Have
or
have
had
ulceration,
bleeding
and
perforation
of
the
stomach and intestinal
• Have heart problems
• Have thrombosis (blood clots inside
the blood vessels)
• Have high blood pressure
• Have kidney problems
• Have liver problems
RHU

Summary of Product characteristics

PLEASE READ CAREFULLY
RHUMANOL CREAMAGEL
Each 100g RHUMANOL CREAMAGEL contains:
Diclofenac diethylammonium 1.17g
(equivalent to diclofenac sodium 1.00g)
DESCRIPTION
A white opaque cream-like gel
INDICATIONS
Topical
symptomatic
treatment
of
the
musculoskeletal
inflammatory conditions. Muscle sprain and strain, tendinitis and
soft tissue injuries. This preparation is recommended for short
term treatment of up to two weeks.
RECOMMENDED DOSAGE
Rub into the affected skin area locally three to four times a day.
Wash the hands thoroughly after application. Treatment of more
than two weeks is not recommended. Do not apply to the ruptured
skin area.
After accessing the risk / benefit ration in each individual patient,
the lowest effective dose for the shortest possible duration should
be used.
ROUTE OF ADMINISTRATION
For topical use only.
CONTRAINDICATIONS
•
Patients with or without chronic asthma in whom attacks of
asthma,
urticarial
or
acute
rhinitis
are
precipitated
by
acetylsalicylic
acid
(aspirin)
or
other
non-steroidal
anti-
inflammatory drugs (NSAIDs)
•
Hypersensitivity to diclofenac or any of the excipients
•
Third trimester of pregnancy
•
The use in children and adolescents aged less than 14 years is
contraindicated
WARNINGS AND PRECAUTIONS
•
The possibility of experiencing systemic adverse event (those
associated with the use of systemic forms of diclofenac) from
application of RHUMANOL CREAMAGEL cannot be excluded if the
preparation is used at higher dosage/large amounts over large
areas of skin and over a prolonged period.
•
Concomitant use of systemic NSAIDs should be cautioned since
the possibility of an increase in incidence of untoward effects,
particularly systemic side effects, cannot be ruled out.
•
RHUMANOL CREAMAGEL
contains
propylene
glycol
which
may
cause mild, localized skin irritation in some people.
•
Like other drugs that inhibit prostaglandin synthetase activity,
diclofenac and other NSAIDs can precipitate bronchospasm if
administrated to patients suffering from or with a previo