FASTUM GEL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

KETOPROFEN

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

KETOPROFEN

Unit dalam pakej:

50 gm; 30 gm; 10 gm; 50 gm

Dikeluarkan oleh:

A. MENARINI MANUFACTURING LOGISTICS & SERVICES S.R.L.

Risalah maklumat

1
FASTUM GEL
_Consumer Medication_
_ _
_Information Leaflet (RiMUP)_
_Ketoprofen (2.5% w/w) _
_ _
WHAT IS IN THIS LEAFLET
1.
What FASTUM is used for
2.
How FASTUM works
3.
Before you take FASTUM
4.
How to take FASTUM
5.
While you are taking FASTUM
6.
Side effects
7.
Storage and Disposal of FASTUM
8.
Product Description
9.
Manufacturer
10.
Product Registration holder
WHAT FASTUM IS USED FOR
Local
treatment
of
painful
disorders of the osteo-articular and
muscular system of rheumatic or
traumatic
origin:
contusions,
distortions,
muscle
strains,
stiff
neck, lumbago. HOW FASTUM WORKS
FASTUM contains ketoprofen and
belongs to a group of medicines called
anti-inflammatory and antirheumatic
drugs (against rheumatism).
BEFORE YOU USE FASTUM
_WHEN YOU MUST NOT USE IT_
DO NOT USE FASTUM IF:
•
If
you
are
allergic
to
the
active
substance or other NSAIDs (non-
steroidal anti-inflammatory drugs),
or to any of the ingredients of this
medicine
(listed
in
section
Ingredients)
•
If
in
the
past
you
have
had
photosensitisation
reactions
(skin
reactions
after
exposure
to
sunlight).
•
If in the past you have had allergies
to
ketoprofen,
tiaprofenic
acid,
fenofibrate,
UV
sun
blockers
or
perfumes.
•
Near open wounds or skin lesions,
around the eyes, on skin areas with
conditions such as dermatosis, acne
or eczema.
•
During
the
third
trimester
of
pregnancy (see section Pregnancy
and Breast-feeding)
DO NOT EXPOSE THE TREATED AREAS TO
SUNLIGHT OR THE UV LAMPS OF TANNING
BEDS DURING THE TREATMENT AND IN THE
TWO WEEKS AFTER ITS END.
Talk to your doctor or pharmacist before
using FASTUM.
The
use,
especially
if
prolonged,
of
products for topical (local) use can give
rise
to
local
sensitisation
phenomena
(increased reactions) or irritation.
Stop
using
FASTUM
immediately
if
any cutaneous (skin) reactions appear,
including
reactions
after
concomitant
use of products containing octocrylene
(octocrylene
is
an
excipient
used
to
prevent degradation caused by light in
various
cosmetics
and
personal-care
products,
such
as
shampoos,
aftershaves

Ciri produk

PACKAGE INSERT
FASTUM GEL
1.
COMPOSITION
100 g of Gel Contain:
Active ingredient: ketoprofen 2.50 g
Excipients:
carbomer
,
ethanol,
neroli fragrance,
lavandin
fragrance,
triethanolamine,
purified water.
2.
PHARMACOLOGICAL PROPERTIES
Ketoprofen, in a suitable vehicle, reaches by transcutaneous route the
inflammation site,
allowing local treatment of pain of joints,
tendons, ligaments and muscles.
Following
oral
administration
of
a
single
dose
within
2
hours
maximum
blood
concentrations are reached.
Plasma half-life of ketoprofen varies from 1 hour to 3 hours: binding
to plasma proteins is
60-90%. Elimination occurs mainly by
urinary route, in glucuronoconjugated form: approximately 90% of the
administrated dose
is excreted within 24 hours.
Conversely the absorption by cutaneous route is very low. In fact the
application of 50-150
mg of ketoprofen by percutaneous route
determines plasma levels of the active ingredient equal to 0.08-0.15
μg/ml about 5-8 hours
after the application.
3.
INDICATIONS
Local treatment of painful disorders of the osteo-articular and
muscular system of
rheumatic or traumatic origin: contusions,
distortions, muscle strains, stiff neck, lumbago. 4.
SIDE EFFECTS
There have been reports of localised skin reactions which might
subsequently spread
beyond the area of application. Cases of
more severe reactions such as bullous or phlyctenular eczema which may
spread or become
generalized have occurred rarely.
Other systemic effects of NSAIDs: these depend on the transdermal
diffusion of the active
ingredient, and thus on
the amount of gel applied, the area involved, the degree of the skin
integrity,the duration of
the treatment
and the use of occlusive dressings (digestive and kidney effects).
The following CIOMS frequencies have been used: very common (≥1/10);
common
(≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000,
<1/1000); very rare (<1/10,000); not known (the frequency cannot be
established based on
the available data).
Immune system disorders
Not
known:
anaphylactic
react