Spedifen 400mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

IBUPROFEN

Available from:

EP PLUS GROUP SDN. BHD.

INN (International Name):

IBUPROFEN

Units in package:

5 x 6tablet Tablets

Manufactured by:

ZAMBON S.p.A.(Manufacturing site)

Patient Information leaflet

SPEDIFEN
® 400 MG TABLETS
Consumer Medication Information Leaflet (RiMUP)
IBUPROFEN (AS L-ARGININE SALT) (400MG)
WHAT IS IN THIS LEAFLET

What SPEDIFEN 400 tablets is used for

How SPEDIFEN 400 tablets works

Before you use SPEDIFEN 400 tablets

How to take SPEDIFEN 400 tablets

While you are using SPEDIFEN 400 tablets

Side effects

Storage and Disposal of SPEDIFEN 400
tablets

Product description

Manufacturer and Product Registration
Holder

Date of revision
WHAT SPEDIFEN 400MG TABLETS IS USED FOR
SPEDIFEN
400
tablet
can
be
used
in
the
following situations:
Pain:
headache
including
migraine,
toothache,
period pain, neuralgia, osteoarticular and muscular
pain,
episiotomy
and
post-partum
pain,
pain
following tooth extraction, fever, post-operative
pain, soft tissues injuries and traumatisms.
Rheumatic
inflammatory
diseases:
rheumatoid
arthritis, ankylosing spondylitis, Still’s Disease.
Degenerative
rheumatic
disease:
osteoarthritis
(cervical,
dorsal
and
lumbar
arthritis,
gonoarthritis, coxoarthritis, polyarthritis, etc).
Non-articular
rheumatic
conditions:
tendonitis,
fibrositis,
bursitis,
myalgia,
lumbago,
scapolohumeral
periarthritis,
sciatica,
radiculoneuritis.
HOW SPEDIFEN 400MG TABLETS WORKS
The active substance contained in SPEDIFEN
400 tablets is ibuprofen which belongs to the
group
of
the
so-called
Non
Steroidal
Anti-
Inflammatory
Drugs
(NSAIDs)
which
have
painkilling,
fever
reducing
and
anti-
inflammatory properties.
The inclusion of the natural amino acid
L-arginine in the formulation enhances the
solubilisation of ibuprofen which results in a
rapid absorption of the active ingredient after
oral administration. A meaningful pain relief
occurs within 15-30 min after oral administration.
BEFORE YOU USE SPEDIFEN 400MG TABLETS
_When you must not take it _

if
you
are
allergic
(hypersensitive)
to
ibuprofen or any of the other ingredients of
SPEDIFEN 400 tablet;

if
you
have
a
history
of
hypersensitivity
reactions (e.g. asthma attacks, tightness of the
airways due to sp

Summary of Product characteristics

6294989
E02.0523
29/05/2023
2
HELVETICA NEUE
Corpo 9 pt. - Interlinea 9,8 pt.
ISTRUZIONE PIEGATA A META’
CON DIMENSIONI FINALI MM 150x280 E
CODICI LAETUS VISIBILI ALL’ESTERNO
IS SPEDIFEN 400 MG CPR - MALESIA
N/A
REV2
YES
IS041 BV-B
150x560/280
N/A
49 (10010)
N/A
LINEA 4
VICENZA
NUOVI TESTI / NEW TEXT
BLACK
P 390 C
N/A
Pharmacodynamics
ATC code: M01AE01
Spedifen contains the active ingredient Ibupro-
fen in the form of arginine salt.
Ibuprofen is a non-steroidal anti-inflammatory
drug with analgesic, antirheumatic and antipyre-
tic properties. Its action is based primarily on a
synthesis inhibition of prostaglandins, which play
a role in inflammatory and painful processes.
Ibuprofen arginine has the same pharmacologi-
cal properties as ibuprofen but is characterized
by higher water solubility.
It is effective after approximately 30 minutes.
Pharmacokinetics
_Absorption_
The active substance peak concentrations of 24
and 40 μg/ml ibuprofen are achieved in serum
28-42 minutes after oral administration of ibupro-
fen 200 mg and respectively 400 mg (as ibupro-
fen arginine).
If Spedifen is taken after meals, the absorption
will be slower and the maximum plasma concen-
trations will be lower.
_Distribution_
Serum half-life is 1.5-2 hours. Protein binding is
approx. 99 %.
_Metabolism_
After hepatic metabolism, ibuprofen is eliminated
rapidly, predominantly in the form of pharmaco-
logically
inactive
metabolites
and
especially
through the kidneys.
_Elimination_
Ibuprofen
does
not
accumulate
even
during
long-term therapy, with ibuprofen and its meta-
bolites being almost completely eliminated 24
hours after the last dose.
Indication
Pain: headache including migraine, toothache,
dysmenorrhoea,
neuralgia,
osteoarticular
and
muscular pain, episiotomy and post- partum pain,
pain
following
tooth
extraction,
post-operative
pain, soft tissues injuries and traumatisms.
Rheumatic Inflammatory diseases :
rheumatoid arthritis, ankylosing spondylitis, Still`s
Disease.
Degenerative rheumatic disease :
osteoarthritis (cervical, do