SKUDEXA (TRAMADOL HYDROCHLORIDE 75MG DEXKETOPROFEN 25MG) FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE; DEXKETOPROFEN TROMETAMOL

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE; DEXKETOPROFEN TROMETAMOL

Unit dalam pakej:

4 Tablets; 15 Tablets; 20 Tablets

Dikeluarkan oleh:

Menarini - Von Heyden Gmbh, Leipziger

Risalah maklumat

SKUDEXA (TRAMADOL HYDROCHLORIDE 75MG / DEXKETOPROFEN
25MG) FILM-COATED TABLETS
Tramadol Hydrochloride 75mg
Dexketoprofen 25mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What SKUDEXAis used for
2.
How SKUDEXA works
3.
Before you use SKUDEXA
4.
How to use SKUDEXA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SKUDEXA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1.WHAT SKUDEXA IS USED FOR
SKUDEXA is used for the symptomatic
short
term
treatment
of
moderate
to
severe acute pain in adults.
2. HOW SKUDEXA WORKS
SKUDEXA
contains
the
active
substances
tramadol
hydrochloride
and
dexketoprofen.
Tramadol hydrochloride is a pain killer
belonging to a group of medicines called
opioids that act on the central nervous
system.
It
relieves
pain
by
acting
on
specific
nerve
cells
of
the
brain
and
spinal cord.
Dexketoprofen
is
a
pain
killer
and
it
belongs to a group of medicines called
non-steroidal
anti-inflammatory
drugs
(NSAIDs).
3. BEFORE YOU USE SKUDEXA
_- When you must not use it _
•
If you are allergic to dexketoprofen,
to tramadol hydrochloride or to any
of
the
other
ingredients
of
this
medicine
•
If you are allergic to acetylsalicylic
acid or to other NSAID
•
If
you
have
suffered
attacks
of
asthma, acute allergic rhinitis (a short
period of inflamed lining of the nose),
nasal polyps (lumps in the nose due
to
allergy),
urticaria
(skin
rash),
angioedema (swollen face, eyes, lips,
or tongue, or respiratory distress) or
wheezing
in
the
chest
after
taking
acetylsalicylic
acid
or
other
non-
steroidal anti-inflammatory medicines
•
If
you
have
had
photo
allergic
or
phototoxic
reactions
(reddening
and/or blistering of the skin exposed
to sunlight) while taking ketoprofen
(a NSAID) or fibrates (drugs used to
lower the level of fats in the blood)
•
If you have a peptic ulcer, stomach or
bowel
bleeding
or
if
you
have
suffered in the past from stomach or
bowel
bleeding,
ulceration
or
perforation,
including
that
due
to
previ

Ciri produk

PACKAGE INSERT
SKUDEXA TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Skudexa (Tramadol hydrochloride 75mg / Dexketoprofen 25mg) Film-Coated
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of
dexketoprofen. Excipients with known effects:
each tablet contains 33.07 mg croscarmellose sodium and 1.83 mg sodium
stearyl fumarate
For the full list of excipients, see section 6.1.
3.
PRODUCT DESCRIPTION
Film-coated tablet.
Skudexa: almost white to slightly yellow, oblong, film-coated tablets
with a break-mark on one side and a debossed
“M” on the other side. The dimension of the film-coated tablet is
ca. 14 mm lengths and ca. 6 mm width.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic short term treatment of moderate to severe acute pain in
adult patients whose pain is considered to
require a combination of tramadol and dexketoprofen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
The recommended dosage is one film-coated tablet (corresponding to 75
mg of tramadol hydrochloride and 25 mg of
dexketoprofen). Additional doses can be taken as needed, with a
minimum dosing interval of 8 hours. The total daily
dose should not exceed three film- coated tablets per day
(corresponding to 225 mg of tramadol hydrochloride and 75
mg of dexketoprofen).
Skudexa is intended for short term use only and the treatment must be
strictly limited to the symptomatic period and
in any case not more than 5 days.
Switching to a single agent analgesia should be considered according
to pain intensity and response of the patient.
Undesirable effects may be minimised by using the lowest number of
doses for the shortest duration necessary to
control symptoms. (see section 4.4).
_Elderly: _
In elderly patients the starting recommended dosage is one film-coated
tablet; additional doses can be taken as
needed with the minimum dose interval of 8 hours and n