KETESSE 25MG FILM COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXKETOPROFEN TROMETAMOL

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

DEXKETOPROFEN TROMETAMOL

Unit dalam pakej:

20 Tablets; 4 Tablets

Dikeluarkan oleh:

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

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
hhh
1
KETESSE
®
25mg FILM COATED TABLET
Dexketoprofen Trometamol (25mg)
WHAT IS IN THIS LEAFLET?
1.
What Ketesse is used for
2.
How Ketesse works
3.
How to use Ketesse
4.
How to use Ketesse
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ketesse
8.
Product Description
9.
Manufacturer
10.
Product
Registration Holder
11.
Date of revision
12.
Serial Number
This
leaflet
answers
some
of
the
common
questions
people
ask
about
KETESSE. It does not contain all the
information
that
is
known
about
KETESSE.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your
doctor
will
have
weighed
the
risks of you taking KETESSE against
the benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
1. WHAT KETESSE IS USED FOR
Ketesse is a pain killer used to treat
mild
to
moderate
pain,
such
as
muscular
pain,
painful
periods
(dysmenorrhoea), toothache.
2. HOW KETESSE WORKS
Ketesse is a pain killer from the group
of medicines called non- steroidal anti-
inflammatory
drugs
(NSAIDs).
You
must talk to a doctor if you do not feel
better or if you feel worse after 3-4
days.
3. BEFORE YOU USE KETESSE
_- When you must not take it _
Do not take Ketesse:
If you are allergic to dexketoprofen l
or to any of the other ingredients of
this medicine(listed in section 6);
If you are allergic to acetylsalicylic
acid or to other non-steroidal anti-
inflammatory medicines;
If you have asthma or have suffered
attacks
of
asthma,
acute
allergic
rhinitis (a short period of inflamed
lining
of
the
nose),
nasal
polyps
(lumps
within
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
suffered
from
photoallergic o

Ciri produk

KETESSE®
tablets
Name and strength of active ingredient
Dexketoprofen trometamol 36.9 mg corresponding to dexketoprofen 25 mg.
Product Description
Film coated tablet.
Ketesse 25 mg: w hite, round, scored film coated tablets.
The tablets can be divided into equal doses.
Pharmacodynamic properties
Pharmacotherapeutic group: propionic acid derivatives
ATC code: M01AE17
Dexketoprofen trometamol is the tromethamine salt of S -(+) -2 -(3 -benzoylphenyl)propionic acid,
an analgesic, anti-inflammatory and antipyretic drug, which belongs to the non -steroidal anti -
inflammatory group of drugs (M01AE).
Mechanism of action
The mechanism of action of non- steroidal antiinflammatory drugs is related to the reduction of
prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Specifically, there is an inhibition of
the transformation of arachidonic acid into cyclic endoperoxides, PGG2 and PGH2, which produce
prostaglandins PGE1, PGE2, PGF2 α and PGD2 and also prostacyclin PGI2 and thromboxanes (TxA2 and
TxB2). Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation
mediators such as kinins, causing an indirect action which would be addi tional to the direct action.
Pharmacodynamic effects
Dexketoprofen has been demonstrated to be an inhibitor for COX -1 and COX -2 activities in experimental
animals and humans.
Clinical efficacy and safety
Clinical studies performed on several pain models demonstrated effective analgesic activity of
dexketoprofen. The onset of the analgesic activity was obtained in some studies at 30 minutes post -
administration. The analgesic e ffect persists for 4 to 6 hours.
Pharmacokinetic properties
Absorption
After oral administration of dexketoprofen trometamol to humans, the Cmax is reached at 30 min (range
15 to 60 min).
When administered concomitantly with food, the AUC does not change, however the Cmax of
dexketoprofen decreases and its absorption rate is delayed (increased tmax).