Ketesse 25mg granules for oral solution

Country: Malaysia

Language: English

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

Active ingredient:

DEXKETOPROFEN TROMETAMOL; DEXKETOPROFEN TROMETAMOL

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

DEXKETOPROFEN TROMETAMOL; DEXKETOPROFEN TROMETAMOL

Units in package:

10sachet Sachets; 20sachet Sachets

Manufactured by:

Laboratorios Menarini S.A.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
KETESSE
® 25MG GRANULES FOR ORAL SOLUTION
_Dexketoprofen trometamol (36.90mg equivalent to 25mg dexketoprofen) _
WHAT IS IN THIS LEAFLET
1.
What Ketesse is used for
2.
How Ketesse works
3.
Before you 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
and
Product
Registration Holder
10.
Date of revision
WHAT KETESSE IS USED FOR
Ketesse is a pain killer from the
group
of
medicines
called
non-
steroidal anti-inflammatory drugs
(NSAIDs).
It
is
used
for
short
term
symptomatic treatment of mild to
moderate acute pain, such as acute
muscular
pain
or
joint
pain,
painful periods (dysmenorrhoea),
toothache.
HOW KETESSE WORKS
Dexketoprofen trometamol is an
analgesic,
anti-inflammatory
and
antipyretic
drug
(drug
helps
to
reduce
heat).
It
belongs
to
the
non-steroidal
anti-inflammatory
(NSAIDs) group of drugs.
The mechanism of action of non-
steroidal
anti
inflammatory
medicinal
products
is
related
to
the
reduction
of
prostaglandin
synthesis
by
the
inhibition
of
cyclooxygenase pathway.
Cyclooxygenase is involved in the
production
of
prostaglandin.
Prostaglandins
are
substances
responsible
in
causing
swelling,
inflammation
and
pain.
By
blocking
cyclooxygenase,
dexketoprofen
prevents
the
production of prostaglandins and
therefore
reduces
inflammation
and pain.
BEFORE YOU USE KETESSE
_When you must not use it _
Do not take Ketesse:
•
If
you
are
allergic
(hypersensitive)
to
dexketoprofen trometamol or
to any of the other ingredients
of of this medicine
•
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 acetylsalicy

Summary of Product characteristics

1
PACKAGE INSERT
KETESSE® GRANULES FOR ORAL SOLUTION.
Dexketoprofen (as trometamol)
1.
NAME OF THE MEDICINAL PRODUCT
Ketesse 25 mg granules for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of granules for oral solution contains 25 mg, as
dexketoprofen trometamol.
Excipients with known effect:
Sucrose with colloidal silica: or 2.40 -2.44 g respectively.
For the full list of excipients, see section 6.1.
3.
PRODUCT DESCRIPTION
Granules for oral solution,lemon
yellow coloured granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term symptomatic treatment of acute pain of mild to moderate
intensity, such as acute musculoskeletal
pain, dysmenorrhoea and dental pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
:
_ _
According to the nature and severity of pain, the recommended dosage
is 25 mg every 8 hours. The total daily
dose should not exceed 75 mg.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to
control symptoms (see section 4.4.).
Ketesse is only intended for short term use and the treatment must be
limited to the symptomatic period.
_Elderly_
:
In elderly patients it is recommended to start the therapy at the
lower end of the dosage range (50 mg total daily
dose). The dosage may be increased to that recommended for the adult
only after good general tolerance has
been ascertained. Due to the possible adverse effect profile (see
section 4.4), elderly individuals should receive
particularly close monitoring.
_Hepatic impairment_
:
Patients with mild to moderate hepatic impairments hould start therapy
at reduced doses (50 mg total daily dose)
and be closely monitored. Ketesse should not be used in patients with
severe hepatic impairment.
_Renal impairment_
:
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired renal function
(creatinine clearance 60 – 89 ml / min) (see section 4.4). Ketesse
should not be used in patients with
moderate to severe renal impa