KETESSE TABLET 25 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DEXKETOPROFEN TROMETAMOL EQV DEXKETOPROFEN

Available from:

A. MENARINI SINGAPORE PTE. LTD.

ATC code:

M01AE17

Dosage:

25mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

DEXKETOPROFEN TROMETAMOL EQV DEXKETOPROFEN 25mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LABORATORIOS MENARINI SA

Authorization status:

ACTIVE

Authorization date:

2005-03-15

Patient Information leaflet

2014MEN-207-1
12 August 2014
_BY VALERIE HUANG AT 3:13 PM, AUG 12, 2014_
2014MEN-207-1
2014MEN-207-1
12 August 2014

Summary of Product characteristics

KETESSE
® TABLETS
Dexketoprofen trometamol
1.
TRADE NAME OF THE MEDICINAL PRODUCT
KETESSE 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet. KETESSE 25 mg: white, round, scored film-coated
tablets, with convex sides. The tablets
can be divided into equal halves for administration of half-doses.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Symptomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain, dysmenorrhoea,
dental pain.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
According to the nature and severity of pain, the recommended dosage
is generally 12.5mg (half a tablet) every
4-6 hours or 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 tablets are not intended for long 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
general population only after good
general tolerance has been ascertained.
HEPATIC IMPAIRMENT:
Patients with mild to moderate hepatic impairment should start therapy
at reduced doses (50 mg total daily
dose) and be closely monitored. KETESSE tablets 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 tablets should not be used in patients
with moderate to severe renal impairment (creatinine clearance ≤59
ml / min) (see section 4.3).
PAEDIATRIC POPULATION:
KETESSE tablets has not bee