ULTRACET TABLET

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

PARACETAMOL; TRAMADOL HCl

Beschikbaar vanaf:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC-code:

N02AX52

Dosering:

325 mg

farmaceutische vorm:

TABLET, FILM COATED

Samenstelling:

PARACETAMOL 325 mg; TRAMADOL HCl 37.5 mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

Janssen Korea Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

2003-09-27

Bijsluiter

NAME OF THE MEDICINAL PRODUCT 
ULTRACET
TM 
(tramadol & paracetamol)

DOSAGE FORMS AND STRENGTHS 
ULTRACET
TM 
tablets are available as light yellow, film-coated tablets.  ULTRACET
TM 
tablets contain 37.5 mg of tramadol hydrochloride and
325mg of paracetamol. For excipients, 
see _List of Excipients_. 

CLINICAL INFORMATION

INDICATIONS 
ULTRACET
TM 
is indicated for the treatment of moderate to severe pain. 

DOSAGE AND ADMINISTRATION 
The tablets should be taken whole, not divided or chewed, with
sufficient liquid, without 
regard to food.  ULTRACET
TM 
should under no circumstances be administered for longer 
than absolutely necessary. If long-term pain treatment
with ULTRACET
TM  
is necessary in 
view of the nature and severity of the illness, then
careful and regular monitoring should be 
carried out (if necessary with breaks in treatment) to establish whether and to what extent 
further treatment is necessary. 

ADULTS AND CHILDREN OVER 16 YEARS 
1 to 2 tablets every 4 to 6 hours as needed for pain relief up
to a maximum of 8 tablets per 
day. 

CHILDREN 
The safety and effectiveness of ULTRACET
TM 
has not been studied in the pediatric 
population (<16 years of age). Therefore,
treatment is not recommended in this population. 

ELDERLY 
Elimination
of the active components may be prolonged in elderly patients over 75 years of 
age. Therefore, if necessary the dosage interval may be
extended according to the patients 
requirements. 

RENAL INSUFFICIENCY/DIALYSIS/HEPATIC INSUFFICIENCY 
The pharmacokinetics of the tramadol/paracetamol combination in patients with renal 
impairment  has  not been studied. Experience with
tramadol suggests that impaired renal 
function results in a
decreased rate and extent of excretion of tramadol. In patients with 
creatinine clearances of less than 30m

Productkenmerken

NAME OF THE MEDICINAL PRODUCT
ULTRACET
®
(tramadol & paracetamol)
DOSAGE FORMS AND STRENGTHS
ULTRACET
®
tablets are available as light yellow, film-coated tablet. ULTRACET
®
tablets
contain 37.5 mg of tramadol hydrochloride and 325mg of paracetamol.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
ULTRACET
®
is indicated for the treatment of moderate to severe pain.
DOSAGE AND ADMINISTRATION
The tablets should be taken orally, whole, not divided or chewed, with
sufficient liquid,
without regard to food. ULTRACET
®
should under no circumstances be administered for
longer than absolutely necessary. If long-term pain treatment with
ULTRACET
®
is necessary
in view of the nature and severity of the illness, then careful and
regular monitoring should be
carried out (if necessary with breaks in treatment) to establish
whether and to what extent
further treatment is necessary.
DOSAGE - ADULTS AND CHILDREN 16 YEARS OF AGE AND OVER
The maximum single dose of ULTRACET
®
is 1 to 2 tablets every 4 to 6 hours as needed for
pain relief up to a maximum of 8 tablets per day. The lowest effective
dose should be used
for the shortest period of time.
TREATMENT WITHDRAWAL
Do not stop use of ULTRACET
®
abruptly. Withdrawal symptoms may be relieved by
tapering the medication (see
_Warnings and Precautions – Treatment withdrawal_
).
CHILDREN BELOW 16 YEARS OF AGE
The
use
of
ULTRACET
®
is
contraindicated
in
children
below
12
years
of
age
(see
_Contraindications_
).
The safety and effectiveness of ULTRACET
®
in children aged 12 to below 16 years of age
has not been established (see
_Contraindications and Warnings and Precautions – Other risk _
_factors for life-threatening respiratory depression in children_
). Therefore, treatment is not
recommended in this population.
ELDERLY (75 YEARS OF AGE AND OLDER)
Elimination of the active components may be prolonged in elderly
patients over 75 years of
age. Therefore, if necessary the dosage interval may be extended
according to the patients
requirements.