Nucynta ER Tablets 50 mg

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Tapentadol Hydrochloride 58.24 mg eqv Tapentadol

Disponible des:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD. (UEN 200411241W)

Codi ATC:

N02AX06

Dosis:

50 mg

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Tapentadol Hydrochloride 58.24 mg eqv Tapentadol 50 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

Janssen Ortho LLC

Estat d'Autorització:

ACTIVE

Data d'autorització:

2014-09-08

Informació per a l'usuari

1 

PRODUCT NAME 
NUCYNTA
®

ER (tapentadol)  extended-release  oral tablets* 
®  Registered Trademark of GRÜNENTHAL GmbH, used under license 
* Licensed by Grünenthal GmbH, Germany

DOSAGE FORMS AND STRENGTHS 
Extended-release  tablet 
Each extended-release  tablet contains: 

  50 mg tapentadol (as hydrochloride) 

  100 mg tapentadol (as hydrochloride) 

  150 mg tapentadol (as hydrochloride) 

  200 mg tapentadol (as hydrochloride) 

  250 mg tapentadol (as hydrochloride) 
50  MG  TABLET:  white  coloured,  oblong-shaped  marked  with  a  black  print  “OMJ  50”  on 
one side 
100  MG  TABLET:  light-blue  coloured,  oblong-shaped  marked  with  a  black  print  “OMJ 
100” on one side 
150  MG  TABLET:  blue-green  coloured,  oblong-shaped  marked  with  a black  print  “OMJ 
150” on one side 
200  MG  TABLET:  blue  coloured,  oblong-shaped  with  a  depression  in  the  middle  running 
lengthwise  on each side and with a black print “OMJ 200” on one side 
250  MG  TABLET:  dark  blue  coloured,  oblong-shaped    with  a  depression  in  the  middle 
running lengthwise on each side and with a white print “OMJ 250” on one side 

For excipients, see _List of Excipients_. Not all strengths may be marketed 

CLINICAL INFORMATION  
INDICATIONS 
NUCYNTA
®
  ER  is  an  opioid  analgesic  indicated  for  the  management  of:  moderate  to 
severe chronic pain in adults unresponsive to non-narcotic analgesia when  a  continuous,  
around-the-clock   opioid  analgesic  is  needed  for  an  extended period of time. 

LIMITATIONS OF USE 
NUCYNTA
®
  ER is not for use: 

  As an as-needed (prn) analgesic 

  For pain that is mild�

Fitxa tècnica

1
PRODUCT
NAME
NUCYNTA
®
ER (tapentadol) extended-release oral tablets*
®
Registered Trademark of GRÜNENTHAL GmbH, used under license
* Licensed by Grünenthal GmbH, Germany
DOSAGE FORMS AND
STRENGTHS
Extended-release tablet
Each extended-release tablet contains:

50 mg tapentadol (as hydrochloride)

100 mg tapentadol (as hydrochloride)

150 mg tapentadol (as hydrochloride)

200 mg tapentadol (as hydrochloride)

250 mg tapentadol (as hydrochloride)
50 MG TABLET: white coloured, oblong-shaped marked with a black print
“OMJ 50” on
one side
100 MG TABLET: light-blue coloured, oblong-shaped marked with a black
print “OMJ
100” on one side
150 MG TABLET: blue-green coloured, oblong-shaped marked with a black
print “OMJ
150” on one side
200 MG TABLET: blue coloured, oblong-shaped with a depression in the
middle running
lengthwise on each side and with a black print “OMJ 200” on one
side
250 MG TABLET: dark blue coloured,
oblong-shaped with a depression
in the middle
running lengthwise on each side and with a white print “OMJ 250”
on one side
For excipients, see _List of Excipients_. Not all strengths may be
marketed
CLINICAL
INFORMATION
INDICATIONS
NUCYNTA
®
ER is an opioid analgesic indicated for the management of: moderate to
severe chronic pain in adults unresponsive to non-narcotic analgesia
when a continuous,
around-the-clock opioid analgesic is needed for an extended period of
time.
LIMITATIONS OF USE
NUCYNTA
®
ER is not for use:

As an as-needed (prn) analgesic

For pain that is mild or not expected to persist for an extended
period of time

For acute pain

For postoperative
pain, unless the patient is already
receiving
chronic opioid
therapy prior to surgery, or if the postoperative pain is expected to
be
moderate to severe and persist for an extended period of time
DOSAGE AND
ADMINISTRATION

Individualize dosing based on patient’s prior analgesic treatment
experience, and
titrate as needed to provide adequate analgesia and minimize adverse
reactions

N