CONCERTA EXTENDED-RELEASE TABLET 36 mg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Methylphenidate 31.13mg eqv Methylphenidate HCl

Fáanlegur frá:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC númer:

N06BA04

Skammtar:

36mg

Lyfjaform:

TABLET, FILM COATED

Samsetning:

Methylphenidate 31.13mg eqv Methylphenidate HCl 36mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

JANSSEN-CILAG MANUFACTURING, LLC

Leyfisstaða:

ACTIVE

Leyfisdagur:

2002-10-11

Upplýsingar fylgiseðill

1 
PRODUCT NAME 
CONCERTA
®
 (methylphenidate hydrochloride)

DOSAGE FORMS AND STRENGTHS 

Extended-release tablets:  

18 MG TABLET 
Capsule-shaped  yellow  tablet  with  “alza  18”  printed  on  one  side  in  black  ink.  Each  tablet 
contains 18 mg of methylphenidate hydrochloride. 

27 MG TABLET 
Capsule-shaped gray tablet with “alza 27” printed on one side in black ink. Each tablet contains 
27 mg of methylphenidate hydrochloride. 

36 MG TABLET 
Capsule-shaped white tablet with “alza 36” printed on one side in black ink. Each tablet contains 
36 mg of methylphenidate hydrochloride. 

54 MG TABLET 
Capsule-shaped brownish-red tablet with “alza 54” printed on one side in black ink. Each tablet 
contains 54 mg of methylphenidate hydrochloride. 

For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 

INDICATIONS

CONCERTA
®
  is  indicated  for  the  treatment  of  Attention  Deficit  Hyperactivity  Disorder 
(ADHD). The efficacy of CONCERTA
®
 in the treatment of ADHD was established in controlled 
trials of children and adolescents aged 6 to 17 and adults
aged 18 to 65 who met DSM-IV criteria 
for ADHD. 

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence 
of  hyperactive-impulsive  or  inattentive  symptoms  that  caused  impairment  and  were  present 
before  age  7  years.    The  symptoms  must  cause  clinically  significant  impairment,  eg,  in  social, 
academic,  or  occupational  functioning,  and  be  present  in  two  or  more  settings,  eg,  school  (or 
work) and at home. The symptoms must not be better accounted for by another mental disorder. 
For the Inattentive type, at least six of the followi

Vara einkenni

1
PRODUCT NAME
CONCERTA
®
(methylphenidate hydrochloride)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets:
18 MG TABLET
Capsule-shaped yellow tablet with “alza 18” printed on one side in
black ink. Each tablet
contains 18 mg of methylphenidate hydrochloride.
27 MG TABLET
Capsule-shaped gray tablet with “alza 27” printed on one side in
black ink. Each tablet contains
27 mg of methylphenidate hydrochloride.
36 MG TABLET
Capsule-shaped white tablet with “alza 36” printed on one side in
black ink. Each tablet contains
36 mg of methylphenidate hydrochloride.
54 MG TABLET
Capsule-shaped brownish-red tablet with “alza 54” printed on one
side in black ink. Each tablet
contains 54 mg of methylphenidate hydrochloride.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
CONCERTA
®
is
indicated
for
the
treatment
of
Attention
Deficit
Hyperactivity
Disorder
(ADHD). The efficacy of CONCERTA
®
in the treatment of ADHD was established in controlled
trials of children and adolescents aged 6 to 17 and adults aged 18 to
65 who met DSM-IV criteria
for ADHD.
CONCERTA
®
should be used as a part of a comprehensive treatment program where
remedial
measures alone prove insufficient. A comprehensive treatment program
for the treatment of
ADHD may include other measures (psychological, educational, social)
for patients with this
disorder. Diagnosis must be made according to the current DSM criteria
or ICD guidelines.
CONCERTA
®
treatment is not indicated in all patients with ADHD and the decision
to use the
drug must be based on a very thorough assessment of the severity of
the patient’s symptoms.
Stimulants
are
not
intended
for
use
in
the
patient
who
exhibits
symptoms
secondary
to
environmental
factors
and/or
other
primary
psychiatric
disorders,
including
psychosis.
Appropriate educational placement is essential, and psychosocial
intervention is often helpful.
Specific etiology of this syndrome is unknown, and there is no single
diagnostic test. Adequate
diagnosis
requires
the
use
of
medica