CONCERTA EXTENDED-RELEASE TABLET 18 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Methylphenidate 15.57mg eqv Methylphenidate HCl

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

N06BA04

Dosage:

18mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Methylphenidate 15.57mg eqv Methylphenidate HCl 18mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

JANSSEN-CILAG MANUFACTURING, LLC

Authorization status:

ACTIVE

Authorization date:

2002-10-11

Patient Information leaflet

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

Summary of Product characteristics

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 following symptoms must
have persisted for at least 6
months, lack of attention to details/careless mistakes; lack of
sustained attention; poor listener;
failure to follow through on tasks; poor organization; avoids tasks
requiring sustained mental
effort; loses things; easily distracted; forgetful. For the
Hyperactive-Impulsive Type, at least six
of the following symptoms must have persisted for at least 6 months;
fidgeting/squirming;