CONCERTA 36 mg Extended-release Tablet

देश: मलेशिया

भाषा: अंग्रेज़ी

स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

सक्रिय संघटक:

METHYLPHENIDATE HYDROCHLORIDE

थमां उपलब्ध:

JOHNSON & JOHNSON SDN BHD

INN (इंटरनेशनल नाम):

METHYLPHENIDATE HYDROCHLORIDE

पैकेज में यूनिट:

30Tablet Tablets

द्वारा बनाया गया:

JANSSEN CILAG MANUFACTURING L.L.C

सूचना पत्रक

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CONCERTA
® EXTENDED RELEASE TABLETS
Methylphenidate hydrochloride (18mg, 27mg, 36mg)
1
WHAT IS IN THIS LEAFLET
1.
What CONCERTA
®
is used for
2.
How CONCERTA
®
works
3.
Before you use CONCERTA
®
4.
How to use CONCERTA
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
CONCERTA
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT CONCERTA
® IS USED FOR
CONCERTA
®
is used for the
treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in
children and adolescents aged 6 to 17
and adults aged 18 to 65 years old.
HOW CONCERTA
® WORKS
CONCERTA
®
improves the activity of
certain parts of the brain which are
under-active. The medicine can help
improve attention (attention span),
concentration and reduce impulsive
behavior.
The medicine is given as part of a
treatment program, which usually
includes:
•
psychological
•
education and
•
social therapy
Although there is no cure for ADHD,
it can be managed using treatment
programs.
BEFORE YOU USE CONCERTA
®
-
_When you must not use it _
You should not take CONCERTA
®
if you:
•
Are allergic to methylphenidate or
any of the other ingredients in
CONCERTA® (see
_PRODUCT _
_DESCRIPTION_
).
•
Have glaucoma, an eye disease.
•
Are being treated or recently been
treated with monoamine oxidase
(MAO) inhibitor medicines
within 14 days.
•
Take CONCERTA
®
for severe
depression and/or for the
prevention or treatment of normal
fatigue states.
•
Use in children under 6 years old.
_ _
-
_Before you start to use it _
Talk to your doctor
_before _
or while
taking CONCERTA
®
if you:
•
Have a heart defect.
•
Have medical conditions related
to blood pressure and heart rate
•
Have tics (movements or sounds
that you cannot control) or
Tourette’s syndrome, or if
someone in your family has tics
or Tourette’s syndrome.
•
Have a serious mental health
problem.
•
Have history of seizures.
•
Have a problem with the blood
vessels in your brai

उत्पाद विशेषताएं

1
PRODUCT NAME
CONCERTA
®
FOR SPECIALIST’S USE ONLY
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.
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 medical and special
psychological, educational,
and social resources. Learning may or may not be impaired.
2
DOSAGE AND ADMINISTRATION
DOSAGE
PATIENTS NEW TO METHYLPHENIDATE
The recom