CONCERTA 36 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METHYLPHENIDATE HYDROCHLORIDE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

N06BA04

الشكل الصيدلاني:

TABLETS EXTENDED RELEASE

تركيب:

METHYLPHENIDATE HYDROCHLORIDE 36 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JANSSEN-CILAG MANUFACTURING, L.L.C, USA

المجموعة العلاجية:

METHYLPHENIDATE

المجال العلاجي:

METHYLPHENIDATE

الخصائص العلاجية:

Concerta is indicated for the treatment of Attention deficit hyperactivity disorder (ADHD).

تاريخ الترخيص:

2022-11-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed
with a doctor’s prescription only
CONCERTA
®
,
PROLONGED-RELEASE TABLETS
Each
CONCERTA
18
MG
tablet
contains
Methylphenidate Hydrochloride 18 mg
Each
CONCERTA
27
MG
tablet
contains
Methylphenidate Hydrochloride 27 mg
Each
CONCERTA
36
MG
tablet
contains
Methylphenidate Hydrochloride 36 mg
Each
CONCERTA
54
MG
tablet
contains
Methylphenidate Hydrochloride 54 mg
Inactive and allergenic ingredients in the
preparation – see section 6 ”Further Information“.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you.
Do not pass it on to others. It may harm them
even if it seems to you that their medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Concerta is intended for the treatment of
Attention Deficit Hyperactivity Disorder )ADHD(
in children over the age of 6, adolescents and
adults up to the age of 65.
Concerta can improve the attention and
concentration and reduce impulsiveness and
hyperactivity in individuals with ADHD.
Concerta is supposed to be given as part of
an ADHD treatment program that can include
consultation or other therapies.
THERAPEUTIC GROUP: Central nervous system
stimulant
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD:
• is sensitive )allergic( to the active ingredient
)methylphenidate hydrochloride( or to any
of the additional ingredients contained
in the medicine )see section 6 – ”Further
Information“(.
• is very anxious, mentally tense, or agitated
)suffers from restlessness – agitation(
• has an eye problem called glaucoma
)increased intraocular pressure(
• has tics or Tourette’s syndrome, or a family
history of Tourette’s syndrome. Tics are
involuntary repeated movements or sounds.
• is taking or has taken within

خصائص المنتج

1
CONCERTA
®
(METHYLPHENIDATE HCL) EXTENDED-RELEASE ORAL TABLETS
18,27,36,54 MG
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
CONCERTA
is indicated for the treatment of
Attention
Deficit Hyperactivity
Disorder (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, e.g., in social, academic, or
occupational functioning,
and be
present
in two or
more settings, e.g., 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;
leaving
seat;
inappropriate
running/climbing;
difficulty
with
quiet
activities;
“on
the
go;”
excessive
talking;
blurting
answers;
can’t
wait
turn;
intrusive.
The
Combined
Type
requires
both
inattentive and hyperactive-impulsive criteria to be met.
1.1 SPECIAL DIAGNOSTIC CONSIDERATIONS
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. The diagnosis
must be based upon a complete history and evaluation of the patient
and not solely
on the presence of the required number of DSM-IV characteristics.
1.2 NEED FOR COMPREHENSIVE TREATMENT PROGRAM
CONCERTA
is indicated as an integral part of a total treatment program for ADHD
WARNING: DRUG DEPENDENCE
CONCERTA
SHOULD BE GIVEN CAUTIOU