CONCERTA methylphenidate hydrochloride 27mg modified release tablet bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

methylphenidate hydrochloride, Quantity: 27 mg

Dostupno od:

Janssen-Cilag Pty Ltd

INN (International ime):

methylphenidate hydrochloride

Farmaceutski oblik:

Tablet, modified release

Sastav:

Excipient Ingredients: cellulose acetate; polyethylene oxide; butylated hydroxytoluene; stearic acid; succinic acid; iron oxide red; poloxamer; Carnauba Wax; hypromellose; sodium chloride; phosphoric acid; povidone; iron oxide yellow; iron oxide black; titanium dioxide; lactose monohydrate; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water

Administracija rute:

Oral

Jedinice u paketu:

30 tablets, 100 tablets, 60 tablets, 28 tablets, 56 tablets

Tip recepta:

(S8) Controlled Drug

Terapijske indikacije:

CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist.,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.,Need for comprehensive treatment programme CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. 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. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,Long term use The effectiveness of CONCERTA for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use CONCERTA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Proizvod sažetak:

Visual Identification: Grey capsule-shaped tablet with "alza 27" printed in black ink on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Licence status A

Datum autorizacije:

2006-08-07

Uputa o lijeku

CONCERTA
®
(211021) ACMI
1
CONCERTA
®
_MODIFIED RELEASE TABLETS _
_Methylphenidate hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CONCERTA
modified release tablets. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
CONCERTA against the benefits this
medicine is expected to have for you
or your child.
If you have any concerns about
taking CONCERTA ask your doctor
or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT IS CONCERTA
USED FOR
CONCERTA is used to treat
Attention Deficit Hyperactivity
Disorder (ADHD). CONCERTA is
part of a comprehensive treatment
program which usually includes
psychological, educational and social
therapy.
CONCERTA is a stimulant that
increases attention and decreases
impulsiveness and hyperactivity in
patients with ADHD.
CONCERTA should be used as part
of a total treatment program for
ADHD that may include counselling
or other therapies.
CONCERTA is not recommended
for use in children less than 6 years
and elderly over 65 years because it
has not been studied in these age
groups.
CONCERTA tablets are made in an
modified release form. This means
that they release the active ingredient
slowly. The outer layer of the
CONCERTA tablet dissolves right
after it is swallowed in the morning,
giving an initial dose of
methylphenidate hydrochloride.
The tablets have a special shell that
allows the rest of the
methylphenidate hydrochloride to be
released from the tablet at a slow rate
throughout the day.
The tablet shell does not dissolve
completely after all the drug has been
released and sometimes the tablet
shell may be seen in your stool. This
is normal.
YOUR DOCTOR MAY HAVE PRESCRIBED
CONCERTA FOR ANOTHER REASON.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU/YOUR
CHILD.
CON

Svojstava lijeka

CCDSv14 210719
Page 1 of 18
CONCERTA (211021) API
AUSTRALIAN PRODUCT INFORMATION
CONCERTA
®
(METHYLPHENIDATE HYDROCHLORIDE)
MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Methylphenidate hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CONCERTA is available as a modified-release tablet for once-a-day oral
administration
containing 18, 27, 36 or 54 mg methylphenidate hydrochloride. It is
designed to have a 12-
hour duration of effect.
Excipient(s) with known effect:
lactose
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CONCERTA 18 mg are yellow capsule-shaped tablets, with “alza 18”
printed in black ink on
one side.
CONCERTA 27 mg are grey capsule-shaped tablets, with “alza 27”
printed in black ink on one
side.
CONCERTA 36 mg are white capsule-shaped tablets, with “alza 36”
printed in black ink on
one side.
CONCERTA 54 mg are brownish-red capsule-shaped tablets, with “alza
54” printed in black
ink on one side.
DRUG DEPENDENCE: CONCERTA should be given cautiously to patients with
a history
of drug dependence or alcoholism. Chronic abusive use can lead to
marked tolerance and
psychological dependence with varying degrees of abnormal behaviour.
Frank psychotic
episodes can occur, especially with parenteral abuse. Careful
supervision is required
during withdrawal from abusive use since severe depression may occur.
Withdrawal
following chronic therapeutic use may unmask symptoms of the
underlying disorder that
may require follow-up.
Product Information - Australia
CCDSv14 210719
Page 1 of 18
CONCERTA (211021) API
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
CONCERTA is indicated for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
Treatment should be commenced by a specialist.
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.
NEED FOR COMPREHENSIVE TREATMENT PROGRAMME
CONCERTA is indica