Concerta Extended Release Tablets

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Methylphenidate hydrochloride 27mg

Pieejams no:

Janssen-Cilag (New Zealand) Ltd

SNN (starptautisko nepatentēto nosaukumu):

Methylphenidate hydrochloride 27 mg

Deva:

27 mg

Zāļu forma:

Modified release tablet

Kompozīcija:

Active: Methylphenidate hydrochloride 27mg Excipient: Butylated hydroxytoluene Cellulose acetate Hypromellose Caranuba Wax Iron oxide black Iron oxide red Iron oxide yellow Opacode black NS-78-17715 Opadry Clear YS-1-19025-A Opadry grey Y-30-17528 Phosphoric acid Poloxamer Polyethylene oxide Povidone Sodium chloride Stearic acid Succinic acid

Vienības iepakojumā:

Bottle, plastic, HDPE botle with polypropylene screw on CRC 28 tablets, 28 tablets

Klase:

Class B2 Controlled Drug

Receptes veids:

Class B2 Controlled Drug

Ražojis:

Janssen Pharmaceuticals Inc

Ārstēšanas norādes:

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. 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.

Produktu pārskats:

Package - Contents - Shelf Life: Bottle, plastic, HDPE botle with polypropylene screw on CRC - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE botle with polypropylene screw on CRC - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE botle with polypropylene screw on CRC - 56 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE botle with polypropylene screw on CRC - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE botle with polypropylene screw on CRC - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2005-12-23

Lietošanas instrukcija

CONCERTA
®
(230516) ACMI
1
CONCERTA
®
_EXTENDED-RELEASE TABLETS _
_Methylphenidate hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CONCERTA
extended-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
extended 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

Produkta apraksts

16.230215
1
CONCERTA(230516)ADS
CONCERTA
®
DATA SHEET
1.
PRODUCT NAME
CONCERTA

Extended – Release Tablets 18 mg methylphenidate hydrochloride
modified release tablet
CONCERTA

Extended – Release Tablets 27 mg methylphenidate hydrochloride
modified release tablet
CONCERTA

Extended – Release Tablets 36 mg methylphenidate hydrochloride
modified release tablet
CONCERTA

Extended – Release Tablets 54 mg methylphenidate hydrochloride
modified release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One extended release tablet contains 18 mg, 27 mg, 36 mg or 54 mg of
methylphenidate hydrochloride.
Excipient(s) with known effect:
Lactose
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
CONCERTA is available as an extended-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.
CONCERTA 18 mg are yellow capsule-shaped tablets, with “alza 18”
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 27 mg are grey capsule-shaped tablets, with “alza 27”
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.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
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.
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