ARTIGE methylphenidate hydrochloride 10mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

methylphenidate hydrochloride, Quantity: 10 mg

Mevcut itibaren:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Adı):

methylphenidate hydrochloride

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: magnesium stearate; calcium phosphate; purified talc; lactose monohydrate; wheat starch; Gelatin

Uygulama yolu:

Oral

Paketteki üniteler:

100 tablets

Reçete türü:

(S8) Controlled Drug

Terapötik endikasyonlar:

Treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Treatment of Narcolepsy.

Ürün özeti:

Visual Identification: White, round, flat, with bevelled edges. One side bears the imprint "CG", the other "A/B" and a score.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2005-06-02

Bilgilendirme broşürü

ARTIGE
®
_methylphenidate hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Artige tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
this medicine against the benefits
they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ARTIGE IS USED
FOR
Artige tablets contain the active
ingredient methylphenidate
hydrochloride. Methylphenidate
hydrochloride is a central nervous
system stimulant.
Artige tablets have two uses. They
are used to treat:
•
Attention Deficit Hyperactivity
Disorder (ADHD); and
•
narcolepsy, a sleep-attack
disorder.
Your doctor may have prescribed it
for another purpose.
THIS MEDICINE SHOULD NOT BE USED
TO PREVENT OR TREAT NORMAL FATIGUE.
_ADHD_
About 3% of children suffer from
ADHD. It makes them unable to sit
still or concentrate on tasks for any
length of time. They may have
trouble learning and doing school
work. They frequently become
difficult to manage, both in school
and at home.
Artige is thought to work by
regulating specific chemicals in the
brain that affect behaviour. It helps to
focus attention, shut out distraction
and allows impulsive people to think
before they act. If successful, it will
enhance an inattentive person's
natural ability.
This medicine is part of a treatment

Ürün özellikleri

1
_ _
AUSTRALIAN PRODUCT INFORMATION ARTIGE
®
(METHYLPHENIDATE)
_DRUG DEPENDENCE: Artige 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. _
1
NAME OF THE MEDICINE
Methylphenidate hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Artige contain methylphenidate hydrochloride 10 mg.
Artige contains lactose, sugars, milk products, lactitol, gluten and
sulfur dioxide.
For the full list of the excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Artige tablets are immediate release white tablets that are scored and
marked AB and CG
on the reverse.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
ADHD was previously known as attention-deficit disorder. Other terms
used to describe
this behavioural syndrome include: minimal brain dysfunction in
children, hyperkinetic
child syndrome, minimal brain damage, minimal cerebral dysfunction,
minor cerebral
dysfunction and psycho-organic syndrome of children.
Artige are 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.
SPECIAL DIAGNOSTIC CONSIDERATIONS FOR ADHD IN CHILDREN
The aetiology of this syndrome is unknown and there is no single
diagnostic test.
Adequate diagnosis requires the use, not only of medical, but also of
psychological,
educational and social resources. C