RITALIN 10 methylphenidate hydrochloride 10 mg tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

methylphenidate hydrochloride, Quantity: 10 mg

Հասանելի է:

Novartis Pharmaceuticals Australia Pty Ltd

Դեղագործական ձեւ:

Tablet, uncoated

Կազմը:

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

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

100

Ռեկվիզորի տեսակը:

(S8) Controlled Drug

Թերապեւտիկ ցուցումներ:

Ritalin 10 tablets and Ritalin LA capsules are indicated for the treatment of ADHD. Ritalin 10 tablets are also indicated for the treatment of narcolepsy. 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. Ritalin 10 / Ritalin LA are indicatedas 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.

Ապրանքի ամփոփագիր:

Visual Identification: Round white tablets marked CG on one side and AB with a break-line on the other, diameter ca. 7.1mmthickness ca. 2.6mm.; 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

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

1991-08-02

Տեղեկատվական թերթիկ

RITALIN
® 10
_methylphenidate hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ritalin 10 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 RITALIN 10 IS
USED FOR
Ritalin 10 tablets contain the active
ingredient methylphenidate
hydrochloride. Methylphenidate
hydrochloride is a central nervous
system stimulant.
Ritalin 10 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.
Ritalin 10 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 medicin

Ապրանքի հատկությունները

1
_ _
AUSTRALIAN
PRODUCT
INFORMATION
RITALIN
®
10/RITALIN
®
LA
(METHYLPHENIDATE)
_DRUG DEPENDENCE: Ritalin 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
Ritalin 10 contain methylphenidate hydrochloride 10 mg.
Ritalin LA modified release capsules contain 10 mg, 20 mg, 30 mg, 40
mg or 60 mg of
methylphenidate hydrochloride.
Ritalin 10 contains lactose, sugars, milk products, lactitol, gluten
and sulfur dioxide.
Ritalin LA contains sucrose.
For the full list of the excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Ritalin 10 tablets are immediate release white tablets that are scored
and marked AB and
CG on the reverse.
Ritalin LA are modified release capsules that presented as follows:
10 mg cotaining white to off-white beads in a light brown opaque hard
gelatin capsule
with the imprint of NVR on the cap and R10 on a white opaque body in
tan-coloured ink.
20 mg containing white to off-white beads in a white opaque hard
gelatin capsule with
imprint NVR on the cap and R20 on body in tan-coloured ink.
30 mg containing white to off-white beads in a yellow opaque hard
gelatin capsule with
the imprint NVR on cap and R30 on body in tan-coloured ink.
40 mg containing white to off-white beads in a light brown opaque hard
gelatin capsule
with the imprint NVR on cap and R40 on body in tan-coloured ink.
60 mg containing white to off-white beads in a light brown opaque cap
and a yellow
opaque body hard gelatin capsule with imprint NVR on cap and R60 on
body in