Ritalin LA

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Methylphenidate hydrochloride 40mg;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Methylphenidate hydrochloride 40 mg

Dosage:

40 mg

Pharmaceutical form:

Modified release capsule

Composition:

Active: Methylphenidate hydrochloride 40mg   Excipient: Ammonio methacrylate copolymer Gelatin Methacrylic acid copolymer type A -/Methacryllic acid-methacrylate coplymer 1:1 Dry powder Iron oxide black Iron oxide red Iron oxide yellow Macrogol 6000 Purified talc Sugar spheres Titanium dioxide Triethyl citrate

Units in package:

Bottle, plastic, HDPE,, 30 capsules

Class:

Class B2 Controlled Drug

Prescription type:

Class B2 Controlled Drug

Manufactured by:

Corden Pharma Bergamo SpA

Therapeutic indications:

Ritalin/Ritalin SR is indicated in the treatment of Attention-Deficit/Hyperactivity Disorder in children aged 6 years or older. Ritalin LA is indicated in the treatment of Attention-Deficit/Hyperactivity Disorder in children aged 6 years or older and in adults. Ritalin/Ritalin SR is indicated for the treatment of narcolepsy in adults. Symptoms include daytime sleepiness, inappropriate sleep episodes, and sudden loss of voluntary muscle tone.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, - 30 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, - 100 capsules - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2001-03-14

Patient Information leaflet

__________________________________________________________________________________________________
Ritalin

LA
1
RITALIN

LA
_METHYLPHENIDATE HYDROCHLORIDE _
_10, 20, 30, 40 and 60 mg capsules_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
_____________________
WHAT IS IN THIS LEAFLET
______________________
This leaflet answers some common
questions about Ritalin LA (long-
acting) capsules
.
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.MEDSAFE.GOVT.NZ.
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 LA IS
USED FOR
______________________
Ritalin LA contains the active
ingredient methylphenidate
hydrochloride. Methylphenidate
hydrochloride is a central nervous
system stimulant.
Ritalin LA capsules are used to treat
Attention Deficit Hyperactivity
Disorder (ADHD) or hyperkinetic
disorder, a behavioural disorder in
children, adolescents, and adults.
About 3 % of children suffer from
ADHD, which 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.
Adults with ADHD often find it hard
to concentrate. They oft

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Novartis New Zealand Limited
Page 1
1.
PRODUCT NAME
RITALIN
®
10 mg Tablets
RITALIN
®
LA 10mg, 20 mg, 30 mg, 40 and 60 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
The active substance is methylphenidate hydrochloride (INN for
alpha-phenyl-2-piperidine
acetic acid methyl ester).
Ritalin tablet contains 10 mg methylphenidate hydrochloride.
Ritalin LA capsule contains 10mg, 20 mg, 30 mg, 40 mg, and 60 mg
methylphenidate
hydrochloride.
3.
PHARMACEUTICAL FORM
TABLET 10 MG:
Immediate release 10mg tablets (divisible). A round, flat, white table
with slightly bevelled
edges containing 10mg methylphenidate. Tablet diameter is approx. 7mm
and is imprinted CG
on one side and A/B, with a score on the other.
LA CAPSULE 10 MG:
Modified-release hard capsule. White to off white beads in a light
brown and white capsule with
imprint NVR and R10 in tan-coloured ink.
LA CAPSULE 20 MG:
Modified-release hard capsule. White to off-white beads in a white
capsule with imprint NVR
and R20 in tan-coloured ink.
LA CAPSULE 30 MG:
Modified-release hard capsule. White to off-white beads in a yellow
capsule with imprint NVR
and R30 in tan-coloured ink.
LA CAPSULE 40 MG:
Modified-release hard capsule. White to off-white beads in a light
brown capsule with imprint
NVR and R40 in tan-coloured ink.
LA CAPSULE 60 MG:
Modified-release hard capsule. White to off-white beads in a light
brown capsule with imprint
NVR and R60 in tan-coloured ink.
NEW ZEALAND DATA SHEET
Novartis New Zealand Limited
Page 2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.1
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD, DSM-IV)
Ritalin is indicated in the treatment of
Attention-Deficit/Hyperactivity Disorder in children aged
6 years or older.
Ritalin LA is indicated in the treatment of
Attention-Deficit/Hyperactivity Disorder in children
aged 6 years or older and in adults.
ADHD was previously known as attention-deficit disorder or minimal
brain dysfunction. Other
terms used to describe this behavioural syndrome in