Ritalin SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Methylphenidate hydrochloride 20mg;  ;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Methylphenidate hydrochloride 20 mg

Dosage:

20 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Methylphenidate hydrochloride 20mg     Excipient: Carbon dioxide Carnauba wax Cetostearyl alcohol Hypromellose Ink Lactose monohydrate Magnesium stearate Methylated spirits Polyethylene glycol hydrogenated castor oil Purified talc Purified water Titanium dioxide

Units in package:

Blister pack, 30 tablets

Class:

Class B2 Controlled Drug

Prescription type:

Class B2 Controlled Drug

Manufactured by:

Ipca Laboratories Limited

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: Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, - 120 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, - 200 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1997-12-15

Patient Information leaflet

RITALIN
®
tablets
1
RITALIN
® TABLET
_METHYLPHENIDATE HYDROCHLORIDE _
_10 mg immediate release tablets _
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ritalin 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.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 IS USED
FOR
Ritalin tablets contain the active
ingredient methylphenidate
hydrochloride. Methylphenidate
hydrochloride is a central nervous
system stimulant. Like all medicines
containing central nervous system
stimulants, Ritalin will be given to
you only under close medical
supervision and after diagnosis.
Ritalin tablets have two uses. They
are used to treat:
•
Attention Deficit Hyperactivity
Disorder (ADHD); and
•
Narcolepsy
Your doctor may have prescribed it
for another purpose.
THIS MEDICINE SHOULD NOT BE USED
TO PREVENT OR TREAT NORMAL FATIGUE.
_ADHD _
ADHD or hyperkinetic disorder is 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.

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
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 includ