Rubifen

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Methylphenidate hydrochloride 10mg;  

MAH:

AFT Pharmaceuticals Ltd

INN:

Methylphenidate hydrochloride 10 mg

dosage:

10 mg

pharmaceutical_form:

Tablet

composition:

Active: Methylphenidate hydrochloride 10mg   Excipient: Calcium hydrogen phosphate dihydrate Magnesium stearate Maize starch Microcrystalline cellulose

units_in_package:

Blister pack, PVC/Al 30, 30 tablets

class:

Class B2 Controlled Drug

prescription_type:

Class B2 Controlled Drug

manufactured_by:

Ipca Laboratories Limited

leaflet_short:

Package - Contents - Shelf Life: Blister pack, PVC/Al 30 - 30 tablets - 24 months from date of manufacture stored at or below 25°C

authorization_date:

1999-10-14

PIL

RUBIFEN
1
RUBIFEN
_METHYLPHENIDATE HYDROCHLORIDE_
Immediate release tablets
Slow-release tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Rubifen.
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 Rubifen against the benefits they expect it will
have.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT RUBIFEN IS USED FOR
RUBIFEN
IS
USED
TO
TREAT
A
BEHAVIOURAL
DISORDER
CALLED
ATTENTION DEFICIT
HYPERACTIVITY DISORDER (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 schoolwork. They frequently become difficult to manage, both in
school
and at
home.
Rubifen
is
a
central
nervous
system
stimulant.
It
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.
RUBIFEN
2
Rubifen
is
part
of
a
treatment
program
that
usually
includes
psychological,
educational, and social therapy.
RUBIFEN IS ALSO USED TO TREAT NARCOLEPSY, A SLEEP-ATTACK DISORDER.
People with narcolepsy have recurring attacks of irresistible daytime
sleepiness
in
spite of having enough sleep at night. A doctor can diagnose
narcolepsy by
recording
wake-sleep patterns.
Narcolepsy is not a normal fatigue state. Rubifen should not be used
to prevent
or
treat normal fatigue.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY RUBIFEN HAS BEEN
PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it
for another
reason.
This
medicine
is
only
available
with
a doctor's
prescription
and
your doctor
has
special permission to prescribe i

SPC

Page 1 of 17
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Rubifen: Methylphenidate hydrochloride (USP) 5 mg, 10 mg and 20 mg
Rubifen SR
:
Methylphenidate hydrochloride (USP) 20 mg sustained release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mg tablet contains methylphenidate 5mg
Each 10mg tablet contains methylphenidate 10mg
Each 20mg tablet contains methylphenidate 20mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Rubifen immediate release 5, 10 and 20 mg tablets: round white tablet
with slightly bevelled edges,
marked RU-5, RU-10 or RU-20 containing 5 mg, 10 mg and 20 mg
methylphenidate respectively with
a score mark on the 10 mg tablets.
Rubifen sustained release 20 mg tablets: oblong white or white-cream
smooth tablet containing 20 mg
methylphenidate in a modified release formulation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD)_
ADHD was previously known as attention-deficit disorder or minimal
brain dysfunction. Other terms
used to describe this behavioural syndrome include: hyperkinetic
disorder, minimal brain damage,
minimal cerebral dysfunction, minor cerebral dysfunction and
psycho-organic syndrome of children.
Rubifen
is
indicated
as
part
of
a
comprehensive
treatment
program
which
typically
includes
psychological, educational and social measures and is aimed at
stabilising children with a behavioural
syndrome
characterised
by
moderate
to
severe
distractibility,
short
attention
span,
hyperactivity,
emotional lability and impulsivity. The diagnosis should be made
according to DSM-IV criteria or the
guidelines in ICD-10. Non-localising (soft) neurological signs,
learning disability and abnormal EEG
may or may not be present, and a diagnosis of central nervous system
dysfunction may or may not be
warranted.
_SPECIAL DIAGNOSTIC CONSIDERATIONS FOR ADHD_
The specific etiology of this syndrome is unknown, and there is no
single diagnostic test. Proper
diagnosis
requires
medical
and
neuropsychological,
educational
and
soc