RITALIN TABLET 10MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

METHYLPHENIDATE HYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

METHYLPHENIDATE HYDROCHLORIDE

Unit dalam pakej:

100Tablet Tablets; 30Tablet Tablets; 200Tablet Tablets; 30 Tablet Tablets

Dikeluarkan oleh:

NOVARTIS FARMACEUTICA S.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
RITALIN
® TABLET
Methylphenidate Hydrochloride
(10mg)
RITALIN
® LA CAPSULE
Methylphenidate Hydrochloride (20 mg, 30 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Ritalin is used for
2.
How Ritalin works
3.
Before you use Ritalin
4.
How to use Ritalin
5.
While you are using Ritalin
6.
Side effects
7.
Storage and Disposal of Ritalin
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT RITALIN IS USED FOR
Ritalin is used for the treatment of
attention-deficit/hyperactivity disorder
(ADHD).
About 3% of children suffer from this
disorder, which makes them unable to sit
still and/or concentrate on tasks for any
length of time. Children with this disorder
may have difficulty in learning and doing
schoolwork. They may frequently become
difficult to manage both in school and at
home. Adults with ADHD often find it
hard to concentrate.
Ritalin is part of an ADHD treatment
program which will usually also include
psychological, educational and social
therapy.
Ritalin is also used for the treatment of
narcolepsy (Ritalin tablets only).
Narcolepsy is a sleep-attack disorder.
People with narcolepsy experience
recurring attacks of irresistible day-time
sleepiness despite adequate night-time
sleep. Ritalin LA capsules are not used to
treat narcolepsy.
HOW RITALIN WORKS
ADHD
Ritalin works by improving the activity of
certain parts of the brain which are
underactive. Ritalin improves attention and
concentration, and reduces impulsive
behavior.
Narcolepsy
Ritalin relieves excessive day-time
sleepiness in people suffering from
narcolepsy.
BEFORE YOU USE RITALIN_ _
Ritalin will only be prescribed by a doctor.
Follow all the doctor’s instructions
carefully, even if they differ from the
general information contained in this
leaflet.
_- When you must not use it _
•
are allergic (hypersensitive) to
methylphenidate or to any of the other
ingredients of Ritalin listed at the end
of this leaflet. If you think you may be
allergic, ask your doctor f

Ciri produk

Novartis
Page 2
Malaysian Package Leaflet
20-Jan-2020
Ritalin, Ritalin LA
RITALIN

RITALIN
 LA
Psychostimulants.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Ritalin: Immediate-release tablet, divisible.
Ritalin LA: Modified-release capsule, hard.
ACTIVE SUBSTANCE
The active substance is methylphenidate hydrochloride.
One Ritalin tablet contains 10 mg methylphenidate hydrochloride.
One Ritalin LA capsule contains 20 mg and 30 mg methylphenidate
hydrochloride.
ACTIVE MOIETY
Methylphenidate (INN for alpha-phenyl-2-piperidine acetic acid methyl
ester).
DESCRIPTION
RITALIN 10MG TABLETS
White, round, flat, with beveled edges. One side bears the imprint
“CG”, the other “A/B” and
score. May contain dark specks.
RITALIN LA 20MG MODIFIED RELEASE CAPSULE
White to off-white beads in a white opaque hard gelatin capsule with
imprint ‘NVR’ on the cap
and ‘R20’ on the body in tan-coloured ink.
RITALIN LA 30MG MODIFIED RELEASE CAPSULE
White to off-white beads in a yellow opaque hard gelatin capsule with
imprint ‘NVR’ on the
cap and ‘R30’ on the body in tan-coloured ink.
EXCIPIENTS
RITALIN TABLET [10 MG]:
calcium phosphate, lactose, wheat starch, gelatin, magnesium stearate,
talc.
RITALIN
LA
CAPSULE
[20
MG
AND
30
MG]:
ammonio
methacrylate
copolymer,
gelatin,
methacrylic acid copolymer, macrogol, sugar spheres, talc, titanium
dioxide (E171), triethyl
citrate, yellow iron oxide (E172) (30 capsules only).
Novartis
Page 3
Malaysian Package Leaflet
20-Jan-2020
Ritalin, Ritalin LA
INDICATIONS
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
behavioral 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