RITALIN SR TABLET 20 mg

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

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Herunterladen Gebrauchsinformation (PIL)
04-06-2014
Herunterladen Fachinformation (SPC)
11-03-2020

Wirkstoff:

METHYLPHENIDATE HCl

Verfügbar ab:

NOVARTIS (SINGAPORE) PTE LTD

ATC-Code:

N06BA04

Dosierung:

20 mg

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

METHYLPHENIDATE HCl 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

PATHEON WHITBY INC

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2000-06-01

Gebrauchsinformation

                                 
 
 
 
 
RITALIN

 
RITALIN

 SR 
RITALIN

 LA 
Psychostimulants. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM(S) 
Ritalin: Immediate-release tablet, divisible. 
Ritalin SR: Sustained-release tablet, non-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 SR tablet contains
20 mg methylphenidate hydrochloride. 
One Ritalin LA capsule contains 20 mg, 30 mg and 40
mg methylphenidate hydrochloride. 
ACTIVE MOIETY 
ACTIVE  SUBSTANCE:  Methylphenidate  (INN  for  alpha-phenyl-2-piperidine  acetic  acid  methyl 
ester). 
Certain dosage strengths and dosage forms may not be available in
all countries.  
EXCIPIENTS 
TABLET [10 MG]: calcium phosphate, lactose, wheat starch, gelatine, magnesium stearate, and 
talc.  
SR  TABLET  [20  MG]:  lactose,  cetostearyl  alcohol,  magnesium  stearate,  hydroxypropyl 
methylcellulose, polyoxyl 40 hydrogenated castor oil, titanium dioxide (E171), talc, carnauba 
wax, and fine black ink. 
LA CAPSULE [20 MG, 30 MG AND 40 MG]: ammonio methacrylate copolymer, black iron oxide 
(E172) (40 mg capsules only), gelatine, methacrylic acid copolymer, macrogol, red iron oxide 
(  E172)  (40  mg  capsules  only),  sugar  spheres,  talc,  titanium  dioxide  (E171),  triethyl  citrate, 
and yellow iron oxide (E172) (30 and 40 mg capsules only). 
Pharmaceutical formulations may vary between countries. 
 
INDICATIONS 
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD, DSM-IV)  
Ritalin/Ritalin  SR  is  indicated  in  the  treatment  of  Attention-Deficit/Hyperactivity  Disorder 
(ADHD) in children aged 6 years or older.  
Ritalin  LA  is  indicated  in  the  treatment  of  ADHD  in  children  age
                                
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Fachinformation

                                RITALIN

RITALIN
 SR
RITALIN
 LA
Psychostimulants.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Ritalin: Immediate-release tablet, divisible.
Ritalin SR: Sustained-release tablet, non-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 SR tablet contains 20 mg methylphenidate hydrochloride.
One Ritalin LA capsule contains 20 mg methylphenidate hydrochloride.
ACTIVE MOIETY
Methylphenidate (INN for alpha-phenyl-2-piperidine acetic acid methyl
ester).
EXCIPIENTS
TABLET [10 MG]:
calcium phosphate, lactose, wheat starch, gelatine, magnesium
stearate, and
talc.
SR
TABLET
[20
MG]:
lactose,
cetostearyl
alcohol,
magnesium
stearate,
hydroxypropyl
methylcellulose, polyoxyl 40 hydrogenated castor oil, titanium dioxide
(E171), talc, carnauba
wax, fine black ink.
LA
CAPSULE
[20
MG]:
ammonio
methacrylate
copolymer,
,
gelatine,
methacrylic
acid
copolymer, macrogol, , sugar spheres, talc, titanium dioxide (E171),
triethyl citrate.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD, DSM-IV)
Ritalin/Ritalin SR is indicated in the treatment of
Attention-Deficit/Hyperactivity Disorder
(ADHD) in children aged 6 years or older.
Ritalin LA is indicated in the treatment of ADHD 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 behavioral syndrome include: hyperkinetic
disorder, minimal brain
damage,
minimal
cerebral
dysfunction,
minor
cerebral
dysfunction
and
psycho-organic
syndrome of patients. Ritalin is indicated as part of a comprehensive
treatment program which
typically includes psychological, educational, and social measures and
is aimed at stabilizing
patients with a behavioral syndrome characterised by moderate to
severe distractibility, short
attention span, hyperactivity, emotional 
                                
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