RITALIN TABLET 10 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

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Active ingredient:

METHYLPHENIDATE HCl

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

N06BA04

Dosage:

10 mg

Pharmaceutical form:

TABLET

Composition:

METHYLPHENIDATE HCl 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Siegfried Barbera S.L

Authorization status:

ACTIVE

Authorization date:

1989-06-29

Patient Information leaflet

                                 
 
 
 
 
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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Summary of Product characteristics

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RITALIN

RITALIN

LA
Psychostimulants.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Ritalin: Immediate-release tablet, divisible, white, round, flat, with
bevelled edges. One side
bears the imprint “CG”, the other “A/B” and score
The tablet can be divided into equal doses.
Ritalin LA 20mg: Modified-release capsule, hard, white opaque gelatin
capsule, imprinted with
“NVR” on the cap and “R20” on the body, containing white to
off-white beads that are roughly
spherical in shape.
ACTIVE SUBSTANCE
The active substance is methylphenidate hydrochloride.
One Ritalin tablet contains 10 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 tribasic, gelatin, lactose monohydrate, magnesium
stearate,
talc and wheat starch.
LA CAPSULE [20 MG]:
ammonio methacrylate copolymer type B, methacrylic acid copolymer
type A/methacrylic acid – methyl methacrylate copolymer 1:1,
polyethylene glycol 6000
/macrogol 6000, sugar spheres (25/30 mesh), talc and triethyl citrate.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD, DSM-IV)
Ritalin 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
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