Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
METHYLPHENIDATE HCl
NOVARTIS (SINGAPORE) PTE LTD
N06BA04
10 mg
TABLET
METHYLPHENIDATE HCl 10 mg
ORAL
Prescription Only
Siegfried Barbera S.L
ACTIVE
1989-06-29
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 Read the complete document
Ritalin Oct 2023.SIN Page 1 of 23 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 Ritalin Oct 2023.SIN Page 2 Read the complete document