CONCERTA Extended-release tablet Ref.[50781] Active ingredients: Methylphenidate

Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND

Product name and form

CONCERTA Extended-Release Tablets 18 mg methylphenidate hydrochloride modified release tablet.

CONCERTA Extended-Release Tablets 27 mg methylphenidate hydrochloride modified release tablet.

CONCERTA Extended-Release Tablets 36 mg methylphenidate hydrochloride modified release tablet.

CONCERTA Extended-Release Tablets 54 mg methylphenidate hydrochloride modified release tablet.

Pharmaceutical Form
CONCERTA is available as an extended-release tablet for once-a-day oral administration containing 18, 27, 36 or 54 mg methylphenidate hydrochloride. It is designed to have a 12-hour duration of effect. CONCERTA 18 mg are yellow capsule-shaped tablets, with “alza 18” printed in black ink on one side. CONCERTA 36 mg are white capsule-shaped tablets, with “alza 36” printed in black ink on one side. CONCERTA 27 mg are grey capsule-shaped tablets, with “alza 27” printed in black ink on one side. CONCERTA 54 mg are brownish-red capsule-shaped tablets, with “alza 54” printed in black ink on one side.

Qualitative and quantitative composition

One extended release tablet contains 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride.

Excipient(s) with known effect: Lactose.

For the full list of excipients, see section 6.1 List of excipients.

Active Ingredient	Description
Methylphenidate	Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space.

List of Excipients
Tablet core: Butylated hydroxytoluene Cellulose acetate Hypromellose Iron oxide black Iron oxide red (27 mg & 54 mg only) Iron oxide yellow Phosphoric acid Poloxamer Polyethylene oxide Povidone Sodium chloride Stearic acid Succinic acid Tablet coating: Carnauba wax OPACODE WB monogramming ink NS-78-17715 BLACK (also contains propylene glycol) OPADRY complete film coating system YS-1-19025-A – CLEAR (also contains macrogol 400) 18 mg: OPADRY II complete film coating system YS-30-12788-A YELLOW 27 mg: OPADRY II complete film coating system Y-30-17528 GRAY 36 mg: Opadry II White Y-30-18037 54 mg: OPADRY II complete film coating system Y-30-15567-A RED (OPADRY II coating systems also contain lactose monohydrate, titanium dioxide and triacetin)

Pack sizes and marketing

CONCERTA tablets are supplied in HDPE bottles containing silica gel desiccant.

Pack sizes: 28, 30, 56, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND

Marketing authorization dates and numbers

14 August 2003 (18 mg, 36 mg & 54 mg)
19 November 2007 (27 mg)

Drugs

Drug	Countries
CONCERTA	Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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