NEUCON Extended-release tablet Ref.[115224] Active ingredients: Methylphenidate

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: JANSSEN PHARMACEUTICA (PTY) LTD, (Reg.No. 1980/011122/07), 2 Medical Road, Halfway House, Midrand 1685, South Africa, RA-JACZA-Medinfo@its.jnj.com

Product name and form

NEUCON 18 mg (extended-release tablets).

NEUCON 27 mg (extended-release tablets).

NEUCON 36 mg (extended-release tablets).

NEUCON 54 mg (extended-release tablets).

Pharmaceutical Form

Extended-release tablets.

18 mg: capsule-shaped yellow tablet with “alza 18” printed on one side in black ink.

27 mg: capsule-shaped grey tablet with “alza 27” printed on one side in black ink.

36 mg: capsule-shaped white tablet with “alza 36” printed on one side in black ink.

54 mg: capsule-shaped brownish-red tablet with “alza 54” printed on one side in black ink.

Qualitative and quantitative composition

Extended-release tablets containing 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride.

Excipient with known effect:

Contains sugar (lactose monohydrate).

Each NEUCON 18 mg tablet contains 6,49 mg lactose monohydrate.

Each NEUCON 27 mg tablet contains 4,94 mg lactose monohydrate.

Each NEUCON 36 mg tablet contains 14,44 mg lactose monohydrate.

Each NEUCON 54 mg tablet contains 7,6 mg lactose monohydrate.

For full list of excipients, see section 6.1.

Active Ingredient

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

Butylated hydroxytoluene
Carnauba wax
Cellulose acetate
Hypromellose
Lactose
Poloxamer
Polyethylene glycol
Polyethylene oxides
Povidone
Propylene glycol
Sodium chloride
Stearic acid
Succinic acid
Synthetic iron oxides
Titanium dioxide
Triacetin

Pack sizes and marketing

NEUCON is available in a square, white, opaque high-density polyethylene (HDPE) bottle with a white polypropylene child resistant closure, with induction sealed tamper-evident membrane. Each HDPE bottle contains one or two desiccants and will hold 30 tablets. The HDPE bottle is packed into an outer carton until required for use.

Marketing authorization holder

JANSSEN PHARMACEUTICA (PTY) LTD, (Reg.No. 1980/011122/07), 2 Medical Road, Halfway House, Midrand 1685, South Africa, RA-JACZA-Medinfo@its.jnj.com

Marketing authorization dates and numbers

NEUCON 18 mg: 46/1.2/0380
NEUCON 27 mg: 46/1.2/0381
NEUCON 36 mg: 46/1.2/0382
NEUCON 54 mg: 46/1.2/0383

Date of registration of the medicine: 20 April 2017

Drugs

Drug Countries
NEUCON South Africa

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