RADD Prolonged-release tablet Ref.[51222] Active ingredients: Methylphenidate

Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

Product name and form

RADD 18 mg (prolonged-release tablet).

RADD 27 mg (prolonged-release tablet).

RADD 36 mg (prolonged-release tablet).

RADD 54 mg (prolonged-release tablet).

Pharmaceutical Form
RADD 18 mg: Yellow, capsule-shaped, biconvex film-coated tablet with 2392 printed in black ink on one side. RADD 27 mg: Grey, capsule-shaped, biconvex film-coated tablet with 2393 printed in black ink on one side. RADD 36 mg: White, capsule-shaped, biconvex film-coated tablet with 2394 printed in black ink on one side. RADD 54 mg: Red-brown, capsule-shaped, biconvex film-coated tablet with 2395 printed in black ink on one side.

Qualitative and quantitative composition

RADD 18 mg: Each prolonged-release tablet contains 18 mg methylphenidate hydrochloride. Contains sugar (lactose monohydrate 193,50 mg).

RADD 27 mg: Each prolonged-release tablet contains 27 mg methylphenidate hydrochloride. Contains sugar (lactose monohydrate 194,25 mg).

RADD 36 mg: Each prolonged-release tablet contains 36 mg methylphenidate hydrochloride. Contains sugar (lactose monohydrate 187,50 mg).

RADD 54 mg: Each prolonged-release tablet contains 54 mg methylphenidate hydrochloride. Contains sugar (lactose monohydrate 174,00 mg).

For the full list of excipients, see section 6.1

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
Colloidal anhydrous silica Fumaric acid Hypromellose Indigo carmine aluminium lake Iron oxide black (E172) Iron oxide red (E172)^1,3 Iron oxide yellow (E172)^1,2 Lactose monohydrate Macrogol 3350 Magnesium stearate Methacrylic acid-methyl methacrylate copolymer (1:1) Methacrylic acid-methyl methacrylate copolymer (1:2) Opacode Black S-1-17823 Partially hydrolysed polyvinyl alcohol Talc Titanium dioxide (E171) Triethyl citrate ¹ Applicable to the 18 mg strength only ² Applicable to the 27 mg strength only ³ Applicable to the 54 mg strength only

Pack sizes and marketing

RADD tablets are packed into white, round HDPE bottles with round, white plastic childresistant screw cap with three break-points, ring and integrated desiccant. Bottles, containing 30 tablets are packed into printed outer cartons.

Marketing authorization holder

Pharma Dynamics (Pty) Ltd, 1^st Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa

Marketing authorization dates and numbers

RADD 18 mg: A51/1.2/0289
RADD 27 mg: A51/1.2/0290
RADD 36 mg: A51/1.2/0291
RADD 54 mg: A51/1.2/0292

09 February 2021

Drugs

Drug	Countries
RADD	South Africa

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