DELMOSART Prolonged-release tablet Ref.[50139] Active ingredients: Methylphenidate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Delmosart 18mg Prolonged-release Tablets.

Pharmaceutical Form

Prolonged-release tablet.

18 mg Tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9 mm, with “2392” printed on one side in black ink.

Qualitative and quantitative composition

Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride equivalent to 15.6 mg of methylphenidate.

Excipient with known effect: contains 183.8 mg of lactose (as monohydrate).

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

Tablet content:

Lactose monohydrate
Hypromellose
Silica, colloidal anhydrous
Magnesium stearate
Fumaric acid
Methacrylic acid–methyl methacrylate copolymer
Triethyl citrate
Talc

Tablet coating:

Polyvinyl alcohol, part hydrolyzed
Macrogol (3350)
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)

Printing ink:

Shellac glaze
Iron oxide black (E172)
Propylene glycol

Pack sizes and marketing

HDPE bottle with a child-resistant PP closure with silica gel desiccant integrated into the closure.

18 mg tablets: 28, 30 or 90 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/1220

15/11/2019

Drugs

Drug Countries
DELMOSART New Zealand, Poland, United Kingdom
 
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