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

Methylphenidate is a CNS stimulant (psychostimulant) with more pronounced effects on central than on motor activities. The mechanism of action in humans is not fully understood; however, it is thought that the effect is due to inhibition of dopamine reuptake in the striatum without triggering a release of dopamine.

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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