MATORIDE XR Prolonged-release tablet Ref.[27779] Active ingredients: Methylphenidate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Product name and form

Matoride XL 18 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Light yellow film-coated tablet of round shape (diameter 8 mm) with a delivery orifice (visible round small hole) on one side.

Qualitative and quantitative composition

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

Excipient(s) with known effect: Each prolonged-release tablet contains 5.99 mg of lactose (as monohydrate) and 0.34 mmol (7.8 mg) of sodium.

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

Drug layer:

Polyethylene oxide
Succinic acid
Povidone (K 25)
Butylhydroxytoluene
Stearic acid

Push layer:

Polyethylene oxide
Sodium chloride
Povidone (K 25)
Butylhydroxytoluene
Iron oxide red (E172)
Stearic acid

Membrane layer:

Cellulose acetate
Poloxamer 188

Drug coat:

Hypromellose
Succinic acid

Film coat:

film coating mixture consisting of:

Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Macrogol 4000
Iron oxide yellow (E172)

Pack sizes and marketing

The prolonged-release tablets are packed in high-density polyethylene (HDPE) bottles with a child-resistant polypropylene closure (PP screw cap) with drying plug.

Pack size:

28 or 30 prolonged-release tablets or

Multipacks: 60 (2x30) or 90 (3x30) prolonged-release tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Marketing authorization dates and numbers

PL 04416/1346

Date of first authorisation: 08 November 2013
Date of latest renewal: 23 July 2016

Drugs

Drug Countries
MATORIDE United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.