SCOPODERM Transdermal patch Ref.[11092] Active ingredients: Scopolamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Scopoderm 1.5mg Patch.

Pharmaceutical Form

Transdermal Patch.

It is a flat, round reservoir patch approximately 1.8 cm in diameter. One side of the patch is tan; the other side is silver and is placed on an oversized clear hexagonal film. The unit is supplied in a flat, sealed, foil-lined, labelled unit dose packet.

Each system has a contact surface area measuring 2.5cm² and hyoscine content of 1.5mg. The average amount of hyoscine absorbed from each system in 72 hours is 1mg.

Qualitative and quantitative composition

Each patch contains 1.5mg hyoscine U.S.P.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Scopolamine

Scopolamine is a naturally occurring belladonna alkaloid and has anticholinergic properties. It acts as a competitive antagonist to acetylchloline and other parasympathomimetic agents. Its mechanism of action in the central nervous system in preventing motion sickness has yet to be elucidated. Scopolamine produces classical symptoms of parasympathetic blockade.

List of Excipients

Drug Reservoir:

Light mineral oil
Polyisobutylene

Backing Film:

Pigmented MDPE/AL/PET/HS Film (vapour coated aluminised polyester with outer coating of pigmented medium density polyethylene (MDPE) and a heat sealable inner coating. Thickness 0.0686 mm.

Release Controlling Membrane:

Polypropylene Film. Thickness 0.0254 mm.

Adhesive (to skin):

Light mineral oil
Polyisobutylene

Release Liner (discarded before use):

Silicone/Polyester Film
Thickness 0.0762 mm

Pack sizes and marketing

Scopoderm – Individually packed into sealed paper laminated aluminium foil pouches. Outer cardboard carton containing two patches.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PL 44673/0170

16 March 2004 / 02 March 2009

Drugs

Drug Countries
SCOPODERM Estonia, Finland, France, Netherlands, New Zealand, Singapore, United Kingdom, South Africa

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