Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Diomed Developments Limited, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR, UK
Pharmacotherapeutic group: Anti inflammatory preparations, non-steroids for topical use
ATC code: M02A A13
The gel is for topical application. It contains the active ingredient, ibuprofen, a phenylpropionic acid derivative which exerts its anti-inflammatory and analgesic effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis.
Because it is formulated in an aqueous/alcoholic gel, the preparation also exerts a soothing and cooling effect when applied to the affected area.
Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively (approximately 22% of a finite dose within 48 hours), achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and the synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side-effects, other than in rare individuals who are hypersensitive to ibuprofen.
Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion.
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
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