MOTIFENE Capsule, hard Ref.[50029] Active ingredients: Diclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: PL 08265/0003Daiichi Sankyo UK Ltd., 1<sup>st</sup> Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Acetic acid derivatives and related substances
ATC code: M01AB05

Motifene is a non-steroidal agent with marked analgesic/anti-inflammatory properties.

It is an inhibitor of prostaglandin synthetase (cyclo-oxygenase).

5.2. Pharmacokinetic properties

Diclofenac sodium is rapidly absorbed from the gut and is subject to first-pass metabolism. Therapeutic plasma concentrations occur about ½ hour after administration of Motifene. The active substance is 99.7% protein bound and the plasma half-life for the terminal elimination phase is 1-2 hours. Approximately 60% of the administered dose is excreted via the kidneys in the form of metabolites and less than 1% in unchanged form. The remainder of the dose is excreted via the bile in metabolised form.

Following rapid gastric passage, the gastro-resistant pellet component of Motifene ensures quick availability of the active component in the blood stream. The prolonged release pellets cause a delayed release of the active component, which means one single daily dose is usually sufficient.

5.3. Preclinical safety data

Not applicable.

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