Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

The plaster should not be applied to mucous membranes. Eye contact with the plaster should be avoided.
The plaster contains propylene glycol which may cause skin irritation. It also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
The plaster should be used with caution in patients with severe cardiac impairment, severe renal impairment or severe hepatic impairment.

One of the lidocaine metabolites, 2,6 xylidine, has been shown to be genotoxic and carcinogenic in rats (see section 5.3). Secondary metabolites have been shown to be mutagenic. The clinical significance of this finding is unknown. Consequently long term treatment with Versatis® 700 mg is only justified if there is a therapeutic benefit for the patient (see section 4.2).

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. An effect on the ability to drive and use machines is unlikely because systemic absorption is minimal (see section 5.2).