Pexion 400 mg Tablets for Dogs

Idiopathic epilepsy
The pharmacological response to imepitoin may vary and efficacy may not be complete. On
treatment, some dogs will be free of seizures, in other dogs a reduction of the number of
seizures will be observed, whilst others will be non-responders. For this reason, careful
consideration should be given before deciding to switch a stabilized dog onto imepitoin from
a different treatment. In non-responders, an increase in seizure frequency may be observed.
Should seizures not be adequately controlled, further diagnostic measures and other
antiepileptic treatment should be considered. When transition between different antiepileptic
therapies is medically required, this should be done gradually and with appropriate clinical
supervision.
The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster
seizures has not been investigated. Therefore, imepitoin should not be used as primary
treatment in dogs with cluster seizures and status epilepticus.
No loss of anticonvulsant efficacy (tolerance development) during continuous treatment of 4
weeks was observed in experimental studies lasting 4 weeks.
No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on
therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies
available (see section 3.8).
Noise phobia
Efficacy for reduction of anxiety and fear associated with noise phobia has not been tested in
dogs younger than 12 months.
Up to 2 days of pre-treatment may be necessary to achieve optimal anxiolytic efficacy in
dogs with noise phobia. See section 3.9.

Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been tested in dogs weighing less
than 2 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or
other disease.
Anxiolytic drugs acting at the benzodiazepine receptor site, such as imepitoin, may lead to
disinhibition of fear-based behaviours. The veterinary medicinal product may therefore result
in an increase or decrease in aggression levels.
In dogs with a history of aggression problems, a careful benefit-risk evaluation should be
made prior to treatment. This evaluation may include consideration of inciting factors or
situations associated with previous aggressive episodes. Prior to initiating treatment in these
cases, behaviour therapy or referral to a behaviour specialist should be considered. In these
dogs, additional measures to mitigate the risk of aggression problems should be
implemented as appropriate before treatment is initiated.

Amended pages: July 2025
Mild behavioural or muscular signs may be observed in dogs upon abrupt termination of
treatment with imepitoin.
The claim for the treatment of noise phobia is based on a pivotal field study which
investigated a 3 day course of treatment for a noise event associated with fireworks. Longer
treatment durations for noise phobia should be at the benefit-risk assessment of the
veterinarian. Consideration should be given to use of a behavioural modification programme.
Special precautions to be taken by the person administering the veterinary medicinal product
to animals:
Ingestion of this veterinary medicinal product may cause dizziness, lethargy and nausea.
In case of accidental ingestion especially by a child, seek medical advice immediately and
show the package leaflet or the label to the physician.
To prevent accidental ingestion of tablets, the cap of the bottle should be replaced
immediately after withdrawing the required number of tablets for one administration.
Special precautions for the protection of the environment:
Not applicable.