Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders.
Special Warnings
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 Interaction with other medicinal products and other forms of interaction).
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 “Dosage for each species, route(s) and method of administration”.
Special precautions for use in animals
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.
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.
Adverse reactions:
Dogs:
Idiopathic epilepsy
Very common (>1 animal / 10 animals treated): | Ataxia1, somnolence1 Emesis1 Increased appetite1,2 |
Common (1 to 10 animals / 100 animals treated): | Hyperactivity1 Apathy1, anorexia1, polydipsia1 Disorientation1 Hypersalivation1, diarrhoea1 Polyuria1 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Agression3 |
Rare (1 to 10 animals / 10,000 animals treated): | Increased sensitivity to sound3 Anxiety3 Elevated Creatinine4 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Elevated blood urea nitrogen (BUN)4, elevated cholesterol (total)4 Prolapse of the nictitating membrane1, impaired vision1. |
1 Mild and generally transient.
2 At the beginning of treatment.
3 Potentially treatment related. It may also be present during the preictal or postictal period or as behaviour changes which occur as part of the disease itself.
4 Mild; however generally not exceeding normal reference ranges and not associated with any clinically significant observations or events.
Noise phobia
Very common (>1 animal / 10 animals treated): | Ataxia1, 2 Increased appetite1,2, lethargy2 |
Common (1 to 10 animals / 100 animals treated): | Emesis2 Aggression2 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Hyperactivity2 Somnolence2 Hypersalivation2 |
1 Transient. Occurred early in the treatment course. In more than half of the dogs that experienced ataxia during a clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
2 Most events are transient, resolving during or shortly after the end of the treatment course.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Pregnancy and lactation
The use of the veterinary medicinal product is not recommended in female dogs during pregnancy and lactation.
Fertility:
Do not use in male breeding animals (see section Symptoms of overdose (and where applicable, emergency procedures and antidotes)).
Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section “Special warnings”).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kg bodyweight, central nervous system (CNS) effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted. At such doses, the symptoms are not usually life-threatening and generally resolve within 24 hours if symptomatic treatment is given.
These CNS effects may include loss of righting reflex, decreased activity, eyelid closure, lacrimation, dry eye and nystagmus.
At 5 times the recommended dose, decreased bodyweight may be observed.
In male dogs administered 10 times the upper recommended therapeutic dose, diffuse atrophy of seminiferous tubules in the testes and associated decreased sperm counts were seen. See also section Use during pregnancy, lactation or lay.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance.
Not applicable.
Withdrawal periods
Not applicable.