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Contra-indications, warnings, etc
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
Because of the nature of epilepsy, the pharmacological response to treatment may vary. 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 “Interactions”).
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
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 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.
Adverse reactions:
Idiopathic epilepsy
The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports).
In epileptic dogs, aggression has been uncommonly reported, and increased sensitivity to sound and anxiety have been rarely reported in the field. These signs are potentially treatment related. They may also be present during the preictal or postictal period or as behaviour changes which occur as part of the disease itself.
A mild elevation in plasma creatinine, urea and cholesterol levels has been observed in dogs treated with imepitoin; however these generally did not exceed the normal reference ranges and were not associated with any clinically significant observations or events.
Noise phobia
The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia (loss of coordination), increased appetite, lethargy (very common); emesis (vomiting), aggression (see section “Special warnings”) (common); hyperactivity, somnolence (drowsiness), hypersalivation (uncommon). Most events are transient, resolving during or shortly after the end of the treatment course.
Transient ataxia was reported very commonly during a clinical trial for noise phobia and occurred early in the treatment course. In more than half of the dogs that experienced ataxia during this clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Overdose (symptoms, emergency procedures, antidotes)
In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kilogram bodyweight, neurological 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 neurological effects may include loss of righting reflex (loss of balance), decreased activity, eyelid closure, lacrimation (excessive tears), dry eye (inadequate tears), and nystagmus (unusual eye movement).
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 "Pregnancy and lactation".
Pregnancy and lactation
The use of the veterinary medicinal product is not recommended in male breeding dogs or in female dogs during pregnancy and lactation. See also section "Overdose".
Interaction with other medicinal products and other forms of interaction
The 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”).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Ingestion of this 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.