Profender - various products - Summary of Product Characteristics (SPC) change
Change to the information provided on adverse events for Profender Modified-release Tablets, Profender Spot-on Solution and Profender Multi-dose Spot-on Solution in the SPC.
Following monitoring of pharmacovigilance data, the Summary of Product Characteristics (SPC) for the following have been updated:
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Profender 15 mg/3 mg Modified-Release Tablets for Small Dogs, Profender 50 mg/10 mg Modified-Release Tablets for Medium Dogs, Profender 150 mg/30 mg Modified-Release Tablets for Large Dogs
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Profender 30 mg / 7.5 mg Spot-on Solution for Small Cats, Profender 60 mg / 15 mg Spot-on Solution for Medium Cats, Profender 96 mg / 24 mg Spot-on Solution for Large Cats
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Profender 85.8 mg/ml + 21.4 mg/ml Multidose Spot-on Solution for Cats
- Profender Modified-release Tablets for Small, Medium and Large Dogs:
Digestive tract disorders (e.g. hypersalivation, vomiting, diarrhoea), neurological disorders (e.g. tremor, incoordination), convulsion, behavioural disorders (e.g. hyperactivity), anorexia, lethargy, recumbency and hyperthermia can occur very rarely following administration of the veterinary medicinal product.
- Profender Spot-on Solution for Small, Medium and Large Cats,
and
- Profender Multi-dose Spot-on Solution for Cats:
Neurological disorders (ataxia, tremor), hypersalivation, vomiting, diarrhoea, application site alopecia, application site pruritus, application site inflammation, behavioural disorders (hyperactivity, anxiety, vocalisation), anorexia and lethargy can occur very rarely following administration of the veterinary medicinal product.
Any veterinary medicinal product which is authorised for marketing in the United Kingdom will have its Summary of Product Characteristics (SPC) available on our Product Information Database.
No medicine is 100% risk free, the SPC includes information on what adverse events have been known to occur following administration of a particular product, these can be found in either section Adverse events (3.6) or Adverse reactions (4.6).
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect.
