Clomicalm
Authorised
This medicine is authorised for use in the European Union
Clomipramine
MedicineVeterinaryAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Clomicalm. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Clomicalm.
For practical information about using Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs. Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy. It contains the active substance clomipramine hydrochloride.
Clomicalm is available as tablets (5, 20 and 80 mg) and can only be obtained with a prescription. The appropriate strength tablet should be used according to the dog’s weight. The tablets are given twice a day with or without food and usually 2 – 3 months is sufficient to control the condition although some dogs may need longer treatment.
Clomipramine is an antidepressant. It works by increasing the levels of certain neurotransmitters, serotonin and noradrenaline, in the central nervous system. A neurotransmitter is a substance that relays signals from a nerve cell to another cell. Since low levels of these neurotransmitters can be linked to depression and anxiety, increasing them can help the dogs feel calmer so improving the behavioural signs in dogs with separation related problems.
Field studies conducted in the USA and Europe showed Clomicalm, when used with behavioural therapy, to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped. Liver effects have been reported particularly in dogs with existing liver problems. Vomiting may be reduced by giving the tablets with a small quantity of food. Clomicalm must not be used in dogs with a known hypersensitivity to clomipramine and related medicines (known as tricyclic antidepressants).
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately. If a child accidentally swallows the medicine, this could cause serious reactions.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clomicalm’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The European Commission granted a marketing authorisation valid throughout the EU for Clomicalm on 1 April 1998.
For more information about treatment with Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Product information
Latest procedure affecting product information: IAIN/0039
21/10/2021
Product details
- Name of medicine
- Clomicalm
- Active substance
- clomipramine hydrochloride
- International non-proprietary name (INN) or common name
- Clomipramine
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QN06AA04
Pharmacotherapeutic group
PsychoanalepticsTherapeutic indication
As an aid in the treatment of separation related disorders in dogs manifested by destruction and inappropriate elimination (defecation and urination) and only in combination with behavioural modification techniques.
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