Reconcile

fluoxetine

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Reconcile?

Reconcile is a veterinary medicine containing the active substance fluoxetine. It is available as chewable tablets containing 8 mg, 16 mg, 32 mg or 64 mg fluoxetine.

What is Reconcile used for?

Reconcile is used, in combination with behavioural-modification techniques, to assist in the treatment of dogs that have behavioural problems (separation anxiety) caused by separation from their owners, their normal home, or other dogs. These behavioural problems might be expressed by excessive barking or howling, inappropriate defecation or urination in the house, or destruction of their surroundings. Reconcile should not be used on its own but only in dogs that are also undergoing behavioural therapy.

Reconcile tablets are given once a day. The strength of tablet to be given is based on the dog’s weight, so that the dog is given between 1 and 2 mg per kilogram of the dog’s bodyweight per day. The tablets are chewable and may be given either with or without food.

How does Reconcile work?

The active substance in Reconcile, fluoxetine, is a selective serotonin-re-uptake inhibitor (SSRI). It works by preventing the neurotransmitter serotonin (5-hydroxytryptamine) from being taken back up into nerve cells in the brain and spinal cord. Neurotransmitters such as serotonin are chemicals that transfer chemical signals from one nerve cell to another. Low levels of serotonin in the central nervous system may be associated with depression, anxiety or aggression. By blocking the re-uptake of serotonin into nerve cells, fluoxetine allows the levels of serotonin to remain higher. This can improve the clinical signs (behavioural problems) of separation-related disorders in dogs. In order to treat a dog with separation anxiety, the animal should not only receive medicines but also behavioural-modification therapy. Behavioural-modification therapy is the most important part of therapy. However, the use of the medicine allows for a more speedy recovery of the animal patient.

How has Reconcile been studied?

Reconcile has been investigated in four different studies in pet dogs for up to eight weeks. The effective dose of Reconcile was established in one study. Another study investigated the efficacy of Reconcile in dogs that also received behavioural-modification therapy, whilst a similar study looked at the efficacy in dogs that did not receive additional behavioural therapy. In both of those studies, the effectiveness of Reconcile was compared with that of placebo (a dummy treatment) for up to eight weeks. The last study was conducted under 'field conditions' in a large number of dogs that were treated for separation anxiety in various veterinary practices or clinics, in two European countries. All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine that can be used to treat dogs with separation-related disorders). The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs. In all the studies Reconcile was given once a day, either with or without food.

What benefit has Reconcile shown during the studies?

The oral administration of Reconcile tablets, as 1 to 2 mg/kg of fluoxetine once a day, is effective for the treatment of separation anxiety in dogs when used in conjunction with behavioural-modification therapy.

The efficacy of Reconcile was higher when compared to placebo when behavioural-modification therapy was also given to the dogs. The efficacy was lower when no behavioural-modification therapy was given. When given in combination with behavioural modification therapy, approximately 42% of dogs given Reconcile improved within one week, compared to only 17% of the dogs given placebo (plus the behavioural-modification therapy). The fluoxetine-treated group continued to have a higher incidence of improvement over the course of the treatment period and by the end of the eight weeks, approximately 72% of the fluoxetine-treated dogs had shown improved behaviour (a global severity score of 50%).

The field study showed that Reconcile was as effective as clomipramine. In conjunction with behavioural-modification therapy, Reconcile showed significant improvements in treating dogs for barking and inappropriate defecation or urination. After eight weeks, two separation anxiety behaviours were significantly improved in the fluoxetine group (inappropriate defecation and destructive behaviour). Six weeks after the end of treatment, five out of the nine separation-anxiety behaviours were still improved in about a third of the treated dogs. The rate of relapse at the end of the post-treatment phase was slightly higher in the fluoxetine group (28%) than in the clomipramine group (23%).

What is the risk associated with Reconcile?

The most common side effects with Reconcile are anorexia (loss of appetite) and lethargy (unresponsiveness). Urinary-tract disorders (such as bladder infections, irregular urination and discomfort in passing urine) and central-nervous-system signs (such as incoordination and disorientation) were also observed. Less commonly, weight loss or loss of condition, dilation of the pupils of the eye and, rarely, seizures were also observed.

To minimise the risk of adverse reactions, the recommended dose of Reconcile should not be exceeded.

For a full list of all side-effects reported with Reconcile, see the package leaflet.

Reconcile tablets should not be used in dogs weighing less than 4 kg, or in dogs with epilepsy or with a history of seizures. Reconcile should also not be used in dogs that may be hypersensitive (allergic) to fluoxetine or other SSRIs. Since Reconcile has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.

Reconcile tablets should not be used at the same time as many other medicines, especially medicines that can affect the central nervous system. See the package leaflet for full information.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

This veterinary medicine has been developed especially for dogs and is not for use in humans. If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.

Why has Reconcile been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Reconcile exceed the risks when used in combination with behavioural-modification techniques as an aid in the treatment of dogs with behavioural problems caused by separation, and recommended that Reconcile be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Reconcile

The European Commission granted a marketing authorisation valid throughout the European Union for Reconcile to Eli Lilly and Company Ltd on 8 July 2008. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Reconcile : EPAR - Summary for the public BG = bălgarski 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public ES = español 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public CS = čeština 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public DA = dansk 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public DE = Deutsch 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public ET = eesti keel 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public EL = elliniká 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public EN = English 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public FR = français 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public IT = italiano 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public LV = latviešu valoda 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public LT = lietuvių kalba 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public HU = magyar 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public MT = Malti 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public NL = Nederlands 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public PL = polski 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public PT = português 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public RO = română 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public SK = slovenčina 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public SL = slovenščina 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public FI = suomi 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public SV = svenska 2008-07-15 2016-10-19
Reconcile : EPAR - Summary for the public HR = Hrvatski 2008-07-15 2016-10-19

This EPAR was last updated on 19/10/2016 .

Authorisation details

Product details

Product details for Reconcile
NameReconcile
Agency product numberEMEA/V/C/000133
Active substance

fluoxetine

International non-proprietary name (INN) or common name

fluoxetine

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QN06AB03






Publication details

Publication details for Reconcile
Marketing-authorisation holder

Eli Lilly and Company Limited

Revision7
Date of issue of marketing authorisation valid throughout the European Union08/07/2008

Contact address:

Eli Lilly and Company Ltd
Priestley Road
Basingstoke
Hampshire
RG24 9NL
United Kingdom

Product information

Product information

19/09/2016  Reconcile -EMEA/V/C/000133 -T/0016

Name Language First published Last updated
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2016-10-19

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  
Reconcile : EPAR - All Authorised presentations HR = Hrvatski 2008-09-24  

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defecation and / or urination) and only in combination with behavioural-modification techniques.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Reconcile : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2010-01-20 2016-10-19

Initial marketing-authorisation documents