Reconcile

fluoxetine

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This is a summary of the European public assessment report (EPAR) for Reconcile. 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 Reconcile.

For practical information about using Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Reconcile and what is it used for?

Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by separation from their owners or homes or from other dogs (separation anxiety). Such problems may include destruction of property, excessive barking or howling and inappropriate defecation and urination in the home.

Reconcile should only be given in combination with behavioural therapy. It contains the active substance fluoxetine.

How is Reconcile used?

Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription. The tablet strength should be chosen according to the dog’s weight. The tablets are given once a day. Symptoms are expected to improve within 1 to 2 weeks. In case there is no improvement within 4 weeks, the veterinarian should re-evaluate treatment.

For further information, see the package leaflet.

How does Reconcile work?

Fluoxetine is an antidepressant. Fluoxetine works by increasing the levels of the neurotransmitter serotonin in the central nervous system. A neurotransmitter is a substance that nerve cells use to communicate with neighbouring cells. Since low levels of serotonin can be linked to depression and anxiety, increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related problems.

What benefits of Reconcile have been shown in studies?

A field study was conducted in a large number of dogs that were treated for separation anxiety in two European countries. All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine 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. The study showed that Reconcile was as effective as clomipramine. After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile group (inappropriate defecation and destructive behaviour).

What are the risks associated with Reconcile?

The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of appetite and lethargy (lack of energy). Other common side effects with Reconcile (which may affect up to 1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and disorientation.

Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits. It must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).

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

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

If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.

Why is Reconcile approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Reconcile?

The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on 8 July 2008.

For more information about treatment with Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

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 24/07/2018 .

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

Nexcyon Pharmaceuticals Ltd

Revision8
Date of issue of marketing authorisation valid throughout the European Union08/07/2008

Contact address:

Nexcyon Pharmaceuticals Ltd
First Floor Denmark House
143 Hight Street
Chalfont St Peter
SL9 9QL
United Kingdom

Product information

Product information

13/07/2018  Reconcile -EMEA/V/C/000133 -R/0018

Name Language First published Last updated
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24
Reconcile : EPAR - Product Information HR = Hrvatski 2008-07-18 2018-07-24

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 2018-07-24

Initial marketing-authorisation documents