Overview

Daxocox is a veterinary medicine used in dogs to treat pain and inflammation associated with osteoarthritis, a condition causing swelling and pain in the joints. It contains the active substance enflicoxib.

The medicine is available as tablets and can only be obtained with a prescription.

Daxocox should be given once a week, immediately before or with the dog’s meal. The dose is based on the dog’s weight.

For more information about using Daxocox, see the package leaflet or contact your veterinarian or pharmacist.

The active substance in Daxocox, enflicoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAID). It works by blocking an enzyme called cyclooxygenase 2 (COX 2). COX 2 is involved in producing substances called prostaglandins, which are involved in pain and inflammation. By blocking the production of prostaglandins, Daxocox reduces pain and inflammation caused by damage to the joints.

Daxocox tablets given weekly reduced pain and inflammation in dogs. In a clinical study involving 242 dogs with clinical signs of osteoarthritis, Daxocox was given to 61 dogs at the approved dose and was more effective than placebo (a dummy treatment). In a second clinical study involving 180 dogs with clinical signs of osteoarthritis, Daxocox was given to 78 dogs and was as effective as another NSAID, mavacoxib, in improving lameness and reducing pain associated with osteoarthritis.

The most common side effects with Daxocox (which may affect up to 1 in 10 animals) are vomiting, soft faeces and/or diarrhoea; these were reported in clinical trials, and most cases recovered without treatment.

In case of adverse reactions, the use of Daxocox should be stopped and general supportive therapy should be given until the signs have completely resolved.

Daxocox must not be used in dogs:
• with problems affecting the stomach or gut, including protein or blood loss;
• with bleeding problems;
• with kidney or liver problems;
• with inadequate blood flow to the heart muscle;
• that are pregnant, breeding or lactating;
• that are hypersensitive (allergic) to enflicoxib, any of the other ingredients in the tablet or sulphonamides;
• that are dehydrated, hypovolaemic (with fluid volume loss) or hypotensive (with low blood pressure), as there is a potential risk of kidney problems.

Daxocox must also not be used with glucocorticoids or other NSAIDs.

For the full list of side effects and restrictions of Daxocox, see the package leaflet.

Safety information has been included in the summary of product characteristics and the package leaflet for Daxocox, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

Daxocox can cause hypersensitivity (allergic) reactions. People who are allergic to NSAIDs should avoid contact with Daxocox.

Some NSAIDs may be harmful for the unborn child, especially during the third trimester of pregnancy. Pregnant women should administer this veterinary medicine with care.

Ingestion of Daxocox may be harmful, especially for children. To avoid accidental ingestion, give the tablet to the dog immediately after it has been removed from the blister packaging and do not split or crush tablets.

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

The European Medicines Agency decided that Daxocox’s benefits are greater than its risks and it can be authorised for use in the EU.

Daxocox received a marketing authorisation valid throughout the EU on 20 April 2021.

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Product information

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20/04/2021

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Product details

Name of medicine
Daxocox
Active substance
enflicoxib
International non-proprietary name (INN) or common name
enflicoxib
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) code
QM01AH95

Pharmacotherapeutic group

Antiinflammatory and antirheumatic products

Therapeutic indication

For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.

Authorisation details

EMA product number
EMEA/V/C/005354
Marketing authorisation holder
Ecuphar NV

Legeweg 157-i
B-8020 Oostkamp
Belgium

Opinion adopted
17/02/2021
Marketing authorisation issued
20/04/2021

Assessment history

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