Enacard Tablets for Dogs 5 mg

Summary of Product characteristics

                                Revised: November 2018
AN: 00955/2018
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENACARD Tablets for Dogs 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Enalapril maleate 5.0 mg
Red iron oxide E172 0.17 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Round non-scored biconvex uncoated pink tablets.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mild, moderate and severe congestive heart failure in
dogs
caused by mitral regurgitation or dilated cardiomyopathy as an
adjunctive
therapy with diuretics. For improved exercise tolerance and increased
survival
in dogs with mild, moderate and severe heart failure.
4.3
CONTRA-INDICATIONS
Do not use in any dog that has evidence of cardiac output failure e.g.
aortic
stenosis.
The product is not recommended for use in pregnant bitches. Safety in
breeding dogs has not been established.
Do not use with potassium-sparing diuretics.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
See other sections.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None known but see other sections.
ii.
Special precautions to be taken by the person administering the
Revised: November 2018
AN: 00955/2018
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medicinal product to the animals
In case of accidental ingestion, seek urgent medical attention showing
the product label to the doctor or nurse. Physicians should contact a
Poison Control Centre for advice concerning cases of human
consumption.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The product has been demonstrated to be generally well tolerated. In
clinical
studies, the overall incidence of side effects was not significantly
greater with
the product than with vehicle tablets. For the most part side effects
have been
mild and transient in nature and have not required discontinuation of
therapy.
The following side effects have been reported:
AZOTEMIA
In clinical trials, 
                                
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