Zelys 1.25 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Ceva Santé Animale

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

1.25 mg/tablet

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

pimobendan

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2018-06-01

Summary of Product characteristics

Health Products Regulatory Authority
14 April 2021
CRN00C3KY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zelys 1.25 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Pimobendan 1.25 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Round in shape beige to light brown tablet, with single score line on
one side.
The tablets can be divided into two equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of canine congestive heart failure originating from
valvular insufficiency (mitral and/or tricuspid valve
regurgitation) or dilated cardiomyopathy.
(See also section 4.9).
4.3 CONTRAINDICATIONS
Do not use pimobendan in hypertrophic cardiomyopathies or in diseases
in which an improvement in cardiac output cannot be
achieved for functional or anatomical reasons (e.g. aortic stenosis).
Since pimobendan is metabolised mainly via the liver, it should not be
used in dogs with severe impairment of liver function.
(See also section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The blood glucose should be tested regularly during treatment in dogs
with existing diabetes mellitus.
Monitoring of cardiac function and morphology is recommended in
animals treated with pimobendan (See also section 4.6)
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store tablets out of reach of the animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental ingestion, especially by a child, may lead to the
occurrence of tachycardia, orthostatic hypotension, flushing of the
face and headaches.
Unused part-tablets should be returned to the open blister space, or
to the bottle and inserted back into the outer packaging.
Keep in a safe place ou