Pimotab 1.25 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

CP-Pharma Handelsgesellschaft mbH

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 area:

pimobendan

Authorization status:

Authorised

Authorization date:

2020-07-17

Summary of Product characteristics

Health Products Regulatory Authority
11 August 2020
CRN009SMP
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pimotab 1.25 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each tablet contains:
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ACTIVE SUBSTANCE:
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Pimobendan 1.25 mg
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EXCIPIENTS:
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For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Light brown with brown spots, round and convex tablet with a
cross-shaped break line on one side.
Tablets can be divided into 2 or 4 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
dilated cardiomyopathy or valvular insufficiency (mitral
and/or tricuspid valve regurgitation).
(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).
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
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.
Since pimobendan is metabolised mainly via the liver, it should not be
used in dogs with severe impairment of liver function.
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 animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
This product may cause tachycardia, orthostatic hypotension, flushing
of the face and headaches.
To avoid accidental ingestion, especially by a child, unused tablet
parts should