Pimotab 1.25 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Pimobendan

Available from:

CP Pharma Handelsgesellschaft mbH

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Pharmaceutical form:

Chewable tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular

Authorization status:

Authorized

Authorization date:

2020-03-03

Summary of Product characteristics

Revised: May 2024
AN: 03334/2023 & 03336/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pimotab 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.
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.
Revised: May 2024
AN: 03334/2023 & 03336/2023
Page 2 of 6
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 t