Cardisan 1.25 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Alfasan Nederland B.V

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Pharmaceutical form:

Chewable tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

pimobendan

Authorization date:

2022-10-07

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cardisan 1.25 mg chewable tablets for dogs (AT, BE, BG, CY, CZ, DE,
EE, EL, ES, FR, HR, HU, IE,
IT, LV, LT, LU, MT, NL, PL, PT, RO, SI, SK, UK(NI))
Cardisan Vet 1.25 mg chewable tablets for dogs (DK, FI, IS, NO, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Pimobendan
1.25 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Citric acid
Povidone
Lactose monohydrate
Cellulose, microcrystalline
Croscarmellose sodium
Chicken flavour
Yeast (dried)
Silica, colloidal hydrated
Magnesium stearate
Chewable tablet.
Light brown with brown spots, round and convex 8 mm tablet with a
cross-shaped break line on one
side. Tablets can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of canine congestive heart failure originating from
dilated cardiomyopathy or valvular
insufficiency (mitral and/or tricuspid valve regurgitation).
3.3
CONTRAINDICATIONS
Do not use pimobendan in cases of hypertrophic cardiomyopathies or in
clinical conditions where an
improvement in cardiac output is not possible 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.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for safe use in the target species:
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 3.6).
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 anim