Vetmedin 5 mg capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pimobendan

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Dosage:

5 milligram(s)

Pharmaceutical form:

Capsule, hard

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:

1999-10-01

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2018
CRN000YHZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmedin 5 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Active Substance
Pimobendan
5.00
mg
Excipients
Titanium Dioxide (E171)
1.232
mg
Sunset Yellow (E110)
0.308
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule, orange/white in colour.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
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 regurgitation) or dilated
cardiomyopathy.
When used in cases of valvular insufficiency in conjunction with
frusemide, the
product has been shown to improve the quality of life and extend life
expectancy in
treated dogs.
When used in a limited number of cases of dilated cardiomyopathy in
large breed
dogs in conjunction with concomitant standard therapy, the product has
been shown
to improve the quality of life and to extend life expectancy in
treated dogs.
Health Products Regulatory Authority
25 May 2018
CRN000YHZ
Page 2 of 6
4.3 CONTRAINDICATIONS
Vetmedin capsules should not be used in cases of hypertrophic
cardiomyopathies or
clinical conditions where an augmentation of cardiac output is not
possible for
functional or anatomical reasons (e.g. aortic stenosis).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
This product should only be used in dogs with cardiac insufficiency.
Do not exceed
the recommended dose.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
None known
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A moderate positive chronotropic effect and vomiting may occur in rare
cases.
However, these effects are dose-dependent and may be avoided by
reducing the
dose in these cases. In rare cases transient dia