VIVITONIN 100 FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-10-2016
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Active ingredient:
PROPENTOFYLLINE
Available from:
Intervet Ireland Limited
ATC code:
QC04AD90
INN (International Name):
PROPENTOFYLLINE
Dosage:
100 mg/tablet
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Propentofylline
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization date:
2001-09-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vivitonin 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Propentofylline
100 mg
EXCIPIENTS:
Titanium dioxide (E171)
0.856 mg
Yellow ferric oxide (E172)
0.258 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Orange yellow oblong tablets, half-scored on both sides, with 'K100' embossed on one side of the tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the improvement of peripheral and cerebral vascular blood circulation in dogs.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 05/10/2016_
_CRN 7024830_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In the case of specific diseases (e.g. kidney disease), appropriate treatment should be administered.
Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart
disease or bronchial disease.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Not applicable.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In rare cases, symptoms of cardiac and cerebral over-stimulation (e.g. tachycardia and/or collapse) have been observed. In
such cases, animals should be treated symptomatically.
Allergic reactions (e.g. urticaria) may occur in rare cases and these necessitate discontinuation of the treatment.
Vomiting has been observed on rare occasions, particularly at the commencement of therapy
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