VITOFYLLIN 100 MG FILM-COATED TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-06-2015
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Active ingredient:
PROPENTOFYLLINE
Available from:
Animalcare Limited
ATC code:
QC04AD90
INN (International Name):
PROPENTOFYLLINE
Dosage:
100 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Propentofylline
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization date:
2012-05-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitofyllin 100 mg film-coated tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, round convex tablets with cross-snap-tab on one and imprinting "100" on the other side.
The tablet can be divided into equal halves and quarters.
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. For improvement in dullness, lethargy and
overall demeanour in dogs.
4.3 CONTRAINDICATIONS
Refer to section 4.7
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substance and/or to any of the other ingredients of the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCE:
Propentofylline
100.00 mg/tablet
EXCIPIENTS:
Ferric Oxide, yellow, (E 172)
0.150 mg/tablet
Titanium Dioxide, (E171)
0.430 mg/tablet
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 03/06/2015_
_CRN 7020774_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Specific diseases (e.g. kidney disease) should be treated accordingly.
Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart
failure or bronchial disease.
In the case of renal failure, the dose should be reduced.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental ingestion.
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY A
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