Vitofyllin 50 mg film-coated tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propentofylline

Available from:

Animalcare Limited

ATC code:

QC04AD90

INN (International Name):

Propentofylline

Dosage:

50 mg/tablet

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

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 50 mg film-coated tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Propentofylline
50.00 mg/tablet
EXCIPIENTS:
Ferric Oxide, yellow, (E 172)
0.075 mg/tablet
Titanium Dioxide, (E171)
0.215 mg/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, round, convex tablets with cross-snap tab on one side and
imprinting “50” on the other side.
The tablet 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 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 2.5 kg.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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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 b