Vitofyllin 50 mg Film-coated Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Propentofylline

Available from:

Animalcare Ltd

ATC code:

QC04AD90

INN (International Name):

Propentofylline

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular

Authorization status:

Authorized

Authorization date:

2012-05-02

Summary of Product characteristics

Revised: April 2017
AN: 00736/2016
Page 1 of 5
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
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Revised: April 2017
AN: 00736/2016
Page 2 of 5
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.
In the event of accidental ingestion of the tablets, seek medical
advice immediately
and show the package leaflet to the physician.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
On rare occasions,(more than 1 but less than 10 animals in 10,000
animals treated),
allergic skin reactions, vomiting and cardiac disturbances have been
reported. In
these cases, the treatment should be stopped.
4.7
US