Vitofyllin 100 mg film-coated tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propentofylline

Available from:

WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG,

ATC code:

QC04AD90

INN (International Name):

Propentofylline

Dosage:

100 mg/tablet

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

propentofylline

Authorization status:

Authorised

Authorization date:

2012-05-11

Summary of Product characteristics

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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitofyllin 100 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Propentofylline
100.00 mg/tablet
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
FILM COATING:
Titanium Dioxide, E 171
0.43 mg/tablet
Ferric Oxide, yellow, E 172
0.15 mg/tablet
Hypromellose
Macrogol 6000
Talc
CORE:
Lactose monohydrate
Maize Starch
Crospovidone
Talc
Silicia, Colloidal Anhydrous
Magnesium Stearate
Film-coated tablets.
Yellow, round, convex tablets with cross breakline tab on one side and
imprinting "100" on the other
side.
The tablet can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the improvement of peripheral and cerebral vascular blood
circulation. For improvement in
dullness, lethargy and overall demeanour in dogs.
3.3
CONTRAINDICATIONS
Refer to section 3.7.
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
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Special precautions for safe use in the target species:
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 case of accidental ingestion, seek medical advice immediately and
show the package leaflet or the
label to the physician.
Wash hands after use.
Special precautions for the protection of