Thiafeline 5 mg Film-coated Tablets for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Thiamazole

Available from:

Le Vet Beheer B.V.

ATC code:

QH03BB02

INN (International Name):

Thiamazole

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Anti Hormone Agent

Authorization status:

Authorized

Authorization date:

2013-08-22

Summary of Product characteristics

Revised: April 2019
AN: 00293/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Thiafeline 5 mg Film-coated Tablets for Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Thiamazole
5
mg
EXCIPIENT(S):
Titanium dioxide (E171)
0.15 mg
Sunset Yellow FCF (E110)
0.09 mg
Quinoline Yellow WS (E104)
0.075 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange biconvex tablets 5.5 mm diameter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the stabilisation of hyperthyroidism in cats prior to surgical
thyroidectomy.
For the long-term treatment of feline hyperthyroidism.
4.3
CONTRAINDICATIONS
Do not use in cats suffering from systemic disease such as primary
liver disease or
diabetes mellitus.
Do not use in cats showing signs of autoimmune disease.
Do not use in animals with disorders of white blood cells, such as
neutropenia and
lymphopenia.
Do
not
use
in
animals
with
platelet
disorders
and
coagulopathies
(particularly
thrombocytopenia).
Do not use in pregnant or lactating females. Refer to section 4.7.
Do not use in cases of hypersensitivity to thiamazole or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: April 2019
AN: 00293/2018
Page 2 of 6
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
As thiamazole can cause haemoconcentration, cats should always have
access to
drinking water.
If more than 10 mg per day is required animals should be monitored
particularly
carefully.
Use of the product in cats with renal dysfunction should be subject to
careful risk :
benefit assessment by the clinician. Due to the effect thiamazole can
have on
reducing the glomerular filtration rate, the effect of therapy on
renal function should
be monitored closely as deterioration of an underlying condition may
occur.
Haematology must be monitored due to risk of leucopenia or haemolytic
anaemia.
An