Felimazole 1.25 mg Coated tablets for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Thiamazole

Available from:

Dechra Regulatory B.V.

ATC code:

QH03BB02

INN (International Name):

Thiamazole

Dosage:

1.25 mg/tablet

Pharmaceutical form:

Coated tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

thiamazole

Authorization status:

Authorised

Authorization date:

2013-09-13

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2019
CRN008S6T
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Felimazole 1.25 mg Coated tablets for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
​
ACTIVE SUBSTANCE
​
​
Thiamazole
​1.25 mg
​
EXCIPIENTS
​
​
Titanium Dioxide (E171)
​0.51 mg
​
Dispersed Ponceau 4R Lake (E124)
​1.35 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Red sugar-coated 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 cases of hypersensitivity to thiamazole or the
excipient, polyethylene
glycol.
Health Products Regulatory Authority
07 January 2019
CRN008S6T
Page 2 of 7
Do not use in pregnant or lactating females.
Please refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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.
Any animal that su