Felimazole 5 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:

5 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:

2008-11-28

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2022
CRN00CCR5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Felimazole 5 mg Coated Tablets for Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Thiamazole 5 mg
EXCIPIENTS
Titanium Dioxide (E171) 0.495 mg
Beta-Carotene (E160a) 0.16 mg
For a full list of excipeints, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Orange 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 pregnant or lactating females.
Do not use in cats with hypersensitivity to thiamazole or the
excipient, polyethylene glycol.
Please refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As thiamazole can cause haemoconcentration, cats should always have
access to drinking water.
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.
Health Products Regulatory Authority
15 January 2022
CRN00CCR5
Page 2 of 5
Haematology must be monitored due to risk of leucopenia o