Vidalta 15 mg prolonged-release tablets for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbimazole

Available from:

Intervet Ireland Limited

ATC code:

QH03BB01

INN (International Name):

Carbimazole

Dosage:

15 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats

Therapeutic area:

carbimazole

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2011-12-09

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2018
CRN000X0F
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vidalta 15 mg prolonged-release tablets for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains:
ACTIVE SUBSTANCE:
Carbimazole 15.0 mg
EXCIPIENTS:
Red ferric oxide (E172) 0.75 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Round, dark pink tablet with little spots.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of hyperthyroidism and hyperthyroidism-associated clinical
signs in cats.
4.3 CONTRAINDICATIONS
Do not use in cats suffering from concurrent systemic diseases, such
as severe
primary liver disease or diabetes mellitus.
Do not use in cats showing signs of auto-immune diseases and/or
altered red or
white blood cell counts, such as anaemia, neutropaenia or
lymphopaenia.
Do not use in cats with platelet disorders (particularly
thrombocytopaenia) or
coagulopathies.
Do not use in cats with hypersensitivity to mercaptoimidazoles such as
carbimazole
or thiamazole (methimazole) or to any of the excipients.
Please refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Health Products Regulatory Authority
20 March 2018
CRN000X0F
Page 2 of 8
Thiamazole (methimazole), the active metabolite of carbimazole,
inhibits thyroid
hormone production and therefore cessation of treatment with
carbimazole will
result in a rapid (within 48 hours) return to pre-treatment thyroid
hormone levels.
Chronic administration is therefore necessary unless surgical or
radiation-induced
thyroidectomy is performed.
A small proportion of cats with thyroid adenoma may fail to respond or
have a poor
response to treatment.
Thyroid carcinoma is a rare cause of hyperthyroidism in the cat and
medical
management alone is not recommended in such cases as it is not
curative.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Treatment should be adjusted acco