Felinta 10 mg Prolonged-release Tablets for Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Carbimazole

Available from:

Milstein C.V.

ATC code:

QH03BB01

INN (International Name):

Carbimazole

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats

Therapeutic area:

Anti Hormone Agent

Authorization status:

Authorized

Authorization date:

2022-10-11

Summary of Product characteristics

Issued: October 2022
AN: 00829/2021
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Felinta 10 mg prolonged-release tablets for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains:
ACTIVE SUBSTANCE:
Carbimazole
10.0 mg
EXCIPIENTS:
FD & C Red No. 3 (E127)
0.25 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Round, pink tablet with speckles and de-bossed with “CAR 10” on
one side and plain on
other side.
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.
Issued: October 2022
AN: 00829/2021
Page 2 of 8
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 THE TARGET SPECIES
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 u