Capstar 57 mg Tablets for Large Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Nitenpyram

Available from:

Elanco Europe Ltd

ATC code:

QP53BX02

INN (International Name):

Nitenpyram

Pharmaceutical form:

Tablet

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2001-08-03

Summary of Product characteristics

Revised: August 2023
AN: 02041/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Capstar 57 mg tablets for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Nitenpyram 57 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to light yellow, round, biconvex tablets, with bevelled edges,
imprinted
on one side with “HIH”, on the other side with “CG”.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of flea infestations (_C. felis_).
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
Do not use on dogs weighing less than 11 kg.
Revised: August 2023
AN: 02041/2022
Page 2 of 5
(ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None.
Special precautions for the protection of the environment:
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Dogs:
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Excessive chewing, licking and/or
grooming
1
,
Hyperactivity, Vocalisation
1
Neurological signs (e.g., muscle
tremor, ataxia, convulsion)
1
Panting
1
Increased scratching
2
1
Transient
2
For the first hour following administration; presumably caused by flea
response to the veterinary medicinal product.
Reporting adverse events is important. It allows continuous safety
monitoring of
a veterinary medicinal product. Reports should be sent, preferably via
a
veterinarian, to either the marketing authorisation holder or its
local
representative or the national competent authority via the national
reporting
system. See the package leaflet for respective contact details.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
Laboratory studies in rats and rabbit