Lotimax 900 mg Chewable Tablets for Dogs

The possibility that other animals in the same household can be a source of re-
infection with ticks, fleas, mites, gastrointestinal nematodes, heartworm and/or
lungworm should be considered, and these should be treated as necessary
with an appropriate product.
The product should be used in dogs with, or at risk from, mixed infestations of
ectoparasites (ticks, fleas or mites) and endoparasites (gastrointestinal
nematodes and/or for prevention of heartworm/lungworm). In the absence of
risk of co-infestation by external and internal parasites, a narrow spectrum
product should be used.
Ticks and fleas must attach to the host and commence feeding in order to be
exposed to the active substance; therefore the risk of the transmission of
tick/flea- borne diseases cannot be excluded.
For the treatment of infections with gastrointestinal nematodes the need for,
and the frequency of, re-treatment as well as the choice of the treatment
(monosubstance or combination product) should be evaluated by the
prescribing veterinarian.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria
immitis prevention, therefore, to minimise the risk of resistance selection, it is
recommended that dogs should be checked for both circulating antigens and
blood microfilariae at the beginning of each heartworm season prior to starting

Issued: November 2024
AN: 03509/2023
monthly preventive treatments.The product is not effective against adult D.
immitis and is not indicated for microfilariae clearance.
Unnecessary use of antiparasitics or use deviating from the instructions given
in the SPC may increase the resistance selection pressure and lead to reduced
efficacy. The decision to use the product should be based on confirmation of
the parasitic species and burden, or of the risk of infection/infestation based on
its epidemiological features, for each individual animal.

Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies 8
weeks of age and older and 1.4 kg of bodyweight and greater. Use of this
veterinary medicinal product in puppies younger than 8 weeks of age or less
than 1.4 kg of bodyweight should be based on a benefit-risk assessment by the
responsible veterinarian.
The recommended dose should be strictly observed in MDR1 mutant (-/-) dogs
with a non-functional P-glycoprotein, which may include Collies and related
breeds.
Prior to first administration, dogs in heartworm endemic areas or who have
visited heartworm endemic areas must be tested for existing heartworm
infection. At the discretion of the veterinarian, infected dogs should be treated
with an adulticide to kill adult heartworms.
Administration of products containing milbemycin oxime (such as this product)
to dogs with a high number of circulating microfilariae is not recommended in
order to avoid hypersensitivity reactions associated with the release of proteins
from dead or dying microfilariae.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Accidental ingestion may cause gastrointestinal disturbances. In order to
prevent access by children, keep the chewable tablets in the blister packs until
required and keep the blister packs in the outer carton out of the reach of
children.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or label to the physician.
Wash hands after handling the tablets.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.

Issued: November 2024
AN: 03509/2023