Contra-indications, warnings, etc
Cat
Milprazon 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg.
Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg.
Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
Do not use in cats weighing less than 2 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney function. The product is not recommended for such animals or only according to risk/benefit analysis by the responsible veterinarian.
On very rare occasions, especially in young cats, systemic signs (such as lethargy), neurological signs (such as ataxia and muscle tremors) and/or gastrointestinal signs (such as emesis and diarrhoea) have been observed after administration of the combination milbemycin/praziquantel.
Dog
Milprazon 2.5 mg/25 mg Tablets for Small Dogs and Puppies Weighing At Least 0.5 kg.
Do not use in puppies of less than 2 weeks of age and/or weighing less than 0.5 kg.
Milprazon 12.5 mg/125 mg Tablets for Dogs Weighing At Least 5 kg.
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
On very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.

Special precautions for use in animals
Cat
It is recommended to treat all the animals living in the same household concomitantly.
In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account.
When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.
Dog
Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed.
The tolerance of the product in young puppies from these breeds has not been investigated.
Clinical signs in Collies are similar to those seen in the general dog population when overdosed.
Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs suffering from microfilaremia is thus not recommended.
In heartworm risk-areas, or in the case it is known that a dog has been travelling to and from heartworm risk regions, before using the product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering the product.
Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted.
No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.
In dogs less than 4 weeks old, tape worm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the event of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor.
Wash hands after use.
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

Overdose:
In case of overdose, in addition to signs observed at the recommended dose, drooling may be observed. This sign will usually disappear spontaneously within a day.

Interactions
The concurrent use of the milbemycin oxime and praziquantel with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Environmental Safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.