Milprazon CHEWABLE 16 mg/40 mg film-coated tablets for cats weighing at least 2
kg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Active substances:
Milbemycin oxime 16 mg
Praziquantel 40 mg
Excipients:
Iron Oxide, yellow (E172) 0.03 mg
Iron Oxide, red (E172) 0.12 mg
Iron Oxide, black (E172) 0.05 mg
Titanium dioxide (E171) 0.21 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Brown, oval, biconvex film-coated tablets with score line on one side.
The tablets can be divided into halves.
4. CLINICAL PARTICULARS
4.1 Target Species
Cats (weighing at least 2 kg).
4.2 Indications for use, specifying the target species
Treatment of mixed infections by immature and adult cestodes and nematodes of the
following species:
- Cestodes:
Dipylidium caninum
Taenia spp.
Echinococcus multilocularis
- Nematodes:
Ancylostoma tubaeforme
Toxocara cati
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Prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against
cestodes is indicated.
4.3 Contraindications
Do not use in cats weighing less than 2 kg.
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients.
4.4 Special warnings for each target species
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, and it is
recommended to seek professional (e. g. veterinary) advice.
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.
4.5 Special precautions for use
Special precautions for use in animals
No studies have been performed with severely debilitated cats or individuals with
seriously compromised kidney or liver function. The veterinary medicinal product is
not recommended for such animals or only according to a benefit/risk assessment by
the responsible veterinarian.
Ensure cats and kittens weighing between 0.5 kg and =2 kg receive the appropriate
tablet strength (4 mg milbemycin oxime/10 mg praziquantel) and the appropriate
dose (1/2 or 1 tablet) for the corresponding weight band (1/2 tablet for cats weighing
0.5 to 1 kg; 1 tablet for cats weighing >1 to 2 kg).
As the tablets are flavoured, they should be stored in a safe place out of the reach of
animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Accidental ingestion of a tablet by a child may be harmful. In order to prevent children
from accessing the veterinary medicinal product, tablets should be administered and
stored out of sight and reach of children.
Part tablets should be returned to the open blister pocket and inserted into the outer
carton.
In the event of accidental ingestion of one or more tablets, seek medical advice
immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
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Other precautions
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable
disease to the World Organisation for Animal Health (WOAH), specific guidelines on
the treatment and follow-up, and on the safeguard of persons, need to be obtained
from the relevant competent authority (e.g. experts or institutes of parasitology).
4.6 Adverse reactions (frequency and seriousness)
Cats:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypersensitivity reaction;
Systemic disorders (e.g. lethargy)*;
Neurological disorders (e.g. ataxia and muscle
tremors)*;
Digestive tract disorders (e.g. emesis and
diarrhoea)*.
*Especially in young cats.
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 also section 16 of the
package leaflet for contact details.
4.7 Use during pregnancy and lactation
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
Can be used in breeding animals.
4.8 Interaction with other medicinal products and other forms of interaction
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 veterinary medicinal product and
other macrocyclic lactones. Also, no such studies have been performed with
reproducing animals.
4.9 Amounts to be administered and administration route
Oral use.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
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Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of
praziquantel per kg are given orally as a single dose. The veterinary medicinal
product should be administered with or after some food. Doing so ensures optimum
protection against heartworm disease.
Depending on the bodyweight of the cat, the practical dosing is as follows:
Body weight Film-coated tablets for
cats
2 - 4 kg ½ tablet
> 4 - 8 kg 1 tablet
> 8 - 12 kg 1½ tablets
The veterinary medicinal product can be inserted into a programme for prevention of
heartworm disease if at the same time treatment against tapeworms is indicated. For
the prevention of heartworm disease: the veterinary medicinal product kills Dirofilaria
immitis larvae up to one month after their transmission by mosquitoes. For regular
prevention of heartworm disease the use of a monosubstance is preferred.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, in addition to adverse events observed at the recommended
dose (see 4.6), drooling may be observed. This sign will usually disappear
spontaneously within a day.
4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Endectocides, Macrocyclic lactones, milbemycin,
combinations
ATCvet code: QP54AB51
5.1 Pharmacodynamic properties
Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the
fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against
mites, against larval and adult stages of nematodes as well as against larvae of
Dirofilaria immitis.
The activity of milbemycin is related to its action on invertebrate neurotransmission:
Milbemycin oxime, like avermectins and other milbemycins, increases nematode and
insect membrane permeability to chloride ions via glutamate-gated chloride ion
channels (related to vertebrate GABAA and glycine receptors). This leads to
hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of
the parasite.
Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active
against cestodes and trematodes. It modifies the permeability for calcium (influx of
Ca2+) in the membranes of the parasite inducing an imbalance in the membrane
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structures, leading to membrane depolarisation and almost instantaneous contraction
of the musculature (tetany), rapid vacuolisation of the syncytial tegument and
subsequent tegumental disintegration (blebbing), resulting in easier expulsion from
the gastrointestinal tract or death of the parasite.
5.2 Pharmacokinetic particulars
In cats under fed condition, praziquantel reaches peak plasma concentrations within
3 hours after oral administration.
The half life of elimination is around 2 hours.
After oral administration in cats under fed condition, milbemycin oxime reaches peak
plasma concentrations within 5 hours. The half life of elimination is around 43 hours
(± 21 hours).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Cellulose, microcrystalline
Lactose monohydrate
Povidone
Croscarmellose sodium
Silica, colloidal anhydrous
Magnesium stearate
Coat:
Hypromellose
Talc
Propylene glycol
Titanium dioxide (E171)
Liver Flavour
Yeast
Iron Oxide, yellow (E172)
Iron Oxide, red (E172)
Iron Oxide, black (E172)
6.2 Major incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life for halved tablets after first opening the immediate packaging: 6 months.
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6.4. Special precautions for storage
Store in the original package in order to protect from moisture. This veterinary
medicinal product does not require any special temperature storage conditions.
Halved tablets should be stored below 25°C in the original blister and be used for the
next administration.
Keep the blister in the outer carton.
6.5 Nature and composition of immediate packaging
Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.
Cardboard box with 1 blister of 2 tablets.
Cardboard box with 1 blister of 4 tablets.
Cardboard box with 12 blisters, each blister contains 4 tablets (total 48 tablets).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.
The veterinary medicinal product should not enter water courses as milbemycin
oxime may be dangerous for fish and other aquatic organisms.