Target species
3.1 Dog.
3.2 Indications for use for each target species
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and
inappropriate behaviours (vocalisation and inappropriate defaecation and/or urination) and only in
combination with behavioural modification techniques.
3.3 Contraindications
Do not use in dogs weighing less than 4 kg.
Do not use in dogs with epilepsy or in dogs with a history of seizures.
Do not use in cases of hypersensitivity to the active substance or other Selective Serotonin
Re-Uptake Inhibitors (SSRIs) or to any of the excipients.
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in dogs less than 6 months
of age or weighing less than 4 kg.
As tablets are flavoured, store tablets out of reach of the animals in order to avoid accidental
ingestion.
Though rare, seizures may occur in dogs treated with the veterinary medicinal product. Treatment
should be stopped if seizures occur.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In humans, the most common symptoms associated with overdose include seizures, somnolence, nausea,
tachycardia, and vomiting.
To avoid accidental ingestion, particularly by a child, unused tablet parts should immediately be
returned to the bottle, the child-resistant closure replaced and the product stored safely out of
the sight and the reach of children. Any uneaten medicated food must be disposed of immediately and
the bowl washed thoroughly.
In case of accidental ingestion, seek medical advice and show the package leaflet or the label to
the physician.
A risk of congenital malformations was observed in infants with mothers exposed to fluoxetine in
early pregnancy. Pregnant women should avoid prolonged skin contact with the product.
The active substance fluoxetine may cause eye-irritation. Therefore, hand-to-eye contact should be
avoided. In case of accidental contact with eyes, rinse immediately with plenty of water.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
In dogs:
Very common
(>1 animal / 10 animals treated):
Common
(1 to 10 animals / 100 animals treated):
Uncommon
(1 to 10 animals / 1,000 animals treated):
Rare
(1 to 10 animals / 10,000 animals treated):
Decreased appetite or appetite loss, lethargy
Cystitis, urinary incontinence, urinary retention, stranguria
Incoordination, disorientation Weight loss/loss of condition Mydriasis
Panting Seizures Vomiting
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.
3.7 Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, foetotoxic
or maternotoxic effect. No effect on the reproductive capacity in male and female rats was noted.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
The use is not recommended during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
3.8 Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product should not be given concomitantly with veterinary medicinal
products that lower the seizure threshold (e.g. phenothiazines such as acepromazine or
chlorpromazine).
Do not use the veterinary medicinal product in conjunction with other serotonergic agents (e.g.
sertraline) and monoamine oxidase inhibitors (MAOIs) [e.g., selegiline hydrochloride ( -deprenyl),
amitraz] or tricyclic amines (TCAs) (e.g. amitriptyline and
clomipramine).
A 6-week washout interval should be observed following discontinuation of therapy with the
veterinary medicinal product prior to the administration of any veterinary medicinal product that
may adversely interact with fluoxetine or its metabolite, norfluoxetine.
Fluoxetine is largely metabolised by the P-450 enzyme system, although the precise isoform in dogs
is unknown. Therefore, fluoxetine should be used with caution with other veterinary medicinal
products.
3.9 Administration routes and dosage
Oral use.
The veterinary medicinal product should be administered orally at a once daily dose of 1 to 2 mg/kg
bodyweight.
Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a
flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
2 equal parts: press down with your thumbs on both sides of the tablet. 4 equal parts: press down
with your thumb in the middle of the tablet.
Clinical improvement with the veterinary medicinal product is expected within 1 to 2 weeks. If no
improvement is noted within 4 weeks, case management should be re- evaluated. Clinical studies have
shown that a beneficial response has been demonstrated for up to 8 weeks treatment with fluoxetine.
The tablets may be given with or without food.
If a dose is missed, the next scheduled dose should be administered as prescribed. At the end of
treatment it is not necessary to taper or reduce doses because of the long half-life of this
veterinary medicinal product.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
At doses in excess of the recommended dose, observed side effects at the therapeutic dose,
including seizures, are exacerbated. In addition, aggressive behaviour was observed. In clinical
studies these side effects were stopped immediately upon
intravenous administration of a standard dose of diazepam.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use
of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of
development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.