Fluoxevet 32 mg, Tablets for Dogs

Excipients:
Qualitative composition of excipients
and other constituents
Silicified microcrystalline celluloseCalcium hydrogen phosphate dihydrateBeef flavourSucraloseSilica, colloidal anhydrous
TalcMagnesium stearateMasking flavour
White to cream, spotted, round convex tablet with a cross-shaped break.
The tablets can be divided into 2 or 4 equal parts.
3. CLINICAL INFORMATION
3.1 Target species
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):
Decreased appetite or appetite loss,
lethargy
Common
(1 to 10 animals / 100 animals treated):
Cystitis, urinary incontinence, urinary
retention, stranguria
Incoordination, disorientation
Uncommon
(1 to 10 animals / 1,000 animals treated):
Weight loss/loss of condition
Mydriasis
Rare
(1 to 10 animals / 10,000 animals treated):
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 (L-deprenyl), amitraz] or tricyclic amines (TCAs) (e.g
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.
4. <