Reconcile - summary of medicine characteristics

Summary of medicine characteristics - Reconcile

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Reconcile 8 mg chewable tablets for dogs

Reconcile 16mg chewable tablets for dogs

Reconcile 32 mg chewable tablets for dogs

Reconcile 64 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each tablet contains:

Reconcile 8 mg: Fluoxetine 8 mg (equivalent to 9.04 mg fluoxetine hydrochloride)

Reconcile 16mg: Fluoxetine 16 mg (equivalent to 18.08mg fluoxetine hydrochloride)

Reconcile 32 mg: Fluoxetine 32 mg (equivalent to 36.16 mg fluoxetine hydrochloride)

Reconcile 64 mg: Fluoxetine 64 mg (equivalent to 72.34 mg fluoxetine hydrochloride)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablet.

Speckled, tan to brown round chewable tablets, embossed on one side with a number (as listed below):

Reconcile 8 mg tablets: 4203

Reconcile 16 mg tablets: 4205

Reconcile 32 mg tablets: 4207

Reconcile 64 mg tablets: 4209

4. CLINICAL PARTICULARS4.1 Target species

Dogs

4.2 Indications for use, specifying the 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.

4.3 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 case of hypersensitivity to fluoxetine or other Selective Serotonin Re-Uptake Inhibitors (SSRIs) or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

The safety of the product has not been established in dogs less than 6 months of age or weighing less than 4 kg.

Though rare, seizures may occur in dogs treated with Reconcile. Treatment should be stopped if seizures occur.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In humans, the most common symptoms associated with overdose include seizures, somnolence, nausea, tachycardia, and vomiting.

4.6 Adverse reactions (frequency and seriousness)

To minimize the risk of adverse reactions, the recommended dose should not be exceeded.

– Decreased appetite (including anorexia); lethargy (very common).
– Urinary tract disorders (cystitis, urinary incontinence, urinary retention, stranguria); central nervous system signs (incoordination, disorientation) (common).
– Weight loss/loss of condition; mydriasis (uncommon).
– Panting, seizures, vomiting (rare).

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reaction(s)
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation, thus the use is not recommended during pregnancy and lactation.

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.

Do not use in breeding animals.

4.8 Interaction with other medicinal products and other forms of interaction

Reconcile 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 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. amitriptyline and clomipramine).

A 6-week washout interval should be observed following discontinuation of therapy with the 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.

4.9 Amounts to be administered and administration route

Reconcile should be administered orally at a once daily dose of 1 to 2 mg/kg bodyweight according to the dosage table below:

Bodyweight (kg)	Tablet strength (mg)	Number of tablets per day
4 – 8	Reconcile 8mg tablet	1
> 8 – 16	Reconcile 16mg tablet	1
> 16 – 32	Reconcile 32mg tablet	1
> 32 – 64	Reconcile 64mg tablet	1

Clinical improvement with the 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.

Reconcile tablets may be given with or without food. The tablets are flavoured and most dogs will consume the tablet when offered by the owner.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: selective serotonin reuptake inhibitors (SSRI)

ATCvet code: QNO6ABO3

5.1 Pharmacodynamic properties

Fluoxetine and its active metabolite nor-fluoxetine have been shown to be highly selective inhibitors of serotonin uptake both in vitro and in vivo. Fluoxetine does not act as a sedative. Fluoxetine inhibits catecholamine uptake only at high concentrations in vitro and has no effect on catecholamine uptake in vivo at doses that are used to inhibit serotonin uptake. As a result of inhibiting serotonin uptake, fluoxetine enhances serotonergic neurotransmission and produces functional effects resulting from increased activation of serotonin receptors. Fluoxetine lacks any significant affinity for neurotransmitter receptors, including the muscarinic cholinergic receptor, adrenergic receptors, or histaminergic H1 receptors, and does not have direct effects on the heart.

5.2 Pharmacokinetic particulars

Fluoxetine is well absorbed after oral administration (approximately72%) and the absorption is not affected by feeding. Fluoxetine is metabolised to norfluoxetine, an equipotent SSRI that contributes to the efficacy of the veterinary medicinal product.

In a 21 day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/kg body weight to laboratory Beagles. The maximum plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) for fluoxetine were approximately dose proportional between 0.75 and 1.5 mg/kg, with a greater than dose proportional increase at 3 mg/kg. After administration, fluoxetine readily appeared in plasma with mean Tmax values ranging from 1.25 to 1.75 hours on day 1 and from 2.5 to 2.75 hours on day 21. Plasma levels readily declined with mean t>/2 values ranging from 4.6 to 5.7 hours on day 1 and from 5.1 to 10.1 hours on day 21. Norfluoxetine plasma levels slowly appeared in plasma and were slowly eliminated with t>/2values ranging from 44.2 to 48.9 hours on day 21. Norfluoxetine Cmax and AUC were generally dose proportional but these values were 3 to 4 fold higher on day 21 than on day 1.

Accumulation of fluoxetine and norfluoxetine occurred following multiple doses until reaching a steadystate within approximately 10 days. Following the last dose administration, fluoxetine and norfluoxetine plasma levels declined steadily in a log-linear fashion. Elimination studies in dogs have shown that 29.8% and 44% of the dose were excreted in urine and faeces, respectively by 14 days following dosing.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Microcrystalline cellulose

Sucrose (as compressible sugar )

Crospovidone

Artificial beef flavour

Silica, colloidal anhydrous

Calcium hydrogen phosphate dihydrate

Magnesium stearate

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 30 days.

Discard any tablets remaining in the container after the shelf life has expired.

6.4. Special precautions for storage

Do not store above 30 °C.

Store in the original container. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant.

6.5 Nature and composition of immediate packaging

White high density polyethylene (HDPE) bottle with a child resistant closure, cotton coil and a desiccant pack.

Each bottle contains 30 tablets.

Pack size of one bottle.

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

7. MARKETING AUTHORISATION HOLDER

FORTE Healthcare ltd

Cougar Lane

Naul

Co. Dublin

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/08/080/001 – 004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 08/07/2008

Date of last renewal: 13/07/2018