Reconcile - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Reconcile 8 mg chewable tablets for dogs

Reconcile 16 mg chewable tablets for dogs

Reconcile 32 mg chewable tablets for dogs

Reconcile 64 mg chewable tablets for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

FORTE Healthcare ltd

Cougar Lane

Naul

Co. Dublin

Ireland

Manufacturer responsible for batch release :

Tairgi Tread -Lia Baile na Sceilge Teo T/A Ballinskelligs

Veterinary Products,

Ballinskelligs,

Co. Kerry,

V23 XR52,

Ireland

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Reconcile 8 mg chewable tablets for dogs

Reconcile 16 mg chewable tablets for dogs

Reconcile 32 mg chewable tablets for dogs

Reconcile 64 mg chewable tablets for dogs fluoxetine

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

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)

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

As an aid in the treatment of separation-related disorders in dogs, such as destruction and vocalisation and inappropriate defaecation and/or urination. This product should only be used in conjunction with a behaviour modification programme recommended by your veterinary surgeon.

• 5. CONTRAINDI­CATIONS

Do not use in dogs weighing less than 4 kg.

Do not use in dogs with epilepsy or 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.

• 6. ADVERSE REACTIONS

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

• – Decreased appetite (including anorexia); lethargy (including calmness and increased sleeping) (very common)

• – Urinary tract disorders (such as bladder infections, irregular urination, discomfort in passing urine); central nervous system signs (incoordination, disorientation) (common)

• – Weight loss/loss of condition; dilation of the pupils of the eye (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

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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

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

Clinical improvement with the product is expected within 1 or 2 weeks. If no improvement is noted within 4 weeks, consult your veterinary surgeon who will need to re-evaluate the dog’s treatment.

Clinical studies have shown that a beneficial response has been demonstrated for up to 8 weeks treatment with fluoxetine.

If a dose is missed, the next scheduled dose should be administered as prescribed.

• 9. ADVICE ON CORRECT ADMINISTRATION

Tablets should be administered orally with or without food and are flavoured so that most dogs will consume the tablet when offered by the owner.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

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.

Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.

Shelf-life after first opening the container: 30 days.

Discard any tablets remaining 30 days after opening.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

The safety of Reconcile 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 the product. Treatment should be stopped if seizures occur.

Tablets should not be used in dogs with epilepsy or a history of seizures

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

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

Pregnancy and lactation :

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.

Interaction with other medicinal products and other forms of interaction:

Please inform your veterinary surgeon if your dog is receiving, or has had, any other medicines, even those not prescribed, as the product should not be given at the same time as many other medicines.

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 liver. Therefore, fluoxetine should be used with caution with other veterinary medicinal products.

Overdose (symptoms, emergency procedures, antidotes) :

In cases of accidental overdose your veterinary surgeon should be consulted immediately and symptomatic therapy should be initiated. Adverse reactions as described above, including seizures, are more common after overdose. In addition, aggressive behaviour was observed.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused product or waste material should be disposed of in accordance with local requirements.

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED