Reconcile
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
16-06-2021
Produktets egenskaber
(SPC)
16-06-2021
Offentlige vurderingsrapport
(PAR)
19-10-2016
Aktiv bestanddel:
fluoxetine
Tilgængelig fra:
Forte Healthcare Limited
ATC-kode:
QN06AB03
INN (International Name):
fluoxetine
Terapeutisk gruppe:
Dogs
Terapeutisk område:
Psychoanaleptics
Terapeutiske indikationer:
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defecation and / or urination) and only in combination with behavioural-modification techniques.
Produkt oversigt:
Revision: 14
Autorisation status:
Authorised
Autorisation dato:
2008-07-08
Indlægsseddel
14
B. PACKAGE LEAFLET
15
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
4.
INDICATION(S)
16
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
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 PARTICULARS
4.1
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.
3
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 pr
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