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Reconcile

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Summary for the public


What is Reconcile?

Reconcile is a veterinary medicine containing the active substance fluoxetine. It is available as chewable tablets containing 8 mg, 16 mg, 32 mg or 64 mg fluoxetine.


What is Reconcile used for?

Reconcile is used, in combination with behavioural modification techniques, to assist in the treatment of dogs that have behavioural problems (separation anxiety) caused by separation from their owners, their normal home, or other dogs. These behavioural problems might be expressed by excessive barking or howling, inappropriate defecation or urination in the house, or destruction of their surroundings. Reconcile should not be used on its own but only in dogs that are also undergoing behavioural therapy.

Reconcile tablets are given once a day. The strength of tablet to be given is based on the dog’s weight, so that the dog is given between 1 to 2 mg per kg of the dog’s bodyweight per day. The tablets are chewable and may be given either with or without food.


How does Reconcile work?

The active substance in Reconcile, fluoxetine, is a selective serotonin re-uptake inhibitor (SSRI). It works by preventing the neurotransmitter serotonin (5-hydroxytryptamine) from being taken back up into nerve cells in the brain and spinal cord. Neurotransmitters such as serotonin are chemicals that transfer chemical signals from one nerve cell to another. Low levels of serotonin in the central nervous system may be associated with depression, anxiety or aggression. By blocking the re-uptake of serotonin into nerve cells, fluoxetine allows the levels of serotonin to remain higher. This can improve the clinical signs (behavioural problems) of separation-related disorders in dogs. In order to treat a dog with separation anxiety, the animal should not only receive medicines but also behavioural modification therapy. Behavioural modification therapy is the most important part of therapy; however, the use of the medicine allows for a more speedy recovery of the animal patient.


How has Reconcile been studied?

Reconcile has been investigated in four different studies in pet dogs for up to 8 weeks. The effective dose of Reconcile was established in one study. Another study investigated the efficacy of Reconcile in dogs which also received behavioural modification therapy, whilst a similar study looked at the efficacy in dogs that did not receive additional behavioural therapy. In both of those studies the effectiveness of Reconcile was compared with that of placebo (a dummy treatment) for up to 8 weeks. The last study was conducted under “field conditions” in a large number of dogs that were treated for separation anxiety in various veterinary practices, or clinics, in two European countries. All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine that can be used to treat dogs with separation-related disorders). The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs. In all the studies Reconcile was given once a day, either with or without food.


What benefit has Reconcile shown during the studies?

The oral administration of Reconcile tablets, as 1 to 2 mg/kg of fluoxetine once a day, is effective for the treatment of separation anxiety in dogs when used in conjunction with behavioural modification therapy.

The efficacy of Reconcile was higher when compared to placebo when behavioural modification therapy was also given to the dogs. The efficacy was lower when no behavioural modification therapy was given. When given in combination with behavioural modification therapy, approximately 42% of dogs given Reconcile improved within one week, compared to only 17% of the dogs given placebo (plus the behavioural modification therapy). The fluoxetine-treated group continued to have a higher incidence of improvement over the course of the treatment period and by the end of the 8 weeks, approximately 72% of the fluoxetinetreated dogs had shown improved behaviour (a global severity score of 50%).

The field study showed that Reconcile was as effective as clomipramine. In conjunction with behavioural modification therapy, Reconcile showed significant improvements in treating dogs for barking and inappropriate defecation or urination. After 8 weeks, two separation anxiety behaviours were significantly improved in the fluoxetine group (inappropriate defecation and destructive behaviour). Six weeks after the end of treatment, five out of the nine separation anxiety behaviours were still improved in about a third of the treated dogs. The rate of relapse at the end of the post-treatment phase was slightly higher in the fluoxetine group (28%) than in the clomipramine group (23%).


What is the risk associated with Reconcile?

The most common side effects with Reconcile are anorexia (loss of appetite) and lethargy (unresponsiveness). Urinary tract disorders (such as bladder infections, irregular urination and discomfort in passing urine) and central nervous system signs (such as incoordination and disorientation) were also observed. Less commonly, weight loss/loss of condition, dilation of the pupils of the eye and, rarely, seizures were also observed.

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

For a full list of all side-effects reported with Reconcile, see the Package Leaflet.

Reconcile tablets should not be used in dogs weighing less than 4 kg, or in dogs with epilepsy or with a history of seizures. Reconcile should also not be used in dogs that may be hypersensitive (allergic) to fluoxetine or other SSRIs. Since Reconcile has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation.

Reconcile tablets should not be used at the same time as many other medicines, especially medicines that can affect the central nervous system. See the Package Leaflet for full information.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

This veterinary medicine has been developed especially for dogs and is not for use in humans. If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.


Why has Reconcile been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Reconcile exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with behavioural problems caused by separation, and recommended that Reconcile be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Reconcile

The European Commission granted a marketing authorisation valid throughout the European Union, for Reconcile to Eli Lilly and Company Ltd on 08.07.2008. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Reconcile
EMEA Product number: EMEA/V/C/000133
Active substance: fluoxetine
INN or common name: Fluoxetine
Species: Dogs
ATCvet Code: QN06AB03
Marketing Authorisation Holder: Eli Lilly and Company Limited
Revision: 4
Date of issue of Market Authorisation valid throughout the European Union: 08/07/2008
Contact address:
Eli Lilly and Company Ltd
Priestley Road,
Basingstoke
Hampshire
RG24 9NL
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE 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
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each tablet contains:
    Active substance:
    Reconcile
    8 mg
    Fluoxetine
    8.0 mg
    (equivalent to 9.04 mg Fluoxetine hydrochloride)
    Reconcile
    16 mg
    Fluoxetine
    16.0 mg
    (equivalent to 18.08 mg Fluoxetine hydrochloride)
    Reconcile
    32 mg
    Fluoxetine
    32.0 mg
    (equivalent to 36.16 mg Fluoxetine hydrochloride)
    Reconcile
    64 mg
    Fluoxetine
    64.0 mg
    (equivalent to 72.34 mg Fluoxetine hydrochloride)
    Excipients:
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Chewable tablets.
    Speckled, tan to brown round chewable tablets, embossed on one side with a number (as listed below):
    Reconcile 8mg tablets: 4203
    Reconcile 16mg tablets: 4205
    Reconcile 32mg tablets: 4207
    Reconcile 64mg 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 defecation 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).
    2/33
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    Special precautions for use in animals
    The safety of Reconcile has not been established in dogs under 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-administration, 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.
    Reported adverse reactions in dogs include:
    - Very common adverse events: decreased appetite (including anorexia); lethargy.
    - Common adverse events: urinary tract disorders (cystitis, urinary incontinence, urinary retention,
    stranguria); central nervous system signs (incoordination, disorientation).
    - Uncommon adverse events: weight loss/loss of condition; mydriasis.
    - Rare adverse events: seizures.
    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.
    4.8 Interaction with other medicinal products and other forms of interaction
    Reconcile tablets 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 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 Reconcile
    tablets 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 drugs.
    3/33
    4.9 Amounts to be administered and administration route
    Reconcile tablets 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 Reconcile tablets 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. Reconcile 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 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 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: selective serotonin reuptake inhibitors (SSRI).
    ATCvet code: QN06AB03
    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, α 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 (~72%) and the absorption is not affected by
    feeding. Fluoxetine is metabolised to norfluoxetine, an equipotent SSRI that contributes to the efficacy
    the product.
    4/33
    In a 21 day study, fluoxetine was administered daily at a dose of 0.75, 1.5 and 3.0 mg/kg to laboratory
    Beagles. The maximum plasma concentration (C max ) 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 T max 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 ½ values ranging from 4.6 to 5.7 hours on day 1
    and from 5.1 to 10.1 on day 21. Norfluoxetine plasma levels slowly appeared in plasma and were
    slowly eliminated with t ½ values ranging from 44.2 to 48.9 hours on day 21. Norfluoxetine C max and
    AUC were generally dose proportional but these values were 3 to 4 hold higher on day 21 than on Day
    1.
    Accumulation of fluoxetine and norfluoxetine occurred following multiple doses until reaching a
    steady-state 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 was excreted in urine and faeces, respectively by 14 days
    following dosing.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Microcrystalline Cellulose
    Sucrose (as Compressible Sugar NF)
    Crospovidone
    Artificial beef flavour
    Silica, colloidal anhydrous
    Calcium hydrogen phosphate dihydrate
    Magnesium stearate
    6.2 Incompatibilities
    None 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 use.
    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
    Printed carton containing one white high density polyethylene (HDPE) bottle.
    The 8 mg, 16 mg and 32 mg tablets are packaged in an HDPE bottle with a child resistant closure,
    cotton coiler and a desiccant canister.
    The 64 mg tablets are packaged in an HDPE bottle with a child resistant closure, desiccant canister
    and cotton coiler.
    Each bottle contains 30 tablets.
    5/33
    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
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    product should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Priestley Road,
    Basingstoke
    Hampshire
    RG24 9NL
    United Kingdom
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/001-004
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    08.07.2008
    10. DATE OF REVISION OF THE TEXT
    08.07.2008
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.europa.eu /
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6/33
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    7/33
    A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer responsible for batch release
    Eli Lilly and Company Ltd
    Speke Operations
    Fleming Road
    Liverpool
    L24 9LN
    UK
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D.
    STATEMENT OF THE MRLs
    Not applicable.
    8/33
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9/33
    A. LABELLING
    10/33
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Outer carton - 8mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 8 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride).
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    As an aid in the treatment of separation-related disorders in combination with behavioural
    modification techniques.
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    11/33
     
    10. SPECIAL STORAGE CONDITIONS
    Do not store above 30ºC.
    Store in the original container. Keep the bottle tightly closed in order to protect from moisture. Do not
    remove the desiccant.
    11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    15. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/001
    16. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    12/33
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Bottle label – 8mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 8 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride)
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    13/33
     
    10. SPECIAL STORAGE CONDITIONS
    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.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/001
    15. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    14/33
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Outer carton – 16mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 16 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride).
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    As an aid in the treatment of separation-related disorders in combination with behavioural
    modification techniques.
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    15/33
     
    10. SPECIAL STORAGE CONDITIONS
    Do not store above 30ºC.
    Store in the original container. Keep the bottle tightly closed in order to protect from moisture. Do not
    remove the desiccant.
    11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    15. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/002
    16. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    16/33
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Bottle label – 16 mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 16 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride)
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    17/33
     
    10. SPECIAL STORAGE CONDITIONS
    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.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/002
    15. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    18/33
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Outer carton – 32 mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 32 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride).
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    As an aid in the treatment of separation-related disorders in combination with behavioural
    modification techniques.
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    19/33
     
    10. SPECIAL STORAGE CONDITIONS
    Do not store above 30ºC.
    Store in the original container. Keep the bottle tightly closed in order to protect from moisture. Do not
    remove the desiccant.
    11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    15. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/003
    16. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    20/33
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Bottle label – 32 mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 32 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride)
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    21/33
     
    10. SPECIAL STORAGE CONDITIONS
    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.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/003
    15. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    22/33
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Outer carton – 64 mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 64 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride).
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    As an aid in the treatment of separation-related disorders in combination with behavioural
    modification techniques.
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    23/33
     
    10. SPECIAL STORAGE CONDITIONS
    Do not store above 30ºC.
    Store in the original container. Keep the bottle tightly closed in order to protect from moisture. Do not
    remove the desiccant.
    11. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    12. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    13. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    14. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    15. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/004
    16. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    24/33
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    Bottle label – 64 mg
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Reconcile 64 mg chewable tablets for dogs
    Fluoxetine (as hydrochloride)
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
    3.
    PHARMACEUTICAL FORM
    Chewable tablet.
    4.
    PACKAGE SIZE
    30 tablets.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    9.
    EXPIRY DATE
    EXP {month/year}
    Once opened, use by….
    25/33
     
    10. SPECIAL STORAGE CONDITIONS
    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.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Eli Lilly and Company Ltd
    Basingstoke
    RG24 9NL
    UK
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/08/080/004
    15. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    26/33
     
    B. PACKAGE LEAFLET
    27/33
    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 and manufacturer:
    Eli Lilly and Company Ltd
    Priestley Road,
    Basingstoke
    Hampshire
    RG24 9NL
    United Kingdom
    2.
    NAME OF VETERINARY THE 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 (as hydrochloride)
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Reconcile is a speckled tan to brown round chewable tablet containing:
    Reconcile 8 mg fluoxetine (as 9.04 mg fluoxetine hydrochloride)
    Reconcile 16 mg fluoxetine (as 18.08 mg fluoxetine hydrochloride)
    Reconcile 32 mg fluoxetine (as 36.16 mg fluoxetine hydrochloride)
    Reconcile 64 mg fluoxetine (as 72.34 mg fluoxetine hydrochloride)
    4.
    INDICATION(S)
    Reconcile tablets are used 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 Reconcile in dogs with epilepsy or a history of seizures.
    28/33
    This product should not be used in case of hypersensitivity to fluoxetine or other Selective Serotonin
    Re-uptake Inhibitors (SSRIs).
    6.
    ADVERSE REACTIONS
    To minimize the risk of adverse reactions, the recommended dose should not be exceeded.
    Reported adverse reactions in dogs include:
    - Very common adverse events: decreased appetite (including anorexia); lethargy (including calmness
    and increased sleeping)
    - Common adverse events: urinary tract disorders (such as bladder infections, irregular urination,
    discomfort in passing urine); central nervous system signs (incoordination, disorientation)
    - Uncommon adverse events: weight loss/loss of condition; dilation of the pupils of the eye
    - Rare adverse events: seizures
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs.
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Reconcile tablets should be administered orally at a once daily dose of 1 to 2 mg/kg bodyweight
    according to the dosage table below:
    Body
    weight
    Tabletstrength(mg)
    Number of tablets
    per day
    (kg)
    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
    The dog’s response to therapy should be evaluated by the veterinary surgeon.
    Clinical improvement 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.
    Professional judgement should be used in monitoring the patient’s response to therapy to determine
    the need for continued treatment beyond 8 weeks or discontinuation of treatment should adverse
    events warrant.
    Reconcile tablets may be given with or without food and are flavoured so that 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.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Reconcile tablets should be administered orally with or without food. Dogs should be dosed daily.
    29/33
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    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.
    Keep out of the reach and sight of children.
    Shelf-life after first opening the container: 30 days.
    Discard any tablets remaining in the container after use.
    Do not use after the expiry date which is stated on the bottle.
    12. SPECIAL WARNING(S)
    The safety of Reconcile has not been established in dogs weighing less than 4 kg, or under 6 months of
    age.
    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.
    People with a known hypersensitivity to fluoxetine should avoid contact with the veterinary medicinal
    product.
    Studies to determine the effects of Reconcile tablets on breeding, pregnant or lactating dogs have not
    been conducted and thus the use in pregnant and lactating dogs is not recommended.
    Reconcile tablets should not be used in dogs with epilepsy or a history of seizures.
    Please inform your veterinary surgeon if your dog is receiving, or has had, any other medicines, even
    those not prescribed, as Reconcile tablets should not be given at the same time as many other
    medicines.
    Further advice for the veterinary surgeon - see section 4.8 of the Summary of Product Characteristics
    for further information on interactions with other medicinal products.
    In cases of accidental overdose your veterinary surgeon should be consulted immediately and
    symptomatic therapy should be initiated. (For further information see section 4.10 of the Summary of
    Product Characteristics).
    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.
    30/33
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    08.07.2008
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.europa.eu /
    15. OTHER INFORMATION
    Pack sizes:
    The tablets are packaged in HDPE bottles, each bottle containing 30 tablets with a cotton coiler and
    desiccant canister.
    For any information about this veterinary medicinal product, please contact the local representative of
    the marketing authorisation holder.
    België/Belgique/Belgien
    Eli Lilly Benelux
    Stoofstraat 52
    B-1000 Brussels
    Tel.: +32 2 548 84 84
    Luxembourg/Luxemburg
    Eli Lilly Benelux
    Stoofstraat 52
    B-1000 Brussels
    Tel.: +32 2 548 84 84
    Република България
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Magyarország
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Česká republika
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Malta
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Danmark
    Eli Lilly Industries Ltd
    Elanco Animal Health
    Priestley Road
    Basingstoke RG24 9NL
    Nederland
    Eli Lilly Nederland B.V.
    Postbus 379
    NL-3990 GD Houten
    Deutschland
    Lilly Deutschland GmbH
    Abt. ELANCO Animal Health
    Teichweg 3
    D-35396 Gießen
    Norge
    Eli Lilly Industries Ltd
    Elanco Animal Health
    Priestley Road
    Basingstoke RG24 9NL
    31/33
    Eesti
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Österreich
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Austria
    Tel.: +43 1 71178-0
    Ελλάδα
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Polska
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    España
    Lilly S.A.
    Elanco Valquimica S.A.
    Avda. de la Industria, 30
    E-28108 Alcobendas
    Madrid
    Portugal
    Lilly Farma – Produtos Farmacêuticos, Lda
    Rua Dr. António Loureiro Borges, 4 – piso 3
    Arquiparque – Miraflores
    P-1495-131 Algés
    France
    Lilly France
    13 rue Pages
    F-92158 Suresnes cedex
    Paris
    România
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Ireland
    Eli Lilly & Company Ltd.
    Elanco Animal Health
    Priestley Road
    Basingstoke UK RG24 9NL
    Slovenija
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Ísland
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Slovenská republika
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Italia
    Eli Lilly Italia S.p.A
    Elanco Animal Health
    Via Gramsci, 733
    SestoFiorentino
    I-50019 Firenze
    Suomi/Finland
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Κύπρος
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    Sverige
    Eli Lilly Industries Ltd
    Elanco Animal Health
    Priestley Road
    Basingstoke RG24 9NL
    32/33
    Latvija
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    United Kingdom
    Eli Lilly Industries Ltd
    Elanco Animal Health
    Priestley Road
    Basingstoke RG24 9NL
    Lietuva
    Eli Lilly Regional Operations GmbH
    Elanco Animal Health
    Kölblgasse 8-10
    A-1030 Wien
    Tel.: +43 1 71178-0
    33/33


    Source: European Medicines Agency


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