Reconcile

Основна информация

  • Търговско наименование:
  • Reconcile
  • Използвай за:
  • Животни
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Reconcile
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Dogs
  • Терапевтична област:
  • PSYCHOANALEPTICS
  • Терапевтични показания:
  • 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.,
  • Каталог на резюме:
  • Revision: 10

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/V/C/000133
  • Дата Оторизация:
  • 07-07-2008
  • EMEA код:
  • EMEA/V/C/000133
  • Последна актуализация:
  • 23-03-2019

Доклад обществена оценка

30 Churchill Place Canary Wharf London E14 5EU United Kingdom

An agency of the European Union

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+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5545

Send a question via our website

www.ema.europa.eu/contact

EMA/CVMP/214641/2008

EMEA/V/C/000133

EPAR summary for the public

Reconcile

fluoxetine

This is a summary of the European public assessment report (EPAR) for Reconcile. It explains how the

Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and

its conditions of use. It is not intended to provide practical advice on how to use Reconcile.

For practical information about using Reconcile, animal owners or keepers should read the package leaflet

or contact their veterinarian or pharmacist.

What is Reconcile and what is it used for?

Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by

separation from their owners or homes or from other dogs (separation anxiety). Such problems may

include destruction of property, excessive barking or howling and inappropriate defecation and urination in

the home.

Reconcile should only be given in combination with behavioural therapy. It contains the active substance

fluoxetine.

How is Reconcile used?

Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription. The

tablet strength should be chosen according to the dog’s weight. The tablets are given once a day.

Symptoms are expected to improve within 1 to 2 weeks. In case there is no improvement within 4 weeks,

the veterinarian should re-evaluate treatment.

For further information, see the package leaflet.

How does Reconcile work?

Fluoxetine is an antidepressant. Fluoxetine works by increasing the levels of the neurotransmitter

serotonin in the central nervous system. A neurotransmitter is a substance that nerve cells use to

communicate with neighbouring cells. Since low levels of serotonin can be linked to depression and anxiety,

increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related

problems.

Reconcile

EMA/CVMP/214641/2008

Page 2/2

What benefits of Reconcile have been shown in studies?

A field study was conducted in a large number of dogs that were treated for separation anxiety in two

European countries. All dogs received behavioural therapy and were treated either with Reconcile or with

clomipramine (another medicine 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. The study showed that Reconcile was as effective as clomipramine.

After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile

group (inappropriate defecation and destructive behaviour).

What are the risks associated with Reconcile?

The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of

appetite and lethargy (lack of energy). Other common side effects with Reconcile (which may affect up to

1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability

to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and

disorientation.

Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits. It

must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other

ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).

For the full list of all side effects and restrictions reported with Reconcile, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into

contact with the animal?

If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.

Why is Reconcile approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile’s

benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Reconcile?

The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on

8 July 2008.

The full EPAR for Reconcile can be found on the Agency’s website: ema.europa.eu/Find

medicine/Veterinary medicines/European public assessment reports. For more information about

treatment with Reconcile, animal owners or keepers should read the package leaflet or contact their

veterinarian or pharmacist.

This summary was last updated in August 2016.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

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:

Pegasus Laboratories Ireland Limited

10 McCurtain Hill

Clonakilty

County Cork

P85 K230

Ireland

Manufacturer responsible for batch release:

QP-Services UK Ltd.

46 High Street

Yatton

Bristol

Somerset

BS49 4HJ

United Kingdom

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)

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

Reconcile 8 mg tablet

>8-16

Reconcile 16 mg tablet

>16-32

Reconcile 32 mg tablet

>32-64

Reconcile 64 mg tablet

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:

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

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency (http://www.ema.europa.eu/).

15.

OTHER INFORMATION

Pack sizes:

One bottle per carton.

The tablets are packaged in HDPE bottles, each bottle containing 30 tablets with a cotton coiler and

desiccant canister.