Clomicalm
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
25-10-2021
Produktets egenskaber
(SPC)
25-10-2021
Offentlige vurderingsrapport
(PAR)
01-07-2016
Aktiv bestanddel:
clomipramine hydrochloride
Tilgængelig fra:
Virbac S.A.
ATC-kode:
QN06AA04
INN (International Name):
Clomipramine
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 elimination (defecation and urination) and only in combination with behavioural modification techniques.
Produkt oversigt:
Revision: 18
Autorisation status:
Authorised
Autorisation dato:
1998-04-01
Indlægsseddel
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
CLOMICALM 5 MG TABLETS FOR DOGS
CLOMICALM 20 MG TABLETS FOR DOGS
CLOMICALM 80 MG 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 responsible for batch
release:
VIRBAC
1ère avenue – 2065 m – LID
06516 Carros
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clomicalm 5 mg tablets for dogs
Clomicalm 20 mg tablets for dogs
Clomicalm 80 mg tablets for dogs
Clomipramine hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine)
20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine)
80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine)
5 mg tablet: Brownish-grey, oval-oblong, divisible. Scored on both
sides.
20 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears
the imprint ‘C/G’, the other ‘G/N’
and scored on both sides.
80 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears
the imprint ‘I/I’, the other no
imprint and scored on both sides.
4.
INDICATION(S)
As an aid in the treatment of separation related disorders manifested
by destruction and inappropriate
elimination (defaecation and urination) and only in combination with
behavioural modification
techniques.
5.
CONTRAINDICATIONS
Do not use in case of known hypersensitivity to clomipramine and
related tricyclic antidepressants. Do
not use in male breeding dogs.
6.
ADVERSE REACTIONS
17
Clomicalm may very rarely
cause vomiting, changes in appetite, lethargy or an elevation in liver
enzymes, which is reversible when the product is discontinued.
Hepato-biliary disease has been
reported, especially with pre-existing conditions, and concurrent
administrations of drugs metabolized
via the hepatic system. Vomiting may be reduced by co-administration
with a small quantity of food.
The frequency of adverse reaction
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clomicalm 5 mg tablets for dogs
Clomicalm 20 mg tablets for dogs
Clomicalm 80 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Clomicalm contains:
ACTIVE SUBSTANCE:
Clomipramine hydrochloride
5 mg (equivalent to 4.5 mg Clomipramine)
Clomipramine hydrochloride
20 mg (equivalent to 17.9 mg Clomipramine)
Clomipramine hydrochloride
80 mg (equivalent to 71.7 mg Clomipramine)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
5 mg tablet: Brownish-grey, oval-oblong, divisible. Scored on both
sides.
20 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears
the imprint ‘C/G’, the other ‘G/N’
and scored on both sides.
80 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears
the imprint ‘I/I’, the other no
imprint and scored on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
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 elimination (defaecation and urination) and only in
combination with behavioural
modification techniques.
4.3
CONTRAINDICATIONS
Do not use in case of known hypersensitivity to clomipramine and
related tricyclic antidepressants.
Do not use in male breeding dogs.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy and safety of Clomicalm has not been established in dogs
weighing less than 1.25 kg or
under six months of age.
4.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals It is recommended that
Clomicalm be administered to dogs with
cardiovascular dysfunction or epilepsy with caution and only after an
assessment of the benefit risk
ratio. Because of its potential anticholinergic properties, Clomicalm
should also be used with care in
dogs with narrow angle glaucoma, reduced gastrointestinal motility or
urinary retention. Clomicalm
should be used under veterin
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