Lepitil 60 mg Chewable Tablets for Dogs
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
29-08-2013
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Active ingredient:
phenobarbital 60 mg
Available from:
Chanelle Pharmaceutical Manufacturing Ltd
ATC code:
QN03AA02
Pharmaceutical form:
Chewable tablet
Therapeutic group:
Phenobarbital
Therapeutic area:
Dogs
Authorization date:
2013-04-24
Summary of Product characteristics
Issued: August 2013
AN. 01712/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lepitil 60mg Flavoured Tablets for Dogs
Lepitil vet 60mg Tablets for Dogs (SE)
Phenobarbital
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
Each tablet contains:
Phenobarbital 60mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White, circular tablet with cross breakline on one side.
The tablets can be divided into equal halves or quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Phenobarbital is an antiepileptic agent for the prevention of seizures due to generalized
epilepsy in dogs.
4.3
CONTRA-INDICATIONS
Do not use in case of hypersensitivity to barbituates.
Do not use in animals with serious impaired hepatic function.
Do not use in animals with serious renal or cardiovascular disorders.
Do not use in dogs weighing less than 6 kg body weight.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The decision to start antiepileptic drug therapy with Phenobarbital should be evaluated
for each individual case and depends on number, frequency, duration and severity of
seizures in dogs.
Administration of tablets should occur at the same time(s) each day, and should be co-
ordinated with feeding times in a consistent manner. Withdrawal or transition from other
Issued: August 2013
AN. 01712/2011
Page 2 of 7
types of antieleptic therapy should be made gradually to avoid precipitating an increase
in the frequency of seizures.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR U
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