Phenoleptil 100mg tablets for dogs
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
27-04-2013
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Active ingredient:
phenobarbital 100 mg
Available from:
Le Vet B.V
ATC code:
QN03AA02
Pharmaceutical form:
Tablet
Therapeutic group:
Phenobarbital
Therapeutic area:
Dogs
Authorization date:
2012-10-24
Summary of Product characteristics
Issued: January 2013
AN: 01563/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHENOLEPTIL 100 mg Tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCE
MG
Phenobarbital
100
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, circular, convex tablet with brown speckles and a crossed score line
on one side (13 mm diameter).
The tablets can be divided into two or four equal parts.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of seizures due to generalised epilepsy in dogs.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensivity to the active substance.
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 10 kg body weight.
4.4 SPECIAL WARNINGS FOR THE 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.
Issued: January 2013
AN: 01563/2011
Page 2 of 7
General recommendations for initiating therapy include a single seizure occurring more
than once every 4-6 weeks, cluster seizure activity (i.e. more than one seizure within 24
h) or status epilepticus regardless of frequency.
To achieve successful therapy, administration of tablets must be at the same time each
day.
Withdrawal or transition from other types of antiepileptic therapy should be
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