Phenoleptil 25 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenobarbital

Available from:

Le Vet BV

ATC code:

QN03AA02

INN (International Name):

Phenobarbital

Dosage:

25 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

phenobarbital

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2013-02-15

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHENOLEPTIL 25 mg Tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
ACTIVE SUBSTANCE:
Phenobarbital
25mg
EXCIPIENTS:
For the 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 (8
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 hypersensitivity to the active substance or to
other barbiturates.
Do not use in animals with seriously impaired hepatic function.
Do not use in animals with serious renal or cardiovascular disorders.
Do not use in dogs weighing less than 2.5 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.
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 hours) or status
epilepticus regardless of frequency.
Some of the dogs are free of epileptic seizures during the treatment,
but some of the dogs show only a
seizure reduction, and some of the dogs are considered to be
non-responders.
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Doses for smaller dogs can not be adjusted in accordance with the
recommended 20% regime, and
therefore special care should be taken in monitoring these animals.
Also see section 4.9.
2
Withdrawal of phenobarbital or transition to or from another type of
antiepileptic therapy should be
made gradually to avoid precipitating an increase in the frequency of
seizures.
Caution is recommended in animals with impai