Phenoleptil 50 mg Tablets for Dogs

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 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 made
gradually to avoid precipitating an increase in the frequency of seizures.
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.

Special precautions for safe use in the target species:
Caution is recommended in animals with impaired hepatic and renal function,
hypovolemia, anaemia and cardiac or respiratory dysfunction.
The chance of hepatotoxic side effects can be diminished or delayed using an
effective dose that is as low as possible. Monitoring of hepatic parameters is
recommended in case of a prolonged therapy
It is recommended to assess the clinical pathology of the patient 2-3 weeks after start
of treatment and afterwards every 4-6 months, e.g. measurement of hepatic enzymes
and serum bile acids. It is important to know that the effects of hypoxia etc. do cause
increased levels of hepatic enzymes after a seizure.
Phenobarbital may increase the activity of serum alkaline phosphatase and
transaminases. These may demonstrate non-pathological changes, but could also
represent hepatotoxicity. Therefore, in the case of suspected hepatotoxicity, liver
function tests are recommended. Increased liver enzyme values do not require a dose
reduction of Phenobarbital if the serum bile acids are in the normal range.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Barbiturates can cause hypersensitivity. People with known hypersensitivity to
barbiturates should avoid contact with the veterinary medicinal product. Administer the
veterinary medicinal product with caution. It is advisable to wear disposable gloves
during administration of the veterinary medicinal product to reduce skin contact. Wash
hands thoroughly after use.
Accidental ingestion may cause intoxication and could be fatal, particularly for children.
Take utmost care that children do not come in contact with the product.
In case of accidental ingestion, seek medical attention immediately, advising medical
services of barbiturate poisoning; show the package leaflet or the label to the
physician. If possible, the physician should be informed about the time and amount of
ingestion, as this information may help to ensure that appropriate treatment is given.
AN: 03691/2024 & 03692/2024
Phenobarbital is teratogenic and may be toxic to unborn and breastfeeding children; it
may affect the developing brain and lead to cognitive disorders. Phenobarbital is
excreted in breast milk. Pregnant women, women of childbearing age and women who
are breastfeeding should avoid accidental ingestion and prolonged skin contact with
the product.

Keep this veterinary medicinal product in its original packaging to avoid accidental
ingestion. Each time an unused part-tablet is stored until next use, it should be
returned to the open blister space and inserted back into the cardboard box.
Special precautions for the protection of the environment:
Not applicable.