Phenoleptil 100 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.
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 renal function, hypovolemia,
anemia and cardiac or respiratory dysfunction.
Before beginning the treatment monitoring of hepatic parameters should be
performed.
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 can 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, so liver function
tests are recommended. Increased liver enzyme values may not always require a
dose reduction of phenobarbital if the serum bile acids are in the normal range.
In the light of isolated reports describing hepatotoxicity associated with combination
anticonvulsant therapy, it is recommended that:
1. Hepatic function is evaluated prior to initiation of therapy (e.g. measurement of
serum bile acids).
2. Therapeutic phenobarbital serum concentrations are monitored to enable the
lowest effective dose to be used. Typically concentrations of 15-45 µg/ml are
effective in controlling epilepsy.
3. Hepatic function is re-evaluated on a regular (6 to 12 months) basis.
4. Seizure activity is re-evaluated on a regular basis.
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
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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.
AN: 03852/2023 & 03858/2023
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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.
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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.
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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.