Epityl 60 mg Flavoured 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.
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, 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 stabilised epileptic patients, it is not recommended to switch between
phenobarbital formulations. However, if this cannot be avoided then additional
caution should be taken. This includes more frequent plasma concentration sampling
to ensure that therapeutic levels are maintained. Monitoring for increased side effects
and for hepatic dysfunction should be conducted more regularly until stabilisation is
confirmed.
Withdrawal or transition from other types of anti-epileptic therapy should be made
gradually to avoid precipitating an increase in the frequency of seizures.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of the animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
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barbiturates should avoid contact with the product.
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children. Take utmost care that children do not come in contact with the
product.
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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.

Revised: January 2025
AN: 01592/2024Page 3 of 8
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to reduce skin contact.
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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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to the open blister space and inserted back into the cardboard box.
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Special precautions for the protection of the environment:
Not Applicable.