Soliphen 60 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.

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Therapeutic phenobarbital serum concentrations should be monitored to enable the
lowest effective dose to be used. Typically, concentrations of 15-40 µg/ml are
effective in controlling epilepsy.
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 use in animals
Caution is recommended in animals with impaired renal function, hypovolemia,
anaemia 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 15-45µg/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.
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.
In stabilised epileptic patients, it is not recommended to switch from other
phenobarbital formulations to the veterinary medicinal product. 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.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of the animals.

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AN: 04040/2022 & 02701/2023Page 3 of 8
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.
Accidental ingestion may cause intoxication and could be fatal, particularly for
children. Take utmost care that children do not come in contact with the veterinary
medicinal product. Keep this 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.
Phenobarbital is teratogenic and may be toxic to unborn and breastfed 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 lactating
women should avoid accidental ingestion and prolonged skin contact with the
product.
It is advisable to wear disposable gloves during administration of the product to
reduce skin contact.
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.
Wash hands thoroughly after use.
Special precautions for the protection of the environment
Not applicable
Other precautions
Not applicable