Soliphen 120 mg Tablet 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.

Revised: May 2024
AN: 04040/2022
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.

Revised: May 2024
AN: 04040/2022
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.