Phenotab Flavoured 25 mg Tablets for Dogs

It is recommended that the clinical pathology of the patient is monitored, the first time
2-3 weeks after initiation of therapy and subsequently every 4-6 months. It is
important to know that the effects of hypoxia can cause increased levels of hepatic
enzymes after a seizure.
Long-term therapy with phenobarbital results in habituation and dependence, which
can lead to a spontaneous return of symptoms upon sudden discontinuation of
therapy.
To achieve successful therapy, administration of tablets at the same time each day is
essential.

Issued: August 2020
AN: 00404/2019
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 required in animals with impaired liver and / or renal function,
hypovolaemia, anemia and cardiac or respiratory dysfunction.
It is recommended to evaluate hepatic function prior to initiation of the therapy. The
chance of hepatotoxic side effects can be diminished or delayed using an effective
dose that is low as possible.
Phenobarbital may increase the activity of serum alkaline phosphatase and
transaminases. These may demonstrate non-pathological changes, but an increase
in the activity of serum alkaline phosphatase and transaminases could also represent
hepatotoxicity. Therefore, in the case of suspected hepatotoxicity, liver function tests
are recommended.
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 stabilized epileptic patients, caution should be taken when switching between
phenobarbital formulations.
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
Barbiturates can cause hypersensitivity. People with known hypersensitivity to
barbiturates should avoid contact with the 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 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. In case of accidental ingestion, seek
medical attention immediately and show the package leaflet or the label to the
physician.
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 women
who are breastfeeding should avoid accidental ingestion due to hand-to-mouth
contact and prolonged skin contact with the product.
It is advisable to wear disposable gloves during administration of the product to
reduce skin contact with the product.
Wash hands thoroughly after use.

Issued: August 2020
AN: 00404/2019