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Phenoleptil 50 mg Tablets for Dogs

Information leaflet

             Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                                            Revised: 16 June 2010
                                                                                  AN: 00229/2010
                     SUMMARY OF PRODUCT CHARACTERISTICS


1.    NAME OF THE VETERINARY MEDICINAL PRODUCT

      Phenoleptil 50 mg Tablets for dogs

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

      Each 320 mg tablet contains

      Active substance               mg
      Phenobarbital                  50

      Excipient(s):
      For a full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM

      Tablet.
      White to off white, circular, biconvex tablets with brown speckles and a score line
      on one side (9 mm diameter). The tablet can be divided into equal halves.

4.    CLINICAL PARTICULARS

4.1   Target species

      Dog.

4.2   Indications for use, specifying the target species

      Prevention of seizures due to generalised epilepsy in dogs.

4.3   Contraindications

      Do not use in case of hypersensivity to the active substance.
      Do not use in animals with serious impaired hepatic function.
      Do not use in animals with serious renal or cardiovascular disorders.

4.4   Special warnings for the target species

      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.
      To achieve successful therapy, administration of tablets must be at the same time
      each day.



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           Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                                          Revised: 16 June 2010
                                                                                AN: 00229/2010
      Withdrawal or transition from other types of antiepileptic therapy should be made
      gradually to avoid precipitating an increase in the frequency of seizures.
      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.

4.5   Special precautions for use

      i. Special precautions for use in animals

      Caution is recommended in animals with impaired hepatic and renal function,
      hypovolemia, anemia 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. Therefore, in the case of suspected hepatotoxicity, liver
      function tests are recommended. Increased liver enzyme values do not 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 from other
      phenobarbital formulations to Phenoleptil 12.5 mg or 50 mg Tablets. However, if
      this can not 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 of therapy with Phenobarbital formulations should be made gradually to
      avoid precipitating an increase in the frequency of seizures.

      ii. Special precautions to be taken by the person administering the veterinary
      medicinal product to animals

      People with known hypersensitivity to barbiturates should avoid contact with the
      veterinary medicinal product. Wash hands after use.
      In case of accidental ingestion seek medical advice immediately and show the
      package leaflet or the label to the doctor.

4.6   Adverse reactions (frequency and seriousness)

      During start of therapy ataxia, sleepiness, slackness and dizziness can occur but
      these effects are usually transitory and disappear in most, but not all, patients with
      continued medication.
      Some animals can demonstrate a paradoxical hyperexcitability, particularly after
      first starting therapy.
      As this hyperexcitability is not linked to overdosage, no reduction of dosage is
      needed.

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