FLAVOURED PHENOBARBITAL 12.5 AND 50MG TABLETS

For the efficient dispensing and administration of phenobarbital.

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Animalcare Ltd | Common Road | Dunnington | York | YO19 5RU

01904 487687 01904 487611

animalcare@animalcare.co.uk www.animalcare.co.uk

Dogs can be dosed down to 5kg (at starting dose) with a 12.5mg tablet

Scored tablets for increased dosing flexibility**

Convenient tablet strengths for simple starting dose calculation (based on 2.5mg/kg bw bid)

1 x 12.5mg tablet per 5kg bw twice daily

½ x 50mg tablet per 10kg bw twice daily

1 x 50mg tablet per 20kg bw twice daily

Tablets presented in blister packs for easy and safe dispensing by practice staff

Durable client record card for the accurate recording of seizures during treatment

...the new approach to phenobarbital therapy in canine epilepsy

*Papich MG. Anticonvulsant Drugs. Veterinary Pharmacology and Therapeutics 9th Edition 2009 Wiley-Blackwell pp494-506**Only 50mg Phenoleptil tablets licensed to be split

“Phenobarbital is considered the first drug of choice for long term treatment of seizure disorders in dogs” Papich, 2009*

Animalcare offers , a flavoured phenobarbital tablet with numerous benefits to both practice and client.

Benefits of to the practice

...the new approach to phenobarbital therapy in canine epilepsy

Scored tablets for easier splitting if required**

Presented in blister packs of 10 tablets

enabling minimal drug exposure during handling

aiding daily dose monitoring

making it easier to monitor remaining supplies

Flavoured tablets for improved patient acceptance

Client record card available for home seizure monitoring

with dosing and emergency advice on reverse

TREATING AND MONITORING YOUR DOG’S EPILEPSY

Brought to you by Animalcare Ltd, suppliers of (phenobarbital)

Phenobarbital therapy

Your dog has been diagnosed with a condition known as epilepsy

which means that he/she is prone to development of recurrent

seizures. In order to reduce the frequency of these seizures, your

vet has prescribed a medication called Phenoleptil, which

contains phenobarbital.

In order to achieve optimum seizure control and minimize side

effects, levels of phenobarbital in your dog’s blood stream need to

be maintained within a specific range. This requires a joint effort

between you and your vet, and is achieved by;

• Administrationoftheprescribeddoseat12hourintervalsatthe

same times each day

• Bloodtestingdruglevels2weeksafterstartingthemedication

or changing the dose

• Routinebloodscreensevery6-12monthsnotonlytoconfirm

adequate drug levels but to assess your dog’s health status and

checkforanydrugrelatedside-effects

Side effects of medication

At the start of medication or after a recent dose increase, your

dog may appear slightly sedated with some incoordination. This

effecttypicallywearsoffafter2weeksbutifitdoesn’tconsultyour

veterinary surgeon.

Other side effects which can sometimes occur with

phenobarbital include;

• Increasedurinationandthirst–youmayhavetotop

up the water bowl and take your dog out for toileting

more often. Avoid restricting access to water since this

can cause dehydration

• Increasedappetite–ifthisoccursitisimportantnottooverfeed

your dog since this can cause obesity. One way to satisfy your

dog’s appetite is to feed smaller meals but more often or feed

alowcaloriediet–yourpracticeshouldbeabletooffermore

advice on diet

• Liverdamage–thisisafairlyuncommonproblemifdruglevels

are maintained within the correct limits. Your vet may check for

this during routine blood screens

What to do in the event of a seizure

Although it is very distressing to see your dog having a seizure, it is

important to stay calm. In most cases your dog will be unconscious

during a seizure and so will not be in pain or distress. Other than

removing any nearby dangers from your dog it is important to avoid

interfering with them and instead start timing and observing the

event from a distance.

Inmostcasesyourdog’sseizurewillonlylast1-2minutesandthere

is no need for them to receive immediate veterinary attention. The

event should however be recorded (see below). If your dog does not

come out of the seizure after 5 minutes, or has repeated seizures in

a24hourperiod,youshouldcontactyourveterinarypracticesince

they will need to see your dog without delay to give additional

anti-seizuremedication.

Monitoring your dog’s epilepsy

Since most seizures occur whilst your dog is at home, your vet is

going to be reliant on your observations of these events in order

to judge response to treatment. Your vet will want to know how

frequently the seizures occur and how long they last.

The chart overleaf can be used to keep a record of your dog’s

seizures. Although there are various types of seizure patterns in

epileptic dogs, your dog is likely to display a similar set of signs

before, during and after a seizure which you will gradually become

familiar with. It is useful to list these for reference for you, your vet

and anyone else who may need to look after your dog.

The seizure diary should be completed after each event. It is very

important that the duration of the seizure is recorded as accurately

as possible.

Note

When you get to the last few tablets it is important to contact

your practice to arrange a further

prescription to avoid running

out of medication and

increasing the risk of

a seizure.

® Phenoleptil is a registered trademark of Le Vet B.V.

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01904 487687 01904 487611

animalcare@animalcare.co.uk www.animalcare.co.ukPHEN-BRA-0510-02

SEIZURE DIARY

Dog’s Name:

Owner’s Name:

Start Date:

Current Medication

Seizure DescriptionAny known events that trigger my dog’s seizures (e.g. sleep, excitement)?

Any behavioral changes noted before a seizure occurs (if any)?

What typically happens during a seizure?Typical behavior just after a seizure?

Seizure Diary Note the duration of the seizure in the appropriate date box. If more than 1 seizure occurs in a day, write the durations of each

seizure in the same box. Complete the monthly duration totals at the bottom of each month.

MEDICATION

DOSE

TIME TO BE GIVEN AT....

(phenobarbital) 12.5mg 50mg

AM

PMAM

PMAM

PM

If the seizure lasts more than 5 minutes or if more than one seizure in 24 hours, contact your practice immediately on;

Daytime:

Out of hours:

More information overleaf.

DAY

MONTH

JANFEB MARCH APRIL MAY

JUNE JULYAUG

SEPTOCT NOV

DEC

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

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25

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31TOTAL

Benefits of to the client

FLAVOURED PHENOBARBITAL 12.5 AND 50MG TABLETS

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Animalcare Ltd | Common Road | Dunnington | York | YO19 5RU

01904 487687 01904 487611

animalcare@animalcare.co.uk www.animalcare.co.uk PHEN-BRA-0510-01

*Flavouring based on yeast extract.

Contra-indications, warnings, etc Do not use in case of hypersensitivity 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. Do not use in dogs weighing less than 5kg body weight. Adverse reactions: 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. Polyuria, polydipsia and polyphagia can occur at average or higher therapeutic active serum concentrations; these effects can be diminished by limiting intake of both food and water. Sedation and ataxia often become significant concerns as serum levels reach the higher ends of the therapeutic range. High plasma concentrations may be associated with hepatotoxicity. Phenobarbital can have deleterious effects on stem cells from bone marrow. Consequences are immunotoxic pancytopenia and/or neutropenia. These reactions disappear after the treatment’s withdrawal. Treating dogs with phenobarbital may lower their TT4 or FT4 serum levels, however this may not be an indication of hypothyroidism. Treatment with thyroid hormone replacement should only be started if there are clinical signs of the disease. If adverse effects are severe, decrease in the administered dose should be recommended. If you notice any serious effects or any other effects not mentioned in this leaflet, please inform your veterinary surgeon.

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. Monitoring of hepatic parameters is recommended in case of a prolonged therapy, because of phenobarbital’s hepatotoxicity. In stabilised epileptic patients, it is not recommended to switch from other phenobarbital formulations to Phenoleptil 12.5mg or 50mg 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.

Use during pregnancy or lactation: Use during pregnancy and lactation only according to the benefit/risk assessment by the responsible veterinarian. User warnings: 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.

Consult datasheet for further dosing and warning information before use.

Legal category: POM-V CD Schedule III

Marketing Authorisation Numbers12.5mg tablets Vm 19994/4005 50mg tablets Vm 19994/4006

® Phenoleptil is a registered trade mark of Le Vet B.V.

Further information is available from:

12.5mg 50mg

PRODUCT CODE XVD121 XVD123

PRESENTATION 12.5mg phenobarbitalOff-white biconvex flavoured* tablets with brown speckles and a score line on one side

50mg phenobarbitalOff-white biconvex flavoured* tablets with brown speckles and a score line on one side

INDICATIONS Prevention of seizures due to generalised epilepsy in dogs

INITIAL DOSE 2.5mg/kg bodyweight twice daily to be given orally at the same time each day

DOSE MONITORING AND ADJUSTMENT

Serum phenobarbital concentrations should be measured after steady state has been achieved (typically after 2 weeks). The ideal therapeutic range for serum phenobarbital concentration is between 15 and 40μg/ml. If serum phenobarbital concentration is less than 15μg/ml or

the seizures are not controlled the dose may be increased by 20% at a time, with associated monitoring of phenobarbital levels up to a maximum serum concentration of 45μg/ml.

CARTON Contains 50 blister strips of 10 tablets each