ORION PHENOBARBITAL ELIXIR phenobarbital 15mg/5mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenobarbital, Quantity: 3 mg/mL

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

INN (International Name):

phenobarbital (phenobarbitone)

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: purified water; ethanol; glycerol; sorbitol; Flavour

Administration route:

Oral

Units in package:

100mL, 500mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 16 JANUARY 2002: Treatment of epilepsy.

Product summary:

Visual Identification: Clear, syrupy liquid; characteristic butterscotch odour; Container Type: Bottle

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

Page 1 of 4
ORION PHENOBARBITAL ELIXIR
Phenobarbital (phenobarbitone)_15mg in 5mL _
CONSUMER MEDICINE INFORMATION
IMPORTANT INFORMATION
ABOUT YOUR MEDICINE
This medicine the doctor has
prescribed for you is called
Orion Phenobarbital Elixir.
The information in this leaflet will
answer some of the questions
you may have about Orion
Phenobarbital Elixir. This leaflet
does not tell you everything.
Your doctor or pharmacist has
been provided with full
information and can answer any
questions you may have.
This leaflet does not replace
the advice given to you by your
doctor. Talk to your doctor or
pharmacist.
You should read this leaflet
before taking Orion
Phenobarbital Elixir and keep it
in a safe place to refer to later.
WHAT ORION
PHENOBARBITAL ELIXIR IS
USED FOR
Orion
Phenobarbital
Elixir
is
used
to
treat
people
with
epilepsy.
It is
a barbiturate
which belongs to a group of
medicines
called
central
nervous
system
depressants
(medicines
that
cause
drowsiness).
Your
doctor
however may have prescribed
Orion Phenobarbital Elixir for
another
purpose.
Ask
you
doctor
if
you
have
any
questions
about
why
Orion
Phenobarbital Elixir has been
prescribed for you.
BEFORE TAKING THIS
MEDICINE
When deciding to take a
medicine, the risks of taking the
medicine must be weighed
against the good it will do. This
is a decision you and your
doctor will make. For
barbiturates the following should
be considered: _ALLERGIES_: Tell
your doctor if you have ever had
any unusual or allergic reactions
to phenobarbital or barbiturates,
or any of the ingredients in Orion
Phenobarbital Elixir (see
PRODUCT DESCRIPTION).
Symptoms of an allergic reaction
may include red itchy skin
rashes, difficulty breathing, hay
fever, swelling of the face, lips,
tongue or other parts of the
body. Tell your doctor if you
are allergic to any other
substances such as food,
preservatives or dyes. _MEDICAL _
CONDITIONS: Do not take Orion
Phenobarbital Elixir if you have,
or have had any of the following
medical conditions:

Porphyria, a rare blood
pigment disorder

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
– ORION PHENOBARBITAL (PHENOBARBITAL (PHENOBARBITONE)
15MG/5ML) ELIXIR
1
NAME OF THE MEDICINE
Phenobarbital (phenobarbitone)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orion Phenobarbital Elixir contains 15mg phenobarbital per 5mL
(0.3%w/v) in a sweetened
sucrose free base. It contains butterscotch flavour, ethanol,
glycerol, sorbitol solution (70% non-
crystallising) and water.
3
PHARMACEUTICAL FORM
Oral Liquid, solution. Clear, syrupy liquid; characteristic
butterscotch odour.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of epilepsy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dose of phenobarbital must be adjusted to the individual giving
consideration to the patient’s
age, weight and condition.
Plasma concentrations required to control epilepsy are usually about
15 to 40 micrograms/mL
(65 to 170 micromoles per L). Drug levels should be monitored so as to
keep within the
therapeutic range.
RECOMMENDED DOSAGE
Adult: 60 to 240 mg per day in 2 to 3 divided doses
Paediatric: 1 to 6 mg per kg per day in 2 to 3 divided doses
Phenobarbital may be given as a single daily dose as it has a long
half-life. Doses must be
individualized.
Geriatric
and
debilitated
patients
may
exhibit
excitement,
confusion
or
depression with usual therapeutic doses, thus lower doses are
recommended.
Phenobarbital should be withdrawn slowly in order to avoid
precipitating seizures or status
epilepticus.
4.3
C
ONTRAINDICATIONS
Not to be administered to:

Patients who are known to be hypersensitive to barbituric acid
derivatives.

Patients with porphyria, severe respiratory depression or pulmonary
insufficiency, renal
impairment, hepatic impairment, sleep apnoea, uncontrolled diabetes
mellitus, severe
anaemia due to folate deficiency, hyperkinetic children, suicidal
potential, alcoholism and
drug dependency.
2
Not to be used in the presence of uncontrolled pain as paradoxical
excitement may be
produced.
Phenobarbital
should
not
be
administered
to
elderly
patients
who
exhibit
nocturnal