EPIDYOLEX cannabidiol 100 mg/mL oral liquid solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cannabidiol, Quantity: 100 mg/mL

Available from:

Chiesi Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: sesame oil; sucralose; ethanol absolute; Flavour

Administration route:

Oral

Units in package:

100 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

EPIDYOLEX is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older.

Product summary:

Visual Identification: Clear, colourless to yellow solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Authorization status:

Registered

Authorization date:

2020-09-21

Patient Information leaflet

EPIDYOLEX CMI v2.0
1
▼
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to
your doctor, or directly at www.tga.gov.au/reporting-problems.
EPIDYOLEX
_Cannabidiol _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EPIDYOLEX. It
does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking EPIDYOLEX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EPIDYOLEX IS
USED FOR
EPIDYOLEX contains cannabidiol,
a medicine which can be used to
treat epilepsy, a condition where
someone has seizures or fits.
EPIDYOLEX is used in combination
with other antiepileptic medicines to
treat seizures that occur with two
rare conditions, called Dravet
syndrome and Lennox-Gastaut
syndrome. It can be used in adults,
adolescents and children of at least
2 years of age.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU START
EPIDYOLEX
_ _
_WHEN YOU MUST NOT HAVE IT _
DO NOT TAKE EPIDYOLEX:
•
if you are allergic to
cannabidiol or any of the other
ingredients of this medicine
(listed in “Product description”
section)
•
if your doctor determines that
you have certain abnormal liver
blood tests.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If the medicine has expired or is
damaged, return it to your
pharmacist for disposal.
_ _
_BEFORE YOU START TREATMENT _
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
WARNINGS AND PRECAUT

Summary of Product characteristics

EPIDYOLEX PI v2.0
Page 1 of 22
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – EPIDYOLEX
® (CANNABIDIOL) ORAL
SOLUTION
1
NAME OF THE MEDICINE
Cannabidiol
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral solution contains 100 mg cannabidiol.
EXCIPIENTS WITH KNOWN EFFECT
Each mL of EPIDYOLEX oral solution contains 79 mg of ethanol absolute,
736 mg sesame
oil, and 0.5 mg of sucralose.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Oral solution
Clear, colourless to yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPIDYOLEX is indicated for use as adjunctive therapy of seizures
associated with Lennox-
Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of
age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
EPIDYOLEX should be initiated and supervised by a neurologist.
_ _
DOSAGE
The recommended starting dose of EPIDYOLEX is 2.5 mg/kg taken twice
daily
(5 mg/kg/day) for one week. After one week, the dose should be
increased to a
maintenance dose of 5 mg/kg twice daily (10 mg/kg/day). Based on
individual clinical
response and tolerability, each dose can be further increased in
weekly increments of
2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum
recommended dose of
10 mg/kg twice daily (20 mg/kg/day).
Any dose increases above 10 mg/kg/day, up to the maximum recommended
dose of
20 mg/kg/day, should be made considering individual benefit and risk
and with adherence
to the monitoring schedule (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS
FOR USE).
▼

EPIDYOLEX PI v2.0
Page 2 of 22
Each EPIDYOLEX carton is supplied with:
-
Two 1 mL syringes graduated in 0.05 mL increments (each 0.05 mL
increment
corresponds to 5 mg EPIDYOLEX)
-
Two 5 mL syringes graduated in 0.1 mL increment