EPIDIOLEX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CANNABIDIOL

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

N03AX24

Pharmaceutical form:

SOLUTION

Composition:

CANNABIDIOL 100 MG / 1 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GW PHARMA LTD, UK

Therapeutic area:

CANNABIDIOL

Therapeutic indications:

Epidiolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Authorization date:

2021-04-14

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (MEDICINES) - 1986
This medicine can be sold with a physician's prescription only
EPIDIOLEX 100 MG/ML CANNABIDIOL
ORAL SOLUTION
ACTIVE INGREDIENT:
Each 1 mL of Epidiolex oral solution contains 100 mg of cannabidiol.
For the list of excipients of the medicine, please see section 2:
“Important information about some of the Epidiolex ingredients”
and section 6: “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any
further questions, contact your physician or pharmacist.
This medicine has been prescribed to treat your/your child’s
illness. Do not pass it on to others. It may harm them, even if it
seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Epidiolex contains cannabidiol.
Epidiolex is used in combination with other medicines to treat
seizures that occur with two rare conditions, called Dravet syndrome
(DS) and Lennox-
Gastaut syndrome (LGS) or to treat seizures that occur in Tuberous
Sclerosis Complex (TSC) patients. It can be used in adults,
adolescents and
children from 1 years of age.
Pharmacotherapeutic group: antiepileptics, other antiepileptics.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE EPIDIOLEX IF:
-
You/your child are hypersensitive (allergic) to cannabidiol, to other
cannabidiol derivatives or to any of the other ingredients of this
medicine (listed
in section 6). If you are not sure, talk to your physician or
pharmacist before taking Epidiolex.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
Talk to your physician or pharmacist before taking Epidiolex if:
• You/your child have or have had liver problems, as your physician
may need to change the dose of Epidiolex or may decide that Epidiolex
is not
appropriate for you.
• The physician may also do blood tests to check the liver before
initiation of this medicine and during treatment, as Epidiolex can
cause liver

Summary of Product characteristics

summary of product characteristics
1 PRODUCT NAME, ACTIVE INGREDIENT STRENGTH, DOSAGE FORM
EPIDIOLEX
ORAL SOLUTION
Active ingredient:
Each 1 mL of Epidiolex oral solution contains 100 mg of cannabidiol.
2 THERAPEUTIC INDICATIONS

EPIDIOLEX is indicated for use as adjunctive therapy of seizures
associated with Lennox-Gastaut
syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex
(TSC) in patients 1 year of age
and older.
3 DOSAGE AND ADMINISTRATION
3.1 ASSESSMENTS PRIOR TO INITIATING EPIDIOLEX
Because of the risk of hepatocellular injury, obtain serum
transaminases (ALT and AST) and total bilirubin
levels in all patients prior to starting treatment with EPIDIOLEX
_[see Warnings and Precautions (5.1)]. _
_ _
3.2 DOSING FOR SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME OR
DRAVET SYNDROME

The starting dosage is 2.5 mg/kg by mouth twice daily (5 mg/kg/day).

After 1 week, the dosage can be increased to a maintenance dosage of 5
mg/kg twice daily
(10 mg/kg/day).

Patients who are tolerating EPIDIOLEX at 5 mg/kg twice daily and
require further reduction of seizures
may benefit from a dosage increase up to a maximum recommended
maintenance dosage of 10 mg/kg
twice daily (20 mg/kg/day), in weekly increments of 2.5 mg/kg twice
daily (5 mg/kg/day), as tolerated.
For patients in whom a more rapid titration from 10 mg/kg/day to 20
mg/kg/day is warranted, the dosage
may be increased no more frequently than every other day.
Administration of the 20 mg/kg/day dosage
resulted in somewhat greater reductions in seizure rates than the
recommended maintenance dosage of
10 mg/kg/day, but with an increase in adverse reactions.
3.3 DOSING FOR SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX

The starting dosage is 2.5 mg/kg by mouth twice daily (5 mg/kg/day).

Increase the dose in weekly increments of 2.5 mg/kg twice daily (5
mg/kg/day), as tolerated, to a
recommended maintenance dosage of 12.5 mg/kg twice daily (25
mg/kg/day). For patients in whom a
more rapid titration to 25 mg/kg/day is warranted,