KANOBIL® EPI

Category of the product: Product from cannabis for medical use
Type of ATC Product:§KANOBIL® EPI is dispensed on prescription in duplicate upon recommendation of medical doctor, specialist in neurology or paediatric neurology.
triangle – absolute prohibition on driving a motor vehicle or handling machines.
§ -narcotic drug
Product Name: KANOBIL® EPI cannabis oil extract for medical use
Generics: tetrahydrocannabinol (THC), cannabidiol (CBD)
Dose:
Oil solution for oral use
(1 mg tetrahydrocannabinol (THC) and
15 mg cannabidiol (CBD))/ 1 ml
(120 mg tetrahydrocannabinol (THC) and
1800 mg cannabidiol (CBD))120 ml

The text is not intended for self-medication!
Text is intended for informative purposes of healthcare workers.


NAME OF PRODUCT
KANOBIL® EPI
tetrahydrocannabinol (THC), cannabidiol (CBD)
ATC N03AX


POSOLOGY AND METHOD OF ADMINISTRATION

Stick strictly to the recommendations from your doctor. The therapy has to be recommended and monitored by a doctor, specialist in neurology or paediatric neurology. Your doctor will tell you how many doses per day you should take and when. You must not change the doses or discontinue the treatment regime without consulting your doctor.
KANOBIL® EPI is for oral administration. Shake the bottle before use. Use the plastic oral dosing syringe for drawing a dose of the oil solution which is equal to the dose given in the recommendation by your doctor.

Carefully press to release the content of the oral dosing syringe in the mouth and swallow.
You can take KANOBIL®EPI with or without food. However, taking KANOBIL® EPI with food can affect the amount your body takes in. You should try, as far as possible, to take KANOBIL® EPI the same way in relation to food each time, so you get the same effect each time.
Depending on the condition for which this medicine is taken, your doctor will determine the daily dose of KANOBIL® EPI according to the following tables:

DOSAGE IN ADULTS WITH REFRACTORY EPILEPSY
(in patients in whom antiepileptic drugs, used as mono or combined therapy, do not provide the satisfactory response)
The therapy includes: a titration period and maintenance period.
Prior to the beginning of the treatment, it is necessary to determine the frequency and the number of seizures.

TITRATION PERIOD
The titration period lasts several weeks, usually 4-5 weeks.
The dosage is expressed as a single dose, in ml (containing 1 mg THC and 15 mg CBD).
Every increase of the dosage is for 2 ml (which is equal to 2 mg THC and 30 mg CBD).

STARTING DOSE
Use 2 ml of the oil solution in the evening before sleeping, during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 1 x 2 ml 2 mg/30mg 2 ml
Day 2 1 x 2 ml 2 mg/30mg 2 ml
Day 3 1 x 2 ml 2 mg/30mg 2 ml
Day 4 1 x 2 ml 2 mg/30mg 2 ml
Day 5 1 x 2 ml 2 mg/30mg 2 ml

If well tolerated, the Starting dose should be repeated during a period of 5 days, and then followed by an Increase of the dose I – by adding 2 ml.
If moderate side effects occur during the Starting dose, the Starting dose should be repeated for 7 more days. If side effects do not disappear or get worse, the therapy should be discontinued.
THE NEXT DOSE – Increase of the dose I
Use 4 ml of the oil solution divided into two equal daily doses during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 2 x 2 ml 4 mg/60 mg 4 ml
Day 2 2 x 2 ml 4 mg/60 mg 4 ml
Day 3 2 x 2 ml 4 mg/60 mg 4 ml
Day 4 2 x 2 ml 4 mg/60 mg 4 ml
Day 5 2 x 2 ml 4 mg/60 mg 4 ml

If Increase of the dose I is well tolerated, it continues with:
Increase of the dose II
Use 6 ml of the oil solution divided into two equal daily doses during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 2 x 3 ml 6 mg/90 mg 6 ml
Day 2 2 x 3 ml 6 mg/90 mg 6 ml
Day 3 2 x 3 ml 6 mg/90 mg 6 ml
Day 4 2 x 3 ml 6 mg/90 mg 6 ml
Day 5 2 x 3 ml 6 mg/90 mg 6 ml

If the Increase of the dose II is well tolerated, it continues with:
Increase of the dose III –
Use 8 ml of the oil solution divided into two equal daily doses during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 2 x 4 ml 8 mg/120 mg 8 ml
Day 2 2 x 4 ml 8 mg/120 mg 8 ml
Day 3 2 x 4 ml 8 mg/120 mg 8 ml
Day 4 2 x 4 ml 8 mg/120 mg 8 ml
Day 5 2 x 4 ml 8 mg/120 mg 8 ml

If Increase of the dose III is well tolerated, it continues with:
Increase of the dose IV –
Use 10 ml of the oil solution divided into two equal daily doses during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 2 x 5 ml 10 mg/150 mg 10 ml
Day 2 2 x 5 ml 10 mg/150 mg 10 ml
Day 3 2 x 5 ml 10 mg/150 mg 10 ml
Day 4 2 x 5 ml 10 mg/150 mg 10 ml
Day 5 2 x 5 ml 10 mg/150 mg 10 ml

If Increase of the dose IV is well tolerated, it continues with:
Increase of the dose V –
Use 12 ml of the oil solution divided into two equal daily doses during a period of 5 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 2 x 6 ml 12 mg/180 mg 12 ml
Day 2 2 x 6 ml 12 mg/180 mg 12 ml
Day 3 2 x 6 ml 12 mg/180 mg 12 ml
Day 4 2 x 6 ml 12 mg/180 mg 12 ml
Day 5 2 x 6 ml 12 mg/180 mg 12 ml

If moderate side effects occur during the titration in any of the intervals, the appropriate increase of the dose should be done during a longer period, or the dose should be increased with smaller dosage. If after 7 days the side effects do not disappear or get worse, the therapy should be discontinued.
The dose reached during the titration, which is well tolerated and which produces an improvement of the clinical status (frequency and number of seizures) is the MAINENANCE DOSE.

MAINTENANCE PERIOD

MAINTENANCE DOSE
Use 12 ml of the oil solution divided into two equal daily doses, in the morning and in the evening, before sleeping (12 mg THC and 180 mg CBD)/day.
During the therapy course, at every 4, 8 and 12 weeks, a laboratory control has to be performed for haematological, hepatic and renal analyses and in order to monitor the occurrence of side effects and tolerance to them. In case of variations that surpass the benefit/risk ratio and when there is no improvement of the clinical status, discontinuation of therapy should be considered.
The maximal daily dose of THC is 12 mg.

DOSAGE IN CHILDREN WITH REFRACTORY EPILEPSY
(children above age of 2 years in whom antiepileptic drugs, used as mono or combined therapy, do not provide the satisfactory response)
The therapy includes: a titration period and maintenance period.
Prior to beginning the treatment, it is necessary to determine the frequency and the number of seizures.

TITRATION PERIOD

The titration period lasts several weeks, usually 3-4 weeks.
The dosage is expressed as a single dose, in ml (containing 1 mg THC and 15 mg CBD).
Every increase of the dosage is for 1 ml.

STARTING DOSE
Use 1 ml of the oil solution in the evening before sleeping, during a period of 7 days.

Day/No. Dosage Total daily dose THC/CBD (mg) The total daily quantity of oil solution (ml)
Day 1 1 x 1 ml 1 mg/15 mg 1 ml
Day 2 1 x 1 ml 1 mg/15 mg 1 ml
Day 3 1 x 1 ml 1 mg/15 mg 1 ml
Day 4 1 x 1 ml 1 mg/15 mg 1 ml
Day 5 1 x 1 ml 1 mg/15 mg 1 ml
Day 6 1 x 1 ml 1 mg/15 mg 1 ml
Day 7 1 x 1 ml 1 mg/15 mg 1 ml

If moderate side effects occur during the Starting dose, the starting dose should be prolonged for 10 days, and then followed by Increase of the dose I. If side effects do not disappear after 10 days, or if severe and unbearable side effects occur, the therapy should be discontinued.
If well tolerated, after 7 days Starting dose continues with:
Increase of the dose I –
Use 2 ml of the oil solution divided into two equal daily doses, in the morning and in the evening, before sleeping, during a period of 7 days.

Day/No. Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
Day 1 2 x 1 ml 2 mg/30 mg 2 ml
Day 2 2 x 1 ml 2 mg/30 mg 2 ml
Day 3 2 x 1 ml 2 mg/30 mg 2 ml
Day 4 2 x 1 ml 2 mg/30 mg 2 ml
Day 5 2 x 1 ml 2 mg/30 mg 2 ml
Day 6 2 x 1 ml 2 mg/30 mg 2 ml
Day 7 2 x 1 ml 2 mg/30 mg 2 ml

If moderate side effects occur while Increasing of the dose I, this dose should be prolonged for 10 days, and then followed by Increase of the dose II. If side effects do not disappear after 10 days, or if severe and unbearable adverse events occur, the therapy should be discontinued.
If well tolerated, after 7 days, the Increase of the dose I should be followed by:
Increase of the dose II
Use 3 ml of the oil solution divided into two daily doses, 1 ml in the morning and 2 ml in the evening, before sleeping, during a period of 7 days.

Day/No. Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
Day 1 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 2 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 3 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 4 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 5 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 6 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml
Day 7 1 x 1 ml + 1 x 2 ml 3 mg/45 mg 3 ml

If moderate side effects occur while increasing of the dose II, this dose should be continued for 10 days. If side effects do not disappear after 10 days, or if severe and unbearable side effects occur, the therapy should be discontinued.
If well tolerated, after 7 days the Increase of the dose II should be followed by:
Increase of the dose III –
Use 4 ml of the oil solution divided into two equal daily doses, one in the morning and one in the evening, before sleeping, during a period of 7 days.

Day/No. Dosage Total daily dose THC/CBD/(mg) The total daily quantity of oil solution (ml)
Day 1 2 x 2 ml 4 mg/60 mg 4 ml
Day 2 2 x 2 ml 4 mg/60 mg 4 ml
Day 3 2 x 2 ml 4 mg/60 mg 4 ml
Day 4 2 x 2 ml 4 mg/60 mg 4 ml
Day 5 2 x 2 ml 4 mg/60 mg 4 ml
Day 6 2 x 2 ml 4 mg/60 mg 4 ml
Day 7 2 x 2 ml 4 mg/60 mg 4 ml

If moderate side effects occur while Increasing the dose III, this dose should be prolonged for 10 days. If side effects do not disappear during the period of 10 days, or if severe and unbearable side effects occur, the therapy should be discontinued.
If well tolerated, the Increase of dose III continues as a maintenance dose.

MAINTENANCE PERIOD

MAINTENANCE DOSE
Use 4 ml of the oil solution divided into two equal daily doses, in the morning and in the evening, before sleeping (4 mg THC and 60 mg CBD)/day.
During the therapy course, at every 4, 8 and 12 weeks, a laboratory control has to be performed for haematological, hepatic and renal analyses and in order to monitor the occurrence of adverse events and the tolerance towards them. In case of variations that surpass the benefit/risk ratio, discontinuation of the therapy should be considered. If during the 12 weeks the frequency and the number of the attacks do not decrease, in respect of the frequency and number of attacks before the start of the treatment, discontinuation of the treatment should be considered.
The maximal daily dose of THC is 4 mg.

Category:

Description

COMPOSITION

(1 mg tetrahydrocannabinol (THC) and 15 mg cannabidiol (CBD))/ 1 ml
(240 mg tetrahydrocannabinol (THC) and 1800 mg cannabidiol (CBD))120 ml

THERAPEUTIC INDICATIONS

KANOBIL® EPI is used in adult patients and children above 2 years age, as symptomatic adjuvant therapy to the standard therapy for refractory epilepsy, when antiepileptic drugs, used as mono or combined therapy, do not provide the satisfactory response.

CONTRAINDICATIONS

Do not take KANOBIL® EPI if:
-if you are allergic to cannabinoids or any of the excipients of this medicine;
-if you or anyone directly related to you has any mental health problems such as schizophrenia, psychosis or other significant psychiatric disorder. This does not include depression due to your primary condition;
-if you are pregnant or breast-feeding.
Do not take KANOBIL® EPI if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking KANOBIL® EPI.


PACKAGING

 A box with a glass bottle containing 120 ml of the oil solution (equal to 120 doses) and a plastic graduated dosing syringe.

Prescription in two copies with the mark “copy” on the second copy and with the ordinal number from the evidence book of prescribed medicines containing narcotics and psychotropic substances