cannabidiol: package leaflet

• If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
• If your dose is more than 1 ml (100 mg), you should use the larger 5 ml syringe.

• If your dose is more than 5 ml (500 mg), you will need to use the larger 5 ml syringe more than once. In this case, keep careful track of how many times you have filled the syringe (e.g., by marking off each 5 ml dose, respectively) so that you take the right dose.

It is important that you use the correct oral syringe to measure your dose. Your doctor or pharmacist will let you know which syringe to use depending on the dose that has been prescribed.
Following the directions from the doctor or pharmacist, the bag containing the other syringes and adaptor should be discarded from the pack unless your doctor or pharmacist tells you to keep both syringes until your final dose has been reached. If you are prescribed a 3-bottle pack all three adaptors should be retained.

the bottle by pushing the cap down whilst turning the cap anti-clockwise.

into the neck of the bottle, and make sure it is fully inserted. The adaptor could come off and cause choking if it is not fully inserted.

syringe fully into the bottle adaptor, and with the oral syringe in place, turn the bottle upside down.

the syringe, so the volume
(number of ml) of solution needed is drawn into the syringe.
Line up the end of the plunger with the prescribed volume marking required, as shown opposite.

If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 5 until the bubble has gone.

and carefully remove the oral syringe from the adaptor.

7.
Place the tip of the oral syringe inside the cheek, and gently push the plunger to release the medicine. Do not push the plunger forcefully or direct the medicine to the back of the mouth or throat.

If the dose is more than 5 ml, repeat Steps 4 to 7 to give the remaining dose using the 5 ml oral syringe.

8.
Screw the child-resistant cap back on the bottle tightly, by turning the cap clockwise – you do not need to remove the bottle adaptor, as the cap will fit over it.

9.
Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out using the plunger.

10. Remove the plunger from the barrel of the syringe, and rinse both parts under tap water. Do not place the oral syringe in a dishwasher.

Shake off any water from both parts and allow them to dry in the air until the next use. Make sure the oral syringe is completely dry before the next use, or it could make the solution appear cloudy if water gets in the bottle.

If the solution in the bottle has turned cloudy, this doesn’t change how well it works.
Continue to use the medicine as normal.

If you or your patient take more Epidyolex than you should
If you may have taken more Epidyolex than you should, tell a doctor or pharmacist immediately, or contact your nearest hospital casualty department, and take the medicine with you.
Signs of taking more Epidyolex than you should include diarrhoea and sleepiness.
If you or your patient forget to take Epidyolex
If you forget to take a dose, do not take a double dose to make up for a forgotten dose. Take the next dose at your regular time. If you miss many doses, please talk to your doctor about the correct dose to take.
If you or your patient stop taking Epidyolex
Do not reduce the dose or stop taking Epidyolex without first talking to your doctor. Stopping this treatment abruptly could increase your seizures. The doctor will explain how to gradually stop taking Epidyolex.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects could be very serious:

Common side effects (may affect more than 1 in 100 people):

• High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving Epidyolex.

Side effects where the frequency is not known (frequency cannot be estimated from the available data):

• People taking this medicine can have thoughts of harming or killing themselves. If you have these thoughts at any time, contact your doctor.

You may get the following side effects with this medicine. Tell the doctor if you have any of the following:

Very common side effects (may affect more than 1 in 10 people):

• feeling drowsy or sleepy
• diarrhoea
• decreased appetite
• fever
• vomiting
• feeling tired

Common side effects (may affect more than 1 in 100 people):

• seizures
• feeling bad-tempered (irritable, aggressive)
• rash
• lack of energy
• cough
• pneumonia
• weight loss
• feeling sick
• urinary tract infection

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5.
How to store Epidyolex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the bottle. The expiry date refers to the last day of that month.

If you have any solution left in the bottle more than 12 weeks after it was first opened, you should not use it.

This medicine does not require any special storage conditions.

Do not throw away any medicine in the wastewater or household waste. Ask your pharmacist about how to throw away any medicine that you no longer use. This will help protect the environment.

6.
Contents of the pack and other information

What Epidyolex contains
- The active substance is cannabidiol. Each ml of oral solution contains 100 mg of cannabidiol.
- The other ingredients are refined sesame oil, anhydrous ethanol, sucralose and strawberry flavour (including benzyl alcohol) (see section 2).

What Epidyolex looks like and contents of the pack
Epidyolex is a clear, colourless to yellow oral solution. It comes in an amber glass bottle which has a child-resistant screw cap.

The following pack sizes are available for Epidyolex:

100 ml (1 × 100 ml bottle) with 2 × 5 ml and 2 × 1 ml calibrated oral dosing syringes and two bottle adaptors.

300 ml (3 × 100 ml bottles) with 2 × 5 ml and 2 × 1 ml calibrated oral dosing syringes and three bottle adaptors.

The 5 ml syringes are graduated in 0.1 ml and the 1 ml in 0.05 ml increments.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Jazz Pharmaceuticals Ireland Ltd
5th Floor
Waterloo Exchange
Waterloo Road
Dublin 4
D04 E5W7
Ireland
Tel: +353 1 968 1631 e-mail: medinfo-int@jazzpharma.com

Manufacturer

Jazz Pharmaceuticals Netherlands B.V.,
Stationsplein 13A, 3818 LE, Amersfoort
The Netherlands e-mail: medinfo-int@jazzpharma.com

This leaflet was last revised in .

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.