Cannabidiol (kan-a-bi-DYE-ol)

Treats seizures in patients with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Brand Name(s):

Epidiolex 100mL Bottle, Epidiolex 100mL Pack/Carton, Epidiolex 60mL Bottle, Epidiolex 60mL Pack/Carton

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Use a dry syringe each time you take this medicine.
• Take this medicine the same way every day, either with or without food.
• You may take this medicine using a silicone feeding tube (including nasogastric or gastrotomy tubes) if needed. Do not use it with tubes made of polyvinyl chloride (PVC) or polyurethane, or silicone nasogastric tubes that are short and narrow.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle in an upright position. Do not refrigerate or freeze. Use this medicine within 12 weeks of first opening the bottle. Throw away any unused medicine after 12 weeks.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how cannabidiol works. Tell your doctor if you are using bupropion, caffeine, clobazam, diazepam, diflunisal, digoxin, efavirenz, everolimus, fenofibrate, gemfibrozil, lamotrigine, lorazepam, morphine, phenytoin, propofol, rifampin, sirolimus, stiripentol, tacrolimus, theophylline, tizanidine, or valproate.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, depression, or a history of alcohol or substance use disorder.
• This medicine may cause the following problems:
  • Liver problems
  • Changes in behavior or mood, including thoughts of suicide
• This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion or unusual excitement, nervousness, or irritability
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, anxiety, irritability, hallucinations, trouble sleeping, unusual behavior, thoughts of hurting yourself or others
• Fever, chills, cough, sore throat, body aches
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Drowsiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088