Epidiolex

Cannabidiol is used to treat seizures in people with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Cannabidiol is for use in adults and children who are at least 1 year old.

Cannabidiol may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to cannabidiol or sesame seed oil.

Cannabidiol is not approved for use by anyone younger than 2 years old.

Tell your doctor if you have ever had:

• liver disease;
• drug or alcohol addiction;
• depression, a mood disorder; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking cannabidiol. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cannabidiol on the baby.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Cannabidiol is usually taken 2 times per day. Take the medicine at the same times each day.

You may take cannabidiol with or without food, but take it the same way each time.

Measure this medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Make sure the dosing syringe is completely dry before measuring your dose.

Cannabidiol liquid may be given through a feeding tube that is not made of polyvinyl chloride (PVC).

This medicine can harm your liver. Your liver function may need to be checked before and during treatment. You may need to stop taking cannabidiol based on the results.

Store at room temperature, away from moisture and heat. Do not refrigerate or freeze. Keep the bottle tightly closed and in an upright position when not in use.

Throw away any unused liquid 12 weeks after you first opened the bottle.

Cannabidiol can affect a drug-screening test and you may test positive for cannabis (marijuana). Tell the laboratory staff that you use cannabidiol.

Do not stop using cannabidiol suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with this medicine can increase drowsiness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of liver problems, such as:

• nausea, vomiting, loss of appetite;
• tiredness, not feeling well;
• right-sided upper stomach pain;
• itching;
• dark urine; or
• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• drowsiness;
• changes in appetite or weight;
• feeling weak or tired;
• infections (fever, flu symptoms, cough, swelling, redness, itching);
• diarrhea;
• sleep problems (insomnia);
• rash; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using cannabidiol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other seizure medications (especially clobazam or valproate); or
• cannabis-based products.

This list is not complete. Many other drugs can affect cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about cannabidiol.