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.

Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment.

Call your doctor at once if you have symptoms such as: nausea, vomiting, loss of appetite, right-sided upper stomach pain, tiredness, itching, dark urine, or yellowing of the skin or eyes.

Avoid driving or hazardous activity until you know how cannabidiol will affect you.

Some people have thoughts about suicide while taking cannabidiol. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Cannabidiol comes as a solution (liquid) to take by mouth. It is usually taken twice daily. You may take cannabidiol either with or without food, but be sure to take it the same way each time. Take cannabidiol at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cannabidiol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Use the oral syringe that came with the medication for measuring the solution. Do not use a household spoon to measure your dose.

Use a dry oral syringe each time that you take the medication. The solution may turn cloudy if water enters the medication bottle or is inside the syringe, but this will not change the safety or how well the medication works.

The oral solution can be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take the medication. Follow these directions carefully.

Your doctor will start you on a low dose of cannabidiol and gradually increase your dose, usually not more than once every week.

Cannabidiol helps to control your condition, but does not cure it. Continue to take cannabidiol even if you feel well. Do not stop taking cannabidiol without talking to your doctor. If you suddenly stop taking cannabidiol, you may experience withdrawal symptoms such as new or worsening seizures. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with cannabidiol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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 cannabidiol 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.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze the solution. Discard any unused oral solution that remains 12 weeks after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Drinking alcohol with cannabidiol 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 of cannabidiol 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to cannabidiol.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking cannabidiol.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.