Cannabidiol

Cannabidiol is used to control seizures in adults and children 1 year of age and older with Lennox-Gastaut syndrome (a disorder that begins in early childhood and causes seizures, developmental delays, and behavioral issues), Dravet syndrome (a disorder that begins in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking), or tuberous sclerosis complex (TSC; a genetic condition that causes tumors to grow in many organs). Cannabidiol is in a class of medications called cannabinoids. It is not known exactly how cannabidiol works to prevent seizure activity.

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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking cannabidiol,

• tell your doctor and pharmacist if you are allergic to cannabidiol, any other medications, sesame seed oil, or any of the ingredients in cannabidiol solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking cannabidiol. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with cannabidiol: St. John's wort; caffeine supplements. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking cannabidiol. Do not start any of these medications while taking cannabidiol without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had depression, mood problems, suicidal thoughts or behavior, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking cannabidiol, call your doctor.
• you should know that cannabidiol may make you drowsy or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking cannabidiol. Alcohol can make certain side effects from cannabidiol worse.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking cannabidiol. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants to treat various conditions during clinical studies became suicidal during their treatment. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as cannabidiol, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Cannabidiol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• tiredness
• difficulty falling asleep or staying asleep
• loss of appetite
• weight loss
• stomach pain or discomfort
• drooling or excessive saliva
• problems with walking

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• redness
• loss of appetite; nausea; vomiting; yellow skin or eyes; itching; unusual darkening of the urine; or right upper stomach area pain or discomfort
• fever, cough, or other signs of infection

Cannabidiol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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