Cannabidiol : Uses, Side Effects, Interactions & More

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 behavior problems), Dravet (a disorder that begins in childhood and causes seizures and can later lead to developmental delays and changes in eating, balance, and gait) or tuberous sclerosis complex (TSC; a genetic condition that causes tumors grow in many organs). Cannabidiol belongs to a class of drugs 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 a day. You can take cannabidiol with or without food, but be sure to take it the same way each time. Take cannabidiol at around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take cannabidiol exactly as directed. Do not take more or less, or take it more often than prescribed by your doctor.

Use the oral syringe that came with the medicine to measure out the solution. Do not use a homemade spoon to measure your dose.

Use a dry oral syringe each time you take the medicine. The solution may turn cloudy if water gets into the medicine bottle or is inside the syringe, but this will not change the safety or effectiveness of the medicine.

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

Your doctor will start with a low dose of cannabidiol and gradually increase it, usually no more than once a week.

Cannabidiol helps control your condition, but it doesn’t cure it. Keep taking cannabidiol even if you feel fine. Do not stop taking cannabidiol without consulting your doctor. If you suddenly stop taking cannabidiol, you may experience withdrawal symptoms, such as new or worsening seizures. Your doctor will likely reduce your dose gradually.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start cannabidiol treatment and each time you get a refill. 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.

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 see the Medication Guide for a list of ingredients.
• ell your doctor and pharmacist what other prescription and over-the-counter medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; medications for anxiety; bupropion (Aplenzin, Zyban); caffeine; carbamazepine (Carbatrol, Equetro, Tegretol, Teril); cimetidine (Tagamet); clarithromycin (in Biaxin); clobazam (Onfi); diazepam (Diastat, Valium); diflunisal; diltiazem (Cardizem, Cartia, Taztia, others); efavirenz (Sustiva); erythromycin (E.E.S, Eryped, Ery-tab); esomeprazole (Nexium); felbamate (Felbatol); fenofibrate (Antara); fluoxetine (Prozac); fluvoxamine (Luvox); gemfibrozil (Lopid); indinavir (Crixivan); isoniazid (Laniazid, in Rifater); itraconazole (Onmel, Sporanox); ketoconazole; Lamotrigine (Lamictal); lansoprazole (Prevacid); lorazepam (Ativan); medications for mental illness; morphine (Astramorph, Kadian); nefazodone; nelfinavir (Viracept); nevirapine (Viramune); omeprazole (Prilosec); oral contraceptives; pantoprazole (Protonix); phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampicin (Rifadin, in Rifamate, in Rifater); ritonavir (Norvir, in Kaletra); sedative sleeping pills; medications for seizures; theophylline (Elixophyllin, Theo-24); ticlopidine; tranquilizers valproate (Depacon); Verapamil (Verelan); and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with cannabidiol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor what herbal products you are taking, especially St. John’s wort.
• Tell your doctor if you drink or have ever drunk large amounts of alcohol or if you use or have ever used illegal drugs or excessive amounts of prescription drugs. 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 can make you drowsy or unable to concentrate. Do not drive a car or operate machinery until you know how this medicine affects you.
• Ask your doctor about the safe use of alcoholic beverages while taking cannabidiol. Alcohol can make certain cannabidiol side effects worse.
• You should know that your mental health can change in unexpected ways and you can become suicidal (thinking about harming or killing yourself or planning or trying to do so) while 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 will experience changes in your mental health if you take an anti-seizure drug like 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 if the risks of taking an anti-seizure medicine are greater than the risks of not taking the medicine. You, your family, or your caregiver should call your doctor immediately 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 asleep or staying asleep; aggressive, angry, or violent behavior; mania (frantic, 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; give away prized possessions; or any other unusual change in behavior or mood. Make sure your family or caregiver knows what symptoms may be serious so they can call your 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. 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 the one you forgot.

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 can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

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

Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store 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 you first open the bottle.

It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not resistant to children and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

Unnecessary medications must be disposed of in special ways to ensure they cannot be consumed by pets, children, and others. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal website (http://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 collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

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 medicine. Ask your pharmacist any questions you have about refilling your prescription.

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