Nabilone

WHY is this medicine prescribed?

Nabilone is used to treat nausea and vomiting caused by cancer chemotherapy in people who have already taken other medications to treat this type of nausea and vomiting without good results. Nabilone is in a class of medications called cannabinoids. It works by affecting the area of the brain that controls nausea and vomiting.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Nabilone comes as a capsule to take by mouth. It is usually taken with or without food two to three times a day during a cycle of chemotherapy. Treatment with nabilone should begin 1 to 3 hours before the first dose of chemotherapy and may be continued for up to 48 hours after the end of the chemotherapy cycle. Take nabilone 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 nabilone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of nabilone and may gradually increase your dose if needed.

Nabilone helps control nausea and vomiting caused by cancer chemotherapy when taken as directed. Always take nabilone according to the schedule prescribed by your doctor even if you are not experiencing nausea or vomiting.

Nabilone may be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication.

What SPECIAL PRECAUTIONS should I follow?

Before taking nabilone,

• tell your doctor and pharmacist if you are allergic to nabilone, other cannabinoids such as dronabinol (Marinol) or marijuana (cannabis), any other medications, or any of the ingredients in nabilone capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, including amitriptyline (in Limbitrol), amoxapine, desipramine (Norpramin) and fluoxetine (Prozac); antihistamines; amphetamines such as amphetamine (in Adderall), dextroamphetamine (Dexedrine, Dextrostat, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin); atropine (Atropen, in Hycodan, in Lomotil, in Tussigon); codeine (in some cough syrups and pain relievers); barbiturates, including phenobarbital (Luminal) and secobarbital (Seconal, in Tuinal); buspirone (BuSpar); diazepam (Valium); digoxin (Lanoxicaps, Lanoxin); disulfiram (Antabuse); ipratropium (Atrovent); lithium (Eskalith, Lithobid); medications for anxiety, asthma, colds, irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; muscle relaxants; naltrexone (Revia, Vivitrol); narcotic medications for pain; propranolol (Inderal); scopolamine (Transderm-Scop); sedatives; sleeping pills; tranquilizers; and theophylline (TheoDur, Theochron, Theolair). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs such as marijuana. Also tell your doctor if you or anyone in your family has or has ever had a mental illness such as bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods), schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) or depression. Also tell your doctor if you have or have ever had high blood pressure or heart, liver, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nabilone, call your doctor.

• you should know that nabilone may make you drowsy and may cause changes in your mood, thinking, memory, judgment, or behavior. You may continue to have these symptoms for up to 72 hours after you finish your treatment with nabilone. You will need to be supervised by a responsible adult during and for several days after your treatment with nabilone. Do not drive a car operate machinery, or participate in dangerous activities while you are taking this medication and for several days after you finish your treatment.

• do not drink alcoholic beverages while you are taking nabilone. Alcohol can make the side effects from nabilone worse.

• you should know that nabilone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

• headache
• dizziness
• unsteady walking
• drowsiness
• sleep problems
• weakness
• dry mouth
• changes in appetite
• nausea
• ''high'' or elevated mood
• difficulty concentrating
• anxiety
• confusion
• depression

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

• fast heartbeat
• hallucinations (seeing things or hearing voices that do not exist)
• difficulty thinking clearly and understanding reality

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

What should I know about STORAGE and DISPOSAL of this medication?

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).

Store nabilone in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many capsules are left so you will know if any are missing.

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.

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

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include:

• fast heartbeat
• dizziness
• lightheadedness
• fainting
• hallucinations
• anxiety
• changes in thinking, behavior, or mood
• confusion
• slowed breathing
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. This prescription is not refillable. Be sure to see your doctor to get a new prescription before you begin each cycle of chemotherapy.

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.