Nabilone Oral capsule

What is this medicine?

NABILONE (NAB i lone) is used to treat nausea and vomiting caused by cancer treatment. It is used by patients who do not respond to other medicines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dizziness or fainting spells on standing
• heart disease
• high or low blood pressure
• history of drug or alcohol abuse problem
• irregular heartbeat
• mental health problems like depression, mania, or schizophrenia
• an unusual or allergic reaction to nabilone, dronabinol, marijuana, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• dronabinol

This medicine may also interact with the following medications:

• alcohol
• amphetamine or other stimulant drugs
• antihistamines for allergy, cough and cold
• atropine
• barbiturates like phenobarbital
• certain medicines for bladder problems like oxybutynin, tolterodine
• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• cocaine
• disulfiram
• ipratropium
• medicines for depression, anxiety, or psychotic disturbances
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• medicines for sleep
• muscle relaxants
• naltrexone
• narcotic pain medicines
• scopolamine
• theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

The first time you take this medicine or have an increase in dose make sure there is a responsible person nearby. You may experience mood changes, easy laughter, or other changes in behavior.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you have low blood pressure or if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not smoke marijuana while you are taking this medicine. It is similar to one of the active substances found in marijuana. You are at increased risk of serious heart and/or nervous system side effects if these drugs are used together.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxiety, depression
• changes in vision
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• hallucinations, loss of contact with reality
• panic reactions
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in appetite
• confused, disoriented
• drowsy
• dry mouth
• headache
• problems with balance, talking, walking
• trouble concentrating
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep this medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.