Nabilone (Oral)

Nabilone is used to treat nausea and vomiting that may happen during cancer treatment. It is only used when other medicines for nausea and vomiting do not work.

Nabilone is only available with your doctor's prescription.

Nabilone will increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you feel sleepy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines, including other narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while you are using this medicine.

If you think you or someone else may have taken an overdose, get emergency help immediately. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may cause serious mental effects. Symptoms of overdose include changes in mood; confusion; trouble breathing; hallucinations (seeing, hearing, or feeling things that are not there); severe nervousness or anxiety; and a fast or pounding heartbeat.

This medicine may make some people feel drowsy, dizzy, or lightheaded, or give them a false sense of well-being. Make sure you know how you respond to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.

Dizziness, lightheadedness, or fainting may happen, especially when you get up suddenly from lying down or sitting. Getting up slowly may help reduce this issue.

Nabilone may cause a dry mouth. For temporary relief, you can use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth remains dry for more than 2 weeks, consult your medical doctor or dentist. Ongoing dryness of the mouth may increase the risk of dental problems, including tooth decay, gum disease, and fungal infections.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted with adult patients, and there is no specific information comparing nabilone use in children to other age groups. Caution should be exercised when prescribing nabilone to children under 18 years old due to its effects on the mind and mood.

Geriatric

Elderly patients may be more likely to experience a fast or pounding heartbeat, feeling faint or lightheaded, and unusual tiredness or weakness. They are usually more sensitive than younger adults to the effects of nabilone. Additionally, the effects this medicine may have on the mind may be particularly concerning for older individuals. Therefore, older people should be monitored closely while using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Itraconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on nabilone may develop.

• Emotional problems or
• Heart disease or
• Low blood pressure or
• Manic or depressive states or
• Severe mental illness or
• Schizophrenia—Nabilone may worsen these conditions.

• Kidney problems or
• Liver problems—Nabilone has not been studied in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Changes in mood
• confusion
• convulsions (seizures)
• delusions
• dizziness or fainting
• fast or pounding heartbeat
• hallucinations (seeing, hearing, or feeling things that are not there)
• mental depression
• nervousness or anxiety
• unusual tiredness or weakness (severe)

Symptoms of overdose

• Difficulty in breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• mental changes (severe)
• nervousness or anxiety (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Clumsiness or unsteadiness
• drowsiness
• dryness of mouth
• false sense of well-being
• headache

Less common or rare

• Blurred vision or any changes in vision
• dizziness or lightheadedness, especially when getting up from a lying or sitting position—more common with high doses
• loss of appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cesamet

In Canada

• ACT Nabilone
• APO-Nabilone
• pms-Nabilone
• RAN-Nabilone
• TEVA-Nabilone

Chemical Class: Cannabinoid

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may lead to other medical problems because of an overdose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules): For nausea and vomiting caused by cancer medicines: Adults—Usually 1 or 2 milligrams (mg) twice a day. Your doctor will tell you how and when to take this medicine while you are taking your cancer medicine. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.