Act Nabilone: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ACT NABILONE (nabilone) is indicated for the management of severe nausea and vomiting associated with cancer therapy.

What it does:

ACT NABILONE decreases nausea (sensation of feeling sick) and vomiting.

When it should not be used:

You should not take ACT NABILONE if:

• you have known sensitivity to marijuana or other cannabinoid agents
• you have a history of psychotic reactions
• you are under the age of 18 years

• you are breastfeeding

• you are pregnant

What the medicinal ingredient is:

The medicinal ingredient in ACT NABILONE is nabilone, a synthetic cannabinoid agent.

What the important nonmedicinal ingredients are: ACT NABILONE 0.5 mg capsule contains the following nonmedicinal ingredients: povidone, starch, gelatin, D&C red # 33, FD&C red # 40, D&C yellow # 10 and titanium dioxide.

ACT NABILONE 1 mg capsule contains the following nonmedicinal ingredients: povidone, starch, gelatin, FD&C blue # 2, FDA/E172 red iron oxide and titanium dioxide.

What dosage forms it comes in:

ACT NABILONE (nabilone) is formulated into capsules of 0.5 mg or 1 mg strengths for oral administration.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Since ACT NABILONE will often impair the mental and/or physical abilities required for the performance of potentially hazardous task, you should not drive a car, operate machinery, or perform any activity that requires mental alertness until the effects of ACT NABILONE are no longer present.

• While taking ACT NABILONE, do not drink alcohol or take other drugs such as sedatives, hypnotics or other substances that can affect the nervous system without consulting with

  your doctor.

• ACT NABILONE should be used with extreme caution if you have severe liver dysfunction or a history of non-psychotic emotional disorders.

BEFORE you use ACT NABILONE talk to your doctor or pharmacist if:

• you are taking any other prescription or non-prescription medicine, or natural/herbal remedies
• you are pregnant or breastfeeding

• you are allergic to nabilone, the main ingredient in

  ACT NABILONE, or any other ingredient in ACT NABILONE (see

  “What the non-medicinal ingredients are”)

• you have hypertension or heart problems

INTERACTIONS WITH THIS MEDICATION

While you are taking ACT NABILONE, do not start any new medicines, including natural or herbal medicines, without speaking to your doctor first. Tell your doctor about all the medicines that you are taking including those that you have bought yourself.

ACT NABILONE can interact with:

• Diazepam
• Sodium secobarbital
• Alcohol
• Codeine
• Any medicine that affects your mental and psychomotor function (e.g., causes hallucinations, weird thoughts, etc).

PROPER USE OF THIS MEDICATION

The label on the container of your medicine should tell you how often to take your medicine and how many doses you should take

each time. If not, or if you are not sure, ask your doctor or pharmacist.

Do not take more doses, or take them more often than your doctor prescribes.

Your doctor prescribed ACT NABILONE for your use only. You should not let anyone else use it.

Usual adult dose:

You will receive ACT NABILONE prior to chemotherapy and, if necessary, after cancer treatment. Based on how likely you are to experience nausea and/or vomiting, caused by your cancer treatment, your doctor will tell you the amount you need to take and how frequently. Follow the directions provided by your doctor for using this medicine. Your doctor may also have to adjust your dose depending on how you react to ACT NABILONE.

Overdose:

Some of the signs of overdose are psychotic episodes including hallucinations, anxiety reactions, respiratory depression, and coma.

Overdose may even occur at prescribed doses. If psychiatric symptoms (e.g., weird thoughts, hallucinations, etc.) are present, contact poison control centre immediately or go to the nearest emergency room.

Missed Dose:

If you forget a dose of ACT NABILONE, you should take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double your dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Some patients may experience drowsiness, psychological high, vertigo, dry mouth, depression, ataxia, asthenia, blurred vision, sensation disturbance, anorexia, headache, orthostatic hypotension, euphoria, and hallucinations. You should tell your doctor or pharmacist about these symptoms.

If your nausea (feeling of sickness) or vomiting do not improve while taking ACT NABILONE, consult your doctor for further advice.

If you feel unwell or have any symptoms that you do not understand, you should contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking ACT NABILONE, contact your doctor or pharmacist immediately.

HOW TO STORE IT

Keep ACT NABILONE out of reach of children. Store it at room temperature (15°C to 25°C) in the package it came in. Protect from light.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/

services/drugs-health-products/medeffectcanada/ adverse-reaction-reporting.htm) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

www.tevacanada.com

Last revised: April 30, 2020