Consumer Information for: CESAMET

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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

What it does

CESAMET® decreases nausea (sensation of feeling sick) and vomiting.

When it should not be used

You should not take CESAMET® 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 Cesamet® is nabilone, a synthetic cannabinoid agent.

What the non-medicinal ingredients are

CESAMET ® contains the following non-medicinal ingredients: D&C Red #33 (0.5 mg capsule), D&C Yellow #10 (0.25 and 0.5 mg capsules), FD&C Blue #1 (0.25 mg capsule), FD&C Blue #2 (1 mg capsule), FD&C Red #40 (0.25 and 0.5 mg capsules), Gelatin, Iron Oxide Red (1 mg capsule), Povidone, Starch, and Titanium Dioxide.

What dosage form it comes in

CESAMET ® (nabilone) is formulated into capsules of 0.25 mg, 0.5 mg, or 1 mg strengths for oral administration.

Warnings and precautions

Serious Warnings and Precautions

  • Since CESAMET® 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 CESAMET are no longer present.
  • While taking CESAMET®, 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.
  • CESAMET® should be used with extreme caution if you have severe liver dysfunction or a history of non-psychotic emotional disorders.

BEFORE you use CESAMET® 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 CESAMET®, or any other ingredient in CESAMET® (see “What the non-medicinal ingredients are”)
  • you have hypertension or heart problems
Interactions with this medication

While you are taking CESAMET®, 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.
CESAMET® 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 CESAMET® for your use only. You should not let anyone else use it.

Usual Dose

Usual adult dose:
You will receive CESAMET® 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 CESAMET®.

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 CESAMET®, 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 CESAMET®, 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.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and seek emergency medical assistance
Common
Drowsiness   ✔  
Dry mouth ✔    
Euphoria   ✔  
Hallucinations     ✔
Somnolence   ✔  
Vertigo   ✔  
Uncommon
Confusion     ✔
Depression   ✔  
Dissociation     ✔
Headache ✔    
Orthostatic hypotension   ✔  
Nightmares   ✔  
Seizure   ✔  
Tachycardia   ✔  
Tremors     ✔

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

How to store

Keep CESAMET® out of reach of children. Store it at room temperature (15 to 30°C) in the package it came in.

Reporting side effects

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

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 leaflet is part III of a three-part "Product Monograph" published when CESAMET® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about CESAMET®. Contact your doctor or pharmacist if you have any questions about the drug.

This document plus the full product monograph, prepared for health professionals can be found at: health-products.canada.ca/dpd-bdpp/index-eng.jsp or by contacting the sponsor:

Bausch Health, Canada Inc.
2150 St-Elzear West
Laval, Quebec
H7L 4A8
1-800-361-4261

This leaflet was prepared by: Bausch Health, Canada Inc.

Last revised: May 24, 2019

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