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Details for: ACT NABILONE

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02393581ACT NABILONENABILONE0.5 MGCAPSULEORAL
02393603ACT NABILONENABILONE1 MGCAPSULEORAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

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 non-medicinal ingredients are

ACT NABILONE 0.5 mg capsule contains the following nonmedicinal ingredients: povidone, starch, gelatin, D and C red # 33, FD and C red # 40, D and C yellow # 10 and titanium dioxide. ACT NABILONE 1 mg capsule contains the following nonmedicinal ingredients: povidone, starch, gelatin, FD and C blue # 2, FDA/E172 red iron oxide and titanium dioxide.

What dosage form 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 nonpsychotic 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 Dose

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.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
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 ACT NABILONE, contact your doctor or pharmacist immediately

How to store

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 side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

  • Talk to your doctor or pharmacist.
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***

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 This leaflet was prepared by: Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 www.tevacanada.com Last revised: April 30, 2020

Date modified: