Consumer Information for: PMS-NABILONE

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

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

What it does

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

When it should not be used
  • You should not take pms-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 pms-NABILONE is nabilone, a synthetic cannabinoid agent.

What the non-medicinal ingredients are

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&D red #40 (0.25 and 0.5 mg capsules), gelatin, iron oxide red (1 mg capsule), pregelatinised starch, povidone, and titanium dioxide.

What dosage form it comes in

Capsules : 0.25 mg, 0.5 mg, and 1 mg

Warnings and precautions

Serious Warnings and Precautions

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

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

  • you are taking any other prescription or nonprescription medicine, or natural/herbal remedies
  • you are pregnant or breastfeeding
  • you are allergic to nabilone, the main ingredient in pms-NABILONE , or any other ingredient in pms- NABILONE (see“What the non-medicinal ingredients are”)
  • you have hypertension or heart problems
Interactions with this medication

While you are taking pms-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.

pms-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 pms-NABILONE for your use only. You should not let anyone else use it.

Usual adult dose

You will receive pms-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 pms-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 pms-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 pms-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, 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 pms-NABILONE, contact your doctor or pharmacist immediately.
How to store

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

Reporting side effects

To monitor drug safety, Health Canada through the Reporting Suspected 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 www.healthcanada.gc.ca/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 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.

This leaflet was prepared by
        Pharmascience Inc.
        Montreal Quebec
        H4P 2T4

Last revised: February 29, 2012

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