Consumer Information for: TEVA-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
TEVA-NABILONE (nabilone) is indicated for the management of severe nausea and vomiting associated with cancer therapy.
What it does
TEVA-NABILONE decreases nausea (sensation of feeling sick) and vomiting.
When it should not be used
You should not take TEVA-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 TEVA-NABILONE is nabilone, a synthetic cannabinoid agent.
What the non-medicinal ingredients are
TEVA-NABILONE contains the following nonmedicinal ingredients: povidone, pregelatinized starch and talc, red iron oxide, FD&C Blue No. 2 (1 mg capsules only), D&C Red No. 33, FD&C Red No. 40, D&C Yellow No. 10 (0.5 mg capsules only).
What dosage form it comes in
TEVA-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 TEVA-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 TEVANABILONE are no longer present.
- While taking TEVA-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.
- TEVA-NABILONE should be used with extreme caution if you have severe liver dysfunction or a history of non-psychotic emotional disorders.
BEFORE you use TEVA-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 TEVA-NABILONE or any other ingredient in TEVA-NABILONE (see “What the nonmedicinal ingredients are”)
- you have hypertension or heart problems
Interactions with this medication
While you are taking 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.
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 TEVA-NABILONE for your use only. You should not let anyone else use it.
Usual Adult Dose
You will receive TEVA-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 TEVANABILONE. Do not open, do not crush, do not chew the capsules. Take it as a whole.
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 TEVA-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 TEVA-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.
| 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 TEVA-NABILONE, contact your doctor or pharmacist immediately.
How to store
Keep TEVA-NABILONE 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 ON 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 found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French) or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Last revised: April 30, 2012
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TEVA-CYCLOSPORINE | 02462486 | TEVA CANADA LIMITED | CYCLOSPORINE 0.05 % / W/V |