Details for: ACT NABILONE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02393581 | ACT NABILONE | NABILONE | 0.5 MG | CAPSULE | ORAL |
| 02393603 | ACT NABILONE | NABILONE | 1 MG | CAPSULE | ORAL |
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
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
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.
| 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