Details for: APO-RASAGILINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02404680 | APO-RASAGILINE | RASAGILINE (RASAGILINE MESYLATE) | 0.5 MG | TABLET | ORAL |
| 02404699 | APO-RASAGILINE | RASAGILINE (RASAGILINE MESYLATE) | 1 MG | TABLET | 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
Your physician has prescribed APO-RASAGILINE (rasagiline mesylate) 0.5 mg or 1 mg tablets. APO- RASAGILINE relieves the signs and symptoms of Parkinson’s disease as initial therapy for early disease and as add-on therapy to levodopa.
Before you begin using APO-RASAGILINE, make sure you understand all the information provided about its possible benefits and risks. If you do not understand any of the information provided, contact your doctor for further clarification.
What it does
APO-RASAGILINE is used to treat the signs and symptoms of Parkinson’s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa).
Parkinson’s disease is a disorder of the central nervous system caused by a lack of dopamine – a substance in the brain used to send messages to your muscles to make them move. APO-RASAGILINE belongs to a class of drugs called monoamine oxidase B inhibitors. APO-RASAGILINE works by blocking the breakdown of dopamine in the brain.
When it should not be used
Do not use APO-RASAGILINE if you:
- are allergic to it or any of the components of its formulation (see list of components at the end of this section). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction (e.g., skin rash, hives) or any severe or unusual side effects.
- have moderate-to severe liver disease
Do not use APO-RASAGILINE if you are taking any of the following medications:
- Cyclobenzaprine (a tricyclic muscle relaxant)
- Demerol (meperidine, pethidine)
- Dextromethorphan (an over-the-counter cough suppressant)
- Other MAO inhibitors for the treatment of Parkinson’s disease or for any other indication
- Pain medications (notably tramadol, methadone, and propoxyphene)
- St. John's Wort
What the medicinal ingredient is
The active substance is rasagiline. Each tablet contains 0.5 mg or 1 mg rasagiline (as rasagiline mesylate).
What the non-medicinal ingredients are
Each APO-RASAGILINE tablet also contains the following inactive ingredients: Isomalt 50:50 and Stearic acid.
What dosage form it comes in
APO-RASAGILINE (rasagiline mesylate tablets) 0.5 mg are white to off-white coloured, round shaped, flat faced bevel edged tablets, engraved “APO” on one side and “RAS” over “0.5” on other side.
APO-RASAGILINE (rasagiline mesylate tablets) 1 mg are white to off-white coloured, round shaped, flat faced bevel edged tablets, engraved “APO” on one side and “RAS” over “1” on other side.
Warnings and precautions
Serious Warnings and Precautions
Some people feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e. without feeling sleepy or drowsy) when taking APO- RASAGILINE. During treatment with APO- RASAGILINE take special care when you drive or operate a machine. If you experience excessive drowsiness or a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.
Before you use APO-RASAGILINE, tell your doctor if you:
- are taking any antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic or tetracyclic antidepressants [e.g. Prozac (fluoxetine), Luvox (fluvoxamine) Zoloft (sertraline), Paxil (paroxetine), Celexa (citalopram) and Effexor (venlafaxine) and Remeron (mirtazapine)]
- are also taking levodopa, as there is the possibility of increased difficulty with movement. Your doctor may lower the dose of your levodopa therapy.
- have mild liver disease. Your dose may be reduced to 0.5 mg/day.
- are under the age of 18.
- are pregnant or planning to become pregnant. APO-RASAGILINE should be used during pregnancy only if clearly needed.
- are breast-feeding
Wait at least 2 weeks after stopping tricyclic, tetracyclic, triazolopyridine, SSRI, or SNRI antidepressant treatment before starting treatment with APO-RASAGILINE.
Wait at least 5 weeks after stopping fluoxetine treatment before starting treatment with APO-RASAGILINE.
APO-RASAGILINE may be taken if you have mild kidney disease but should not be taken if you have moderate to severe kidney impairment.
Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease or the drugs used to treat Parkinson’s disease. Therefore, your doctor should perform periodic skin examinations.
It is also important to tell your doctor before beginning treatment if:
- you drive or operate machinery
- you or your family member/caregiver notices you are developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others. These behaviors are called impulse control disorders. Your doctor may need to review your treatments.
Interactions with this medication
See the DO NOT TAKE APO-RASAGILINE section for important safety information about drugs not to use at the same time as APO-RASAGILINE.
Please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, even those obtained without a prescription. APO-RASAGILINE may interact with the following medications or you might require a dose adjustment:
- Antidepressants
- Ciprofloxacin (an antibiotic) or other CYP1A2 inhibitors - if you take the antibiotic ciprofloxacin or other CYP1A2 inhibitors you should use 0.5 mg daily of APO-RASAGILINE
- Demerol (meperidine) or some other pain medications
- Dextromethorphan (an over-the-counter anti- cough drug)
- Levodopa – levodopa dose may be reduced
- Other MAOIs (monoamine oxidase inhibitors)
- Sympathomimetic amines including amphetamines, some decongestants, cold remedies, and weight loss products
Proper use of this medication
Usual Dose
Take APO-RASAGILINE exactly as instructed by your doctor. You should talk with your doctor or pharmacist if you are unsure.
The recommended dose of APO-RASAGILINE is 0.5 mg or 1 mg taken orally once daily either with or without food. Your doctor will determine which dose is appropriate for you.
Do not take more than the maximum recommended daily dose of 1 mg. Taking more than 1 mg may cause serious side effects which could include a severe headache, seizures, and a sudden rise in blood pressure. Should you experience these side effects seek immediate emergency medical assistance. For any other unusual symptoms you have not had before, call your doctor immediately.
Overdose
If you think that you may have taken too many APO- RASAGILINE tablets, contact a hospital emergency department, the nearest Poison Control Centre or your doctor or pharmacist immediately. You may require medical attention even if there are no symptoms. Take the APO-RASAGILINE carton/bottle with you to show the doctor or pharmacist.
Missed Dose
If you have forgotten to take a dose of APO- RASAGILINE take the next dose at the usual time. Do not take a double dose to make up for the one you missed.
Side effects and what to do about them
Like all medicines, APO-RASAGILINE can have side effects.
The most commonly observed side effects that occurred in patients receiving rasagiline mesylate as monotherapy are: headache, flu-like symptoms, musculoskeletal pain, joint pain, depression, urinary urgency, indigestion and falls.
In patients receiving APO-RASAGILINE as adjunct to levodopa therapy the most common side effects are: lack of coordination, accidental injury, weight loss, posture-dependant low blood pressure, vomiting, loss of appetite, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, bruising, trouble sleeping, hands and legs swelling, and abnormal skin sensation.
APO-RASAGILINE may cause hallucinations. Tell your doctor immediately if this happens to you while taking APO-RASAGILINE.
Taking more than 1 mg may cause serious side effects which could include a severe headache, seizures, and a sudden rise in blood pressure. Should you experience these side effects seek immediate emergency medical assistance. For any other unusual symptoms you have not had before or are not mentioned here, contact your doctor or pharmacist immediately.
Serious side effects could result when taking APO- RASAGILINE together with other medications. Therefore, please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, even those obtained without a prescription. Serious reactions (coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse), and sometimes fatal reactions could occur if you take APO-RASAGILINE together with Demerol (meperidine) or some other pain medications (tramadol, methadone, tapentadol, and propoxyphene). Serious reactions (brief episodes of psychosis or bizarre behavior) could occur if you take APO-RASAGILINE together with dextromethorphan (an over-the-counter anti-cough drug). Taking APO- RASAGILINE together with other MAOIs (monoamine oxidase inhibitors) increases the risk of serious reactions such as hypertensive crisis.
| 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 |
|---|---|---|---|
| Very Common | |||
| Dyskinesia: difficulty performing common movements | ✔ | ||
| Uncommon | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Angina pectoris: Chest pain | ✔ | ||
| Balance disorder, fall | ✔ | ||
| Hallucinations: Seeing, hearing or sensing things that are not real | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, cough, runny nose, aches and pains, Flu-like symptoms | ✔ | ||
| Dystonia: prolonged muscle contractions | ✔ | ||
| Skin cancer: irregular or new skin lesions | ✔ | ||
| Uncommon | |||
| Stroke: numbness, weakness, confusion, blurred vision | ✔ | ||
| Heart attack: chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating | ✔ | ||
| Hypotension: Low blood pressure that makes you feel dizzy or faint especially when getting up from a lying or sitting position | ✔ | ||
| Unknown | |||
| Serotonin syndrome: a combination of symptoms possibly including confusion, fever, headaches, blood pressure and pulse alterations, muscle twitching. | ✔ | ||
| Hypertensive crisis: severe headache, seizures, confusion, excessively elevated blood pressure. | ✔ | ||
| Feeling sleepy, drowsy, suddenly falling asleep without warning. | ✔ | ||
| Compulsive behaviour: urges to gamble, increased sexual urges, excessive eating and spending or any other abnormal behaviour. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO- RASAGILINE, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children. Store at 15°C to 30°C.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- By completing a Patient Side Effect Reporting Form and sending it by:
- Fax toll-free to 1-866-678-6789 (toll-free), or
- Mail to:
Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
3 ways to report:
Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need informationut how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: March 18, 2020