Details for: TEVA-RASAGILINE - 0.5, 1 mg
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02418436 | TEVA-RASAGILINE | RASAGILINE (RASAGILINE MESYLATE) | 0.5 MG | TABLET | ORAL |
| 02418444 | TEVA-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 TEVA-RASAGILINE
(rasagiline mesylate) 0.5 mg or 1 mg tablets. TEVARASAGILINE
relieves the signs and symptoms of
Parkinson’s disease as initial therapy for early disease and as
add-on therapy to dopamine agonists in early stages or
levodopa in more advanced stages of the disease.
Before you begin using TEVA-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
TEVA-RASAGILINE is used to treat the signs and symptoms
of Parkinson’s disease as monotherapy (without levodopa) or
as adjunct therapy (with dopamine agonists or 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.
TEVA-RASAGILINE belongs to a class of drugs called
monoamine oxidase B inhibitors. TEVA-RASAGILINE
works by blocking the breakdown of dopamine in the brain.
When it should not be used
Do not use TEVA-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 TEVA-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 mesylate).
What the non-medicinal ingredients are
Each TEVA-RASAGILINE tablet also contains the following inactive ingredients: colloidal silicon dioxide mannitol, starch, pregelatinized starch, stearic acid and talc.
What dosage form it comes in
TEVA-RASAGILINE tablets are white to off-white, round, flat, bevelled tablets, marked with “GIL 0.5” on one side and plain on the other side for the 0.5 mg tablet or “GIL 1” on one side and plain on the other side for the 1 mg tablet.
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 TEVA-RASAGILINE. During treatment with TEVA-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 TEVA-RASAGILINE; tell your doctor if you:
- are taking any antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine 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. TEVA-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 TEVA-RASAGILINE.
Wait at least 5 weeks after stopping fluoxetine treatment
before starting treatment with TEVA-RASAGILINE.
TEVA-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 TEVA-RASAGILINE section for
important safety information about drugs not to use at the
same time as TEVA-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. TEVA-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 TEVA-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 TEVA-RASAGILINE exactly as instructed by your
doctor. You should talk with your doctor or pharmacist if you
are unsure.
The recommended dose of TEVA-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
Missed Dose
If you have forgotten to take a dose of TEVA-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, TEVA-RASAGILINE can have side
effects.
The most commonly observed side effects that occurred in
patients receiving TEVA-RASAGILINE as monotherapy are:
headache, flu-like symptoms, musculoskeletal pain, joint pain,
depression, urinary urgency, indigestion and falls.
In patients receiving TEVA-RASAGILINE as adjunct to
dopamine agonist or 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.
TEVA-RASAGILINE may cause hallucinations. Tell your
doctor immediately if this happens to you while taking TEVA-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 TEVARASAGILINE 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 TEVA-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 TEVA-RASAGILINE together with dextromethorphan (an over-the-counter anticough drug). Taking TEVA-RASAGILINE together with other MAOIs (monoamine oxidase inhibitors) increases the risk of serious reactions such as hypertensive crisis.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Dyskinesia: difficulty performing common movements | ✔ | ||
| COMMON | |||
| 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 TEVA-RASAGILINE, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store at room temperature (15-30°C).
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 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
- 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 in the MedEffect™ 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. 1255005 (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
Last revised: June 16, 2016