Patient Medication Information: uses, side effects, how to take - Teva-Rasagiline
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 TEVA-RASAGILINE. While you are taking TEVA-RASAGILINE, take special care when you drive or operate a machine. You should avoid driving or using a machine and talk to your healthcare professional right away if you experience:
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What is TEVA-RASAGILINE used for?
TEVA-RASAGILINE is used in adults to treat the signs and symptoms of Parkinson’s disease:
- alone in patients with early Parkinson’s disease.
- together with other medicines called dopamine agonists in patients with early Parkinson’s disease.
- together with levodopa in patients with more advanced Parkinson’s disease.
Before you start taking 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, talk to your healthcare professional.
How does TEVA-RASAGILINE work?
Parkinson’s disease is a disorder of the central nervous system caused by a lack of dopamine. Dopamine is a chemical 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.
What are the ingredients in TEVA-RASAGILINE?
Medicinal ingredients: rasagiline mesylate.
Non-medicinal ingredients are: colloidal silicon dioxide, mannitol, pregelatinized starch, starch, stearic acid and talc.
TEVA-RASAGILINE comes in the following dosage forms:
Tablets; 0.5 mg and 1 mg
Do not use TEVA-RASAGILINE if:
- you are allergic to rasagiline or to any of the non-medicinal ingredients in TEVA- RASAGILINE.
- you have moderate-to severe liver disease
you are taking any of the following medications:
- Cyclobenzaprine (a muscle relaxant)
- Antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic or tetracyclic antidepressants (such as fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, venlafaxine, mirtazapine)
- Dextromethorphan (an over-the-counter cough suppressant)
- Other MAO inhibitors for the treatment of Parkinson’s disease or for any other indication, including depression
- Pain medications (such as meperidine or pethidine, tramadol, methadone, tapentadol and propoxyphene)
- St. John's Wort (an herbal product used to treat depression)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-RASAGILINE. Talk about any health conditions or problems you may have, including if you:
- are taking antibiotics, used to treat bacterial infections (such as ciprofloxacin, pefloxacin, norfloxacin), cimetidine, used to treat stomach problems or amiodarone, used to treat heart problems.
- are also taking levodopa. It is possible you will have increased difficulty with movement if you are taking TEVA-RASAGILINE and levodopa. Your healthcare professional may lower your dose of levodopa.
- have liver problems. Your healthcare professional may lower your dose 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 breastfeeding
- have kidney problems. Your healthcare professional might decide that you should not take TEVA-RASAGILINE due to your kidney problems.
Other warnings you should know about:
Serotonin Toxicity: TEVA-RASAGILINE can cause serotonin toxicity, a rare but potentially life-threatening condition. You may develop serotonin toxicity if you take MAOIs, certain antidepressants or opioid medications while taking TEVA-RASAGILINE. Symptoms include:
- high body temperature (above 380C), heavy sweating;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, flushing;
- involuntary eye movements;
- agitation, feeling restless.
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.
Skin Cancer (melanoma): 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. While you are taking TEVA-RASAGILINE, your healthcare professional should do periodic skin examinations.
Hallucinations (seeing and hearing things that are not there) and other mental health problems: TEVA-RASAGILINE can cause or worsen mental health problems. Some patients taking medications similar to TEVA-RASAGILINE have reported intense urges that they cannot control. For example:
- an intense need to gamble
- increased sexual urges
- strong desire to spend money
- binge eating
- compulsive eating
- punding (the compulsive need to carry out repetitive actions)
If you notice, or your family notices, that you are developing any unusual behaviors, talk to your healthcare professional right away.
It is also important to tell your healthcare professional before beginning treatment if you drive or operate machinery.
Tyramine-Rich Foods: Foods rich in the amino acid tyramine, such as old or aged cheese, cured, smoked or processed meats, pickled or fermented foods and alcoholic beverages like beer and red wine, can cause your blood pressure to increase. You should avoid these food while you are taking TEVA-RASAGILINE as large increases in blood pressure are possible. If you feel unwell after eating foods rich in tyramine while you are taking TEVA-RASAGILINE, talk to your healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not use TEVA-RASAGILINE with the following medications due to the risk of serious side effects:
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The following may interact with TEVA-RASAGILINE:
- Ciprofloxacin, pefloxacin or norfloxacin (antibiotics used to treat bacterial infections) or other CYP1A2 inhibitors, such as cimetidine (used to treat stomach problems) and amiodarone (used to treat heart problems) - if you take any of these medicines you should take the 0.5 mg dose of TEVA-RASAGILINE.
- Levodopa – your levodopa dose may need to be reduced
- Sympathomimetic amines including amphetamines, some decongestants, cold remedies, and weight loss products
How to take TEVA-RASAGILINE:
- Take TEVA-RASAGILINE exactly as instructed by your healthcare professional. You should talk with your healthcare professional if you are unsure.
- Do not stop taking TEVA-RASAGILINE or change your dose without talking to your healthcare professional.
TEVA-RASAGILINE can be taken with or without food.
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 healthcare professional immediately.
Overdose:
| If you think you, or a person you are caring for, have taken too much TEVA-RASAGILINE, contact a healthcare professional, hospital emergency department or regional poison control centre immediately even if there are no symptoms. |
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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.
What are possible side effects from using TEVA-RASAGILINE?
These are not all the possible side effects you may have when taking AZILECT. If you experience any side effects not listed here, tell your healthcare professional.
Side effects in patients taking TEVA-RASAGILINE alone may include:
- musculoskeletal pain
- joint pain
- depression
- urinary urgency
- indigestion
Side effects in patients taking TEVA-RASAGILINE together with a dopamine agonist or levodopa may include:
- lack of coordination
- accidental injury
- weight loss
- vomiting
- loss of appetite
- joint pain
- abdominal pain
- nausea, constipation
- dry mouth, rash
- bruising
- trouble sleeping
- hands and legs swelling
- abnormal skin sensation
Serious side effects and what to do about them
| Symptom/Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| 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 | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Keep out of the reach and sight of children.
Store at room temperature (15-30°C).
If you want more information about TEVA-RASAGILINE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.