Patient Medication Information: uses, side effects, how to take - Jamp Rasagiline (Jamp Pharma, 0.5 mg)
ABOUT THIS MEDICATION
What the medication is used for:
Your physician has prescribed JAMP Rasagiline (rasagiline mesylate) 0.5 mg or 1 mg tablets. JAMP Rasagiline 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 JAMP 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:
JAMP 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. JAMP Rasagiline belongs to a class of drugs called monoamine oxidase B inhibitors. JAMP Rasagiline works by blocking the breakdown of dopamine in the brain.
When it should not be used: Do not use JAMP 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 JAMP 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 nonmedicinal ingredients are:
Each JAMP Rasagiline tablet also contains the following inactive ingredients: Colloidal anhydrous silica, microcrystalline cellulose, mannitol, maize starch, pregelatinized starch, citric acid, stearic acid and purified talc.
What dosage forms it comes in:
JAMP Rasagiline tablets are white to off-white, round, flat, bevelled tablets, marked with “0.5” on one side and plain on the other side for the 0.5 mg tablet or “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 JAMP Rasagiline. During treatment with JAMP 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 JAMP 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. JAMP 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 JAMP Rasagiline.
Wait at least 5 weeks after stopping fluoxetine treatment before starting treatment with JAMP Rasagiline.
JAMP 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 JAMP Rasagiline section for important safety information about drugs not to use at the same time as JAMP 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. JAMP 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 JAMP 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 JAMP Rasagiline exactly as instructed by your doctor. You should talk with your doctor or pharmacist if you are unsure.
The recommended dose of JAMP 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 you have taken too much JAMP Rasagiline, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you have forgotten to take a dose of JAMP 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, JAMP Rasagiline can have side effects.
The most commonly observed side effects that occurred in patients receiving JAMP Rasagiline as monotherapy are: headache, flu-like symptoms, musculoskeletal pain, joint pain, depression, urinary urgency, indigestion and falls.
In patients receiving JAMP 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.
JAMP Rasagiline may cause hallucinations. Tell your doctor immediately if this happens to you while taking JAMP 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 JAMP 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 JAMP 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 JAMP Rasagiline together with dextromethorphan (an over-the-counter anti-cough drug). Taking JAMP Rasagiline together with other MAOIs (monoamine oxidase inhibitors) increases the risk of serious reactions such as hypertensive crisis.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your doctor, nurse or pharmacist | 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 | ✓ | |||||
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your doctor, nurse or pharmacist | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
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 JAMP Rasagiline, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children. Store at room temperature (15oC to 30oC). Protect from light.
REPORTING SUSPECTED 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. |
MORE INFORMATION
If you want more information about JAMP Rasagiline:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-866-399-9091.
1310, rue Nobel
Boucherville, Québec
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Last Prepared: September 4, 2019