Details for: JAMP RASAGILINE
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02491974 | JAMP RASAGILINE | RASAGILINE (RASAGILINE MESYLATE) | 0.5 MG | TABLET | ORAL |
| 02491982 | JAMP 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 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
- 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 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 form 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
- 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 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:
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.
| Symptom / effect | Talk to your doctor, nurse or pharmacist Only if severe | Talk to 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. | ✔ | ||
How to store
Keep out of the reach and sight of children. Store at room temperature (15oC to 30oC). Protect from light.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- 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://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-866-399-9091.
1310 rue Nobel,
Boucherville, Québec,
Canada, J4B 5H3
Last Prepared: September 4, 2019