Patient Medication Information: uses, side effects, how to take - Jamp Rivastigmine Capsules
What is JAMP Rivastigmine Capsules used for?
JAMP Rivastigmine Capsules is used in adults to treat symptoms of:
- mild to moderate Alzheimer’s disease
- dementia happening at least 2 years after the diagnosis of Parkinson’s disease.
How does JAMP Rivastigmine Capsules work?
People with Alzheimer’s disease have low amounts of acetylcholine in the brain. It is a substance that is thought to be necessary for memory and other mental functions. JAMP Rivastigmine Capsules helps stop the breakdown of acetylcholine. This helps increase the amount of acetylcholine in the brain. JAMP Rivastigmine Capsules treats the symptoms and does not cure the disease.
What are the ingredients in JAMP Rivastigmine Capsules?
Medicinal ingredient: Rivastigmine (as rivastigmine hydrogen tartrate) Non-medicinal ingredients:
Capsules: Colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose. The capsule shell is made of gelatin, iron oxide red and iron oxide yellow (for the 3 mg, 4.5 mg and 6 mg strengths), iron oxide yellow (only for the 1.5 mg strength) and titanium dioxide.
The ingredients of the imprinting ink: For the 1.5 mg, 3 mg, 6 mg strengths: FD&C Red No. 40 Aluminum Lake, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.
For the 4.5 mg strength: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.
JAMP Rivastigmine Capsules comes in the following dosage forms:
Capsules: 1.5 mg, 3 mg, 4.5 mg or 6 mg of rivastigmine (as rivastigmine hydrogen tartrate).
Do not use JAMP Rivastigmine Capsules if:
- you are allergic to rivastigmine (including rivastigmine patches) or to any of the other ingredients in this medicine
- you are allergic to a similar type of medicine
- you have severe liver problems
you have had a previous allergic skin reaction with rivastigmine patches. The skin reaction:
- spread beyond the patch size and / or was more severe at the patch site (such as blisters, increasing skin inflammation, swelling);
- did not improve within 48 hours after removal of the patch
- you have had severe rash on large areas of your body or blistering of the skin, mouth, eyes, or genitals when taking rivastigmine capsules.
- you have a history of heart problems including heart rhythm problems
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Rivastigmine Capsules. Talk about any health conditions or problems you may have, including if you:
- have a condition that affects your heart and / or blood vessels (e.g., coronary artery disease, congestive heart failure)
- have fainting episodes
- have or had liver or kidney problems
- are taking any other medicines
- have or have a history of ulcers or bleeding in the stomach or intestines
- have an increased risk of developing ulcers (e.g. you are taking nonsteroidal anti-inflammatory drugs (NSAIDS) or high doses of acetylsalicylic acid [ASA])
- have or had problems in passing urine
- have or have had seizures (such as epilepsy)
- have a respiratory disease that affects breathing (e.g., asthma or obstructive pulmonary disease)
- have a low body weight (less than 50 kg)
- are planning to have an operation with general anesthesia (medication that puts you to sleep)
- have uncontrolled involuntary movements of the body, face or limbs (extrapyramidal disorder).
have an increased risk of developing serious and possibly life-threatening heart rhythm problems. Risk factors include if you:
- have heart failure.
- recently had a heart attack.
- have a slower than usual heartbeat.
- have been told by a healthcare professional that you have low potassium or magnesium levels in your blood.
- have or have a family history of heart rhythm problems.
- take medicines that are known to cause heart rhythm problems.
- are pregnant, think you might be pregnant or plan to become pregnant
- are breastfeeding or planning to breastfeed
- are older than 85 years of age.
Other warnings you should know about:
JAMP Rivastigmine Capsules can cause serious side effects, including:
Gastro-intestinal problems:
- These include severe nausea, vomiting and diarrhea. You may become dehydrated if these problems happen for a long time. You may become dehydrated if they are not addressed. You or your caregiver should always monitor for these side effects during your treatment. Tell your healthcare professional if these side effects persist. Your dose may need to be changed.
- Women are more at risk to experience these side effects than men.
- JAMP Rivastigmine Capsules can also cause increased acid secretion in the stomach. This can lead to bleeding in the gastrointestinal tract.
- Extrapyramidal symptoms: JAMP Rivastigmine Capsules can make nervous system problems, like slow or uncontrollable movements, trembling, seizures and changes in walking patterns worse. Your healthcare professional will monitor these conditions during JAMP Rivastigmine Capsules treatment.
Stevens-Johnson Syndrome (SJS) (severe skin rash): This rare, serious and life-threatening skin reaction was reported in patients using JAMP Rivastigmine Capsules. Stop taking JAMP Rivastigmine Capsules and get medical help right away if you experience:
- a severe rash or any other serious skin reaction such as blistering or peeling of the lips, eyes, mouth, nose or genitals.
- fever, chills, headache, cough, body aches or swollen glands.
Heart rhythm problems: JAMP Rivastigmine Capsules may cause serious heart rhythm problems such as:
- QT Prolongation (a heart rhythm condition where the heart muscle takes longer to contract and relax than usual).
- Torsade de pointes (a life-threatening irregular heartbeat) in patients with risk factors.
- Pancreatitis (inflammation of the pancreas): It can occur shortly after starting treatment or even after several months or years of treatment with JAMP Rivastigmine Capsules.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Driving vehicles and using machines: JAMP Rivastigmine Capsules may cause you to feel dizzy or drowsy. If you feel dizzy or drowsy, do not drive, use machines or perform any other tasks that require your attention. Your healthcare professional will tell you if you can drive or use machines.
Pregnancy: It is not known if JAMP Rivastigmine Capsules can harm an unborn baby. Therefore, you should not use it if you can become pregnant unless your healthcare professional has determined the potential benefits outweigh the potential risks to your baby. If you discover that you are pregnant during your treatment with JAMP Rivastigmine Capsules, tell your healthcare professional right away.
Breastfeeding: It is not known if JAMP Rivastigmine Capsules can pass into breast milk and harm a breastfed baby. Therefore, JAMP Rivastigmine Capsules is not recommended during breastfeeding. Talk to your healthcare professional about other ways to feed your baby during your treatment with JAMP Rivastigmine Capsules.
Surgery: Tell any doctor, dentist, pharmacist, or healthcare professional that you see, that you are taking this medicine. JAMP Rivastigmine Capsules may exaggerate the effects of some muscle relaxants used during anesthesia.
Check-ups and testing:
- Alzheimer’s disease and cholinesterase inhibitors, such as JAMP Rivastigmine Capsules, may cause a low appetite and / or significant weight loss. Your healthcare professional will closely monitor your appetite and weight during your treatment with JAMP Rivastigmine Capsules.
- Your healthcare professional may also monitor your heart rate during this time.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with JAMP Rivastigmine Capsules:
- Other cholinesterase inhibitors or cholinomimetic medicines (used to treat symptoms of Alzheimer’s disease, dementia, myasthenia gravis, glaucoma and urinary problems). Examples include bethanechol.
- Anticholinergic medicines (used to treat various conditions such as asthma, chronic obstructive pulmonary disease (COPD), bladder problems, gastrointestinal disorders, and symptoms of Parkinson’s disease). Examples include oxybutynin and tolterodine.
- Medicines used to treat nausea and vomiting such as metoclopramide
- Medicines used to treat high blood pressure and chest pain, such as atenolol (beta-blockers)
- Medicines used to prevent pain during surgery
Medicines that are known to lengthen a part of the heartbeat called “QT interval”. These can
include:
- Medicines that can affect your heart rhythm or the electrical system of your heart such as quinidine, amiodarone, sotalol
- Medicines used to treat depression like citalopram, escitalopram, amitriptyline
- Medicines used to treat mental disorders like phenothiazine derivatives, sertindole, pimozide, ziprasidone
- Medicines used to treat stomach problems like cisapride
- Medicines used to treat allergies like mizolastin
Medicines used to treat bacterial infections such as clarithromycin, erythromycin,
- moxifloxacin
- Medicines used to treat malaria such as halofrantrine
- Medicines used to prevent and control seizures
- Nicotine or tobacco products
How to take JAMP Rivastigmine Capsules:
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Take JAMP Rivastigmine Capsules with food. Take JAMP Rivastigmine Capsules twice a day, once with your breakfast and once with your evening meal.
- Taking JAMP Rivastigmine Capsules at the same time each day will help you remember when to take your medicine.
- Capsules: Swallow the capsules whole with a drink. Do not open or crush the capsules.
Usual adult dose:
- Your healthcare professional will tell you how much JAMP Rivastigmine Capsules to take.
- The maximum dose is 6 mg twice a day (12 mg / day).
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.
Overdose:
Symptoms of taking too much JAMP Rivastigmine Capsules can include:
- nausea, vomiting, or diarrhea. This can lead to dehydration.
- high or low blood pressure, slow heartbeat, slower breaths, muscle weakness
- headache, dizziness, hallucinations, confusion, fainting, sleepiness
- stomach pain, shaking, sweating
Missed Dose:
- If you miss a dose of JAMP Rivastigmine Capsules, take the next dose at the usual time. Do not take two doses at once.
- Do not stop taking JAMP Rivastigmine Capsules or change your dose without talking with your
If you think you, or a person you are caring for, have taken too much JAMP Rivastigmine Capsules, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- professional.
- Your healthcare professional will tell you your new dose if you stop taking JAMP Rivastigmine Capsules for more than three days.
What are possible side effects from using JAMP Rivastigmine Capsules?
These are not all the possible side effects you may have when taking JAMP Rivastigmine Capsules. If you experience any side effects not listed here, tell your healthcare professional.
- nausea, vomiting,
- loss of appetite, weight loss
- dizziness, headache
- accidental falls
- diarrhea, constipation, stomach discomfort after meals, stomach pains, heartburn
- inability to adequately retain urine (urinary incontinence)
- difficulty in sleeping, tiredness, weakness
- agitation, confusion, nightmares, restlessness, anxiety, aggression
- excessive sweating
- a general feeling of being unwell
- fever, stuffy or runny nose
- joint pain, muscle pain or spasms, muscle stiffness
- shortness of breath
- high blood pressure, lightheadedness due to low blood pressure
- ringing in the ears
- blurry vision
- trembling
- too much saliva
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 | ||
| COMMON | |||
Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, weakness, shortness of breath | √ | ||
| Severe nausea, vomiting and / or diarrhea, dehydration: thirst, headache, general discomfort, loss of appetite, decreased urine, confusion, unexplained tiredness | √ | ||
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 | ||
Urinary tract infection: pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | √ | ||
| UNCOMMON | |||
Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. | √ | ||
| Fainting | √ | ||
Heart rhythm problems: irregular or fast or slow heartbeat, shortness of breath, dizziness, fainting | √ | ||
Myocardial infarction (heart attack): pressure or squeezing pain in the chest, jaw, left arm, between the shoulder blades or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | √ | ||
| Seizures: fits or convulsions | √ | ||
| Severe confusion | √ | ||
| Stomach ulcer and gastrointestinal bleeding: blood in the stools, black, tarry stools or vomiting blood | √ |
|---|
Stroke: sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty in walking or loss of balance or coordination; suddenly feeling dizzy or sudden severe headache with no known cause | √ | ||
|---|---|---|---|
| RARE | |||
| Chest pain | √ | ||
| VERY RARE | |||
Hallucinations: seeing, feeling or hearing things that are not there | √ | ||
Liver disorder: yellowing of skin and the whites of eyes, darkening of the urine, unexplained nausea, vomiting, loss of appetite, itching, upper stomach pain, tiredness | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Stevens-Johnson Syndrome (SJS) (severe skin rash): redness, blistering and / or peeling of the skin and / or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||
| UNKNOWN | |||
Extrapyramidal symptoms: problems controlling movements of the body or limbs, including, but not limited to, stiff limbs, trembling hands, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want | √ |
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.
Storage:
- Do not use JAMP Rivastigmine Capsules after the expiry date.
- Keep JAMP Rivastigmine Capsules in a safe place and out of reach and sight of children.
- Store JAMP Rivastigmine Capsules between 15- 30°C.
If you want more information about JAMP Rivastigmine Capsules:
- 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); or by calling 1-866-399-9091.
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville, Quebec
J4B 5H3, Canada.
Last revised: OCT 02, 2024
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/health-canada/services/drugs-health- products/medeffect-canada/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.