Details for: JAMP RIVASTIGMINE
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02485362 | JAMP RIVASTIGMINE | RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) | 1.5 MG | CAPSULE | ORAL |
| 02485370 | JAMP RIVASTIGMINE | RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) | 3 MG | CAPSULE | ORAL |
| 02485389 | JAMP RIVASTIGMINE | RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) | 4.5 MG | CAPSULE | ORAL |
| 02485397 | JAMP RIVASTIGMINE | RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) | 6 MG | CAPSULE | 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
JAMP RIVASTIGMINE is one of a group of drugs known as
"cholinesterase inhibitors" which is used for the treatment of
the symptoms of patients with mild to moderate Alzheimer's
disease or with dementia occurring at least 2 years following
the diagnosis of Parkinson's disease. Although there are
differences between the two types of dementias in terms of
changes to the brain and to mental function, it is known that
with both conditions there are decreased levels of
acetylcholine, a substance which is found in the brain and
which is thought to be necessary for good cognitive function
(memory and other mental function).
The symptoms include progressive memory loss, increasing
confusion and behavioural changes, as a result of which it
becomes more and more difficult to carry out activities of daily
living.
This medication should only be taken after proper diagnosis of
your condition has been made by your doctor.
What it does
People with Alzheimer's disease have decreased levels of
acetylcholine, a substance which is found in the brain and
which is thought to be necessary for memory and other mental
functions. Rivastigmine works by inhibiting an enzyme
(acetylcholinesterase) which breaks down acetylcholine. This
in turn increases the amount of acetylcholine in the brain.
Rivastigmine is a treatment of symptoms, not a cure of the
disease.
In clinical studies with rivastigmine, most patients with
Alzheimer's disease had improved memory and other mental
functions, or showed no further decline, as compared to
placebo (sugar tablet) for up to 6 months. However,
rivastigmine may take as long as 12 weeks to begin working,
and patient response to this medicine will vary.
When it should not be used
If any of the following conditions apply to you, tell your doctor and do not use JAMP RIVASTIGMINE
- If you know that you are allergic (hypersensitive) to rivastigmine or to any of the other substances listed in this leaflet (see 'What the nonmedicinal ingredients are'),
- If you have ever had an allergic reaction to a similar type of medicine,
- If you have severe liver problems.
- If you have had a previous allergic skin reaction with rivastigmine patch that spread beyond the patch size and/or if there was a more severe reaction at the patch site (such as blisters, increasing skin inflammation, swelling) that did not improve within 48 hours after removal of the transdermal patch.
- If you have had severe rash on large areas of your body or blistering of the skin, mouth, eyes, or genitals when taking rivastigmine patch, rivastigmine capsules or oral solution.
JAMP RIVASTIGMINE should only be used if prescribed to you by your doctor.
What the medicinal ingredient is
JAMP RIVASTIGMINE contains the active substance rivastigmine hydrogen tartrate.
What the non-medicinal ingredients are
JAMP RIVASTIGMINE capsules contain the following inactive substances: hypromellose 5cP, magnesium stearate, microcrystalline cellulose and silica colloidal anhydrous. The capsule shell is made of gelatin with red and/or yellow iron oxide and titanium dioxide. The printing ink is based on red iron oxide.
What dosage form it comes in
Capsules: Each hard gelatin capsule contains 1.5, 3.0, 4.5 or 6.0 mg of rivastigmine as rivastigmine hydrogen tartrate.
Warnings and precautions
BEFORE you use JAMP RIVASTIGMINE talk to your doctor of pharmacist if:
- you have, or ever had irregular heartbeat
- you have, or ever had asthma or a severe respiratory disease;
- you have, or ever had seizures (fits or convulsions);
- you have a history of stomach ulcers or have an increased risk of developing ulcers (for example you are taking non-steroidal anti-inflammatory drugs (NSAIDS) or high doses of acetylsalicylic acid [ASA];
- you have a low body weight (less than 50 kg);
- you have, or ever had difficulties in passing urine;
- you have, or ever had liver or kidney problems;
- you have, or ever had inflammation of the pancreas;
- you are pregnant, planning on becoming pregnant, or breast feeding.
- you suffer from trembling;
- you have fainting episodes;
- you experience gastro-intestinal reactions such as severe nausea (feeling sick), vomiting (being sick) and diarrhea. You may become dehydrated (losing too much fluid) if vomiting or diarrhea are prolonged.
Talk to your doctor right away if you have skin inflammation, blisters or swelling of the skin that are increasing and spreading.
Your doctor will determine whether you can take JAMP RIVASTIGMINE and how closely you will need to be monitored while you are on this medicine.
Can I drive vehicles and operate machinery?
Your doctor will tell you whether your illness allows you to drive vehicles and operate machinery safely. If you feel dizzy or drowsy, do not drive, use machines or perform any other tasks that require your attention.
Interactions with this medication
Make sure your doctor knows if you are taking, have recently
taken, or begin to take, any other medicines, including drugs,
or herbal (natural) products that you can buy without a
prescription.
JAMP RIVASTIGMINE should not be given at the same time
as other medicines with similar effects (cholinomimetic agents)
or with anticholinergic medicines (e.g. medicines used to
relieve stomach cramps or spasms, or to treat Parkinson's
disease or to prevent travel sickness).
JAMP RIVASTIGMINE should not be given together with
metoclopramide (a medicine used to alleviate or prevent
nausea and vomiting). There may be additive effects such as
stiff limbs and trembling hands.
Your doctor will tell you if you can also take JAMP
RIVASTIGMINE with your current medications. If you have to
undergo surgery while taking JAMP RIVASTIGMINE, you
should inform the doctor before you are given any anaesthetics
(drugs that produce a loss of sensation).
Caution when JAMP RIVASTIGMINE is taken together with
beta-blockers (medicines such as atenolol used to treat
hypertension, angina, and other heart conditions). There may
be additive effects such as bradycardia (slow heartbeat) that
may result in syncope (fainting, loss of consciousness).
Proper use of this medication
This medicine has been prescribed only for you. It must not be
given to anybody else or used for any other illnesses.
JAMP RIVASTIGMINE should be taken with food.
Swallow the capsules whole with a drink, without opening or
crushing them.
Usual dose:
You must take JAMP RIVASTIGMINE twice a day, once with
your breakfast and once with your evening meal. Taking JAMP
RIVASTIGMINE at the same time each day will help you
remember when to take your medicine.
Your doctor will tell you what dosage of JAMP RIVASTIGMINE
to take, starting with a low dose and gradually increasing,
depending on how you respond to the treatment. The highest
dose that should be taken is 6 mg twice a day (12 mg/day).
To benefit from your medicine you must take it every day. If
you have questions about how long to take JAMP
RIVASTIGMINE, talk to your doctor or your pharmacist.
Overdose:
- Some people who have accidentally taken too much rivastigmine have experienced nausea (feeling sick), vomiting (being sick) and diarrhea. You may become dehydrated (losing too much fluid) if vomiting or diarrhea are prolonged.
- Some people may also experience high blood pressure, hallucinations, slow heart beat and fainting.
If you find you have forgotten to take your dose of JAMP RIVASTIGMINE, do not worry, wait and take the next dose at the usual time. Do NOT take two doses at once.
Do not stop taking JAMP RIVASTIGMINE or change your dose without talking with your doctor.
If you stop taking JAMP RIVASTIGMINE for more than three days, do NOT begin to take JAMP RIVASTIGMINE again without contacting your doctor.
Side effects and what to do about them
As with all medicines, patients taking JAMP RIVASTIGMINE
may experience side effects, although not everybody gets them.
In clinical studies most side effects of rivastigmine were of mild
to moderate intensity.
The most common side effects (affect between 1 and 10 in
every 100 patients) noted were:
- feeling sick (nausea), being sick (vomiting), diarrhea, stomach discomfort after meal, stomach pains and loss of appetite;
- dizziness, headache, sleepiness, drowsiness, trembling;
- agitation, confusion, nightmares, anxiety;
- weakness, fatigue, a general feeling of being unwell;
- sweating;
- weight loss. Other common side effects reported with rivastigmine are:
- muscle stiffness, difficulty in carrying out movements, uncontrollable movement of mouth, tongue and limbs, abnormally decreased muscular movement (worsening of Parkinson’s disease symptoms),
- irritation, reddening, rashes, itching (skin reactions),
- losing too much fluid (dehydration),
- restlessness,
- too much saliva,
- abnormal way of walking,
- light-headedness due to low blood pressure,
- high blood pressure.
- difficulty in sleeping,
- change in blood test results related to liver function,
- accidental falls,
- abnormal posture with poor control of movements,
- inability to adequately retain urine (urinary incontinence). Very rare side effects (affect less than 1 in 10,000 patients):
- blister. Additional side effects reported with rivastigmine at an unknown frequency:
- aggression,
- alternating heart rhythms(heart disorders).
- skin inflammation, blisters or swelling of the skin that are increasing and spreading.
| Symptom / effect | Talk with your doctor or pharmacist right away Only if severe | Talk with your doctor or pharmacist right away In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Common | |||
| Crushing chest pain heart attack) | ✔ | ||
| Losing too much fluid (dehydration) | ✔ | ||
| Uncommon | |||
| Fainting | ✔ | ||
| Depression | ✔ | ||
| Loss of coordination, difficulty in speaking and signs of brain disorder (stroke) | ✔ | ||
| Rare | |||
| Chest pain | ✔ | ||
| Fits or convulsion (seizures) | ✔ | ||
| Rash, itching | ✔ | ||
| Gastric (stomach) and duodenal (intestinal) ulcers | ✔ | ||
| Very Rare | |||
| Blood in stools or when vomiting | ✔ | ||
| Severe vomiting that can lead to a rupture of the esophagus | ✔ | ||
| Urinary tract infection | ✔ | ||
| Severe upper stomach pain, often with nausea and vomiting (inflammation of the pancreas) | ✔ | ||
| Heart problems/fast, slow or irregular heart beats | ✔ | ||
| Hallucinations | ✔ | ||
| Blistering of the skin, mouth, eyes and genitals | ✔ | ||
| Unknown | |||
| Yellow skin, yellowing of the whites of eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite (liver disorders including hepatitis) | ✔ | ||
| Stiff limbs, trembling hands, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want (extrapyramidal symptoms) | ✔ | ||
How to store
- Do not use JAMP RIVASTIGMINE after the expiry date.
- Store JAMP RIVASTIGMINE at room temperature (15-30°C).
- Keep JAMP RIVASTIGMINE in a safe place and out of the reach and sight of children.
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
Please consult your doctor or pharmacist with any questions or
concerns you may have regarding your individual condition.
This document plus the full product monograph, prepared for
health professionals can be found by contacting the sponsor,
JAMP Pharma Corporation, at:
1-866-399-9091.
This leaflet was prepared by
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision: January 31, 2019