Consumer Information for: EXELON

EXELON^® is used in adults to treat symptoms of:

• mild to moderate Alzheimer’s disease

• Parkinson’s disease with an unknown cause

• dementia happening at least 2 years after the diagnosis of Parkinson’s disease

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. EXELON^® helps stop the break down of acetylcholine. This helps increase the amount of acetylcholine in the brain. EXELON^® is treats the symptoms and does not cure the disease.

Medicinal ingredients: rivastigmine (as rivastigmine hydrogen tartrate)

Non-medicinal ingredients:

Capsules: gelatin with red and/or yellow iron oxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose and silicon dioxide, titanium dioxide

Oral solution: citric acid, purified water, quinoline yellow WS dye E104, sodium benzoate and sodium citrate.

EXELON^® oral solution contains sodium benzoate (benzoic acid) which can irritate skin, eyes, and mucous membranes.

Capsules: 1.5 mg, 3 mg, 4.5 mg or 6 mg of rivastigmine (as rivastigmine hydrogen tartrate).

Oral solution: 2 mg / mL of rivastigmine (as rivastigmine hydrogen tartrate).

• 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 (patch, capsules or oral solution)

• If you have a history of heart problems including heart rhythm problems

• 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 non-steroidal 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 breast feeding or planning to breast feed

• are older than 85 years of age.

EXELON^® 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.
  • EXELON^® can also cause increased acid secretion in the stomach. This can lead to bleeding in the gastrointestinal tract.
• Extrapyramidal symptoms: EXELON^® can make nervous system problems, like slow or uncontrollable of movements, trembling, seizures and changes in walking patterns worse. Your healthcare professional will monitor these conditions during EXELON^® treatment.

• Stevens-Johnson Syndrome (SJS) (severe skin rash): This rare serious and life-threatening skin reaction was reported in patients using EXELON^®. Stop taking EXELON^®. 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: EXELON^® 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 EXELON^®.

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: EXELON^® 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 EXELON^® 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 EXELON^®, tell your healthcare professional right away.

Breastfeeding: It is not known if EXELON^® can pass into breast milk and harm a breastfed baby. Therefore, EXELON^® is not recommended during breastfeeding. Talk to your healthcare professional about other ways to feed your baby during your treatment with EXELON^®.

Surgery: Tell any doctor, dentist, pharmacist, or healthcare professional that you see, that you are taking this medicine. EXELON^® may exaggerate the effects of some muscle relaxants used during anesthesia.

Check-ups and testing:

• Alzheimer’s disease and cholinesterase inhibitors, such as EXELON^®, may cause a low appetite and/or significant weight loss. Your healthcare professional will closely monitor your appetite and weight during your treatment with EXELON^®.

• 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.

• 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, levofloxacin, moxifloxacin

  • Medicines used to treat malaria such as halofrantrine

• Medicines used to prevent and control seizures

• Nicotine or tobacco products

• Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• Take EXELON^® with food. Take EXELON^® twice a day, once with your breakfast and once with your evening meal.

• Taking EXELON^® 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.

• Oral solution:

1. Remove oral dosing syringe from its protective case. Push down and twist child resistant closure to open bottle.

2. Insert tip of syringe into opening of white stopper.

3. While holding the syringe, pull the plunger tip to the level (see markings on side of syringe) that equals the dose prescribed by your healthcare professional.

4. Before removing syringe containing prescribed dose from bottle, push out large bubbles by moving plunger up and down a few times. After the large bubbles are gone, pull the plunger again to the level that equals the dose prescribed by your healthcare professional. Do not worry about a few tiny bubbles. This will not affect your dose in any way. Remove the syringe from the bottle.

5. You may swallow EXELON^® Oral Solution directly from the syringe or mix with a small glass of water, cold fruit juice or soda; be sure to stir completely and to drink the entire mixture right away. DO NOT MIX WITH OTHER LIQUIDS.

6. After use, wipe outside of syringe with a clean tissue and put it back in its case. Close bottle using child resistant closure.

• Symptoms of taking too much EXELON^® can include:

  • nausea, vomiting, or diarrhea. This can lead to dehydration.

  • high or low blood pressure, slow heart beat, slower breaths, muscle weakness

  • headache, dizziness, hallucinations, confusion, fainting, sleepiness

  • stomach pain, shaking, sweating

• If you miss a dose of EXELON^®, take the next dose at the usual time. Do not take two doses at once.

• Do not stop taking EXELON^® or change your dose without talking with your healthcare professional.

• Your healthcare professional will tell you your new dose if you stop taking EXELON^® for more than three days.

These are not all the possible side effects you may have when taking EXELON^®. 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, light-headedness due to low blood pressure

• ringing in the ears

• blurry vision

• trembling

• too much saliva

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.

Keep EXELON^® in a safe place and out of the reach and sight of children.

• Capsules: Store EXELON^® capsules between 15° C - 30°C.

• Oral solution: EXELON^® oral solution between 15° C - 30°C in the original package in an upright position.

• 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/drugproducts/drug-product-database.html); the manufacturer’s website https://knighttx.com, by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.

This leaflet was prepared by Knight Therapeutics Inc., Montreal, QC H3Z 3B8.

EXELON is a registered trademark.

Last revised: OCT 03, 2023