Consumer Information for: EXELON PATCH 15

EXELON PATCH is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease (a type of dementia).

EXELON PATCH belongs to a group of medicines called “cholinesterase inhibitors”. 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 PATCH works by blocking an enzyme that breaks down acetylcholine called acetylcholinesterase. This in turn increases the amount of acetylcholine in the brain, which improves memory.

Medicinal ingredients: rivastigmine

Non-medicinal ingredients: acrylic copolymer, poly (butylmethacrylate, methyl-methacrylate), silicon adhesive applied to a flexible polymer backing film, silicon oil and vitamin E.

Transdermal patch: 4.6 mg/ 24h (EXELON PATCH 5; available in light peach packaging), 9.5 mg/ 24h (EXELON PATCH 10; available in light violet packaging) and 13.3 mg/ 24h (EXELON PATCH 15; available in pink packaging).

• you are allergic to rivastigmine or to any other ingredients in EXELON PATCH.

• you are allergic to a similar type of medicine (e.g., carbamate derivatives).

• you have severe liver disease.

• 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 a severe skin reaction while wearing rivastigmine patches or taking rivastigmine capsules or oral solution. This includes rashes on large areas of the body or blistering of the skin, mouth, eyes, or genitals.

• you have or have had heart problems (e.g., irregular heartbeat).

• have a condition that affects your heart and/or blood vessels (e.g., coronary artery disease, congestive heart failure).

• have unexplained fainting episodes.

• have liver or kidney problems.

• are currently taking any other medicines.

• have an ulcer or have a history of ulcers in the stomach or intestines.

• have an increased risk of developing ulcers (e.g., you are taking non-steroidal inflammatory drugs (NSAIDs) or high doses of acetylsalicylic acid (ASA)).

• have or have had problems with 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 body weight below 50 kg. You are more likely to experience side effects during your treatment with EXELON PATCH.

• 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). EXELON PATCH may worsen your symptoms.

• 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.

• Allergic skin reactions: These may develop at any time during your treatment with EXELON PATCH. Skin reactions at the patch site are usually mild to moderate in severity. However, more serious skin reactions can occur. Tell your healthcare professional right away if:

  • you experience an allergic skin reaction that spreads beyond the patch site.

  • you experience severe skin reactions at the patch site (e.g., redness, swelling, blisters or skin lesions).

  • the symptoms do not improve within 48 hours after removing the patch.

• Stevens-Johnson Syndrome (SJS)(severe skin rash): This rare serious and life-threatening skin reaction was reported in patients using EXELON PATCH. Stop wearing EXELON PATCH 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: Some cholinesterase inhibitors, such as EXELON PATCH, 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.

• Gastrointestinal problems:

  • These include severe nausea, vomiting and diarrhea, especially at the start of your treatment or when your dose is increased. 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 adjusted or reduced.

  • Cholinesterase inhibitors, such as EXELON PATCH, can also cause increased acid secretion in the stomach. This can lead to bleeding in the gastrointestinal tract.

• Pancreatitis (inflammation of the pancreas): It can occur shortly after starting treatment or even after several months or years of treatment with EXELON PATCH.

See the “Serious side effects and what to do about them” table, for more information on these and other serious side effects.

Driving and using machines: Your healthcare professional will tell you whether your illness allows you to drive vehicles and use machines safely. EXELON PATCH may make you feel dizzy or sleepy, especially at the start of your treatment or when your dose is increased. If EXELON PATCH affects you, do not drive or use any tools or machinery.

Pregnancy: It is not known if EXELON PATCH 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 PATCH, tell your healthcare professional right away.

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

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

Check-ups and testing:

• Alzheimer’s disease and cholinesterase inhibitors, such as EXELON PATCH, 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 PATCH.

• 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 (an autoimmune neuromuscular disorder), or treat glaucoma, and urinary retention)

• anticholinergic medicines (used to treat various conditions such as asthma, chronic obstructive pulmonary disease (COPD), an overactive bladder, gastrointestinal disorders, and symptoms of Parkinson’s disease)

• medicines that are known to lengthen a part of the heartbeat called “QT interval”. These can include:

  • medicines used to treat an irregular heart rhythm (e.g., quinidine, amiodarone, sotalol)

  • certain medicines used to treat depression (e.g., citalopram, escitalopram)

  • medicines used to treat psychotic symptoms (e.g., phenothiazine derivatives, pimozide, ziprasidone)

  • medicines used to increase movement in the gastrointestinal tract (e.g., cisapride)

  • medicines used to treat allergies

  • certain medicines used to treat bacterial infections (e.g., moxifloxacin, erythromycin, levofloxacin, clarithromycin)

  • medicines used to treat malaria

• metoclopramide (used to treat and prevent nausea and vomiting, to help with emptying of the stomach and chronic acid reflux)

• beta blockers (used to treat high blood pressure and chest pain)

• medicines used to prevent and control seizures

• muscle relaxants used during surgery

• nicotine or tobacco products

An overdose can happen if you wear more than one patch at a time. It can be serious and life threatening. Symptoms of an overdose with EXELON PATCH may include:

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

• high blood pressure

• hallucinations (seeing or hearing things that are not there) • general feeling of discomfort usually due to a slow heartbeat

• fainting

If you have forgotten to apply your EXELON PATCH, apply a new patch immediately. You may apply the next patch at the usual time the next day, after removing the previous day’s patch. Do not apply two patches to make up for the one that you missed. ONLY ONE patch should be worn at a time.

If you have not been applying EXELON PATCH for more than 3 days, do not apply the next patch before you have talked to your healthcare professional. You may need to restart your treatment with a lower dose.

• 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); 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: AUG 15, 2023