Exelon (rivastigmine) – Patch Transdermal System Overview

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USES: Rivastigmine is used to treat mild to moderate forms of a certain type of brain disorder (dementia) related to Alzheimer's disease or to Parkinson's disease. This medication does not cure dementia, but it may temporarily improve memory, awareness, and the ability to perform daily functions. It works by increasing the amount of a certain natural substance (acetylcholine) in the brain that is believed to be involved with normal memory and mental functions. Rivastigmine belongs to a class of medications called cholinesterase inhibitors.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow all instructions for how to properly apply and use the patches. If you have any questions, consult your doctor or pharmacist.

Apply this medication to the skin, usually once daily or as directed by your doctor. Do not open the sealed pouch until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch as directed to a clean, dry, hairless area on the back, upper arm, or chest. Do not apply the patch to red/irritated/broken areas of skin or to areas where you have applied creams or lotions. Avoid applying it to areas where tight clothing may rub the patch off. You can bathe with the patch on.

When changing your patch, remove the old patch, fold it in half with the sticky sides together, and throw it away out of reach of children and pets. Apply a new patch to a different area to prevent skin irritation. Do not apply a new patch to the same area for at least 2 weeks.

Do not touch your eyes while you are handling the patch. Wash your hands with soap and water after each application.

To reduce nausea and vomiting, your doctor will direct you to start using a lower dose of the patch and gradually increase your dose based on your medical condition, weight, and response to treatment. Follow your doctor's directions carefully. Do not apply more patches or leave the patch on for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, change your patch at the same time each day.

If you have not used this medication for several days or more, consult your doctor or pharmacist before restarting it. You will be directed to restart treatment with the lowest dosage of the patch to reduce the chance of developing very severe vomiting. Your doctor will then gradually increase your dosage to your target dose. Follow your doctor's instructions exactly.

Tell your doctor if your condition worsens.

SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, stomach pain, headache, dizziness, drowsiness, depression, anxiety, or skin irritation at the application site may occur. If you have Parkinson's disease, its symptoms may worsen, especially shaking (tremors). If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weight loss, slow/irregular heartbeat, frequent/difficult urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: black/tarry stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using rivastigmine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., ulcers, bleeding), heart problems (e.g., sick sinus syndrome, conduction disorders, irregular heartbeat), breathing/lung problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), seizures, problems urinating (e.g., due to enlarged prostate).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

While wearing your patch, avoid exposing it to direct heat (e.g., prolonged direct sunlight, heating pads, electric blankets, heat lamps, saunas, hot tubs). Heat may cause more drug to be released into your body, increasing the chance of side effects.

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

If you have other medical conditions, you may need to take medications that have side effects such as drowsiness or confusion. These side effects may affect your mental function and how well rivastigmine works. Your doctor will need to consider all the medications you take and may adjust your treatment or monitor you more closely. Tell your doctor or pharmacist of all the medications you take, including those that cause drowsiness or confusion such as: some antihistamines (e.g., diphenhydramine), anticholinergic drugs (e.g., atropine, scopolamine), anti-seizure drugs (e.g., carbamazepine), antispasmodic drugs (e.g., dicyclomine, oxybutynin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that may cause drowsiness or confusion. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This drug may be harmful if swallowed. If swallowing or overdose is suspected, remove the patch if possible and contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: sweating, very slow heartbeat, severe dizziness, fainting, trouble breathing, seizures.

NOTES: Do not share this medication with others.

Your doctor should check your weight periodically to monitor for side effects.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) in the sealed pouch. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.