rivastigmine 9.5 mg/24 hour transdermal patch

Generic name:
Rivastigmine patch - transdermal

Pronunciation
(riv-uh-STIG-meen)

Brand name(s)
Exelon

Rivastigmine is used to treat confusion (dementia) related to Alzheimer's disease and to Parkinson's disease. Rivastigmine does not cure either of these diseases, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of natural substances (neurotransmitters) in the brain.

Read the Patient Information Leaflet if available from 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 the patch to the skin as directed by your doctor, usually once daily. Do not open the sealed pouch until ready to use. Open the pouch and remove the patch from the protective liner. Do not cut the patch. Apply the patch as directed to a clean, dry, hairless area on the back, upper arm, or chest. Remove the old patch first before applying a new patch. Do not wear 2 patches at the same time. 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.

If the patch falls off before it is due to be changed, apply a new patch right away and replace the new patch at the regularly scheduled time the next day. Do not try to reapply the old patch or use tape to keep a loose patch from falling off.

Do not touch your eyes while you are handling the patch. Wash your hands with soap and water after each application. If the medication comes in contact with your eyes or if your eyes become red after handling the patch, rinse your eyes right away with water. Tell your doctor if the redness or other symptoms do not go away.

Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as nausea and diarrhea), your doctor will start this medication using a lower dose of the patch and may increase your dose after 4 weeks. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often than prescribed. Do not apply more than one patch per day 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 do not use rivastigmine for 3 or more days in row, talk with your doctor before starting again. You may need to restart at a lower dose.

Tell your doctor if your condition gets worse.

Nausea, vomiting, loss of appetite/weight loss, diarrhea, weakness, dizziness, drowsiness, shakiness (tremors), and skin irritation at the application site may occur. If any of these effects last or get worse, contact your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if any of these serious side effects occur:

• slow heartbeat
• black stools
• vomit that looks like coffee grounds
• severe stomach/abdominal pain
• seizures
• trouble urinating

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using rivastigmine, tell your doctor or pharmacist if you are allergic to it (including any serious allergic skin reaction with past use of the patch); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing/lung problems (such as asthma, COPD-chronic obstructive pulmonary disease)
• stomach/intestinal problems (such as ulcers, bleeding)
• heart problems (such as sick sinus syndrome, other conduction disorders)
• fainting
• seizures
• problems urinating (such as due to enlarged prostate)
• liver disease

Rivastigmine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using rivastigmine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using rivastigmine safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

While wearing your patch, avoid exposing it to direct heat (such as 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.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aspirin/nonsteroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen, naproxen)
• metoclopramide

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that if taken together with rivastigmine may increase your risk for stomach/intestinal bleeding. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea/vomiting that is severe or doesn't stop, excessive sweating, very slow heartbeat, slow or shallow breathing, seizure.

Do not share this medication with others.

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

If you miss a dose, use it as soon as you remember. Replace the new patch at the regularly scheduled time the next day. Do not use 2 patches to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.