Adlarity

Store in the refrigerator. Keep the patch in the sealed pouch until ready to use. 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.

IMPORTANT: 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.

Read the Patient Information Leaflet and Instructions for Use 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 patch. If you have any questions, ask your doctor or pharmacist.

Apply the patch to the skin as directed by your doctor, usually once weekly. Do not open the sealed pouch until ready to use. Do not cut the patch or use a damaged patch.

Before use, remove one sealed pouch (containing the patch) from the refrigerator and allow it to reach room temperature. Do not warm up the patch any other way by using other heat sources such a microwave, hair dryer, heating pad, or direct sunlight. The patch should be applied within 24 hours after taking it out of the refrigerator. Choose a clean, dry, area of skin with little or no hair to apply the patch. The recommended application site is the back (avoiding the spine). If you need to, you may apply the patch to the upper buttocks or upper outer thighs. Avoid areas where the patch might be rubbed off by tight clothing or undergarments. Do not apply to skin that is red, irritated, or cut. Do not shave or use creams, lotions, or powder on the application site.

Wash your hands before and after handling the patch. Peel off the backing from the patch and apply the patch to the chosen application site. Press the patch firmly in place for about 30 seconds to make sure it stays on. Only one patch should be applied at a time. When changing your patch, remove the old patch, fold it in half with the sticky side together, and throw it away out of reach of children and pets. Do not flush the patch down the toilet. You may use mineral oil or baby oil to wipe off any remaining stickiness left by the old patch at the application site. 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.

While wearing the patch, avoid exposure to heat for long periods of time (see also Precautions section). However, keep the patch on during showers or baths.

The 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 at a low dose and gradually increase your dose over weeks to months. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often than prescribed. If you stop using this medication, contact your doctor for instructions before you start using it again.

If your doctor is changing your treatment with donepezil from the tablet form to this patch form, carefully follow your doctor's directions for when to start using the patch and when to stop taking the tablet(s). Ask your doctor or pharmacist if you have any questions.

Use this medication regularly to get the most benefit from it. To help you remember, change the patch on the same day each week. Mark your calendar with a reminder. It may take several weeks before you get the full benefit of this drug.

If the patch falls off before it is time to change it, do not try to reapply the patch. Choose a new application site and apply a new patch. Then replace the new patch 7 days later to start a new weekly schedule.

Tell your doctor if your condition gets worse.

Nausea, vomiting, diarrhea, loss of appetite, dizziness, drowsiness, tiredness, trouble sleeping, shakiness (tremor), or muscle cramps may occur as your body adjusts to the drug. These effects usually last 1 to 3 weeks and then lessen. Redness, itching, or irritation at the application site may also occur. If any of these effects last or get worse, tell 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 you have any serious side effects, including: trouble urinating, severe stomach/abdominal pain, black stools, vomit that looks like coffee grounds.

Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting, seizures.

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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 donepezil, tell your doctor or pharmacist if you are allergic to it; 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 problems (such as asthma, chronic obstructive pulmonary disease), seizures, stomach/intestinal disease (such as ulcers, bleeding), trouble urinating (such as enlarged prostate).

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).

Donepezil 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 donepezil, 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 donepezil safely.

While wearing your patch, avoid long exposure 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 are: aspirin/non-steroidal anti-inflammatory drugs (such as ibuprofen, naproxen).

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 donepezil 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.

If someone has overdosed and has 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, seizures.

Do not share this medication with others.

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