• Adlarity is a prescription medicine used to treat mild, moderate, and severe dementia of the Alzheimer’s type.
• It is not known if this medicine is safe and effective in children.

See the Instructions for Use that comes with your prescription for step-by-step instructions on how to apply, remove, and throw away (dispose of) Adlarity.

• Use Adlarity exactly how your healthcare provider tells you to use it.
• Adlarity transdermal system is for skin use only.
• Apply 1 transdermal system at a time to your skin 1 time weekly (every 7 days).
• Apply to clean, dry, intact skin with little to no hair.
• If your transdermal system falls off, or if you miss a dose, apply a new transdermal system right away. You should remove your transdermal system 7 days later.
• If you stop treatment, call your healthcare provider for instructions before you start again.
• In case of overdose, get medical help or contact a live poison help line right away.

Usual Adult Dose for Alzheimer’s Disease

- recommended starting dosage is 5 mg/day. After 4 to 6 weeks, the dosage may be increased to the maximum recommended dosage of 10 mg/day.
If a patient has been on 5 mg/day oral donepezil for at least 4-6 weeks or on 10 mg/day of oral donepezil, the recommended starting dosage is 10 mg/day.
Administer Adlarity as one transdermal system applied to the skin once weekly.

- Use: treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

You should not use Adlarity if you:

• are allergic to donepezil or to medicines that contain piperidines. See the end of this page for a complete list of ingredients.
• have had a skin reaction called allergic contact dermatitis to Adlarity

Ask your healthcare provider if you are not sure if you should use the Adlarity transdermal system.

Before using Adlarity

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including problems with irregular, slow, or fast heartbeats.
• have stomach ulcers.
• have problems passing urine.
• have seizures.
• have asthma or other lung problems.
• are pregnant or plan to become pregnant. It is not known if Adlarity will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Adlarity passes into your breast milk.

• Do not touch your eyes after you touch the transdermal system. In case of accidental contact with your eyes, or if your eyes become red after handling the transdermal system, rinse your eyes right away with water and get medical help if symptoms do not go away.
• Avoid exposure to heat sources, such as excessive sunlight, saunas, sunrooms, or heating pads, for long periods of time. Too much medicine could be absorbed into your body.

Adlarity may cause serious side effects, including:

• Skin reactions. Skin reactions that include redness and itching may happen at the application site. Stop treatment and call your healthcare provider if you get any of these skin reactions and they do not get better within 2 days (48 hours) after the transdermal system is removed:
  • increased redness or swelling
  • peeling or blistering of the skin
  • spreading beyond the application site
• Slow heartbeat and fainting. Call your healthcare provider right away if you feel faint or lightheaded.
• More stomach acid. This increases the chance of ulcers and bleeding. The risk is higher for some people, such as those who have had ulcers or take NSAIDs. Call your healthcare provider right away if you have any of these symptoms:
  • heartburn or stomach pain that is new or does not go away.
  • nausea or vomiting, blood in your vomit, or dark vomit that looks like coffee grounds.
  • bowel movements or stools that look like black tar.
• Problems passing urine. Call your healthcare provider right away if you have problems passing urine.
• Seizures. Call your healthcare provider right away if you have seizures.
• Worsening of lung problems in people with asthma or other lung disease. Call your healthcare provider if you have new or worsening lung problems.

The most common side effects of donepezil, the medicine in Adlarity, are:

• nausea
• diarrhea
• not sleeping well
• vomiting
• muscle cramps
• feeling tired
• not wanting to eat

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Adlarity may affect the way other medicines work and other medicines may affect how Adlarity works.

Especially tell your healthcare provider if you take medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Ask your healthcare provider if you are not sure if any of your medicines are NSAIDs. Taking NSAIDs and Adlarity together may make you more likely to get stomach ulcers.

Adlarity taken with certain medicines used for anesthesia may cause side effects. Tell your healthcare provider or dentist that you use the Adlarity transdermal system before you have:

• surgery
• medical procedures
• dental surgery or procedures

Know the medicines that you take. Keep a list of all of your medicines. Show it to your healthcare provider before you start a new medicine.