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INDICATIONS

EXELON^® PATCH (rivastigmine transdermal system) is a prescription medicine used to treat mild, moderate, and severe memory problems (dementia) associated with Alzheimer’s disease.

EXELON PATCH is also used to treat people with mild to moderate memory problems (dementia) associated with Parkinson’s disease.

IMPORTANT SAFETY INFORMATION

EXELON PATCH should not be used if the patient is allergic to any component in EXELON PATCH, including the active ingredient rivastigmine. EXELON PATCH should also not be used if the patient has had a skin reaction that spread beyond the patch size, had blisters, increased skin redness, or swelling, or did not get better within 48 hours after removal of the EXELON PATCH.

Mistakes in using EXELON PATCH have resulted in serious side effects; some cases have required hospitalization, and rarely, have led to death. Most mistakes have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Only one EXELON PATCH should be worn at a time. If you accidentally apply more than one EXELON PATCH, remove all of them and inform the doctor immediately.

EXELON PATCH can also cause serious stomach side effects, including nausea, vomiting, diarrhea, dehydration, decreased appetite, weight loss, and bleeding in your stomach (ulcers). Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. The incidence and severity of these reactions are dose related. For this reason, treatment should be initiated with EXELON PATCH at a dose of 4.6 mg/24 hours and titrated to a dose of 9.5 mg/24 hours, and then 13.3 mg/24 hours, if appropriate. If you have not taken EXELON PATCH for more than 3 days, do not start taking it again until you have talked with a doctor.

Some people have had a serious skin reaction called allergic contact dermatitis (ACD) when using EXELON PATCH. Stop using EXELON PATCH and call your health care provider right away if you experience reactions that spread beyond the patch size, are intense in nature, and do not improve within 48 hours after the patch is removed. Symptoms of ACD may be intense and include itching, redness, swelling, warmth or tenderness of the skin, or peeling or blistering of the skin, which may ooze, drain, or crust over.

The most common side effects of EXELON PATCH include depression, headache, anxiety, dizziness, stomach pain, urinary tract infections, muscle weakness, tiredness, and trouble sleeping.

Weight should be checked while the person is using EXELON PATCH. Weight loss/loss of appetite may occur. People below 50 kg (110 lbs) may experience more side effects and may have to stop using EXELON PATCH due to these side effects.

People at risk for stomach ulcers or who take certain medicines should tell their doctor before starting EXELON PATCH, because serious stomach problems, such as bleeding, may occur.

EXELON PATCH may cause fainting or slow heart rate; people with certain heart conditions should tell their doctor before starting therapy. People with serious lung conditions and difficulty breathing, bladder problems, or seizures should consult their doctor before using EXELON PATCH. Extrapyramidal symptoms (e.g., uncontrollable facial or body movements, including tremor and restlessness) could occur or get worse. Parkinsonian symptoms, particularly tremor, have worsened in Parkinson’s disease dementia patients treated with EXELON (rivastigmine tartrate) capsules. Before using EXELON PATCH, people should also tell their doctor about any medical conditions they have, including if they have had a loss of appetite or are losing weight, or if they have had a skin reaction to rivastigmine (the medicine in EXELON PATCH) in the past. People on EXELON PATCH who feel dizzy or drowsy should not drive or use machines.

Tell the doctor about all other prescription or nonprescription medicines the patient is taking.

EXELON PATCH should not be taken at the same time as metoclopramide (used to treat heartburn, nausea, and vomiting) and with medicines that have a similar effect on the body and the brain (cholinomimetic agents) or with anticholinergic medicines. EXELON PATCH should not be taken at the same time as medicines that reduce your blood pressure (beta-blockers). Inform the doctor if the patient needs surgery requiring anesthesia while using EXELON PATCH.

Please see full Prescribing Information and Patient Product Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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