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, or has had an allergic reaction to a similar type of medicine. There have been some cases of skin reactions (e.g., rash, itchiness, and hives) that extend beyond the site of patch application. Speak to the doctor before using EXELON PATCH.
Mistakes in using EXELON PATCH have resulted in serious side effects; some cases have required hospitalization, and rarely, 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 cause gastrointestinal adverse reactions, including significant nausea, vomiting, diarrhea, decreased appetite, and weight loss. 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, if appropriate. If you have not taken EXELON PATCH for more than 3 days, do not start taking it again until you have talked to a doctor.
The most common side effects with EXELON PATCH 9.5 mg/24 hours were nausea, vomiting, and diarrhea.
The most common side effects with EXELON PATCH 13.3 mg/24 hours were nausea, vomiting, fall, decreased weight, application site redness, decreased appetite, diarrhea, and urinary tract infection.
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, restlessness) could occur or get worse. Parkinsonian symptoms, particularly tremor, have worsened in Parkinson's disease dementia patients treated with EXELON (rivastigmine tartrate) capsules. 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 with other medicines that have a similar effect on the body and the brain (cholinomimetic agents) or with anticholinergic medicines. Inform the doctor if the patient needs surgery requiring anesthesia while using EXELON PATCH.
