Exelon (Transdermal)

Rivastigmine patch is used to treat dementia (memory loss) linked to mild, moderate, or severe Alzheimer's disease, or mild to moderate dementia related to Parkinson's disease. Rivastigmine will not cure these diseases and it will not prevent them from getting worse. However, rivastigmine can enhance thinking ability in some patients with these conditions.

In Alzheimer's disease, many chemical changes occur in the brain. One of the earliest and most significant changes is a reduction in a chemical called acetylcholine (ACh). ACh is important for the brain to function properly. Rivastigmine is a cholinesterase inhibitor. It slows down the breakdown of ACh, allowing it to accumulate and have a stronger effect. However, as Alzheimer's disease progresses, there will be less ACh, so rivastigmine may not be as effective.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause serious skin reactions such as blistering, burning, crusting, dryness, flaking, itching, scaling, severe redness, soreness, or swelling of the skin. Call your doctor right away if these skin reactions spread beyond the patch size, if they get worse, or if symptoms do not improve within 48 hours after removing the patch.

Having more than one patch on your body at the same time can cause you to get too much of this medicine. Make sure you remove the used patch before wearing a new one to decrease your risk of having serious side effects. If you accidentally use more than one patch at a time, call your doctor right away.

This medicine may cause nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns. Call your doctor right away if you have severe diarrhea, dry mouth, thirst, unusual tiredness, and less urine than usual. These could be symptoms of dehydration (loss of too much body fluid). Dehydration is more likely to occur if you have diarrhea or vomiting.

This medicine may also increase your risk of having seizures or tremors, stomach or bowel bleeding or ulcers, heart rhythm problems, bladder or urinating problems, or lung or breathing problems. Talk with your doctor before using this medicine if you have any concerns.

Before you have any kind of surgery or dental treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Using rivastigmine together with medicines that are sometimes used during surgery or dental treatments may increase the effects of these medicines.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it compared to the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following points should be taken into account:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done to determine how age affects the effects of rivastigmine in children. Safety and effectiveness have not been established.

Geriatric

So far, appropriate studies have not shown any specific problems in older adults that would limit the usefulness of rivastigmine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. Your doctor may need to adjust the dose or take other precautions if you are taking this medicine. It's especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you are taking.

• Bromopride

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acebutolol
• Amifampridine
• Atenolol
• Betaxolol
• Bisoprolol
• Bupropion
• Carteolol
• Carvedilol
• Celiprolol
• Donepezil
• Esmolol
• Labetalol
• Levobunolol
• Metipranolol
• Metoclopramide
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Oxybutynin
• Tolterodine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Asthma, history of
• Chronic obstructive pulmonary disease (COPD), history of
• Heart block
• Seizures or tremors
• Sick-sinus syndrome (heart rhythm problem)
• Stomach or bowel ulcers
• Urinary tract blockage or difficulty urinating—Use with caution. This medicine may worsen these conditions.

• Kidney disease, moderate to severe—Use with caution. The effects may be stronger due to slower removal of this medicine from your body. A lower dose may be needed.

• Liver disease, mild to moderate—Use with caution. The effects may be stronger due to slower removal of this medicine from your body. A lower dose may be needed.

• Low body weight (below 50 kilograms)—Use with caution. The side effects of this medicine may be increased. A lower dose may be needed.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Less common

• Blurred vision
• dizziness
• headache
• loss of bladder control
• nervousness
• pounding in the ears
• slow or fast heartbeat

Rare

• Abdominal or stomach pain or tenderness
• arm, back, or jaw pain
• chest pain, tightness, heaviness, or discomfort
• confusion
• convulsions
• decreased urine
• difficult or troubled breathing
• dilated neck veins
• extreme fatigue
• false beliefs that cannot be changed by facts
• irregular breathing
• irregular heartbeat
• loss of consciousness
• rapid breathing
• seizures
• severe nausea or vomiting
• shortness of breath
• sunken eyes
• swelling of the face, fingers, feet, or lower legs
• wrinkled skin

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• fast, pounding, or irregular heartbeat or pulse
• hives or welts
• itching
• itching, scaling, severe redness, soreness, or swelling of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred vision
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• increasing muscle weakness
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness
• watering of mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• discouragement
• fear
• feeling of constant movement of self or surroundings
• feeling sad or empty
• irritability
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• nausea
• redness at the application site
• sensation of spinning
• stomach pain
• tiredness
• trouble concentrating
• trouble sleeping
• upper stomach pain
• vomiting
• weight loss

Rare

• Blindness
• burning, stinging, or pain at application site
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased vision
• difficulty with moving
• eye pain
• hearing loss
• itchy skin
• muscle pain or stiffness
• pain in the joints
• pale skin
• tearing
• troubled breathing with exertion
• unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Exelon

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Cholinesterase Inhibitor, Centrally Acting

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the skin patch:

• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, and hairless skin area on your upper or lower back, upper arm, or chest. Do not put the patch over rashes, cuts, or irritated skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
• Press the patch firmly in place for 30 seconds with the palm of your hand to make sure that the edges of the patch stick well.
• The patch should stay in place, even when you are showering, bathing, or swimming. Apply a new patch if it falls off.
• After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least 14 days. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.
• After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch. Make sure to dispose of it out of the reach of children and pets.
• Try to change the patch at the same time each day. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the usual time on the next day.
• Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.
• Do not touch your eyes after you touch the patch.
• Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight for long periods of time.
• Make sure you wash your hands with soap and water before and after applying the patch.

Do not stop using this medicine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first. You may need to start the medicine again using a lower dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (patch):For dementia associated with Alzheimer's disease or Parkinson's disease: Adults—At first, one 4.6 milligram (mg) patch once a day. After at least 4 weeks, your doctor will increase your dose as needed. If you have mild to moderate Alzheimer's disease or Parkinson's disease dementia, usual dose is 9.5 mg patch or 13.3 mg patch per day. If you have severe Alzheimer's disease, 13.3 mg patch per day. However, the dose is usually not more than one 13.3 mg patch per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you go 3 days in a row or longer without wearing a patch, do not apply a new one until you have talked to your doctor. You might need to go back to a lower dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What drugs can help improve or slow down memory loss?