Uses for Exelon

Rivastigmine is used to treat mild to moderate dementia (memory loss and mental changes) associated with Alzheimer's disease or Parkinson's disease. Rivastigmine will not cure or stop Alzheimer's disease or Parkinson's disease from getting worse, however, rivastigmine can improve the thinking ability in some patients.

In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Rivastigmine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so rivastigmine may not work as well.

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

Before using Exelon

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, 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 performed on the relationship of age to the effects of rivastigmine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivastigmine in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 take.

• Bromopride

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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 cause an increased 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 change the dose or how often you use one or both of the medicines.

• Oxybutynin
• Tolterodine

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Application site reaction from rivastigmine skin patch, history of—Should not be used in patients with this condition.

• Asthma, history of or
• Heart problems, including slow heartbeat or hypotension (low blood pressure), or
• Lung or breathing problems (eg, obstructive pulmonary disease), history of or
• Seizures, history of or
• Stomach or bowel problems (eg, bleeding, ulcers), or history of or
• Urinary tract blockage or difficult urination—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe or
• Liver disease, mild or moderate—Use with caution. A lower dose of rivastigmine may be given to patients with these conditions.

Proper use of Exelon

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

It is best to take this medicine with food.

Rivastigmine seems to work best when it is taken at regularly spaced times, usually two times a day, in the morning and evening.

If you are using the oral liquid:

• Measure your dose with the dosing syringe that comes with the package.
• You may swallow directly from the syringe or you may mix the medicine with a small glass of water, soda, or cold fruit juice before taking it. You may use the mixture for up to 4 hours.

Swallow the capsule whole. Do not crush, break, or chew it.

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 oral dosage forms (capsules or solution):
  • For treatment of Alzheimer's disease:
    • Adults—At first, 1.5 milligrams (mg) two times a day. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 6 mg two times a day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of Parkinson's disease:
    • Adults—At first, 1.5 milligrams (mg) two times a day. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 6 mg two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed your dose for more than 3 days, call your doctor right away. You may need to go back to a lower dose.

Storage

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

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.

Precautions while using Exelon

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Rivastigmine may cause nausea, vomiting, diarrhea, stomach pain, loss of appetite, or weight loss. Tell your doctor if any of these problems are severe, because they could cause other health problems such as dehydration.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

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

Rivastigmine may cause some people to become dizzy, clumsy, or unsteady. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not stop taking this medicine or decrease your dose without first checking with your doctor. Stopping this medicine suddenly or decreasing the dose by a large amount may cause mental or behavior changes.

If you think you or someone else may have taken an overdose of rivastigmine, get emergency help at once. Taking an overdose of rivastigmine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Side Effects of Exelon

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

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

More common

• Diarrhea
• indigestion
• loss of appetite
• loss of strength
• nausea and vomiting
• weight loss

Less common

• Fainting

Rare

• Aggression
• convulsions (seizures)
• trembling and shaking of the hands and fingers
• trouble urinating

Incidence not known

• Bloody or black, tarry stools
• chest pain or discomfort
• constipation
• difficulty with speaking
• drooling
• lightheadedness, dizziness, or fainting
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• severe stomach pain
• shortness of breath
• shuffling walk
• slow or irregular heartbeat
• stiffness of the limbs
• trouble urinating
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual tiredness
• vomiting of blood or material that looks like coffee grounds

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

Symptoms of overdose

• Chest pain or discomfort
• increased sweating
• increased watering of the mouth
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• nausea (severe)
• pale or blue lips, fingernails, or skin
• seizures
• slow or irregular heartbeat
• trouble breathing
• unusual tiredness
• vomiting (severe)

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. Also, 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

• Abdominal or stomach pain or cramping
• bloated or full feeling
• confusion
• dizziness
• headache
• mental depression
• seeing, hearing, or feeling things that are not there
• trouble sleeping

Less common

• General feeling of discomfort or illness
• runny nose

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.