In the U.S.—

In Canada—

• Dementia symptoms treatment adjunct

Rivastigmine (riv-a-STIG-meen) is used to treat the symptoms of mild to moderate Alzheimer's disease. Rivastigmine will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, rivastigmine can improve thinking ability in some patients with Alzheimer's disease.

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, in the following dosage forms:

Oral
• Capsules (U.S. and Canada)

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 rivastigmine the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rivastigmine or to other medications. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Rivastigmine has not been studied in pregnant women. However, rivastigmine has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether rivastigmine passes into human breast milk. However, use of rivastigmine is not recommended in nursing mothers.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of rivastigmine in children with use in other age groups.

Older adults—Studies on rivastigmine have been done only in middle-aged and older patients. Information on the effects of rivastigmine is based on these patients.

Other 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 rivastigmine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Inflammation or pain medicine, except narcotics—Stomach irritation may be increased

• Neuromuscular blocking agents (medicines used in surgery to relax muscles)—Rivastigmine may increase the effects of these medicines; your doctor may change the dose of rivastigmine before you have surgery

• Asthma (or history of) or
• Blockage in the intestines or stomach, or
• Heart problems, including slow heartbeat or hypotension (low blood pressure), or
• Stomach ulcer (or history of) or
• Urinary tract blockage or difficult urination—Rivastigmine may make these conditions worse
• Epilepsy or history of seizures or
• Diabetes, hormone, or thyroid problems that are poorly controlled—Rivastigmine may cause seizures

Take this medicine only as directed by your doctor.Do not take more or less of it, and do not take it more or less often than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Rivastigmine is best taken 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.

Dosing—

The dose of rivastigmine 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 rivastigmine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (capsules):
  • For treatment of Alzheimer's disease:
    • Adults—To start, 1.5 milligrams (mg) twice a day. Your doctor may increase your dose gradually if you are doing well on this medicine. However, the dose is usually not more than 6 mg twice a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if you do not remember within a few hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not take your morning and evening doses close together.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store away from heat and direct light.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits.

Tell your doctor if your symptoms get worse, or if you notice any new symptoms.

Before you have any kind of surgery, dental treatment, or emergency treatment, tell the doctor 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 are not alert.

Rivastigmine causes a large number of patients to have problems with their stomachs and intestines. Tell your doctor about any nausea, vomiting, stomach pain or loss of appetite.

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.

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 as soon as possible 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
  • High blood pressure;  fainting 
  
  

• Rare
  • Aggression;  convulsions (seizures);  trembling and shaking of hands and fingers;  trouble in urinating 
  
  

• Symptoms of overdose
  • Seizures;  fast weak pulse;  greatly increased sweating;  greatly increased watering of mouth;  irregular breathing ;  increasing muscle weakness;  large pupils;  low blood pressure;  nausea;  slow heartbeat;  vomiting (severe) 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

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

• Less common
  • General feeling of discomfort or illness;  increased sweating;  runny nose 
  
  

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