Rivastigmine

What it is used for

Rivastigmine Transdermal System is a prescription medicine used to treat:

• Mild, moderate, and severe memory problems (dementia) associated with Alzheimer's disease.
• Mild-to-moderate memory problems (dementia) associated with Parkinson's disease (PD).

Based on clinical trials conducted over 6 to 12 months, Rivastigmine Transdermal System was shown to help with cognition which includes (memory, understanding communication and reasoning) and with doing daily tasks. Rivastigmine Transdermal System does not work the same in all people. Some people treated with Rivastigmine Transdermal System may:

• Seem much better
• Get better in small ways or stay the same
• Get worse but slower than expected
• Not change and then get worse as expected

Some patients will not benefit from treatment with Rivastigmine Transdermal System. Rivastigmine Transdermal System does not cure Alzheimer's disease. All patients with Alzheimer's disease get worse over time.

Rivastigmine Transdermal System comes as a transdermal system that delivers rivastigmine (the medicine in Rivastigmine Transdermal System) through the skin.

It is not known if Rivastigmine Transdermal System is safe or effective in children under 18 years of age.

The most important thing to know

Rivastigmine Transdermal System is for skin use only.

How to take it

• Rivastigmine Transdermal System exactly as your healthcare provider tells you to use it.
• Rivastigmine Transdermal Systems come in 3 different dosage strengths.
• Your healthcare provider may change your dose as needed
• Wear only 1 Rivastigmine Transdermal System at a time.
• Rivastigmine Transdermal System is for skin use only.
• Only apply Rivastigmine Transdermal System to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts.
• Avoid applying Rivastigmine Transdermal System to areas on your body that will be rubbed against tight clothing.
• Do not apply Rivastigmine Transdermal System to skin that has cream, lotion, or powder on it.
• Change your Rivastigmine Transdermal System every 24 hours at the same time of day. You may write the date and time you put on the Rivastigmine Transdermal System with a ballpoint pen before applying the patch to help you remember when to remove it.
• Change your application site every day to avoid skin irritation. You can use the same area, but do not use the exact same spot for at least 14 days after your last application.
• Check to see if the Rivastigmine Transdermal System has become loose when you are bathing, swimming, or showering.
• Rivastigmine Transdermal System is designed to deliver medication during the time it is worn. If your Rivastigmine Transdermal System falls off before its usual replacement time, put on a new rivastigmine transdermal system right away. Replace the new patch the next day at the same time as usual. Do not use overlays, bandages, or tape to secure an Rivastigmine Transdermal System that has become loose or try to reapply an Rivastigmine Transdermal System that has fallen off.
• If you miss a dose or forget to change your Rivastigmine Transdermal System apply your next Rivastigmine Transdermal System as soon as you remember. Do not apply 2 rivastigmine transdermal systems to make up for the missed dose.
• If you miss more than 3 doses of applying Rivastigmine Transdermal System, call your healthcare provider before putting on a new Rivastigmine Transdermal System. You may need to restart Rivastigmine

Transdermal System at a lower dose.

• Always remove the old Rivastigmine Transdermal System from the previous day before you apply a new one.
• Having more than 1 Rivastigmine Transdermal System on your body at the same time can cause you to get too much medicine. If you accidentally use more than 1 Rivastigmine Transdermal System at a time, call your healthcare provider right away. If you are unable to reach your healthcare provider, call your local Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Side effects, and when to stop

Rivastigmine Transdermal System may cause serious side effects, including:

• Medication overdose. Hospitalization and rarely death may happen when people accidently wear more than 1 patch at the same time. It is important that the old Rivastigmine Transdermal System be removed before you apply a new one. Do not wear more than 1 Rivastigmine Transdermal System at a time.
• Stomach or bowel (intestinal) problems, including:
  • nausea
  • vomiting
  • diarrhea
  • dehydration
  • loss of appetite
  • weight loss
  • bleeding in your stomach (ulcers)
• Skin reactions. Some people have had a serious skin reaction called allergic contact dermatitis (ACD) when using Rivastigmine Transdermal System. Stop using Rivastigmine Transdermal System and call your healthcare 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
  • peeling or blistering of the skin that may ooze, drain or crust over
• heart problems
• seizures
• problems with movement (tremors)

The most common side effects of Rivastigmine Transdermal System include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Rivastigmine Transdermal System. For more information, ask your healthcare provider or pharmacist.

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

Who should not take it

Do not use Rivastigmine Transdermal System if you:

• are allergic to rivastigmine, carbamate derivatives, or any of the ingredients in Rivastigmine Transdermal System. See the end of this leaflet for a complete list of ingredients in Rivastigmine Transdermal System.
• have had a skin reaction that:
  • spread beyond the Rivastigmine Transdermal System size
  • had blisters, increased skin redness, or swelling
  • did not get better within 48 hours after you removed the Rivastigmine Transdermal System

Ask your healthcare provider if you are not sure if you should use Rivastigmine Transdermal System.

What to say before you start

Before you use Rivastigmine Transdermal System, tell your healthcare provider if you:

• have or have had a stomach ulcer
• are planning to have surgery
• have or have had problems with your heart
• have problems passing urine
• have or have had seizures
• have problems with movement (tremors)
• have asthma or breathing problems
• have a loss of appetite or are losing weight
• have had a skin reaction to rivastigmine (the medicine in Rivastigmine Transdermal System) in the past.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if the medicine in Rivastigmine Transdermal System will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if the medicine in Rivastigmine Transdermal System passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Rivastigmine Transdermal System.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• a medicine used to treat inflammation [nonsteroidal anti-inflammatory drugs (NSAIDs)]
• other medicines used to treat Alzheimer's or Parkinson's disease
• an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, or certain asthma medicines, or certain medicines to prevent motion or travel sickness
• metoclopramide, a drug given to relieve symptoms of nausea, gastroesophageal reflux disease(GERD), or nausea and vomiting after surgery or chemotherapy treatment
• If you are undergoing surgery while using Rivastigmine Transdermal System, inform your doctor because Rivastigmine Transdermal System may exaggerate the effects of anesthesia, or the effects of a betablocker, a type of medicine given for high blood pressure, heart disease, and other medical conditions

Ask your healthcare provider if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

What to avoid

• Do not touch your eyes after you touch the Rivastigmine Transdermal System. In case of accidental contact with your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
• Rivastigmine Transdermal System can cause drowsiness, dizziness, weakness, or fainting. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Rivastigmine Transdermal System affects you.
• Avoid exposure to heat sources such as excessive sunlight, saunas, or sunrooms for long periods of time.

Storing it

• Store Rivastigmine Transdermal System between 68°F to 77°F (20°C to 25°C).
• Keep Rivastigmine Transdermal System in the sealed pouch until ready to use.

Keep Rivastigmine Transdermal System and all medicines out of the reach of children.

General information about the safe and effective use of Rivastigmine Transdermal System.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Rivastigmine Transdermal System for a condition for which it was not prescribed. Do not give Rivastigmine Transdermal System to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Rivastigmine Transdermal System. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Rivastigmine Transdermal System that is written for health professionals.

For more information, go to www.bpirx.com or call 1-800-367-3395.