Rivastigmine Patch

• If you have an allergy to rivastigmine or any other part of rivastigmine patch.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had a skin reaction to this medicine or another form of rivastigmine patch in the past.
• If you are taking any of these drugs: Acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, esmolol, labetalol, metoclopramide, metoprolol, nadolol, nebivolol, penbutolol, pindolol, propranolol, sotalol, or timolol.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take rivastigmine patch with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking rivastigmine patch as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take this medicine by mouth. Use on your skin only.
• Do not use patches that are cut or do not look right.
• Wash your hands before and after use.
• Put patch on clean, dry, healthy skin on the upper or lower back. If you are not able to do this, put on upper arm or chest.
• Put patch on a site without hair.
• Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
• Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
• Move the patch site with each new patch. Do not put on the same site for 14 days.
• If the patch falls off, put a new one on.
• Put patch on at the same time of day.
• Do not put on more than 1 patch at a time. Take off the old patch before you put a new one on. Wearing more than 1 patch at a time can lead to very bad and sometimes deadly overdose.
• Be careful to not knock loose the patch while bathing or showering.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.
• If you get rivastigmine patch in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.
• Do not put on 2 doses or extra doses.
• If you miss taking this medicine for a few days in a row, call your doctor before you start taking it again.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Belly pain.
• Feeling tired or weak.
• Not able to sleep.
• Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Recommended Dosing

Initial Dose

Initiate treatment with one 4.6 mg/24 hours rivastigmine transdermal system applied to the skin once daily [see Dosage and Administration (2.4)].

Dose Titration

Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. For patients with severe AD, 13.3 mg/24 hours is the effective dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].

Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease Dementia

The effective dosage of rivastigmine transdermal system is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.

Severe Alzheimer’s Disease

The effective dosage of rivastigmine transdermal system in patients with severe Alzheimer’s disease is 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.

Interruption of Treatment

If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength rivastigmine transdermal system. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours rivastigmine transdermal system and titrate as described above.

Dosing in Specific Populations

Dosing Modifications in Patients with Hepatic Impairment

Consider using the 4.6 mg/24 hours rivastigmine transdermal system as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in SpecificPopulations (8.6) and Clinical Pharmacology (12.3)].

Dosing Modifications in Patients with Low Body Weight

Carefully titrate and monitor patients with low body weight (<50 kg) for toxicities (e.g., excessive nausea, vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 hours rivastigmine transdermal system if such toxicities develop.

Switching to Rivastigmine Transdermal System from Rivastigmine Tartrate Capsules or Rivastigmine Tartrate Oral Solution

Patients treated with rivastigmine tartrate capsules or oral solution may be switched to rivastigmine transdermal system as follows:

• A patient who is on a total daily dose of <6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours  rivastigmine transdermal system. • A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours  rivastigmine transdermal system.

Instruct patients or caregivers to apply the first patch on the day following the last oral dose.

Important Administration Instructions

Rivastigmine transdermal system is for transdermal use on intact skin.

(a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

(b) Apply the rivastigmine transdermal system once a day

• Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. • Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. If sites on the back are not accessible, apply the patch to the upper arm or chest. • Do not apply to a skin area where cream, lotion, or powder has recently been applied.

(c) Do not apply to skin that is red, irritated, or cut.

(d) Replace the rivastigmine transdermal system with a new patch every 24 hours. Instruct patients to only wear 1 patch at a time (remove the previous day’s patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.

(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.

(f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).

(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.

(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Metoclopramide

Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and rivastigmine transdermal system is not recommended.

Cholinomimetic and Anticholinergic Medications

Rivastigmine transdermal system may increase the cholinergic effects of other cholinomimetic medications and may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). Concomitant use of rivastigmine transdermal system with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [seeWarnings and Precautions (5.4)].

Beta-blockers

Additive bradycardic effects resulting in syncope may occur when rivastigmine is used concomitantly with beta-blockers, especially cardioselective beta-blockers (including atenolol). Concomitant use is not recommended when signs of bradycardia including syncope are present.

Mechanism of Action

Although the precise mechanism of action of rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that rivastigmine alters the course of the underlying dementing process.

Pharmacodynamics

After a 6-mg oral dose of rivastigmine in humans, anticholinesterase activity is present in cerebrospinal fluid for about 10 hours, with a maximum inhibition of about 60% 5 hours after dosing.

In vitro and in vivo studies demonstrate that the inhibition of cholinesterase by rivastigmine is not affected by the concomitant administration of memantine, an N-methyl-D-aspartate receptor antagonist.

Pharmacokinetics

Absorption

After the initial application of rivastigmine transdermal system, there is a lag time of 0.5 to 1 hour in the absorption of rivastigmine. Concentrations then rise slowly typically reaching a maximum after 8 hours, although maximum values (Cmax) can also occur later (at 10 to 16 hours). After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application. At steady state, trough levels are approximately 60% to 80% of peak levels.

Rivastigmine transdermal system 9.5 mg/24 hours gave exposure approximately the same as that provided by an oral dose of 6 mg twice daily (i.e., 12 mg/day).  Inter-subject variability in exposure was lower (43% to 49%) for the rivastigmine transdermal system formulation as compared with the oral formulations (73% to 103%).  Fluctuation (between Cmax and Cmin) is less for rivastigmine transdermal system than for the oral formulation of rivastigmine.

Figure 2 displays rivastigmine plasma concentrations over 24 hours for the 3 available patch strengths.

Figure 2: Rivastigmine Plasma Concentrations Following Dermal 24-Hour Patch Application

Over a 24-hour dermal application, approximately 50% of the drug content of the patch is released from the system.

Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the patch was applied to the upper back, chest, or upper arm. Two other sites (abdomen and thigh) could be used if none of the 3 other sites is available, but the practitioner should be aware that the rivastigmine plasma exposure associated with these sites was approximately 20% to 30% lower.

There was no relevant accumulation of rivastigmine or the metabolite NAP226-90 in plasma in patients with Alzheimer’s disease with daily dosing.

The pharmacokinetic profile of rivastigmine transdermal patches was comparable in patients with Alzheimer’s disease and in patients with dementia associated with Parkinson’s disease.

Distribution

Rivastigmine is weakly bound to plasma proteins (approximately 40%) over the therapeutic range. It readily crosses the blood-brain barrier, reaching CSF peak concentrations in 1.4 to 2.6 hours. It has an apparent volume of distribution in the range of 1.8 to 2.7 L/kg.

Metabolism

Rivastigmine is extensively metabolized primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite NAP226-90. In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%). Based on evidence from in vitro and animal studies, the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.

The metabolite-to-parent AUC∞ ratio was about 0.7 after rivastigmine transdermal system application versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal treatment. Less NAP226-90 is formed following patch application, presumably because of the lack of presystemic (hepatic first pass) metabolism. Based on in vitro studies, no unique metabolic routes were detected in human skin.

Elimination

Renal excretion of the metabolites is the major route of elimination. Unchanged rivastigmine is found in trace amounts in the urine. Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours. Less than 1% of the administered dose is excreted in the feces. The apparent elimination half-life in plasma is approximately 3 hours after patch removal. Renal clearance was approximately 2.1 to 2.8 L/hr.

Age

Age had no impact on the exposure to rivastigmine in Alzheimer’s disease patients treated with rivastigmine transdermal system.

Gender and Race

No specific pharmacokinetic study was conducted to investigate the effect of gender and race on the disposition of rivastigmine transdermal system. A population pharmacokinetic analysis of oral rivastigmine indicated that neither gender (n=277 males and 348 females) nor race (n=575 Caucasian, 34 Black, 4 Asian, and 12 Other) affected clearance of the drug. Similar results were seen with analyses of pharmacokinetic data obtained after the administration of rivastigmine transdermal system.

Body Weight

A relationship between drug exposure at steady state (rivastigmine and metabolite NAP226-90) and body weight was observed in Alzheimer’s dementia patients. Rivastigmine exposure is higher in subjects with low body weight. Compared to a patient with a body weight of 65 kg, the rivastigmine steady-state concentrations in a patient with a body weight of 35 kg would be approximately doubled, while for a patient with a body weight of 100 kg the concentrations would be approximately halved [see Dosage and Administration (2.2)].

Renal Impairment

No study was conducted with rivastigmine transdermal system in subjects with renal impairment. Based on population analysis creatinine clearance did not show any clear effect on steady state concentrations of rivastigmine or its metabolite.

Hepatic Impairment

No pharmacokinetic study was conducted with rivastigmine transdermal system in subjects with hepatic impairment. Following a single 3-mg dose, mean oral clearance of rivastigmine was 60% lower in hepatically impaired patients (n=10, biopsy proven) than in healthy subjects (n=10). After multiple 6-mg twice a day oral dosing, the mean clearance of rivastigmine was 65% lower in mild (n=7, Child-Pugh score 5 to 6) and moderate (n=3, Child-Pugh score 7 to 9) hepatically impaired patients (biopsy proven, liver cirrhosis) than in healthy subjects (n=10). [see Dosage and Administration (2.2), Specific Population (8.6)].

Smoking

Following oral rivastigmine administration (up to 12 mg/day) with nicotine use, population pharmacokinetic analysis showed increased oral clearance of rivastigmine by 23% (n=75 smokers and 549 nonsmokers).

Drug Interaction Studies

No specific interaction studies have been conducted with rivastigmine transdermal system. Information presented below is from studies with oral rivastigmine.

Effect of Rivastigmine on the Metabolism of Other Drugs

Rivastigmine is primarily metabolized through hydrolysis by esterases. Minimal metabolism occurs via the major cytochrome P450 isoenzymes. Based on in vitro studies, no pharmacokinetic drug interactions with drugs metabolized by the following isoenzyme systems are expected: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6.

No pharmacokinetic interaction was observed between rivastigmine taken orally and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is not affected by administration of rivastigmine.

Effect of Other Drugs on the Metabolism of Rivastigmine

Drugs that induce or inhibit CYP450 metabolism are not expected to alter the metabolism of rivastigmine.

Population pharmacokinetic analysis with a database of 625 patients showed that the pharmacokinetics of rivastigmine taken orally were not influenced by commonly prescribed medications such as antacids (n=77), antihypertensives (n=72), beta-blockers (n=42), calcium channel blockers (n=75), antidiabetics (n=21), nonsteroidal anti-inflammatory drugs (n=79), estrogens (n=70), salicylate analgesics (n=177), antianginals (n=35), and antihistamines (n=15).

Rivastigmine Transdermal System

(riv-ah-STIG-meen)

Rivastigmine transdermal system is for skin use only.

What is rivastigmine transdermal system?

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.

Based on clinical trials conducted over 6 to 12 months rivastigmine transdermal system was shown to help with cognition which includes (memory, understanding communication, 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 patch 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.

Who should not use rivastigmine transdermal system?

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 should I tell my healthcare provider before using rivastigmine transdermal system?

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 the 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 the rivastigmine transdermal system passes into your breast milk. You and your healthcare provider should decide if you will use the rivastigmine transdermal system or breastfeed. You should not do both.

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 beta-blocker, 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.

How should I use rivastigmine transdermal system?

• Use 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 a patch that has become loose or try to reapply a 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.

What should I avoid while using rivastigmine transdermal system?

• 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 sun-rooms for long periods of time.

What are the possible side effects of rivastigmine transdermal system?

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:

• depression • headache • anxiety • dizziness • stomach pain • urinary tract infections • muscle weakness • tiredness • trouble sleeping

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.

How should I store rivastigmine transdermal system?

• Store rivastigmine transdermal system between 68oF to 77oF (20oC to 25oC). • 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, call 1-800-525-8747.

What are the ingredients of rivastigmine transdermal system?

Active ingredient: rivastigmine
Excipients include: acrylic copolymer, poly (butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E

T2015-34/T2015-35

February 2015/February 2015

Instructions for Use

Rivastigmine Transdermal System

(riv-ah-STIG-meen)

You will need the following supplies (See Figure A):

Rivastigmine transdermal system is supplied in cartons containing 30 patches (see Figure A)

Figure A

• Rivastigmine transdermal system is a thin, beige, plastic patch that sticks to the skin. Each rivastigmine transdermal system is sealed in a pouch that protects it until you are ready to put it on (See Figure A). • Only 1 rivastigmine transdermal system should be worn at a time. Do not apply more than 1 rivastigmine transdermal system at a time to the body. • Do not open the pouch or remove the rivastigmine transdermal system until you are ready to apply it.

Using rivastigmine transdermal system:

Step 1. Choose an area to apply the rivastigmine transdermal system (See Figure B).

• Instructions for Caregivers: Apply rivastigmine transdermal system to the upper or lower back if it is likely that the patient will remove it. If this is not a concern, the rivastigmine transdermal system can be applied instead to the upper arm or chest. Do not apply the rivastigmine transdermal system to areas where it can be rubbed off by tight clothing or belts. • Only apply the rivastigmine transdermal system to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts.

Figure B

The diagram represents areas on the body where rivastigmine transdermal system may be applied. Only 1 patch should be worn at a time. Do not apply multiple patches to the body.

Step 2. Remove the rivastigmine transdermal system from the pouch (See Figure C).

Carefully cut the pouch along the dotted line to open and remove the rivastigmine transdermal system. Save the pouch for later use.

Figure C

• Do not cut or fold the rivastigmine transdermal system itself.

Step 3. Remove 1 side of the adhesive liner (See Figure D).

• A protective liner covers the sticky (adhesive) side of the rivastigmine transdermal system. Peel off 1 side of the protective cover. Do not touch the sticky part of the rivastigmine transdermal system with your fingers.

Figure D

Step 4. Apply the rivastigmine transdermal system to your skin (See Figure E).

• Apply the sticky (adhesive) side of the rivastigmine transdermal system to your chosen area of skin and then peel off the other side of the protective cover.

Figure E

• Press down on the rivastigmine transdermal system firmly for 30 seconds to make sure that the edges stick to your skin (See Figure F).

Figure F

Step 5: Wash your hands with soap and water right away.

Note:

• If your rivastigmine transdermal system falls off, select a new area, and repeat Steps 2 to 5 to apply a new rivastigmine transdermal system. • Be sure to replace the new rivastigmine transdermal system the next day at the same time as usual.

Removing your rivastigmine transdermal system:

Step 6. Remove the rivastigmine transdermal system from the skin (See Figure G).

• Gently pull on 1 edge of the rivastigmine transdermal system to remove it from your skin.

Figure G

Throwing away the used rivastigmine transdermal system:

Step 7. Throw away the used rivastigmine transdermal system (See Figure H).

• Fold the used rivastigmine transdermal system in half (with the sticky sides together) and put it back into the pouch that you saved.

Figure H

• Throw away the used rivastigmine transdermal system safely and out of the reach of children and pets. • Some medicine stays in the patch for 24 hours after you use it and should be folded together (sticky side together) and safely thrown away. Do not try to re-use rivastigmine transdermal systems.

Step 8: Wash your hands with soap and water right away.

• After you remove the rivastigmine transdermal system, if any adhesive remains on your skin, you can use soap and water or an oil-based substance (such as baby oil) to remove the adhesive. Alcohol or other dissolving liquids (such as nail polish remover) should not be used.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Sandoz Inc.
Princeton, NJ 08540

T2015-34/T2015-35/T2015-36
February 2015/February 2015/February 2015

0003862 USG