EXELON (rivastigmine) Capsules, Patches, Oral solution

Update: FDA Approves EXELONRivastigmine Patch July 6, 2007

EXELON Patch (rivastigmine transdermal system) has been approved in the United States for the treatment of mild to moderate Alzheimer's disease patients

What is EXELON?

EXELON improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

EXELON is used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease.

EXELON may also be used for other purposes not listed in this medication guide.

Important information about EXELON

Before taking EXELON, tell your doctor if you have a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats), an enlarged prostate, urination problems, asthma, obstructive pulmonary disease, or a seizure disorder such as epilepsy.

Stop using EXELON and call your doctor at once if the medicine causes you to have stomach pain, nausea and vomiting, and loss of appetite.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is important to use EXELON regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you stop taking EXELON for any reason, do not restart the medication without talking to your doctor first. You may need to restart treatment with a lower dose.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking EXELON.

EXELON can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking EXELON?

Before taking EXELON, tell your doctor if you have:

• a heart rhythm disorder such as "sick sinus syndrome" (slow heartbeats);

• an enlarged prostate or urination problems;

• epilepsy or other seizure disorder; or

• asthma or obstructive pulmonary disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take EXELON.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether EXELON passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take EXELON?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

EXELON is usually taken twice a day, in the morning and evening. Follow your doctor's directions.

Take EXELON with food.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking EXELON. You may need to stop using the medicine for a short time.

Take the EXELON capsule with a full glass of water. Do not use a regular table spoon to measure a dose of EXELON oral liquid (solution). Use the syringe provided.

You may swallow the oral liquid directly from the syringe or mix the medicine with a small glass of water, fruit juice, or soda. Do not use any other liquids to mix with EXELON oral liquid.

Stir the medicine mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

After using the syringe, wipe the outside of it with a clean tissue and put the syringe back into its case. Close the medicine bottle using the child resistant closure.

It is important to use EXELON regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

amily: verdana; font-size: 12px; font-style: normal; font-weight: normal; color: #000000; text-align: justify;">If you stop taking EXELON for any reason, do not restart the medication without talking to your doctor first. You may need to restart treatment with a lower dose.

Store EXELON at room temperature away from moisture and heat in an upright position.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

If you miss several doses in a row, call your doctor before taking any more of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe nausea, vomiting, drooling, sweating, blurred vision, feeling light-headed, slow heartbeat, shallow breathing, muscle weakness, fainting, or seizure (convulsions).

What should I avoid while taking EXELON?

EXELON can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

EXELON side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using EXELON and call your doctor at once if you have any of these serious side effects:

• stomach pain, nausea and vomiting, loss of appetite;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like blood or coffee grounds;

• feeling light-headed, fainting;

• chest pain;

• confusion, agitation, extreme fear; or

• pain or burning when you urinate.

Less serious EXELON side effects may include:

• upset stomach, diarrhea;

• weight loss;

• weakness, dizziness;

• swelling in your hands or feet;

• joint pain;

• cough, runny or stuffy nose;

• increased sweating;

• sleep problems (insomnia); or

• headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect EXELON?

Before taking EXELON, tell your doctor if you are using any of the following drugs:

• atropine (Donnatal, and others);

• belladonna;

• clidinium (Quarzan);

• dicyclomine (Bentyl);

• glycopyrrolate (Robinul);

• hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);

• mepenzolate (Cantil);

• methantheline (Provocholine);

• methscopolamine (Pamine);

• propantheline (Pro-Banthine); or

• scopolamine (Transderm-Scop).

This list is not complete and there may be other drugs that can interact with EXELON. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about EXELON.

What does my medication look like?

EXELON is available with a prescription under the brand name EXELON. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• EXELON 2 mg/mL - clear, yellow solution in a 4 oz (120 mL) bottle with an oral dosing syringe

• EXELON 1.5 mg - capsule

• EXELON 3 mg - capsule

• EXELON 4.5 mg - capsule

• EXELON 6 mg - capsule

• EXELON Patch - 5cm², 4.6 mg/24 hours - 10cm², 9.5 mg/24 hours

This medicine may require a prescription in your country in ordre to conform with local rules and regulations.