What is the most important information I should know about fesoterodine?

Do not take this medication if you are allergic to fesoterodine, if you have uncontrolled glaucoma, or if you have a blockage of the urinary tract, stomach, or intestines.

Before taking fesoterodine, tell your doctor if you have urination problems, myasthenia gravis, severe constipation, liver or kidney disease, glaucoma, or a personal or family history of "Long QT syndrome."

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Fesoterodine 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.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Fesoterodine can decrease perspiration and you may be more prone to heat stroke.

Avoid drinking alcohol. It can increase some of the side effects of fesoterodine.

There are many other medicines that can interact with fesoterodine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is fesoterodine?

Fesoterodine reduces spasms of the bladder muscles.

Fesoterodine is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence.

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

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

You should not take this medication if you are allergic to fesoterodine or if you have:

• a blockage of the urinary tract (difficulty urinating);
• a blockage in your stomach or intestines; or
• untreated or uncontrolled glaucoma.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking fesoterodine, tell your doctor if you have:

• urination problems;
• myasthenia gravis;
• severe constipation;
• liver disease;
• kidney disease;
• glaucoma; or
• a personal or family history of "Long QT syndrome."

FDA pregnancy category C. It is not known whether fesoterodine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether fesoterodine 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.

Fesoterodine is not for use in children.

Adults who are 75 years or older may be more likely to have side effects from this medication.

How should I take fesoterodine?

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. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Store fesoterodine at room temperature away from moisture and heat.

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.

What happens if I overdose?

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

Overdose symptoms may include dry mouth, blurred vision, and fast heartbeat.

What should I avoid while taking fesoterodine?

Fesoterodine can cause blurred vision or side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake, alert, and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Fesoterodine can decrease perspiration and you may be more prone to heat stroke.

Avoid drinking alcohol. It can increase some of the side effects of fesoterodine.

What are the possible side effects of fesoterodine?

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 fesoterodine and call your doctor at once if you have any of these serious side effects:

• chest pain, fast or uneven heart rate;
• swelling of your hands or feet;
• urinating less than usual or not at all; or
• painful or difficult urination.

Less serious side effects may include:

• dry mouth, dry eyes;
• blurred vision;
• dizziness, drowsiness;
• constipation;
• stomach pain or upset;
• cough, dry throat;
• back pain; or
• sleep problems (insomnia).

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 fesoterodine?

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

• arsenic trioxide (Trisenox);
• conivaptan (Vaprisol);
• an antibiotic such as clarithromycin (Biaxin), clotrimazole (Mycelex Troche), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), itraconazole (Sporanox), ketoconazole (Nizoral), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), telithromycin (Ketek), troleandomycin (Tao), or voriconazole (Vfend);
• an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafril), desipramine (Norpramin), nefazodone, paroxetine (Paxil), or sertraline (Zoloft);
• anti-malaria medications such as chloroquine (Arelan), mefloquine (Lariam), or halofantrine (Halfan);
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);
• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir);
• medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
• migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
• narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

This list is not complete and there are many other medicines that can interact with fesoterodine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about fesoterodine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.01. Revision date: 11/10/2008.