Fesoterodine

WHY is this medicine prescribed?

Fesoterodine is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Fesoterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fesoterodine comes as an extended release (long-acting) tablet to take by mouth. It is usually taken with or without food, once a day. Take fesoterodine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fesoterodine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with plenty of liquid; do not split, chew, or crush them.

Your doctor may start you on a low dose of fesoterodine and increase your dose if your symptoms are not controlled. Talk to your doctor about how fesoterodine works for you

Your symptoms should begin to improve during the first few weeks of your treatment with fesoterodine. However, it may take up to 12 weeks for you to feel the full benefit of fesoterodine. Tell your doctor if your symptoms do not improve after you have taken fesoterodine for several weeks.

Fesoterodine may help control your symptoms, but it will not cure your condition. Continue to take fesoterodine even if you feel well. Do not stop taking fesoterodine without talking to your doctor. If you stop taking fesoterodine, your symptoms may return.

What SPECIAL PRECAUTIONS should I follow?

Before taking fesoterodine,

• tell your doctor and pharmacist if you are allergic to fesoterodine, tolterodine (Detrol, Detrol LA), any other medications, or any of the ingredients in fesoterodine tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); diltiazem (Cardizem, Cartia XT, Dilacor XR®, others); erythromycin (ERY-C, Ery-Tab); certain HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, or ulcers; other medications for urinary problems; and verapamil (Calan, Covera-HS, Isoptin SR, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are unable to empty your bladder, and if you have or have ever had slowed or delayed emptying of your stomach, or glaucoma (increased pressure in the eye that may lead to vision loss). Your doctor may tell you not to take fesoterodine.

• tell your doctor if you have or have ever had a slow or weak urine stream, constipation, any conditions that affect your stomach or intestines, myasthenia gravis (a disease that causes severe muscle weakness), or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fesoterodine, call your doctor.

• you should know that fesoterodine may cause drowsiness and blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking fesoterodine. Alcohol can add to the drowsiness caused by this medication.

• you should know that fesoterodine may make it harder for your body to cool down when it gets very hot. Avoid exposure to extreme heat, and call your doctor or get emergency medical treatment if you have fever or other signs of heat stroke such as dizziness, upset stomach, headache, confusion, and fast pulse after you are exposed to heat.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do IF I FORGET to take a dose?

Skip the missed dose and take your next dose at the regular time the next day. Do not take two doses of fesoterodine in the same day.

What SIDE EFFECTS can this medicine cause?

Fesoterodine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• constipation
• difficulty emptying the bladder
• dry eyes
• dry throat
• cough
• back pain

Some side effects can be serious. If you experience any of these symptoms, stop taking fesoterodine and get emergency medical treatment:

• swelling of the face, throat, tongue, or lips
• hoarseness
• difficulty swallowing or breathing

Fesoterodine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• blurred vision
• hot. dry and red skin
• dry mouth
• difficulty emptying your bladder
• rapid heartbeat
• rapid breathing
• nausea or vomiting
• upper body rash
• confusion
• hallucinations (seeing things or hearing voices that do not exist)
• anxiety
• restlessness
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.