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

Fesoterodine is also used to treat neurogenic detrusor overactivity in children at least 6 years old who weigh more than 55 pounds (25 kilograms).

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take fesoterodine with liquid, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your child's doctor may change your child's dose after the first week if:

• the child weighs more than 77 pounds (35 kilograms); and

• the child has severe kidney problems or is taking certain medicines.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Urinary Incontinence:

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a day

Maximum dose: 8 mg once a day

Comments:
-This drug can be administered with or without food.
-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).
-Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.

Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Adult Dose for Urinary Frequency:

4 mg orally once a day; based on individual response and tolerability, the dose may be escalated to 8 mg orally once a day

Maximum dose: 8 mg once a day

Comments:
-This drug can be administered with or without food.
-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).
-Full effect is usually observed between 2 and 8 weeks; therefore, it is recommended to reevaluate efficacy after 8 weeks of therapy.

Use: For overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency

Usual Pediatric Dose for Neurogenic Bladder:

6 Years and Older:
Weighing greater than 25 kg and up to 35 kg:
4 mg orally once a day, the dose may be increased to 8 mg orally once a day

Weighing greater than 35 kg:
4 mg orally once a day, increase the dose to 8 mg orally once a day, after one week

Comments:
-This drug can be taken with or without food.
-This drug should be taken with liquid and swallowed whole (not chewed, divided, or crushed).

Use: For the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg

You should not use fesoterodine if you are allergic to fesoterodine or tolterodine, or if you have:

• a blockage of the urinary tract (difficulty urinating);

• a bladder obstruction or other urination problems;

• a blockage in your stomach or intestines; or

• untreated or uncontrolled narrow-angle glaucoma.

Tell your doctor if you have ever had:

• glaucoma;

• a stomach or intestinal disorder, including severe constipation;

• liver or kidney disease; or

• myasthenia gravis (may worsen while you are taking fesoterodine).

Tell your doctor if you are pregnant or breastfeeding.

Not approved for use by anyone younger than 6 years old or anyone who weighs less than 55 pounds.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Fesoterodine can cause blurred vision, dizziness, and drowsiness. Avoid driving or hazardous activity until you know how fesoterodine will affect you. Your reactions could be impaired.

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

Avoid drinking alcohol or you could have increased drowsiness.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Fesoterodine may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain or constipation;

• a weak stream of urine, or trouble emptying your bladder;

• little or no urination; or

• headache, dizziness, drowsiness.

Older adults may be more likely to have side effects such as dry mouth, constipation, upset stomach, increased urination, dizziness, or painful urination.

Common side effects of fesoterodine may include:

• painful urination;

• blurred vision;

• weight gain;

• dry mouth; or

• stomach pain, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can affect fesoterodine, especially:

• other medicine to treat overactive bladder;

• an antibiotic or antifungal medicine to treat infection;

• antiviral medicine for HIV or hepatitis C;

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• cancer medicine;

• glaucoma medicine;

• medicine to treat Parkinson's disease; or

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may affect fesoterodine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.