Uses

This medication is used to treat certain bladder problems (overactive bladder, neurogenic detrusor overactivity). Overactive bladder is a problem with how your bladder stores urine. Neurogenic detrusor overactivity is a bladder control condition caused by brain, spinal cord, or nerve problems. Symptoms of these conditions may include frequent urination, strong sudden urges to urinate that are hard to control, or involuntary loss of urine (incontinence). By relaxing the muscles in the bladder, fesoterodine improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using fesoterodine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once a day. Take each dose with a full glass of liquid. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition, other medications you are taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). For children, the dosage may also be based on their weight.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Dry mouth, dry eyes, constipation, dizziness, drowsiness, or blurred vision may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• constipation lasting 3 or more days
• severe stomach/abdominal pain
• trouble urinating
• signs of kidney infection (such as burning/painful urination, lower back pain, fever)

Get medical help right away if you have any very serious side effects, including:

• fast heartbeat
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking fesoterodine, tell your doctor or pharmacist if you are allergic to it; or to tolterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• problems emptying your bladder (urinary retention, bladder outflow obstruction)
• stomach/intestinal problems (such as blockage, constipation, ulcerative colitis, slowed movement of stomach/intestines)
• a certain eye condition (narrow-angle glaucoma)
• kidney disease
• liver disease
• a certain muscle disease (myasthenia gravis)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, dry mouth, and constipation.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• pramlintide
• potassium tablets/capsules

Other medications can affect the removal of fesoterodine from your body, which may affect how fesoterodine works. Examples include certain azole antifungals (such as itraconazole, ketoconazole), mifepristone, among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that can cause drowsiness, constipation or blurred vision. Ask your pharmacist about the safe use of those products.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe drowsiness or unconsciousness, unusual excitement, mental/mood changes.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.