Fesoterodine fumarate Oral tablet

What is this medicine?

FESOTERODINE (fes oh TER oh deen) is used to treat overactive bladder. This medicine reduces the amount of bathroom visits.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• difficulty passing urine
• glaucoma
• intestinal obstruction
• kidney disease
• liver disease
• an unusual or allergic reaction to fesoterodine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• antihistamines for allergy, cough and cold
• atropine
• certain medicines for bladder problems like oxybutynin, tolterodine
• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• certain medicines for travel sickness like scopolamine
• clarithromycin
• ipratropium
• itraconazole
• ketoconazole
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

It may take 2 or 3 months to notice the full benefit from this medicine. Your health care professional may also recommend techniques that may help improve control of your bladder and sphincter muscles. These techniques will help you need the bathroom less frequently.

You may need to limit your intake of tea, coffee, caffeinated sodas, and alcohol. These drinks may make your symptoms worse. Keeping healthy bowel habits may lessen bladder symptoms. If you currently smoke, quitting smoking may help reduce irritation to the bladder muscle.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water will help.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• chest pain
• fast, irregular heartbeat
• fever
• swelling of the ankles, feet, hands
• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in vision
• constipation
• dizziness
• dry eyes or mouth
• nausea
• stomach upset
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.