Fesoterodine extended-release tablets

What is this medicine?

FESOTERODINE (fes oh TER oh deen) is used to treat overactive bladder. This medicine reduces the amount of bathroom visits. It may also help to control wetting accidents.

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.

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

• breathing problems

• fast, irregular heartbeat

• 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

• drowsiness

• dry eyes or mouth

• upset stomach

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

What if I miss a dose?

If you miss a dose, skip the missed dose and begin taking this medicine again the next day. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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.

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

• kidney disease

• liver disease

• myasthenia gravis

• prostate disease

• stomach or intestine problems

• an unusual or allergic reaction to fesoterodine, tolterodine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

It may take a few weeks to notice the full benefit from this medicine.

You may need to limit your intake tea, coffee, caffeinated sodas, and alcohol. These drinks may make your symptoms worse.

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. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

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.

Avoid extreme heat. This medicine can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.