Fesoterodine

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.

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

Common Side Effects of Toviaz

You should tell your doctor if any of the following side effects are severe or don't go away:

• Dry mouth, dry throat, and bad taste in your mouth
• Dry eyes
• Headache or dizziness
• Urinary tract infection (UTI) or constipation
• Back pain
• Sleepiness
• Respiratory tract infection

Serious Side Effects of Toviaz

You should stop using this medicine and call your doctor if you experience any of the following serious side effects:

• Chest pain
• Changes in heart rhythm
• Heat stroke
• Swelling of the face, eyes, lips, and tongue (angioedema)
• Hives
• Disorders of the digestive tract, including irritable bowel syndrome (IBS) and diverticulitis

• Take fesoterodine exactly as your doctor tells you to take it.
• Your doctor may give you the lower 4 mg dose of fesoterodine if you have certain medical conditions, such as severe kidney problems.
• Take fesoterodine with liquid and swallow the tablet whole. Do not chew, divide, or crush the tablet.
• You can take fesoterodine with or without food.
• If you miss a dose of fesoterodine, begin taking fesoterodine again the next day. Do not take 2 doses of fesoterodine in the same day.

If you take too much fesoterodine, call your doctor or go to an emergency department right away.

• Store fesoterodine at room temperature, 68° to 77°F (20° to 25°C); brief periods permitted between 59° to 86°F (15° to 30°C)
• Protect the medicine from moisture by keeping the bottle closed tightly.
• Safely throw away fesoterodine that is out of date or no longer needed.

Keep fesoterodine and all medicines out of the reach of children.

You should not use this medicine if you are allergic to fesoterodine or tolterodine (Detrol), or if you have:

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

• a blockage in your stomach or intestines; or

• untreated or uncontrolled narrow-angle glaucoma.

To make sure fesoterodine is safe for you, tell your doctor if you have:

• glaucoma;

• liver or kidney disease;

• urination problems;

• severe constipation;

• a muscle disorder such as myasthenia gravis; or

• if you have very little urine or a weak stream of urine.

FDA pregnancy category C. It is not known whether fesoterodine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether fesoterodine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Fesoterodine is not for use in children.

Adults who are 75 years or older may be more likely to have side effects from this medicine.

Fesoterodine is usually taken once daily. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

You may take fesoterodine with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Store at room temperature away from moisture and heat.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fesoterodine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fesoterodine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fesoterodine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fesoterodine in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., constipation, dizziness, dry mouth, upset stomach, or urinary tract infection), or age-related liver or kidney problems, which may require caution in patients receiving fesoterodine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fesoterodine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fesoterodine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Itraconazole
• Potassium

Using fesoterodine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

Using fesoterodine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole
• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fesoterodine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma, narrow-angle or
• Intestinal or stomach problems (e.g., severe constipation) or
• Myasthenia gravis (severe muscle weakness) or
• Urinary problems (e.g., blockage)—Use with caution. May make these conditions worse.

• Glaucoma, narrow-angle, uncontrolled or
• Liver disease, severe or
• Stomach problems (e.g., gastric retention) or
• Urinary retention—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• It is used to treat an overactive bladder.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry mouth.
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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• FESO
• Fesoterodine Fumarate

Commonly reported side effects of fesoterodine include: xerostomia. Other side effects include: constipation. See below for a comprehensive list of adverse effects.

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