Flavoxate reduces muscle spasms of the bladder and urinary tract.

Flavoxate is used to treat bladder symptoms such as painful urination, frequent or urgent urination, increased night-time urination, bladder pain, and incontinence (urine leakage). These bladder symptoms are often caused by overactive bladder, prostate enlargement, bladder infections, or irritation of the urethra.

Flavoxate will not treat a bladder infection. Infections must be treated with an antibiotic.

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

You should not use flavoxate if you have bleeding or a blockage in your digestive tract (stomach or intestines), a bladder obstruction, or if you are unable to urinate.

Flavoxate comes as a tablet. Flavoxate usually is taken three or four times a day. This drug may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flavoxate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may occasionally change your flavoxate dose to make sure you get the best results.

Call your doctor if your symptoms do not improve, or if they get worse.

If your doctor has also prescribed medicine to treat a bladder infection, use that medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store flavoxate at room temperature away from moisture, heat, and light.

You should not use flavoxate if you are allergic to it, or if you have:

• blockage in your digestive tract (stomach or intestines);

• stomach or intestinal bleeding; or

• bladder obstruction or if you are unable to urinate.

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

• glaucoma; or

• urination problems.

flavoxate is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Flavoxate is not approved for use by anyone younger than 12 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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).

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

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.

flavoxate may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

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

Common side effects of flavoxate may include:

• nausea, vomiting, dry mouth;

• headache, dizziness, drowsiness;

• pounding heartbeats or fluttering in your chest;

• confusion, nervousness; or

• rash or itching.

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.

Other drugs may interact with flavoxate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.