Darifenacin reduces muscle spasms of the bladder and urinary tract.

Darifenacin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

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

You should not take darifenacin if you are have untreated or uncontrolled narrow-angle glaucoma, a stomach disorder causing delayed emptying, or if you have trouble emptying your bladder.

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 water.

Darifenacin can be taken with or without food.

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

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

Usual Adult Dose for Urinary Incontinence:

Initial dose: 7.5 mg orally once a day
Maintenance dose: The dosage may be increased to 15 mg orally once a day as early as 2 weeks after starting therapy

Comments:
-This drug may be taken with or without food.
-The tablet should be swallowed whole with water and not chewed, divided, or crushed.

Use: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Usual Adult Dose for Urinary Frequency:

Initial dose: 7.5 mg orally once a day
Maintenance dose: The dosage may be increased to 15 mg orally once a day as early as 2 weeks after starting therapy

Comments:
-This drug may be taken with or without food.
-The tablet should be swallowed whole with water and not chewed, divided, or crushed.

Use: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

You should not take darifenacin if you are allergic to it, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;

• a stomach disorder causing delayed emptying; or

• if you have trouble emptying your bladder.

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

• glaucoma;

• liver disease;

• ulcerative colitis;

• a blockage in your stomach or intestines;

• 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 darifenacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using darifenacin.

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

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.

Overdose can cause vision problems.

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

Unless your doctor tells you otherwise, continue your normal diet.

darifenacin 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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Darifenacin may cause serious side effects. Stop using darifenacin and call your doctor at once if you have:

• severe stomach pain or constipation;

• confusion, hallucinations;

• little or no urinating;

• pain or burning when you urinate; or

• signs of dehydration--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects of darifenacin may include:

• nausea, indigestion;

• constipation;

• headache, dizziness;

• dry mouth; or

• blurred vision.

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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with darifenacin, especially:

• clarithromycin;

• flecainide;

• thioridazine;

• an antidepressant--amitriptyline, clomipramine, desipramine, doxepin, imipramine, nefazodone, nortriptyline;

• antifungal medicine--itraconazole, ketoconazole; or

• HIV or AIDS medicine--nelfinavir, ritonavir.

This list is not complete. Other drugs may interact with darifenacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.