Enablex reduces muscle spasms of the bladder and urinary tract.

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

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

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

Avoid becoming overheated or dehydrated during exercise and in hot weather. Enablex can decrease perspiration and you may be more prone to heat stroke.

Stop using this medication and call your doctor if you have serious side effects such as hot and dry skin, extreme thirst, severe stomach pain or constipation, pain or burning when you urinate, or if you stop urinating.

This medication 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.

Take Enablex exactly as prescribed by your doctor. 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.

Enablex 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 daily with liquid

The dosage may be increased to 15 mg orally once daily two weeks after starting therapy.

Usual Adult Dose for Urinary Frequency:

Initial dose: 7.5 mg orally once daily with liquid

The dosage may be increased to 15 mg orally once daily two weeks after starting therapy.

You should not take Enablex if you are allergic to darifenacin, 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 Enablex 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 Enablex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

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.

This medicine 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 to Enablex: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Enablex 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 Enablex side effects 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 Enablex, 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.