Enablex

Enablex

What is Enablex?

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

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

Warnings

You should not take Enablex if you have untreated or uncontrolled angle-closure glaucoma, a stomach disorder that causes delayed emptying, or if you have difficulty emptying your bladder.

Avoid overheating or dehydration during exercise and in hot weather. Enablex may reduce sweating and may make you more susceptible to heat stroke.

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

This medication may cause blurred vision and affect your thinking or reactions. Be careful when driving or doing anything that requires your attention and clear vision.

Before you take this medicine

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

• untreated or uncontrolled angle-closure glaucoma;

• a stomach disorder causing delayed emptying; or

• if you have difficulty 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 disease 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 medication.

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

How should I take Enablex?

Take Enablex exactly as your doctor has told you. Follow all instructions on your prescription label. Your doctor may occasionally change your dose to ensure 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, protected from moisture, heat and light.

Dosage information

Usual adult dose for urinary incontinence:

Initial dose: 7.5 mg orally once daily with liquid

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

Usual Adult Dose for Frequent Urination:

Initial dose: 7.5 mg orally once daily with liquid

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

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose can lead to vision problems.

What to avoid

This medicine may cause blurred vision and affect your thinking or reactions. Be careful when driving or doing anything that requires your attention and clear vision.

Side effects of Enablex

Get emergency medical help if you have any of these problemsSigns of an allergic reaction to Enablex:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Stop using Enablex and call your doctor immediately if you have:

• severe stomach pain or constipation;

• confusion, hallucinations;

• little or no urination;

• pain or burning when urinating; or

• Signs of dehydration - feeling very thirsty or hot, unable to urinate, sweating profusely, or hot and dry skin.

Common side effects of Enablex 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Enablex?

Tell your doctor about all the medicines you take and those you start or stop taking during your treatment with Enablex, especially:

• clarithromycin;

• flecainide;

• thioridazine;

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

• Antifungals – itraconazole, ketoconazole; or

• HIV or AIDS medications – Nelfinavir, Ritonavir.

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

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.