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Enablex®
(en-a-blex)
(darifenacin) extended-release tablets

Read this Patient Information leaflet about Enablex® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

What is Enablex?

Enablex is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

• Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
• Urgency: a strong need to urinate right away
• Frequency: urinating often

It is unknown if Enablex is safe and effective in children.

Who should not take Enablex?

Do not take Enablex if you:

• are not able to empty your bladder (“urinary retention”)
• have delayed or slow emptying of your stomach (“gastric retention”)
• have an eye problem called “uncontrolled narrow-angle glaucoma”

What should I tell my healthcare provider before starting Enablex?

Before starting Enablex, tell your doctor if you:

• have trouble emptying your bladder or if you have a weak urine stream
• have any stomach or intestinal problems, or problems with constipation
• have liver problems
• have any other medical conditions
• are pregnant or are planning to become pregnant. It is not known if Enablex can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Enablex passes into breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you take Enablex.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Enablex and certain other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take a:

• antifungal medicine ketoconazole (Nizoral®) or itraconazole (Sporanox®)
• antibiotic medicine clarithromycin (Biaxin®)
• anti-HIV medicine ritonavir (Norvir®) or nelfinavir (Viracept®)
• medicine to treat depression nefazadone (Serzone®)
• medicine to treat an abnormal heartbeat flecainide (Tambocor™)
• antipsychotic medicine thioridazine (Mellaril®)
• medicine to treat depression called a tricyclic antidepressant

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I take Enablex?

• Take Enablex exactly as prescribed. Your doctor will prescribe the dose that is right for you. Take Enablex 1 time daily with water.
• Enablex should be swallowed whole. Do not chew, cut or crush Enablex tablet.
• Enablex may be taken with or without food.
• If you take too much Enablex call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Enablex?

Enablex can cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how Enablex affects you.

What are the possible side effects of Enablex?

Enablex may cause serious side effects including:

• Serious allergic reaction. Stop taking Enablex and get medical help right away if you have:
  • hives, skin rash or swelling
  • severe itching
  • swelling of your face, mouth or tongue
  • trouble breathing

The most common side effects with Enablex are:

• constipation
• dry mouth
• headache
• heartburn
• nausea
• urinary tract infection
• blurred vision
• heat exhaustion or heat-stroke. This can happen when Enablex is used in hot environments.
  Symptoms of heat exhaustion may include:
  • decreased sweating
  • dizziness
  • tiredness
  • nausea
  • increase body temperature

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Enablex. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Enablex?

• Store Enablex at room temperature, between 59° F to 86° F (15° C to 30° C).
• Keep Enablex out of the light.

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

General information about Enablex.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Enablex for a condition for which it was not prescribed. Do not give Enablex to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Enablex. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Enablex that is written for health professionals.

What are the ingredients in Enablex?

Active ingredient: darifenacin

Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15 mg tablet also contains iron oxide red and iron oxide yellow.

Last reviewed on RxList: 3/22/2012
This monograph has been modified to include the generic and brand name in many instances.