Darifenacin extended-release tablets

Generic Name: darifenacin (DAR-i-FEN-a-sin)
Brand Name: Enablex

Darifenacin extended-release tablets is used for:

Treating overactive bladder in adults who frequently experience symptoms such as an urgent need to urinate, a need to urinate often, or leakage of urine.

Darifenacin extended-release tablets is a muscarinic receptor antagonist. It works by relaxing muscles in the bladder.

Do NOT use darifenacin extended-release tablets if:

  • you are allergic to any ingredient in darifenacin extended-release tablets
  • you are unable to empty your bladder (urinary retention), have delayed or slowed emptying of the stomach (gastric retention), or have uncontrolled narrow-angle glaucoma, or are at risk of any of these problems
  • you have severe liver problems
  • you are taking a solid oral potassium product (eg, tablet)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: How to Manage Your Overactive Bladder

Before using darifenacin extended-release tablets:

Some medical conditions may interact with darifenacin extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have stomach or bowel problems (eg, blockage, inflammation, colitis), constipation, trouble emptying your bladder, a weak urine stream, or myasthenia gravis
  • if you have increased pressure in the eyes, glaucoma, or liver problems

Some MEDICINES MAY INTERACT with darifenacin extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by darifenacin extended-release tablets
  • Cimetidine, clarithromycin, itraconazole, ketaconazole, nefazodone, posaconazole, protease inhibitors (eg, boceprevir, nelfinavir, ritonavir), or telithromycin because they may increase the risk of darifenacin extended-release tablets's side effects, such as blurred vision and dizziness
  • Anticholinergics (eg, scopolamine) because the risk of side effects, such as dry mouth, constipation, or blurred vision, may be increased
  • Flecainide, thioridazine, or tricyclic antidepressants (eg, amitriptyline, imipramine) because the risk of their side effects may be increased by darifenacin extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if darifenacin extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use darifenacin extended-release tablets:

Use darifenacin extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with darifenacin extended-release tablets. Talk to your pharmacist if you have questions about this information.
  • Take darifenacin extended-release tablets by mouth with or without food.
  • Darifenacin extended-release tablets is usually taken once daily with water.
  • Swallow darifenacin extended-release tablets whole. Do not break, crush, or chew before swallowing.
  • If you miss a dose of darifenacin extended-release tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses in the same day.

Ask your health care provider any questions you may have about how to use darifenacin extended-release tablets.

Important safety information:

  • Darifenacin extended-release tablets may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use darifenacin extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Heat exhaustion or heatstroke caused by decreased sweating can occur while you are taking darifenacin extended-release tablets (eg, if you become overheated in a warm environment or during increased physical activity). Seek immediate medical attention if you experience decreased sweating, dizziness, increased body temperature, nausea, or tiredness.
  • Darifenacin extended-release tablets may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the face, lips, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
  • Darifenacin extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using darifenacin extended-release tablets while you are pregnant. It is not known if darifenacin extended-release tablets is found in breast milk. If you are or will be breast-feeding while you take darifenacin extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of darifenacin extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; dry eyes; dry mouth; flu-like symptoms; headache; heartburn; mild stomach pain; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; confusion; difficult or painful urination; fainting; hallucinations; inability to urinate; irregular heartbeat; severe or persistent constipation or stomach pain; severe or persistent headache, dizziness, or drowsiness; swelling of the hands, ankles, or feet; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal vision.

Proper storage of darifenacin extended-release tablets:

Store darifenacin extended-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep darifenacin extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about darifenacin extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Darifenacin extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take darifenacin extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about darifenacin extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to darifenacin extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using darifenacin extended-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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