Enablex Extended-Release TabletsGeneric Name: Darifenacin
Enablex Extended-Release Tablets are 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.
Enablex Extended-Release Tablets are a muscarinic receptor antagonist. It works by blocking the chemical (acetylcholine) that causes the bladder to spasm, which reduces muscle spasms of the bladder.
Do NOT use Enablex Extended-Release Tablets if:
- you are allergic to any ingredient in Enablex Extended-Release Tablets
- you are unable to empty your bladder (urinary retention), have delayed or slow emptying of the stomach (gastric retention), have uncontrolled narrow-angle glaucoma, or are at risk for these problems
- you have a history of severe liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Enablex Extended-Release Tablets:
Some medical conditions may interact with Enablex 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 any stomach or intestinal problems (eg, inflammation), constipation, trouble emptying your bladder, a weak urine stream, or myasthenia gravis
- if you have glaucoma or liver problems
Some MEDICINES MAY INTERACT with Enablex Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antifungal medicines (eg, itraconazole, ketoconazole), cimetidine, HIV medicines (eg, nelfinavir, ritonavir), macrolide antibiotics (eg, clarithromycin), or nefazodone because side effects, such as increased blurred vision and dizziness, may occur
- Anticholinergics (eg, scopolamine) because they may increase the risk of Enablex Extended-Release Tablets's side effects
- Digoxin, flecainide, thioridazine, or tricyclic antidepressants (eg, amitriptyline, imipramine) because the risk of their side effects may be increased by Enablex Extended-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Enablex 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 Enablex Extended-Release Tablets:
Use Enablex 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 Enablex Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.
- Take Enablex Extended-Release Tablets by mouth with or without food.
- Enablex Extended-Release Tablets are usually taken once daily with liquid.
- Swallow Enablex Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
- If you miss a dose of Enablex Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Enablex Extended-Release Tablets.
Important safety information:
- Enablex Extended-Release Tablets may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Enablex 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 Enablex Extended-Release Tablets (eg, if you become overheated in a warm environment or during increased physical activity). Seek immediate medical attention if you experience sudden or severe tiredness, weakness, anxiety, dizziness, or fainting.
- Enablex 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 Enablex Extended-Release Tablets while you are pregnant. It is not known if Enablex Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Enablex Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Enablex 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; diarrhea; dizziness; dry eyes; dry mouth; flu-like symptoms; headache; nausea; stomach pain; stomach upset; 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); back pain; bloody or cloudy urine; chills; confusion; fever; hallucinations; inability to urinate despite an urge to do so; irregular heartbeat; pain below the ribs; pain or burning when you urinate; unusual or severe headache.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal vision.Proper storage of Enablex Extended-Release Tablets:
Store Enablex Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Enablex Extended-Release Tablets out of the reach of children and away from pets.
- If you have any questions about Enablex Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Enablex Extended-Release Tablets are 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.
This information is a summary only. It does not contain all information about Enablex Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Enablex Prescribing Information (FDA)
- Enablex Consumer Overview
- Enablex Detailed Consumer Information (PDR)
- Enablex Advanced Consumer (Micromedex) - Includes Dosage Information
- Darifenacin Professional Patient Advice (Wolters Kluwer)