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|Darifenacin Extended-Release Tablets

Darifenacin Extended-Release Tablets

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 reduces muscle spasms of the bladder by blocking the chemical (acetylcholine) that causes the bladder to spasm.

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 slow emptying of the stomach (gastric retention), 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 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 any stomach or intestinal problems, constipation, trouble emptying your bladder, a weak urine stream, or myasthenia gravis
• if you have 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:

• Antifungal medicines (eg, ketoconazole, itraconazole), HIV medicines (eg, ritonavir, nelfinavir), macrolide antibiotics (eg, clarithromycin), nefazodone, or cimetidine because side effects, such as increased dizziness and blurred vision, may occur
• Tricyclic antidepressants (eg, amitriptyline, imipramine), digoxin, flecainide, or thioridazine because 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.

• Darifenacin Extended-Release Tablets may be taken with or without food.
• Darifenacin Extended-Release Tablets comes with an additional patient leaflet. Read it carefully and reread it each time you get Darifenacin Extended-Release Tablets refilled.
• This medicine is usually taken once daily with liquid.
• Swallow Darifenacin Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Darifenacin 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 Darifenacin Extended-Release Tablets.

Important safety information:

• Darifenacin Extended-Release Tablets may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Darifenacin Extended-Release Tablets. Using Darifenacin Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Heat exhaustion or heatstroke due to 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 sudden or severe tiredness, weakness, anxiety, dizziness, or fainting.
• Heat prostration (due to decreased sweating) can occur when Darifenacin Extended-Release Tablets is used in hot environments. Do not become overheated in hot weather or during exercise or other activities because heatstroke may occur.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Darifenacin Extended-Release Tablets during pregnancy. It is unknown if Darifenacin Extended-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while you are taking Darifenacin Extended-Release Tablets, check with your doctor or pharmacist to discuss the 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; diarrhea; dizziness; dry eyes; dry mouth; dry eyes; flu-like symptoms; headache; nausea; stomach pain; stomach upset; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody or cloudy urine; chills; fever; inability to urinate despite an urge to do so; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Store Darifenacin Extended-Release Tablets at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.

This information is a summary only. It does not contain all information about Darifenacin 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.