Darifenacin

Darifenacin is used to treat an overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control). Darifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.

Darifenacin comes as an extended-release (long-acting) tablet to take by mouth. Take with or without food once a day. Take with plenty of water. Take darifenacin at around the same time every day.

Take darifenacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will start you on a low dose of darifenacin and may increase your dose after 2 weeks.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking darifenacin,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking darifenacin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have urinary obstruction (a blockage of urine flow), any type of blockage in the digestive system, benign prostatic hypertrophy (BPH; enlargement of the prostate) or glaucoma. Your doctor will probably tell you not to take darifenacin.
• tell your doctor if you have or have ever had severe constipation, ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum), myasthenia gravis (a nerve problem that makes muscles weak), or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking darifenacin, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking darifenacin.
• you should know that darifenacin may cause blurred vision or make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that darifenacin reduces sweating, which may cause heat prostration (collapse due to high body temperature) in hot weather.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take two doses in the same day or a double dose to make up for a missed one.

Darifenacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth or eyes
• constipation
• upset stomach
• stomach pain
• diarrhea
• weakness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• difficulty urinating or being unable to urinate or burning pain during urination
• sudden swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• shortness of breath or difficulty breathing
• headache, confusion, feeling tired or sluggish, hallucinations

Darifenacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• vision problems

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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