Darifenacin, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat the symptoms of urinary frequency, urinary urgency, urinary leakage, and incontinence caused by bladder spasms. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antispasmodic; anticholinergic

Generic and brand names: darifenacin, oral; Enablex

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of urinary frequency, urinary urgency, urinary leakage, and incontinence caused by bladder spasms.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Gastroesophageal reflux disease (GERD) or esophagitis (trouble swallowing)
• Glaucoma
• Liver disease
• Myasthenia gravis
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as prescribed. Do not take more than directed because increasing the dosage increases the risk of side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Do not break, crush, or chew the tablets. Swallow them whole with a full glass of water. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe constipation, blurred vision, extreme weakness, decreased urination.

What should I watch out for?

Dry mouth is a common side effect of this medicine. If it becomes bothersome, tell your healthcare provider.

This medicine may cause drowsiness, blurred vision, and dizziness. Do not drive or operate machinery unless you are fully alert and able to see clearly.

This medicine increases the risk of heat stroke because it reduces sweating. Avoid extreme heat, saunas, hot tubs, and exercising too much.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, swelling of your tongue or throat, tightness in your chest, increased trouble breathing).

Serious (Report these to your healthcare provider right away.): Severe vision problems or eye pain, confusion, clumsiness, severe headache, slurred speech, hallucinations, unusual tiredness or weakness, severe stomach pain, severe nausea or vomiting, severe constipation or diarrhea, trouble urinating, decreased or painful urination, irregular heartbeat, high blood pressure, severe dizziness or fainting, decreased sweating, fever, unexplained swelling in hands or feet.

Other: Constipation, heartburn, stomach cramps, mild nausea or vomiting, stuffy nose, restlessness, dizziness, headache, drowsiness, dry mouth, dry eyes, dilated pupils, blurred vision.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), metronidazole, norfloxacin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), perphenazine, pimozide (Orap), risperidone (Risperdal), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Atomoxetine (Strattera)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), doxorubicin (Doxil), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and tamoxifen
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), flecainide, metoprolol (Toprol), nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Lomitapide (Juxtapid)
• Medicines to treat breathing or lung problems such as ipratropium (Atrovent) and tiotropium (Spiriva)
• Metoclopramide (Metozolv, Reglan)
• Pain medicines such as hydrocodone, hydromorphone (Dilaudid, Exalgo), meperidine, methadone (Dolophine, Methadose), morphine, oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol/acetaminophen (Ultracet)
• St. John's wort

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.