Darifenacin, Oral dar-i-FEN-a-sin

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 for 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
• an enlarged prostate or trouble urinating
• gastroesophageal reflux disease (GERD) or esophagitis (trouble swallowing)
• glaucoma
• liver disease
• myasthenia gravis
• severe ulcerative colitis
• stomach or intestinal problems, or problems with constipation

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.

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 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.

If you need emergency care, surgery, 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 are unable to 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, slurred speech, hallucinations, muscle weakness, severe stomach pain, severe constipation or diarrhea, trouble urinating, irregular heartbeat, high blood pressure.

Other: Constipation, dry mouth, dry eyes, decreased sweating, nausea, vomiting, change in sense of taste, stuffy nose, restlessness, dizziness, headache, dilated pupils, heartburn, stomach cramps.

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:

• antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, metronidazole (Flagyl), norfloxacin (Noroxin), and rifampin (Rifadin)
• anticholinergic medicines such as atropine sulfate, benztropine (Cogentin), dicyclomine (Bentyl), l-hyoscyamine (Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• antidepressants such as amitriptyline, doxepin, fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox CR), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), and paroxetine (Paxil)
• antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• anti-HIV medicines such as delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• antipsychotic medicines such as chlorpromazine, fluphenazine, haloperidol (Haldol), perphenazine, and thioridazine
• antiseizure medicines such as carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
• cimetidine (Tagamet)
• heart medicines such as amiodarone (Cordarone; Pacerone), digoxin (Lanoxin, Digitek, Lanoxicaps), diltiazem (Cardizem, Dilacor, Tiamate, Tiazac), flecainide (Tambocor), quinidine, and verapamil (Calan, Covera, Isoptin)
• imatinib (Gleevec)
• St. John's Wort

Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit affects the way this medicine works and may increase the risk of side effects.

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.