Darifenacin extended-release tablets

What are Darifenacin extended-release tablets?

DARIFENACIN (Enablex®) helps to control an overactive bladder, a chronic condition that can be improved with medication. Darifenacin may decrease the number of bathroom visits and help to control wetting accidents. Generic darifenacin extended-release tablets are not yet available.

What should my health care professional know before I receive Darifenacin?

They need to know if you have any of these conditions:

• difficulty passing urine

• glaucoma

• intestinal obstruction

• kidney disease

• liver disease

• stomach problems like pyloric stenosis or reflux, or other problems with proper emptying of the contents of the stomach

• an unusual or allergic reaction to darifenacin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take darifenacin extended-release tablets by mouth. Swallow the tablets with a drink of water. Do not chew, crush, or split the tablets. Darifenacin can be taken with or without food. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your health care professional's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Darifenacin?

• alcohol-containing beverages

• amantadine

• aprepitant

• atropine

• bosentan

• caffeine

• chloroquine

• cimetidine

• cisapride

• cyclobenzaprine

• diltiazem

• donepezil

• duloxetine

• galantamine

• gefitinib

• grapefruit juice

• hydroxychloroquine

• hyoscyamine

• imatinib, STI-571

• memantine

• metoclopramide

• omeprazole

• quinine

• rifampin, rifapentine, or rifabutin

• rivastigmine

• scopolamine

• some antibiotics (clarithromycin, dalfopristin; quinupristin, erythromycin, norfloxacin, troleandomycin)

• some medicines for colds, hay fever, or allergies

• some medicines for fungal infections, like fluconazole, itraconazole, ketoconazole or voriconazole

• some medicines for heart rhythm disturbances (amiodarone, digoxin, disopyramide, flecainide, propafenone, quinidine)

• some medicines for mental depression or psychotic disorders

• some medicines for seizures (carbamazepine, phenobarbital, phenytoin, primidone)

• some medicines for treating HIV infection or AIDS

• some medicines for treating pain (hydrocodone, morphine, oxycodone, propoxyphene)

• tacrine

• tegaserod

• tolterodine

• topiramate

• verapamil

• water pills (diuretics)

• zafirlukast

• zileuton

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Darifenacin?

Your health care professional may recommend techniques that may help improve control of your bladder and sphincter muscles. Such techniques will help train you to need the bathroom less frequently.

You may need to limit your intake of tea, coffee, caffeinated sodas, and alcohol. These drinks may aggravate your symptoms. Keeping healthy bowel habits may lessen bladder symptoms. If you currently smoke, quitting smoking may help reduce irritation to the bladder muscle.

You may get dizzy or have blurred vision. Do not drive, use machinery, or do anything that requires mental alertness until you know how darifenacin affects you.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, will help.

Darifenacin rarely causes dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating drops may help. See your ophthalmologist if the problem does not go away or is severe.

What side effects may I notice from receiving Darifenacin?

Serious side effects are not common. Side effects that you should report to your prescriber or health care professional as soon as possible:

• any signs of an allergic reaction, like skin itching or hives

• blurred vision or difficulty focusing vision

• confusion

• difficulty passing urine

• severe dizziness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation

• dry eyes

• dry mouth

• headache

• indigestion or stomach upset

• mild dizziness or drowsiness

• nausea

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.