Darifenacin extended-release tablets

What is this medicine?

DARIFENACIN (dar ee FEN a sin) is used to treat overactive bladder. This medicine reduces the amount of bathroom visits. It may also help to control wetting accidents.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush or chew this medicine. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• difficulty passing urine

• fast, irregular heartbeat

• fever

• flushing

• memory loss

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

• constipation

• headache

What may interact with this medicine?

• clarithromycin

• flecainide

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

• medicines for HIV or AIDS like ritonavir or nelfinavir

• nefazodone

• thioridazine

• tricyclic antidepressants like amitriptyline, imipramine, or nortriptyline

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.

Where should I keep my medicine?

Keep out of the reach of children.

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.

What should I tell my health care provider before I take this medicine?

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

• difficulty passing urine

• glaucoma

• intestinal obstruction

• kidney disease

• liver disease

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

It may take a few weeks to notice the full benefit from this medicine.

You may need to limit your intake of tea, coffee, caffeinated sodas, and alcohol. These drinks may make your symptoms worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating drops may help. See your eye care professional if the problem does not go away or is severe.

Avoid extreme heat. This medicine can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.