Darifenacin extended-release tablets

What is this medication?

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.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Enablex

What should I tell my care team before I take this medication?

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Do not cut, crush or chew this medication. Take it as directed on the prescription label at the same time every day. You can take this medication with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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 may interact with this medication?

• Clarithromycin
• Flecainide
• Medications for fungal infections, such as fluconazole, itraconazole, ketoconazole or voriconazole
• Medications for HIV or AIDS, such as ritonavir or nelfinavir
• Nefazodone
• Thioridazine
• Tricyclic antidepressants, such as amitriptyline, imipramine, or nortriptyline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

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

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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

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

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

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.