Pronunciation:

dar-i-FEN-a-sin

Brand Names:

• Enablex

Dosage Forms:

• Tablet, Extended Release

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Antimuscarinic

Uses of This Medicine:

Darifenacin is used to treat bladder problems such as frequent need to urinate or loss of control of urinary function.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of darifenacin in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desipramine
• Flecainide
• Imipramine
• Thioridazine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma or
• Stomach problems or
• Urinary retention—You should not use darifenacin; it will make these conditions worse.

• Liver problems—You should not use darifenacin if you have severe liver problems.

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • To treat bladder problems:
    • Adults—7.5 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

This medicine may cause some people to have vision problems. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well.

Use caution during exercise or hot weather. Overheating may result in heat exhaustion.

This medicine may cause constipation, call your doctor if you get severe stomach pain or become constipated.

This medicine may cause dryness of the mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Frequency unknown

Decrease in frequency of urination

decrease in urine volume

difficulty in passing urine

dribbling, painful urination

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Changes in vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

difficulty having a bowel movement (stool)

dry mouth

heartburn

indigestion

stomach discomfort upset or pain

Less common

Bladder pain

bloody or cloudy urine

diarrhea

difficult, burning, or painful urination

dizziness

dry eyes

frequent urge to urinate

lack or loss of strength

lower back or side pain

nausea

Frequency unknown

Accidental injury

bloating or swelling of face, arms, hands, lower legs, or feet

blurred vision

changes in vision

chills

congestion

cough producing mucus

difficulty breathing

difficulty in moving

dry skin

dryness or soreness of throat

fever

general feeling of discomfort or illness

headache

hoarseness

itching of the vagina or genital area

itching skin

joint pain

loss of appetite

muscle aches and pains

muscle pain or stiffness

nervousness

pain during sexual intercourse

pain in joints

pain or tenderness around eyes and cheekbones

pounding in the ears

rash

runny nose

shortness of breath or troubled breathing

slow or fast heartbeat

sneezing

stuffy nose

tender, swollen glands in neck

thick, white vaginal discharge with no odor or with a mild odor

tightness in chest

tingling of hands or feet

trouble in swallowing

unusual weight gain or loss

voice changes

vomiting

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.