darifenacin (Oral route)

dar-i-FEN-a-sin

Commonly used brand name(s):

In the U.S.

• Enablex

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Antimuscarinic

Uses For darifenacin

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

darifenacin is available only with your doctor's prescription.

Before Using darifenacin

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 darifenacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to darifenacin 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.

Pediatric

Studies on darifenacin 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.

Geriatric

darifenacin 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

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.

Interactions with Medicines

Using darifenacin 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

Using darifenacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

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 darifenacin. 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 darifenacin

Dosing

The dose of darifenacin 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 darifenacin. 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 darifenacin, 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 darifenacin

darifenacin 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.

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

darifenacin 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.

darifenacin Side Effects

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:

• Decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine
• dribbling, painful urination

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:

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• dry mouth
• heartburn
• indigestion
• stomach discomfort upset or pain

• 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

• 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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