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|Enablex

DARIFENACIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Enablex

† Not commercially available in Canada.

Category

• Antispasmodic (urinary bladder)

Description

Darifenacin (dar-i-FEN-a-cin) 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, in the following dosage forms:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using 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. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Darifenacin has not been studied in pregnant women. However, studies in animals have shown that darifenacin may cause unwanted effects in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether darifenacin passes into breast milk. However, darifenacin does pass into the milk of animals. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

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.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking darifenacin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• CYP2D6 substrates such as
• Flecainide (e.g., Tambocor) or
• Imipramine (e.g., Tofranil) or
• Thioridazine (e.g., Mellaril) or
• Tricyclic antidepressants (antidepressant used to treat mental depression)—Effects of these medicines may be increased

• CYP3A4 inhibitors such as
• Clarithromycin (e.g., Biaxin) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Nefazoxone (e.g., Serzone) or
• Nelfinavir (e.g., Viracept) or
• Ritonavir (e.g., Norvir)—May increase the effects of darifenacin.

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 This Medicine

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.

• 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—

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

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.

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

Developed: 04/12/2005

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