Generic Name: DARIFENACIN EXTENDED-RELEASE - ORAL
Pronounced: (dar-e-fen-A-sin)

Enablex Oral Side Effects

Dry mouth, constipation, nausea, stomach upset, stomach pain, blurred vision, dry eyes, dizziness, or weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• severe stomach/abdominal pain
• constipation for 3 or more days
• difficulty urinating
• signs of kidney infection (e.g., burning/painful urination, lower back pain, fever)

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Enablex Oral Precautions

Before taking darifenacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• problems emptying your bladder (urinary retention)
• severe blockage of stomach/intestines (gastric retention)
• a certain eye condition (uncontrolled narrow angle glaucoma)
• severe liver disease

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other bladder problems (e.g., bladder outflow obstruction)
• stomach/intestinal disease (e.g., ulcerative colitis)
• slowed movement of stomach/intestines
• severe constipation
• controlled narrow angle glaucoma
• liver disease
• enlarged prostate
• a certain muscle disease (myasthenia gravis)

This drug may cause dizziness or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.