October 13, 2015
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Enablex Consumer (continued)

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, tell your doctor or pharmacist promptly.

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

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

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 right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations).

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.

Read the Enablex (darifenacin extended-release tablets) Side Effects Center for a complete guide to possible side effects

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (urinary retention), other bladder problems (such as bladder outflow obstruction), stomach/intestinal blockage (gastric retention), liver disease, personal or family history of glaucoma (angle-closure type), bowel disease (such as ulcerative colitis), slowed movement of stomach/intestines, constipation, enlarged prostate, a certain muscle/nerve 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

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Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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