|Manufacturer:||Novartis Pharmaceuticals Corporation|
The following events have been reported in association with darifenacin use in worldwide postmarketing experience.
Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of darifenacin in their causation cannot be reliably determined.General: hypersensitivity reactions, including angioedema.Central Nervous: confusion and hallucinations.Cardiovascular: palpitations
ENABLEX® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
-- Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.
-- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.
-- Involuntary discharge of URINE that is associated with an abrupt and strong desire to void. It is usually related to the involuntary contractions of the detrusor muscle of the bladder (detrusor hyperreflexia or detrusor instability).
ENABLEX® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.
ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.
-- holding or keeping within the stomach matter which is normally moved on.
Angle Closure Glaucoma
-- A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
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