Daritor-7.5/Daritor-15 Special Precautions

Risk of Urinary Retention: Darifenacin should be used with caution to patients with clinically significant bladder outflow obstruction due to the risk of urinary retention.
Decreased Gastrointestinal Motility: Like other anticholinergic drugs, Darifenacin may decrease gastrointestinal motility. Darifenacin should be used with caution in patients with gastrointestinal obstructive disorders due to the risk of gastric retention and with other conditions such as severe constipation, ulcerative colitis, and myasthenia gravis.
Controlled Narrow-Angle Glaucoma: Patients with narrow-angle glaucoma should use Darifenacin with caution and if only the benefits outweigh the risks.
Angioedema: In some cases, angioedema occurs after the first dose in the face, lips, tongue and/or larynx as reported with darifenacin use. Angioedema associated with upper airway swelling (tongue, hypopharynx, and larynx) may be life-threatening and discontinuation of therapy is advised. Appropriate measures necessary to ensure patient airway should be promptly provided.
Patients with Hepatic Impairment: The daily dose for patients with moderate hepatic impairment (Child-Pugh B) should not exceed 7.5 mg. Darifenacin has not been studied in patients with severe haptic impairment (Child-Pugh C) and therefore is not recommended for use.
Effects on ability to drive and use machines: As with other antimuscarinic agents, Darifenacin tablets may produce effects such as dizziness, blurred vision, insomnia and somnolence. Patients experiencing these side effects should not drive or use machines. For Darifenacin tablets, these side effects have been reported to be uncommon.