What is Darifenacin used for?

1 INDICATIONS AND USAGE Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency ( 1 )

How does Darifenacin work?

11 DESCRIPTION Darifenacin is an extended-release tablet for oral administration which contains 7.

What pharmaceutical form is Darifenacin available in?

Darifenacin: Tabletki o przedłużonym działaniu 7,5 mg (doustna)

Is Darifenacin OTC or prescription only?

Darifenacin requires a doctor's prescription.

What are the side effects of Darifenacin?

6 ADVERSE REACTIONS The most frequently reported adverse reactions (greater than 3%) for darifenacin extended-release tablets are: constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying

Who should NOT take Darifenacin?

4 CONTRAINDICATIONS Darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: urinary retention gastric retention, or uncontrolled narrow-angle glaucoma. Darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions ( 4 ): urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.

Does Darifenacin interact with other medications?

7 DRUG INTERACTIONS Caution should be taken when darifenacin extended-release tablets are used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants ( 7.2 ) The concomitant use of darifenacin extended-release tablets with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmaco

Can Darifenacin be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pregnancy: Darifenacin extended-release tablets should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus ( 8.1 ) Nursing Mothers: It is not known whether darifenacin is excreted into human milk and therefore caution should be exercised before darifenacin extended-release tablets are administered to a nursing woman (8.3) Pediatric Use: The safety and effectiveness of darifenacin extended-release tablets in pediatric

What precautions should be taken with Darifenacin?

• Caution should be exercised in patients with history of stomach or intestinal problems, constipation, trouble emptying your bladder, weak urine stream, myasthenia gravis, increased eye pressure, liver impairment, any allergy, who are taking other medications, during pregnancy and breastfeeding. • It may cause dizziness or blurred vision, do not drive a car or operate machinery while taking this medication. • It may cause heat stroke during hot weather.

What ATC class does Darifenacin belong to?

Darifenacin: ATC G04BD10. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Darifenacin

7,5 mg, Tabletki o przedłużonym działaniu

INN: Darifenacinum

Data updated: 2026-04-13

Available in:

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Form

Tabletki o przedłużonym działaniu

Dosage

7,5 mg

Route

doustna

Storage

—

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