Darifenacin Hydrobromide
Emselex · ATC code G04BD10
Also known as: Darifenasin hidrobromür
- Key facts
- Active substance
- Darifenacin Hydrobromide
- ATC code
- G04BD10
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Emselex 7.5 mg prolonged-release tablets · Emselex 15 mg prolonged-release tablets
- Marketing authorisation holder
- pharmaand GmbH
- Information as of
- 2026-10-29
Key facts
Darifenacin hydrobromide (Emselex) is an antimuscarinic given as prolonged-release tablets to treat the symptoms of overactive bladder.
What it is used for
- Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency in adults with overactive bladder syndrome.
Dosing
- Starting dose 7.5 mg daily (also in patients ≥ 65 years); reassess after 2 weeks and, if needed, increase to 15 mg daily.
- Moderate hepatic impairment (Child Pugh B): only if the benefit outweighs the risk, restricted to 7.5 mg daily; mild hepatic impairment and renal impairment: no adjustment, but caution.
- With potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, quinidine, cimetidine) or moderate CYP3A4 inhibitors (e.g. fluconazole, erythromycin, grapefruit juice): start with 7.5 mg; may be titrated to 15 mg if well tolerated.
- Once daily with liquid, with or without food; swallowed whole, not chewed, divided or crushed.
- Not recommended in children below 18 years.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Urinary retention, gastric retention.
- Uncontrolled narrow-angle glaucoma.
- Myasthenia gravis.
- Severe hepatic impairment (Child Pugh C).
- Severe ulcerative colitis, toxic megacolon.
- Concomitant treatment with potent CYP3A4 inhibitors.
Important warnings
- Caution in autonomic neuropathy, hiatus hernia, significant bladder outflow obstruction, risk of urinary retention, severe constipation or gastrointestinal obstruction (e.g. pyloric stenosis).
- Other causes of frequent urination (heart failure, renal disease) should be assessed first; urinary tract infection should be treated.
- Caution with decreased gastrointestinal motility, reflux or medicines that can cause oesophagitis (e.g. oral bisphosphonates).
- Caution in pre-existing cardiac disease.
- Stop and seek immediate medical attention with oedema of the tongue or laryngopharynx or difficulty breathing.
Side effects
- Very common: dry mouth (20.2% with 7.5 mg and 35% with 15 mg) and constipation (14.8% and 21%).
- Common: headache, dry eye, nasal dryness, abdominal pain, nausea, dyspepsia.
- Uncommon include urinary tract infection, dizziness, visual disturbance and urinary retention; not known: confusional state, hallucination.
Interactions
- Potent CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole) are contraindicated; ketoconazole increased AUC 5-fold. Potent P-gp inhibitors such as ciclosporin and verapamil should be avoided.
- Digoxin: monitoring when starting, stopping or changing the darifenacin dose.
- Other antimuscarinics, anti-parkinson agents and tricyclic antidepressants may enhance anticholinergic effects.
Pregnancy and breastfeeding
- Not recommended during pregnancy.
- During breast-feeding a benefit-risk decision is needed, as a risk to the child cannot be excluded.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Emselexpharmaand GmbH · EMEA/H/C/000554
Source: European Medicines Agency (EMA), product information
Germany
- Darifenacin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- EmselexVLD DANIŞMANLIK TIBBİ ÜRÜNLER VE TANITIM HİZMETLERİ LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 6 more European countries
- Iceland
- Emselex
- Liechtenstein
- Emselex
- Netherlands
- Darifenacine Aristo
- Norway
- Emselex
- Portugal
- Darifenacina Aristo
- Spain
- Darifenacina Aristo
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
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Sources
- European Medicines Agency. Emselex – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/emselex-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.