Characteristics of the medicinal product
EMSELEX is presented in white round tablets (7.5 mg) or light peach (15 mg) prolonged release containing the active ingredient darifenacin ("extended release" indicates that darifenacin is released slowly from the tablet over a few hours).
Therapeutic indications
EMSELEX is used to treat urge incontinence (sudden lack of control of urination), increased frequency (frequent need to urinate) and urgency (urge to urinate urgently) urinary in adult patients with overactive bladder syndrome. The medicine can only be obtained with a prescription.
Method of use
The recommended starting dose is 7.5 mg once a day. The dose can be increased to 15 mg in patients who require greater relief from symptoms. The tablets can be taken both during and away from meals and must be swallowed whole with liquid without being chewed, divided or crushed.
Mechanisms of action
The active ingredient of EMSELEX is darifenacin, an anticholinergic that blocks the M3 muscarinic receptor in the body and consequently relaxes the bladder muscles responsible for urine excretion. This increases the capacity of the bladder, modifies the way the bladder contracts and decreases the number of contractions. In this way EMSELEX prevents unwanted urination.
Studies carried out
EMSELEX has been the subject of four main studies involving a total of 2078 patients of both sexes with overactive bladder symptoms. EMSELEX was given at different doses (from 3.75 to 30 mg a day) and was compared with a placebo (a dummy treatment) or with tolterodine, another drug used for this disorder. The main parameter for determining the efficacy of the treatment was the number of incontinence cases that occurred within a week.
Benefits found following the studies
The four combined studies showed greater efficacy of EMSELEX than placebo in reducing incontinence cases. Patients treated with doses of 7.5 and 15 mg of EMSELEX recorded 10.6 (68%) and 12.5 (77%) episodes of incontinence less per week, respectively, while in patients treated with placebo the reduction was resulting respectively in 7 and 7.5 (54 and 58%) weekly cases.
Associated risks
The most common side effects, ie those reported by more than one in 10 patients, were dry mouth and constipation. For the full list of all side effects reported with EMSELEX, see the Package Leaflet.
EMSELEX should not be used in patients who may be hypersensitive (allergic) to darifenacin or to any of the excipients or to patients with:
• urinary retention (difficulty urinating);
• gastric retention (problems in emptying the stomach contents);
• uncontrolled narrow angle glaucoma (high pressure in the eye resistant to treatment);
• myasthenia gravis (neurological disease that causes muscle weakness);
• severe liver failure (severe liver disease);
• severe ulcerative colitis (severe inflammation of the large intestine resulting in ulcer formation and bleeding);
• toxic megacolon (very serious complication of colitis, see above).
EMSELEX should not be administered concomitantly with medicinal products such as cyclosporine (for transplant patients), verapamil (a heart medicine), protease inhibitors (drugs such as ritonavir, used in AIDS patients), ketoconazole and itraconazole (used to treat fungal infections).
Grounds for approval
The Committee for Medicinal Products for Human Use (CHMP) concluded that EMSELEX showed an efficacy similar to that of other anticholinergic drugs used for the treatment of overactive bladder syndrome. The CHMP therefore decided that the benefits of EMSELEX outweigh the risks in the symptomatic treatment of urgency incontinence and / or increased urinary frequency and urgency in patients with overactive bladder syndrome, recommending the release of the placing authorization on the market of EMSELEX.
Further information
On 22 October 2004, the European Commission granted a marketing authorization valid throughout the European Union for EMSELEX to Novartis Europharm Limited.
The full evaluation version (EPAR) is available at the following address.
Last update of this summary: March 2006
