Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
darifenacin hydrobromide
pharmaand GmbH
G04BD10
darifenacin hydrobromide
Urologicals, Drugs for urinary frequency and incontinence
Urinary Incontinence, Urge; Urinary Bladder, Overactive
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Revision: 26
Authorised
2004-10-22
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER EMSELEX 7.5 MG PROLONGED-RELEASE TABLETS Darifenacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Emselex is and what it is used for 2. What you need to know before you take Emselex 3. How to take Emselex 4. Possible side effects 5. How to store Emselex 6. Contents of the pack and other information 1. WHAT EMSELEX IS AND WHAT IT IS USED FOR HOW EMSELEX WORKS Emselex reduces the activity of an overactive bladder. This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold. WHAT EMSELEX CAN BE USED FOR Emselex belongs to a class of medicines which relax the muscles of the bladder. It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMSELEX DO NOT TAKE EMSELEX: • if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6). • if you suffer from urinary retention (inability to empty your bladder). • if you have gastric retention (problems emptying the contents of the stomach). • if you suffer from uncontrolled narrow-angle glaucoma (high pressure in the eyes that is not being adequately treated). • if you have myasthenia gravis (a disease marked by unusual tiredness and weakness of select Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Emselex 7.5 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg of darifenacin (as hydrobromide) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended starting dose is 7.5 mg daily. After 2 weeks of starting therapy, patients should be reassessed. For those patients requiring greater symptom relief, the dose may be increased to 15 mg daily, based on individual response. _Elderly patients (≥ 65 years) _ The recommended starting dose for the elderly is 7.5 mg daily. After 2 weeks of starting therapy, patients should be reassessed for efficacy and safety. _ _ For those patients who have an acceptable tolerability profile but require greater symptom relief, the dose may be increased to 15 mg daily, based on individual response (see section 5.2). _ _ _Paediatric population _ Emselex is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy. _ _ _Renal impairment _ No dose adjustment is required in patients with impaired renal function. However, caution should be exercised when treating this population (see section 5.2). _Hepatic impairment _ No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A). However, there is a risk of increased exposure in this population (see section 5.2). Patients with moderate hepatic impairment (Child Pugh B) should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7.5 mg daily (see section 5.2). Emselex is contraindicated in patients Leggi il documento completo