البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
duloxetine hydrochloride
Eli Lilly Nederland B.V.
N06AX21
duloxetine
Psychoanaleptics,
Urinary Incontinence, Stress
Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Revision: 28
Authorised
2004-08-11
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER YENTREVE 40 MG HARD GASTRO-RESISTANT CAPSULES YENTREVE 20 MG HARD GASTRO-RESISTANT CAPSULES Duloxetine (as hydrochloride) 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What YENTREVE is and what it is used for 2. What you need to know before you take YENTREVE 3. How to take YENTREVE 4. Possible side effects 5. How to store YENTREVE 6. Contents of the pack and other information 1. WHAT YENTREVE IS AND WHAT IT IS USED FOR YENTREVE contains the active substance duloxetine. YENTREVE increases the levels of serotonin and noradrenaline in the nervous system. YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women. Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise. YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities. The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YENTREVE DO NOT TAKE YENTREVE IF YOU: - are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inh اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION YENTREVE 20 mg Each capsule contains 20 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule may contain up to 37 mg sucrose. YENTREVE 40 mg Each capsule contains 40 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule may contain up to 74 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg’ and an opaque blue cap, imprinted with ‘9544’. YENTREVE 40 mg Opaque orange body, imprinted with ’40 mg’ and an opaque blue cap, imprinted with ‘9545’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). YENTREVE is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of YENTREVE is 40 mg twice daily without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy. Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness. However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily. 3 The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies. The benefit of treatment should be re-assessed at regular intervals. Combining YENTREVE with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT. اقرأ الوثيقة كاملة