البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
duloxetine
Eli Lilly Nederland B.V.
N06AX21
duloxetine
Psychoanaleptics,
Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major
Duloxetine Lilly is indicated in adults for:Treatment of major depressive disorderTreatment of diabetic peripheral neuropathic painTreatment of generalised anxiety disorderDuloxetine Lilly is indicated in adults.
Revision: 9
Authorised
2014-12-08
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE LILLY 30 MG HARD GASTRO-RESISTANT CAPSULES DULOXETINE LILLY 60 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. See section 4. WHAT IS IN THIS LEAFLET : 1. What Duloxetine Lilly is and what it is used for 2. What you need to know before you take Duloxetine Lilly 3. How to take Duloxetine Lilly 4. Possible side effects 5. How to store Duloxetine Lilly 6. Contents of the pack and other information 1. WHAT DULOXETINE LILLY IS AND WHAT IT IS USED FOR Duloxetine Lilly contains the active substance duloxetine. Duloxetine Lilly increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Lilly is used in adults to treat: • depression • generalised anxiety disorder (chronic feeling of anxiety or nervousness) • diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain) Duloxetine Lilly starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine Lilly when you are feeling better to prevent your depression or anxiety from returning In people with diabetic neuropathic pain it can take some weeks befor اقرأ الوثيقة كاملة
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Duloxetine Lilly 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule may contain up to 56 mg sucrose. Duloxetine Lilly 60 mg Each capsule contains 60 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule may contain up to 111 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Duloxetine Lilly 30 mg Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’. Duloxetine Lilly 60 mg Opaque green body, imprinted with ‘60 mg’ and an opaque blue cap, imprinted with ‘9542’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Lilly is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Major depressive disorder_ The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 weeks of treatment. 3 After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse. In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. _Generalised anxiety disorder_ اقرأ الوثيقة كاملة