Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
duloxetine
Mylan Pharmaceuticals Limited
N06AX21
duloxetine
Psychoanaleptics,
Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Treatment of major depressive disorder;Treatment of diabetic peripheral neuropathic pain;Treatment of generalised anxiety disorder;Duloxetine Mylan is indicated in adults.
Revision: 18
Authorised
2015-06-19
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE MYLAN 30 MG HARD GASTRO-RESISTANT CAPSULES DULOXETINE MYLAN 60 MG HARD GASTRO-RESISTANT CAPSULES duloxetine 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 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 Mylan is and what it is used for 2. What you need to know before you take Duloxetine Mylan 3. How to take Duloxetine Mylan 4. Possible side effects 5. How to store Duloxetine Mylan 6. Contents of the pack and other information 1. WHAT DULOXETINE MYLAN IS AND WHAT IT IS USED FOR Duloxetine Mylan contains the active substance duloxetine. Duloxetine Mylan increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Mylan 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 Mylan 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 Mylan when you are feeling better to prevent your depression or anxiety from returning. In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 30 mg capsules Each capsule contains 30 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule contains 62.1 mg sucrose. For the full list of excipients, see section 6.1. 60 mg capsules Each capsule contains 60 mg of duloxetine (as hydrochloride). _Excipient(s) with known effect _ Each capsule contains 124.2 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule 30 mg capsules Opaque blue cap and opaque white body approximately 15.9 mm, imprinted in gold ink with ‘MYLAN’ over ‘DL 30’ on both the cap and the body. 60 mg capsules Opaque blue cap and opaque yellow body approximately 21.7 mm, imprinted in white ink with ‘MYLAN’ over ‘DL 60’ on both the cap and the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Mylan is indicated in adults. 3 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. 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 Прочетете целия документ