Country: Sweden
Bahasa: Sweden
Sumber: Läkemedelsverket (Medical Products Agency)
duloxetinhydroklorid
Ebb Medical AB
N06AX21
duloxetine hydrochloride
60 mg
Enterokapsel, hård
natriumlaurilsulfat Hjälpämne; sackaros Hjälpämne; sockersfärer Hjälpämne; duloxetinhydroklorid 67,356 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 112 (4 x 28) kapslar; Burk, 28 kapslar
Avregistrerad
2019-07-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DULMIS 30 MG GASTRO-RESISTANT CAPSULES, HARD DULMIS 60 MG GASTRO-RESISTANT CAPSULES, HARD 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 Dulmis is and what it is used for 2. What you need to know before you take Dulmis 3. How to take Dulmis 4. Possible side effects 5. How to store Dulmis 6. Contents of the pack and other information 1. WHAT DULMIS IS AND WHAT IT IS USED FOR Dulmis contains the active substance duloxetine. Dulmisincreases the levels of serotonin and noradrenaline in the nervous system. Dulmis 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) Dulmis 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 Dulmis 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 your doctor if you do not feel better after 2 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULMIS DO NOT TAKE DU Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dulmis 30 mg gastro-resistant capsules, hard Dulmis 60 mg gastro-resistant capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dulmis 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains approximately 63.7 mg sucrose. Dulmis 60 mg Each capsule contains 60 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains approximately 127.4 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Dulmis 30 mg Opaque blue cap and opaque white body capsules printed (cap E/body 127) of 15 mm approximately. Dulmis 60 mg Opaque blue cap and opaque green body capsules printed (cap E/body 129) of 19 mm approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Dulmis 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. 2 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 _ The recommended starting dose in patients with generalised anxiety diso Baca dokumen lengkap