Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
DULOXETINE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N06AX21
DULOXETINE 60 mg
GASTRO-RESISTANT HARD CAPSULE
DULOXETINE 60 mg
POM
PSYCHOANALEPTICS
Withdrawn
2015-07-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ARITAVI 30 MG HARD GASTRO-RESISTANT CAPSULES ARITAVI 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 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 Aritavi is and what it is used for 2. What you need to know before you take Aritavi 3. How to take Aritavi 4. Possible side effects 5. How to store Aritavi 6. Contents of the pack and other information 1. WHAT ARITAVI IS AND WHAT IT IS USED FOR Aritavi contains the active substance duloxetine. Aritavi increases the levels of serotonin and noradrenaline in the nervous system. Aritavi 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) Aritavi 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 Aritavi 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 ARITAVI D Olvassa el a teljes dokumentumot
1 1. NAME OF THE MEDICINAL PRODUCT Aritavi 30 mg hard gastro-resistant capsules Aritavi 60 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Each capsule contains 60 mg of duloxetine (as hydrochloride). Excipient with known effect: Each capsule contains 100.6 mg sucrose. Excipient with known effect: Each capsule contains 201.3 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Opaque grey body imprinted with ‘DLX 30’ and an opaque blue cap imprinted with ‘DLX 30’, length 18.0 mm. Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap imprinted with ‘DLX 60’, length 20.4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Aritavi 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. After consolidation of the anti-depressive 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 2 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 disorder is 30 mg once daily with or without food. In patients with insufficient respons Olvassa el a teljes dokumentumot