Land: Storbritannien
Sprog: engelsk
Kilde: myHealthbox
Duloxetine (as duloxetine hydrochloride)
Milpharm Limited
N06AX21
Duloxetine (as duloxetine hydrochloride)
60mg
Gastro-resistant capsule, hard
Oral use
Blister packs: 7, 14, 28, 30 and 98 capsules; bottle pack: 30, 98, 250 and 1000 capsules
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
Other antidepressants
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.
Authorised
2015-07-29
DULOXETINE 30 MG GASTRO-RESISTANT CAPSULES, HARD DULOXETINE 60 MG GASTRO-RESISTANT CAPSULES, HARD Duloxetine (as hydrochloride) PACKAGE LEAFLET: INFORMATION FOR THE USER 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 any 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 is and what it is used for 2. What you need to know before you take Duloxetine 3. How to take Duloxetine 4. Possible side effects 5. How to store Duloxetine 6. Contents of the pack and other information Duloxetine contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine is used 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 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 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 Læs hele dokumentet
Duloxetine Milpharm 60mg gastroresistant capsules Summary of Product Characteristics Updated 10Aug2015 | Aurobindo Pharma Milpharm Ltd. 1. Name of the medicinal product Duloxetine Milpharm 60 mg gastroresistant capsules, hard 2. Qualitative and quantitative composition Each hard capsule contains 60 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each capsule contains 143.52 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastroresistant capsule, hard Blue opaque /green opaque, size “l” hard gelatin capsule filled with white to off white pellets and imprinted with "X" on blue opaque cap and "03" on green opaque body with black ink 4. Clinical particulars 4.1 Therapeutic indications Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Milpharm 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 uptitrations. Therapeutic response is usually seen after 24 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 longterm treatment at a dose of 60 to 120 mg/day could be Læs hele dokumentet