Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Duloxetine hydrochloride
Accord Healthcare Ireland Ltd.
N06AX21
Duloxetine hydrochloride
Gastro-resistant capsule, hard
duloxetine
Marketed
2023-01-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE ACCORD 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 Accord is and what it is used for 2. What you need to know before you take Duloxetine Accord 3. How to take Duloxetine Accord 4. Possible side effects 5. How to store Duloxetine Accord 6. Contents of the pack and other information 1. WHAT DULOXETINE ACCORD IS AND WHAT IT IS USED FOR Duloxetine Accord contains the active substance duloxetine. Duloxetine Accord increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Accord 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 Accord 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 Accord 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 a Prečítajte si celý dokument
Health Products Regulatory Authority 06 January 2023 CRN00D3G3 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine Accord 60 mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule, hard contains 60 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each gastro-resistant capsule, hard contains approximately 119.2 - 135.6 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque blue cap and opaque green body capsules printed (cap E/body 129) of 19 mm approximately, filled with off-white to beige/salmon spherical pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Accord 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 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 disorder is 30 mg once daily with or without food. In patients with insufficient response the dose should be increased to 60 mg, which is the us Prečítajte si celý dokument