Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Duloxetine
Clonmel Healthcare Ltd
N06A
Duloxetine
30 milligram(s)
Gastro-resistant capsule, hard
oral use
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety diso
Product subject to prescription which may not be renewed (A)
STADA Arzneimittel AG
Psychoanaleptics; Other antidepressants
ANTIDEPRESSANTS
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder
Marketed
2015-09-25
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE CLONMEL 30MG GASTRO-RESISTANT CAPSULES, HARD DULOXETINE CLONMEL 60MG 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 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 Clonmel is and what it is used for 2. What you need to know before you take Duloxetine Clonmel 3. How to take Duloxetine Clonmel 4. Possible side effects 5. How to store Duloxetine Clonmel 6. Contents of the pack and other information 1. WHAT DULOXETINE CLONMEL IS AND WHAT IT IS USED FOR Duloxetine Clonmel contains the active substance duloxetine. Duloxetine Clonmel increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Clonmel 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 Clonmel 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 Clonmel when you are feeling better to prevent your depression or anxiety from returning. In people with diabetic neuropathic pain it can take some weeks Läs hela dokumentet
Health Products Regulatory Authority 21 December 2021 CRN00CMFC Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine Clonmel 30 mg gastro resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule, hard contains 30 mg of duloxetine (as hydrochloride). Excipient(s) with known effect Each gastro-resistant capsule, hard contains 66 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Duloxetine Clonmel 30 mg capsules are body-white, cap-dark blue, filled with off white gastro-resistant pellets with a length of 15.9 ±1 mm and a width of 5.82 ±1 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Clonmel 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 usual maint Läs hela dokumentet