Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Duloxetine
KRKA, d.d., Novo mesto
N06AX; N06AX21
Duloxetine
60 milligram(s)
Gastro-resistant capsule, hard
Oral use
: 7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box
Product subject to prescription which may not be renewed (A)
KRKA, d.d.
Psychoanaleptics, other antidepressants
Other antidepressants; duloxetine
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.
Marketed
2015-03-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DULOXETINE KRKA 30 MG HARD GASTRO-RESISTANT CAPSULES DULOXETINE KRKA 60 MG HARD GASTRO-RESISTANT CAPSULES duloxetine 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 Krka is and what it is used for 2. What you need to know before you take Duloxetine Krka 3. How to take Duloxetine Krka 4. Possible side effects 5. How to store Duloxetine Krka 6. Contents of the pack and other information 1. WHAT DULOXETINE KRKA IS AND WHAT IT IS USED FOR Duloxetine Krka contains the active substance duloxetine. Duloxetine Krka increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Krka 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 Krka 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 Krka 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 Прочитать полный документ
Health Products Regulatory Authority 26 January 2022 CRN00CLM3 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine Krka 60mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gastro-resistant capsule contains 60 mg duloxetine (as duloxetine hydrochloride). Excipient with known effect: sucrose. Each 60 mg hard gastro-resistant capsule contains up to 87 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule White to almost white pellets in a hard gelatine capsule size 1 (average length: 19.4 mm). The capsule body is yellowish green and the cap dark blue. The capsule body is imprinted with 60 in black. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Krka 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 Прочитать полный документ