Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
duloxetine
Zentiva, k.s.
N06AX21
duloxetine
Other antidepressants
Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.,
Revision: 11
Authorised
2015-08-20
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE ZENTIVA 30 MG GASTRO-RESISTANT HARD CAPSULES DULOXETINE ZENTIVA 60 MG GASTRO-RESISTANT HARD 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 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 Zentiva is and what it is used for 2. What you need to know before you take Duloxetine Zentiva 3. How to take Duloxetine Zentiva 4. Possible side effects 5. How to store Duloxetine Zentiva 6. Contents of the pack and other information 1. WHAT DULOXETINE ZENTIVA IS AND WHAT IT IS USED FOR Duloxetine Zentiva contains the active substance duloxetine. Duloxetine Zentiva increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine Zentiva 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 Zentiva 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 Zentiva when you are feeling better to prevent your depression or anxiety from returning. In people with diabetic neuropathic pain it can take Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine Zentiva 60 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Duloxetine Zentiva 30 mg gastro-resistant hard capsules Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine. Excipient(s) with known effect Each capsule contains 42.26 – 46.57 mg of sucrose. Duloxetine Zentiva 60 mg gastro-resistant hard capsules Each capsule contains duloxetine hydrochloride equivalent to 60 mg duloxetine. Excipient(s) with known effect Each capsule contains 84.51 - 93.14 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Duloxetine Zentiva 30 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 15.9 mm with white opaque body and light-blue opaque cap which contain off-white to light-brown-yellow spherical pellets. Duloxetine Zentiva 60 mg gastro-resistant hard capsules Hard opaque gelatin capsules of length approx. 19.4 mm with ivory opaque body and light-blue opaque cap which contain off-white to light-brown-yellow 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 Zentiva is indicated in adults. For further information see section 5.1. 3 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 Lire le document complet