Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
DULOXETINE HYDROCHLORIDE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N06AX21
DULOXETINE HYDROCHLORIDE 30 mg
GASTRO-RESISTANT HARD CAPSULE
DULOXETINE HYDROCHLORIDE 30 mg
POM
PSYCHOANALEPTICS
Authorised
2016-03-15
pildulocaps30mg1.6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ONELAR 30 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 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 Onelar is and what it is used for 2. What you need to know before you take Onelar 3. How to take Onelar 4. Possible side effects 5. How to store Onelar 6. Contents of the pack and other information 1. WHAT ONELAR IS AND WHAT IT IS USED FOR Onelar contains the active substance duloxetine. Onelar increases the levels of serotonin and noradrenaline in the nervous system. Onelar 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) Onelar 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 Onelar when you are feeling better to prevent your depression or anxiety from returning. pildulocaps30mg1.6 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 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONELAR DO NOT TAKE ONELAR IF YOU: - are Baca dokumen lengkap
spcdulocaps30mg1.6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Onelar 30 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipients with known effect: each capsules contains 76.5mg sucrose and 0.0009mg carmoisine For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsule. Hard gelatine capsules, size “3”, about 15.9mm in length, with white body and blue cap containing off white pellet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Onelar 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 spcdulocaps30mg1.6 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 maintenance dose in most patients. In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once Baca dokumen lengkap