Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Duloxetine hydrochloride
Aspire Pharma Ltd
N06AX21
Duloxetine hydrochloride
30mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5060209731285
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. • The full name of this medicine is Duloxetine 30mg and 60mg Gastro-resistant Capsules, hard, but within the leaflet it will be referred to as Duloxetine capsules. WHAT IS IN THIS LEAFLET 1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE CAPSULES 3. HOW TO TAKE DULOXETINE CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DULOXETINE CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR Duloxetine capsules contain the active substance duloxetine. Duloxetine capsules increase the levels of serotonin and noradrenaline in the nervous system. Duloxetine capsules are 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 capsules start 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 capsules 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 Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine 30mg Gastro-resistant Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipient with known effect: Each capsule contains 100.6 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque grey body imprinted with ‘DLX 30’ and an opaque blue cap, imprinted with ‘DLX 30’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine 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 anti-depressive 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 maintenance dose in most patients. In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above). Doses up to 120 Leggi il documento completo