Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Duloxetine hydrochloride
Disposable Medical Equipment Ltd
N06AX21
Duloxetine hydrochloride
60mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5060342241894
PACKAGE LEAFLET: INFORMATION FOR THE USER DEPALTA 30MG GASTRO-RESISTANT CAPSULES, HARD DEPALTA 60MG GASTRO-RESISTANT CAPSULES, HARD 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 Depalta Gastro-resistant Capsules are and what they are used for 2. What you need to know before you take Depalta Gastro-resistant Capsules 3. How to take Depalta Gastro-resistant Capsules 4. Possible side effects 5. How to store Depalta Gastro-resistant Capsules 6. Contents of the pack and other information 1. WHAT DEPALTA GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR Depalta Gastro-resistant Capsules contain the active substance duloxetine. Duloxetine increases the level of serotonin and noradrenaline in the nervous system. Depalta is used to treat the following conditions in adults: • depression • 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) • generalised anxiety disorder (chronic feeling of anxiety or nervousness) Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule when you are feeling better to prevent your depression or anxie Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depalta 60mg gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 60 mg of duloxetine (as hydrochloride). Excipients with known effect: Each capsule contains 167 mg sucrose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule. White to off white spherical to oval pellets filled in hard gelatin capsule shells of size"1" with “ ” imprinted in grey ink on opaque blue coloured cap and "086” imprinted in black ink on clear transparent body. 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 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 maintenance dose in most patients. In patients with co-morbid major depressive disorder, the start Læs hele dokumentet