País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DULOXETINEHYDROCHLORIDE 67,2 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 60 mg/stuk
Egis Pharmaceuticals Private Limited Company Keresztiiri út 30-38 1106 BUDAPEST (HONGARIJE)
N06AX21
DULOXETINEHYDROCHLORIDE 67,2 mg/stuk SAMENSTELLING overeenkomend met ; DULOXETINE 60 mg/stuk
Maagsapresistente capsule, hard
COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; GLYCEROLMONOSTEARAAT (E 471) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; MAÏSZETMEEL ; NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; POVIDON (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; WITTE INKT, COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; GELATINE (E 441) ; GLYCEROLMONOSTEARAAT (E 471) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; MAÏSZETMEEL ; NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; POVIDON (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; WITTE INKT,
Oraal gebruik
Duloxetine
Hulpstoffen: COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); GELATINE (E 441); GLYCEROLMONOSTEARAAT (E 471); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN (E 132); MAÏSZETMEEL; NATRIUMHYDROXIDE (E 524); POLYSORBAAT 80 (E 433); POVIDON (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); WITTE INKT;
2015-09-17
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DULODET 30 MG HARDE MAAGSAPRESISTENTE CAPSULES DULODET 60 MG HARDE MAAGSAPRESISTENTE 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 Dulodet is and what it is used for 2. What you need to know before you take Dulodet 3. How to take Dulodet 4. Possible side effects 5. How to store Dulodet 6. Contents of the pack and other information 1. WHAT DULODET IS AND WHAT IT IS USED FOR Dulodet contains the active substance duloxetine. Dulodet increases the levels of serotonin and noradrenaline in the nervous system. Dulodet 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) Dulodet 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 Dulodet 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 after 2 months. 2. WHAT YOU NEED TO KNOW BEFORE Y Llegiu el document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dulodet 30 mg harde maagsapresistente capsules Dulodet 60 mg harde maagsapresistente capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Each capsule contains 60 mg of duloxetine (as hydrochloride). Excipientwith known effect Each capsule contains from 52,38 to 70,92 mg - sucrose. Each capsule contains from 104,74 to 141,83 mg - sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Hard gelatin capsule #3, ink-printed in yellow with “DLX” on the opaque blue cap and “30 mg” on the opaque white body. Hard gelatin capsule #1, ink-printed in white with “DLX” on the opaque blue cap and “60 mg” on the opaque green body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Dulodet 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 2 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 Llegiu el document complet