Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MIRTAZAPINE 0-WATER 15 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N06AX11
MIRTAZAPINE 0-WATER 15 mg/stuk
Orodispergeerbare tablet
ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CALCIUMSTEARAAT (E 470A) ; CROSPOVIDON (E 1202) ; DEXTRINE ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours ; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; SULFIET (SO3)2- ; TOCOFEROL, DL-ALFA (E 307), ASPARTAAM (E 951) ; CALCIUMSTEARAAT (E 470A) ; CROSPOVIDON (E 1202) ; DEXTRINE ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN ; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours ; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; SULFIET (SO3)2- ; TOCOFEROL, DL-ALFA (E 307),
Oraal gebruik
Mirtazapine
Hulpstoffen: ASPARTAAM (E 951); CALCIUMSTEARAAT (E 470A); CROSPOVIDON (E 1202); DEXTRINE; MALTODEXTRINE; MANNITOL (D-) (E 421); NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); SINAASAPPELSMAAKSTOF 55.301 AP 0551; SULFIET (SO3)2-; TOCOFEROL, DL-ALFA (E 307);
1900-01-01
Sandoz B.V. Pagina 1 van 12 Mirtazapine orodispergeerbare tablet 15/30/45 mg, RVG 33366-7-8 1313-V18 1.3.1.3 Bijsluiter Oktober 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIRTAZAPINE ORODISPERGEERBARE TABLET 15 MG, ORODISPERGEERBARE TABLETTEN MIRTAZAPINE ORODISPERGEERBARE TABLET 30 MG, ORODISPERGEERBARE TABLETTEN MIRTAZAPINE ORODISPERGEERBARE TABLET 45 MG, ORODISPERGEERBARE TABLETTEN mirtazapine 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 [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [nationally completed name] is one of a group of medicines called ANTIDEPRESSANTS . [nationally completed name] is used to treat depressive illness in adults. nationally completed name] will take 1 to 2 weeks before it starts working. After 2 to 4 weeks you may start feeling better. You must talk to your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. More information is in section 3 heading "When can you expect to start feeling better". 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING [NATIONALLY COMPLETED NAME]: • if you are ALLERGIC to mirtazapine or any of the other ingredients of this medicine (listed in s Lue koko asiakirja
Sandoz B.V. Page 1/14 Mirtazapine orodispergeerbare tablet 15/30/45 mg, RVG 33366-7-8 1311-V18 1.3.1.1 Samenvatting van de productkenmerken Oktober 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mirtazapine orodispergeerbare tablet 15 mg, orodispergeerbare tabletten Mirtazapine orodispergeerbare tablet 30 mg, orodispergeerbare tabletten Mirtazapine orodispergeerbare tablet 45 mg, orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [nationally completed name 15 mg]: Each orodispersible tablet contains 15 mg of mirtazapine. Excipients with known effects Each orodispersible tablet contains 3 mg of aspartame (E 951), 15 nanograms of sulphites and 0.047 mg of benzyl alcohol. [nationally completed name 30 mg]: Each orodispersible tablet contains 30 mg of mirtazapine. Excipients with known effects Each orodispersible tablet contains 6 mg of aspartame (E 951), 30 nanograms of sulphites and 0.093 mg of benzyl alcohol. [nationally completed name 45 mg]: Each orodispersible tablet contains 45 mg of mirtazapine. Excipients with known effects Each orodispersible tablet contains 9 mg of aspartame (E 951), 45 nanograms of sulphites and 0.14 mg of benzyl alcohol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White to off-white, round, flat tablets with bevelled edges and plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sandoz B.V. Page 2/14 Mirtazapine orodispergeerbare tablet 15/30/45 mg, RVG 33366-7-8 1311-V18 1.3.1.1 Samenvatting van de productkenmerken Oktober 2020 [nationally completed name] is indicated in adults for the treatment of episodes of major depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, Lue koko asiakirja