Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BUPROPIONHYDROCHLORIDE 150 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 130,2 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N06AX12
BUPROPIONHYDROCHLORIDE 150 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 130,2 mg/stuk
Tablet met gereguleerde afgifte
AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 1500 ; MACROGOL 400 ; MACROGOL 8000 ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505) ; ZOUTZUUR (E 507),
Oraal gebruik
Bupropion
Hulpstoffen: AMMONIA (E 527); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); ETHYLCELLULOSE (E 462); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE ZWART (E 172); MACROGOL 1500; MACROGOL 400; MACROGOL 8000; NATRIUMSTEARYLFUMARAAT; POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SILICIUMDIOXIDE (E 551); TRIETHYLCITRAAT (E 1505); ZOUTZUUR (E 507);
2015-04-16
Sandoz B.V. Page 1/10 Bupropion HCl Sandoz 150 mg, tabletten met gereguleerde afgifte RVG 114395 1313-v16 1.3.1.3 Bijsluiter December 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUPROPION HCL SANDOZ® RETARD 150 MG, TABLETTEN MET GEREGULEERDE AFGIFTE bupropion 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 [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 used to treat DEPRESSION . It interacts with chemicals in the brain called noradrenaline and dopamine, which are linked to depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] _ _ DO NOT TAKE [NATIONALLY COMPLETED NAME]: if you are/have: • ALLERGIC to bupropion or any of the other ingredients of this medicine (listed in section 6) • TAKING any other medicines which contain BUPROPION • EPILEPSY or a history of fits • a BRAIN TUMOUR • undergoing abrupt WITHDRAWAL FROM ALCOHOL OR any medicines known to be associated with a risk of withdrawal, particularly - MEDICINES WHICH CALM , induce sleep or relax muscles with active substance names ending with "azepam" Sandoz B.V. Page 2/10 Bupropion HCl Sandoz 150 mg, tabletten met gereguleerde afgifte RVG 114395 1313-v16 1.3. Baca dokumen lengkapnya
Sandoz B.V. Page 1/19 Bupropion HCl Sandoz ® 150 mg, tabletten met gereguleerde afgifte RVG 114395 1311-v19 1.3.1.1 Samenvatting van de Productkenmerken December 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 150 mg of bupropion hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. White to pale yellow, round, biconvex tablets (diameter approximately 7.5 mm) plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] is indicated for the treatment of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in Adults _ The recommended starting dose is 150 mg, given once daily. An optimal dose was not established in clinical studies. If no improvement is seen after 4 weeks treatment at 150 mg, the dose may be increased to 300 mg, given once daily. There should be an interval of at least 24 hours between successive doses. The onset of action for bupropion has been noted 14 days after starting therapy. As with all antidepressants the full antidepressant effect of [Nationally completed name] may not be evident until after several weeks of treatment. Sandoz B.V. Page 2/19 Bupropion HCl Sandoz ® 150 mg, tabletten met gereguleerde afgifte RVG 114395 1311-v19 1.3.1.1 Samenvatting van de Productkenmerken December 2022 Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. Insomnia is a very common adverse event which is often transient. Insomnia may be reduced by avoiding dosing at bedtime (provided there is at least 24 hours between doses). _Paediatric Population _ [Nationally completed name] is not indicated for use in children or adolescents aged less than 18 years (see section 4.4). The safety and efficacy of [Nationally completed name] in pa Baca dokumen lengkapnya