País: Països Baixos
Idioma: neerlandès
Font: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BUPROPIONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; BUPROPION
Zentiva Pharma GmbH Bruningstrasse 50 65926 FRANKFURT AM MAIN (DUITSLAND)
N06AX12
BUPROPIONHYDROCHLORIDE COMPOSITION corresponding to ; BUPROPION
Tablet met gereguleerde afgifte
AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CYSTEINE (L-)HYDROCHLORIDE 1-WATER (E 920) ; ETHYLCELLULOSE (E 462) ; GLYCEROLDIBEHENAAT ; IJZEROXIDE ZWART (E 172) ; MACROGOL 1450 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT
Oraal gebruik
Bupropion
2019-04-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BUPROPION HCL ZENTIVA 300 MG TABLETTEN MET GEREGULEERDE AFGIFTE Bupropion hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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<,> Llegiu el document complet. This includes any possible side effects not listed in this leaflet. See section 4.> WHAT IS IN THIS LEAFLET 1. What is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a medicine prescribed by your doctor to treat your depression. It’s thought to interact with chemicals in the brain called _ noradrenaline _ and _ dopamine_, which are linked with depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ _ DO NOT TAKE : If you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6). If you are taking any other medicines which contain bupropion If you have been diagnosed with epilepsy or have a history of seizures If you have an eating disorder, or used to (for example, bulimia or anorexia nervosa) If you have a brain tumour If you are usually a heavy drinker who has just stopped or are about to stop drinking If you have severe liver problems If you recently stopped taking sedatives, or if you are going to stop them while you’re taking If you are taking or have been taking other medicines for depression called monoamine oxidase inhibitors (MAOI
Bupropion hydrochloride modified-release tablets 1 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bupropion HCl Zentiva 300 mg tabletten met gereguleerde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bupropion hydrochloride 300 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release tablet. Creamy-white to pale yellow, round, tablet printed with "GS2" on one side and plain on the other side. The tablet diameter is approximately 9.3 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONSis indicated for the treatment of major depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Llegiu el document completis available only in 300 mg strength. For the dose of 150 mg, please use the other alternate suitable product available on market. 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 may not be evident until after several weeks of treatment. 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 is not indicated for use in children or adolescents aged less than 18 years (see section 4.4). The safety and efficacy of in patients under 18 years of age have not been established. OLDER PEOPLE Bupropion hydrochloride modified-release tablets 2 E