Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
bupropionhydroklorid
Bluefish Pharmaceuticals AB
N06AX12
Bupropion hydrochloride
300 mg
Tablett med modifierad frisättning
propylenglykol Hjälpämne; bupropionhydroklorid 300 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter; Blister, 7 tabletter; Blister, 60 tabletter; Blister, 30 x 1 tabletter (endosförpackning)
Godkänd
2018-10-24
PACKAGE LEAFLET: INFORMATION FOR THE USER BUPROPION BLUEFISH 150 MG MODIFIED-RELEASE TABLETS BUPROPION BLUEFISH 300 MG MODIFIED-RELEASE TABLETS 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 doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bupropion Bluefish is and what it is used for 2. What you need to know before you take Bupropion Bluefish 3. How to take Bupropion Bluefish 4. Possible side effects 5. How to store Bupropion Bluefish 6. Contents of the pack and other information 1. WHAT BUPROPION BLUEFISH IS AND WHAT IT IS USED FOR Bupropion Bluefish 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_ . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPROPION BLUEFISH DO NOT TAKE BUPROPION BLUEFISH: • 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 Bupropion Bluefish • if you are taking or have been taking other medicines for depression called monoamine oxidase inhi Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bupropion Bluefish 150 mg modified-release tablets Bupropion Bluefish 300 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 150 mg modified-release tablets: Each tablet contains bupropion hydrochloride 150 mg. 300 mg modified-release tablets: Each tablet contains bupropion hydrochloride 300 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. Bupropion Bluefish 150 mg modified-release tablets: Creamy-white to pale yellow, round, tablet printed with "GS3" on one side and plain on the other side. The diameter of tablet is approximately 7 mm. Bupropion Bluefish 300 mg modified-release tablets 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 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bupropion Bluefish 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 Bupropion Bluefish 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_ Bupropion Bluefish is not indicated for use in children or adolescents aged less than 18 years (see section 4 Đọc toàn bộ tài liệu