국가: 스웨덴
언어: 스웨덴어
출처: Läkemedelsverket (Medical Products Agency)
bupropionhydroklorid
Bluefish Pharmaceuticals AB
N06AX12
Bupropion hydrochloride
150 mg
Tablett med modifierad frisättning
propylenglykol Hjälpämne; natriumlaurilsulfat Hjälpämne; bupropionhydroklorid 150 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter
Godkänd
2022-07-25
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 전체 문서 읽기