Bupropion Bluefish 150 mg Tablett med modifierad frisättning

Țară: Suedia

Limbă: suedeză

Sursă: Läkemedelsverket (Medical Products Agency)

Ingredient activ:

bupropionhydroklorid

Disponibil de la:

Bluefish Pharmaceuticals AB

Codul ATC:

N06AX12

INN (nume internaţional):

Bupropion hydrochloride

Dozare:

150 mg

Forma farmaceutică:

Tablett med modifierad frisättning

Compoziție:

propylenglykol Hjälpämne; natriumlaurilsulfat Hjälpämne; bupropionhydroklorid 150 mg Aktiv substans

Tip de prescriptie medicala:

Receptbelagt

Rezumat produs:

Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter

Statutul autorizaţiei:

Godkänd

Data de autorizare:

2022-07-25

Caracteristicilor produsului

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