Bupropion Bluefish 300 mg Tablett med modifierad frisättning

País: Suècia

Idioma: suec

Font: Läkemedelsverket (Medical Products Agency)

ingredients actius:

bupropionhydroklorid

Disponible des:

Bluefish Pharmaceuticals AB

Codi ATC:

N06AX12

Designació comuna internacional (DCI):

Bupropion hydrochloride

Dosis:

300 mg

formulario farmacéutico:

Tablett med modifierad frisättning

Composición:

propylenglykol Hjälpämne; bupropionhydroklorid 300 mg Aktiv substans

tipo de receta:

Receptbelagt

Resumen del producto:

Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter; Blister, 7 tabletter; Blister, 60 tabletter; Blister, 30 x 1 tabletter (endosförpackning)

Estat d'Autorització:

Godkänd

Data d'autorització:

2018-10-24

Informació per a l'usuari

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

Fitxa tècnica

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