Bupropion HCl Zentiva 300 mg tabletten met gereguleerde afgifte

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

BUPROPIONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; BUPROPION

Disponible desde:

Zentiva Pharma GmbH Bruningstrasse 50 65926 FRANKFURT AM MAIN (DUITSLAND)

Código ATC:

N06AX12

Designación común internacional (DCI):

BUPROPIONHYDROCHLORIDE COMPOSITION corresponding to ; BUPROPION

formulario farmacéutico:

Tablet met gereguleerde afgifte

Composición:

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

Vía de administración:

Oraal gebruik

Área terapéutica:

Bupropion

Fecha de autorización:

2019-04-02

Información para el usuario

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 <,>
. 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

Ficha técnica

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 INDICATIONS
is indicated for the treatment of major depressive
episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
is 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