Bupropion HCl Neuraxpharm 300 mg tabletten met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BUPROPIONHYDROCHLORIDE 300 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 260,4 mg/stuk

Beschikbaar vanaf:

Neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Strasse 23 D-40764 LANGENFELD (DUITSLAND)

ATC-code:

N06AX12

INN (Algemene Internationale Benaming):

BUPROPIONHYDROCHLORIDE 300 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 260,4 mg/stuk

farmaceutische vorm:

Tablet met gereguleerde afgifte

Samenstelling:

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 ; 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, 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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Bupropion

Autorisatie datum:

2019-04-08

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPROPION HCL NEURAXPHARM 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 doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bupropion HCl Neuraxpharm 300 mg is and what it is used for
2.
What you need to know before you take Bupropion HCl Neuraxpharm 300 mg
3.
How to take Bupropion HCl Neuraxpharm 300 mg
4.
Possible side effects
5.
How to store Bupropion HCl Neuraxpharm 300 mg
6.
Contents of the pack and other information
1.
WHAT BUPROPION HCL NEURAXPHARM 300 MG IS AND WHAT IT IS USED FOR
Bupropion HCl Neuraxpharm 300 mg 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 HCL NEURAXPHARM 300 MG
_ _
DO NOT TAKE BUPROPION HCL NEURAXPHARM 300 MG:
•
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 HCl Neuraxpharm 300 mg
•
If you are tak

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bupropion HCl Neuraxpharm 300 mg tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bupropion hydrochloride 300 mg (equivalent to
260.40 mg bupropion).
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
Bupropion HCl Neuraxpharm 300 mg is indicated for the treatment of
major depressive episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Bupropion HCl Neuraxpharm 300 mg 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 Bupropion HCl Neuraxpharm 300 mg 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).
-
SWITCHING PATIENTS FROM BUPROPION PROLONGED-RELEASE TABLETS:
When switching patients from the twice daily prolonged release
bupropion tablet to Bupropion HCl
Neuraxpharm 300 mg tablets, the same total daily dose should be given
when possible.
PAEDIATRIC POPULATION
2
Bupropion HCl Neuraxpharm 300 mg is not