Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

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

INN (mednarodno ime):

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

Farmacevtska oblika:

Tablet met gereguleerde afgifte

Sestava:

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

Pot uporabe:

Oraal gebruik

Datum dovoljenje:

1900-01-01

Navodilo za uporabo

Sandoz B.V. Page 1/9
Bupropion HCl Sandoz ® retard 300 mg, tabletten met
gereguleerde afgifte
RVG 128679
1313 -V2
1.3.1.3 Bijsluiter December 2022
Package leaflet: Information for the user
Bupropion HCl Sandoz ® retard 300 mg, tabletten met gereguleerde afgifte
bupropion h ydrochloride
Read all of this leaflet carefully be fore you start taking 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 [nationally completed name] is and what it is used for
2. What you need to know before you take [nationally completed name]
3. How to take [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1. What [nationally completed name] is and what it is used for
[nationally completed name] is used to treat depression . It interact s with chemicals in the brain called
noradrenaline and dopamine, which are linked to depression.
2. Wh at you need to know before you take [nationally completed name]
Do not take [nationally completed name] :
if you are/have:
• allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)
• taking any other medicines which contain bupropion
• epilepsy or a history of fits
• a brain tumour
• undergoing abrupt withdrawal from alcohol or any medicines known to be associated with a risk of
withdrawal, particularly
- medicines which calm , induce sleep or relax muscles with active substance names ending with
"azepam"
- or similar sedatives
• a severe long -lasting liver disease marked by degeneration and thickening of

Lastnosti izdelka

Sandoz B.V. Page 1/18
Bupropion HCl Sandoz retard 300 mg, tabletten met
gereguleerde afgifte
RVG 128679
1311 -V2
1.3.1.1 Samenvatting van de Productkenmerken December 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified -release tablet contains 300 mg of bupropion hydrochloride
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Modified -release tablet
Creamy -white to pale yellow, round, tablets (diameter approximately 9.3 mm) printed with "GS2" on one
side and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[To be completed nationally] 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
an tidepressants the full antidepressant effect of [To be completed nationally] 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.