Bupropion HCl 1A Pharma retard 150 mg, tabletten met gereguleerde afgifte

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

BUPROPIONHYDROCHLORIDE 150 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 130,2 mg/stuk

INN (Medzinárodný Name):

BUPROPIONHYDROCHLORIDE 150 mg/stuk SAMENSTELLING overeenkomend met ; BUPROPION 130,2 mg/stuk

Forma lieku:

Tablet met gereguleerde afgifte

Zloženie:

COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 1500 ; MACROGOL 400 ; MACROGOL 8000 ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 90 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505) ; ZOUTZUUR (E 507)

Spôsob podávania:

Oraal gebruik

Dátum Autorizácia:

1900-01-01

Príbalový leták

1A Pharma GmbH
Page 1/10
Bupropion HCl 1A Pharma
®
retard 150 mg, 300 mg,
tabletten met gereguleerde afgifte
RVG 128743; 128748
1313-v1
1.3.1.3 Bijsluiter
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPROPION HCL 1A PHARMA
® RETARD 150 MG, TABLETTEN MET GEREGULEERDE AFGIFTE
BUPROPION HCL 1A PHARMA
® RETARD 300 MG, TABLETTEN MET GEREGULEERDE AFGIFTE
Bupropion hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 interacts
with chemicals in the brain called
noradrenaline and dopamine, which are linked to depression.
2.
WHAT 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
1A Pharma GmbH
Page 2/10
Bupropion HCl 1A Pharma
®
retard 150 mg, 300 mg,
tabletten met gereguleerde afgifte
RVG 1

Súhrn charakteristických

1A Pharma GmbH
Page 1/20
Bupropion HCl 1A Pharma retard 150 mg, 300 mg
tabletten met gereguleerde afgifte
RVG 128743; 128748
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bupropion HCl 1A Pharma retard 150 mg, tabletten met gereguleerde
afgifte
Bupropion HCl 1A Pharma retard 300 mg, tabletten met gereguleerde
afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[NATIONALLY COMPLETED NAME] 150 MG MODIFIED-RELEASE TABLET}
Each modified-release tablet contains 150 mg of bupropion
hydrochloride
Excipient(s) with known effect
Each modified release tablet contains 0.29 mg sodium.
Excipient(s) with known effect
Each modified release tablet contains 0.004 mg sodium.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Modified-release tablet
{[NATIONALLY COMPLETED NAME] 150 MG MODIFIED-RELEASE TABLET}
White to pale yellow, round, biconvex tablets
(diameter approximately 7.5 mm)
plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{[NATIONALLY COMPLETED NAME] 300 MG MODIFIED-RELEASE TABLET}
Each modified-release tablet contains 300 mg of bupropion
hydrochloride
{[NATIONALLY COMPLETED NAME] 300 MG 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.
1A Pharma GmbH
Page 2/20
Bupropion HCl 1A Pharma retard 150 mg, 300 mg
tabletten met gereguleerde afgifte
RVG 128743; 128748
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
Januari 2024
[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.