Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

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

Commercializzato da:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codice ATC:

N06AX12

INN (Nome Internazionale):

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

Forma farmaceutica:

Tablet met gereguleerde afgifte

Composizione:

AMMONIA (E 527) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 1500 ; MACROGOL 400 ; MACROGOL 8000 ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 90 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505) ; ZOUTZUUR (E 507),

Via di somministrazione:

Oraal gebruik

Area terapeutica:

Bupropion

Dettagli prodotto:

Hulpstoffen: AMMONIA (E 527); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); ETHYLCELLULOSE (E 462); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE ZWART (E 172); MACROGOL 1500; MACROGOL 400; MACROGOL 8000; NATRIUMSTEARYLFUMARAAT; POVIDON K 90 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SILICIUMDIOXIDE (E 551); TRIETHYLCITRAAT (E 1505); ZOUTZUUR (E 507);

Data dell'autorizzazione:

2015-04-16

Foglio illustrativo

Sandoz B.V.
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Bupropion HCl Sandoz 150 mg, tabletten met
gereguleerde afgifte
RVG 114395
1313-v16
1.3.1.3 Bijsluiter
December 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPROPION HCL SANDOZ® RETARD 150 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
-
MEDICINES WHICH CALM
, induce sleep or relax muscles with active substance names ending
with
"azepam"
Sandoz B.V.
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Bupropion HCl Sandoz 150 mg, tabletten met
gereguleerde afgifte
RVG 114395
1313-v16
1.3.

Scheda tecnica

Sandoz B.V.
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Bupropion HCl Sandoz
®
150 mg, tabletten met
gereguleerde afgifte
RVG 114395
1311-v19
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 150 mg of bupropion
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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] 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 [Nationally
completed name] may not be evident until
after several weeks of treatment.
Sandoz B.V.
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Bupropion HCl Sandoz
®
150 mg, tabletten met
gereguleerde afgifte
RVG 114395
1311-v19
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
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 _
[Nationally completed name] is not indicated for use in children or
adolescents aged less than 18 years
(see section 4.4). The safety and efficacy of [Nationally completed
name] in pa