Bupropion HCl retard Teva 150 mg, tabletten met gereguleerde afgifte

Nchi: Uholanzi

Lugha: Kiholanzi

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

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Teva B.V. Swensweg 5 2031 GA HAARLEM

ATC kanuni:

N06AX12

INN (Jina la Kimataifa):

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

Dawa fomu:

Tablet met gereguleerde afgifte

Tungo:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505)

Njia ya uendeshaji:

Oraal gebruik

Eneo la matibabu:

Bupropion

Idhini ya tarehe:

2019-11-25

Taarifa za kipeperushi

Bupropion, NL/H/4484/001, 28.10.22
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUPROPION HCL RETARD TEVA 150 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 {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
{Product name} 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 {PRODUCT NAME}
DO NOT TAKE {PRODUCT NAME}
•
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
{Product name}
•
IF YOU ARE TAKING OR HAVE BEEN TAKING OTHER MEDICINES FOR DEPRESSION
called monoamine oxidase
inhibitor

Tabia za bidhaa

Bupropion, NL/H/4484/001, 27.04.23
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SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAAM VAN HET GENEESMIDDEL
Bupropion HCl retard Teva 150 mg, tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg bupropion hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet
Creamy white to pale yellow, round, biconvex tablet approximately of
8.1 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{Product 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 bupropion 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 prolonged release tablets
When switching patients from the twice daily prolonged release
bupropion tablet to {Product name}, the
same total daily dose should be given when possible.
Paediatric population
{Product name} is not indicated for use in children or adolescents
aged less than 18 years (see section 4.4).
The safety and efficacy of bupropion in patients under 18 years of age
have not been established.
Bupropion, NL/H/4484/001, 27.04.23
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Elderly
Efficacy h