WELLBUTRIN XR 300 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BUPROPION HYDROCHLORIDE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

N07BA02

الشكل الصيدلاني:

TABLETS

تركيب:

BUPROPION HYDROCHLORIDE 300 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAUSCH HEALTH COMPANIES INC., CANADA

المجموعة العلاجية:

BUPROPION

المجال العلاجي:

BUPROPION

الخصائص العلاجية:

Wellbutrin XR is indicated for the treatment of major depressive episodes.Following satisfactory response, continuation with Wellbutrin XR therapy is effective in preventingrelapse.

تاريخ الترخيص:

2024-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
1986
The medicine is dispensed according to a physician’s prescription
only
WELLBUTRIN XR 150 mg modified release tablets
Each tablet contains:
bupropion hydrochloride 150 mg
WELLBUTRIN XR 300 mg modified release tablets
Each tablet contains:
bupropion hydrochloride 300 mg
For the list of the inactive and allergenic ingredients in the
medicine, see section
6
Additional information .
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
Wellbutrin XR is not intended for treatment of children under 18 years
of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Wellbutrin XR is a medicine intended for the treatment of depression.
It is
thought to interact with chemicals in the brain called
noradrenaline and
dopamine
.
Therapeutic group:
Other antidepressants.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive (allergic) to bupropion or to any of the additional
ingredients contained in this medicine (listed in section 6).
•
You are taking any other medicines that contain bupropion
•
You have been diagnosed with epilepsy or have a history of seizures
•
You have or used to have an eating disorder (for example, bulimia or
anorexia nervosa)
•
You have a brain tumor
•
You are usually a heavy drinker and have just stopped, or are about to
stop, drinking
•
You have severe liver problems
•
You recently stopped taking sedatives, or you are going to stop them,
while
taking Wellbutrin XR
•
You are taking or have taken other medicines for depression or for
Parkinson’s disease called
monoamine oxidase inhibitors
(MAOIs) in the
last 14 days.
If one of these apply to you, talk to your physician straight awa

خصائص المنتج

Page 1 of 16
WELLBUTRIN
XR
1.
NAME OF THE MEDICINAL PRODUCT
WELLBUTRIN XR 150 mg.
WELLBUTRIN XR 300 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bupropion hydrochloride 150 mg or 300 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet._ _
150 mg tablet: Creamy white to pale yellow round tablet imprinted with
“GS
5FV 150
” in black
ink on one side and the other side plain.
300 mg tablet: Creamy white to pale yellow round tablet imprinted with
“GS
5YZ 300
” in black
ink on one side and the other side plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
WELLBUTRIN XR is indicated for the treatment of major depressive
episodes.
Following satisfactory response, continuation with WELLBUTRIN XR
therapy is effective in
preventing relapse.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM TRIALS. THESE TRIALS DID
NOT SHOW AN
INCREASE IN THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR WITH
ANTIDEPRESSANT USE IN
SUBJECTS AGED 65 AND OLDER _[SEE WARNINGS AND PRECAUTIONS (4.4)]. _
IN PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY,
MONITOR CLOSELY FOR
WORSENING, AND FOR EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS.
ADVISE FAMILIES
AND CAREGIVERS OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION
WITH THE
PRESCRIBER _[SEE WARNINGS AND PRECAUTIONS (4.4)]._
Page 2 of 16
Posology
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 WELLBUTRIN