Wellbutrin XR 150mg modified release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BUPROPION HYDROCHLORIDE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

N06AX12

INN (International Name):

BUPROPION HYDROCHLORIDE 150 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

BUPROPION HYDROCHLORIDE 150 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2007-08-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
WELLBUTRIN XR 150 MG MODIFIED RELEASE TABLETS
WELLBUTRIN XR 300 MG MODIFIED RELEASE TABLETS
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 Wellbutrin XR is and what it is used for
2.
What you need to know before you take Wellbutrin XR
3.
How to take Wellbutrin XR
4.
Possible side effects
5.
How to store Wellbutrin XR
6.
Contents of the pack and other information
1.
WHAT WELLBUTRIN XR IS AND WHAT IT IS USED FOR
Wellbutrin XR 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 WELLBUTRIN XR
DO NOT TAKE WELLBUTRIN XR:
•
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
Wellbutrin XR
•
IF YOU ARE TAKING OR HAVE BEEN
TAKING OTHER MEDICINES FOR DEPRESSION
called
_monoamine _
_oxidase inhibitors_
(MAOIs) in the last 14 days.
IF ANY OF THESE APPLIES T

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
WELLBUTRIN XR 150 mg modified release tablets.
WELLBUTRIN XR 300 mg modified release tablets.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 XR 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 WELLBUTRIN SR TABLETS
:
When switching patients from the twice daily prolonged release
bupropion tablet to WELLBUTRIN
XR tablets, the same total daily dose should be given when possible.
_ _
_ _
_Pediatric population _
_ _
WELLBUTRIN XR is not indicated for use in children or adolescents aged
less than 18 years (see
section 4.4). The safety and efficacy of WELLBUTRIN XR in patient