BUPROPION XR 150 ADCO #N/A

País: República de Sud-àfrica

Idioma: anglès

Font: South African Health Products Regulatory Authority (SAHPRA)

Disponible des:

Adcock Ingram Limited

Dosis:

Not Indicated

formulario farmacéutico:

#N/A

Composición:

None

Estat d'Autorització:

Registered

Informació per a l'usuari

Date of approval: 07 June 2023
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
BUPROPION XR 150 ADCO 150 MG EXTENDED-RELEASE TABLETS
BUPROPION HYDROCHLORIDE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BUPROPION
XR 150 ADCO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
BUPROPION XR 150 ADCO has been prescribed for you personally and you
should not
share your medicine with other people. It may harm them, even if their
symptoms are
the same as yours.
WHAT IS IN THIS LEAFLET
1. What BUPROPION XR 150 ADCO is and what it is used for
2. What you need to know before you take BUPROPION XR 150 ADCO
3. How to take BUPROPION XR 150 ADCO
4. Possible side effects
5. How to store BUPROPION XR 150 ADCO
6. Contents of the pack and other information
1. WHAT BUPROPION XR 150 ADCO IS AND WHAT IT IS USED FOR
BUPROPION XR 150 ADCO contains bupropion hydrochloride which belongs
to a class of
medicines called antidepressants. It’s thought to interact with
chemicals in the brain called
noradrenaline and dopamine, which are linked with depression (mood
disorder that causes a
persistent feeling of sadness and loss of interest).
BUPROPION XR 150 ADCO is used for the treatment of depression and
preventing a relapse
and recurrence of further depressive episodes.
S5
Date of approval: 07 June 2023
PATIENT INFORMATION LEAFLET
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPROPION XR 150 ADCO
DO NOT TAKE BUPROPION XR 150 ADCO:
•
if you are 18 years or younger.
•
if you are hypersensitive (allergic) to bupropion or any of the other
ingredients of
BUPROPION XR 150 ADCO listed in section 6.
•
if you have a condition that causes fits (seizures), such as epilepsy,
or if you have a
history of fits.
•
if you are being treated with other medicines containing bupropion as
this may induce
fits.
•
if you have a brain tumour.
•
if you are undergoing abrupt discontinuation of alcohol, sedatives
(medicines us

Fitxa tècnica

Date of approval: 07 June 2023
PROFESSIONAL INFORMATION
SCHEDULING STATUS
1. NAME OF THE MEDICINE
BUPROPION XR 150 ADCO 150 mg extended-release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bupropion hydrochloride 150 mg.
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Extended-release tablets.
White to pale yellow, round, biconvex tablets, plain on both the
sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BUPROPION XR 150 ADCO is indicated for the treatment of depression as
defined by DSM IV
criteria.
Following a satisfactory response, continuation with BUPROPION XR 150
ADCO therapy is
effective in preventing relapse and preventing recurrence of further
depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by medical practitioners experienced in
the treatment of depression.
BUPROPION XR 150 ADCO should be swallowed whole. The tablets must not
be crushed, cut
or chewed as this may lead to an increased risk of adverse effects
including seizures.
There should be an interval of at least 24 hours between successive
doses.
Insomnia which is a very common transient side effect of BUPROPION XR
150 ADCO may be
reduced by avoiding dosing at bedtime (provided there is at least 24
hours between doses) or, if
clinically indicated, by dose reduction.
S5
Date of approval: 07 June 2023
PROFESSIONAL INFORMATION
INITIAL TREATMENT
The initial dose of BUPROPION XR 150 ADCO is 150 mg taken as a single
daily dose in the
morning. Patients who are not responding adequately to a dose of 150
mg/day may benefit from
an increase to the usual adult target dose of 300 mg/day given once
daily.
SWITCHING PATIENTS FROM SUSTAINED-RELEASE TABLETS
When switching patients from sustained-release tablets to BUPROPION XR
150 ADCO
extended-release tablets: give the same total daily dose when
possible.
Patients who are currently being treated with sustained-release
tablets at 300 mg/day (e.g. 150
mg twice daily) may be switched to BUPROPION XR 150