Zyban 150 mg prolonged release tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-10-2023
Summary of Product characteristics
(SPC)
03-10-2023
Active ingredient:
BUPROPION HYDROCHLORIDE
Available from:
GlaxoSmithKline (Ireland) Limited
ATC code:
N06AX; N06AX12
INN (International Name):
BUPROPION HYDROCHLORIDE
Dosage:
150 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antidepressants; bupropion
Authorization status:
Marketed
Authorization date:
2000-06-23
Patient Information leaflet
Reason for Update: Type II workshare variation (NL/H/xxxx/WS/724) –
GDS v 33 - Addition of ADR panic attack and UK (NI) removal from
PIL- RTQ 1
Market: Ireland
Agency Approval Date:
Text Date: 11/08/2023
Issue and Draft No.: Issue 14 Draft 2
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYBAN 150 MG PROLONGED 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 Zyban is and what it is used for
2.
What you need to know before you take Zyban
3.
How to take Zyban
4.
Possible side effects
5.
How to store Zyban
6.
Contents of the pack and other information
1.
WHAT ZYBAN IS AND WHAT IT IS USED FOR
Zyban is a medicine prescribed to help you stop smoking, when you also
have motivational support
such as taking part in a ‘stop smoking’ programme.
ZYBAN
WILL BE MOST EFFECTIVE IF YOU ARE FULLY COMMITTED TO GIVING UP
SMOKING.
Ask your doctor or
pharmacist for advice on treatments and other support to help you
stop.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYBAN
DON’T TAKE ZYBAN:
•
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
(such as WELLBUTRIN,
to treat
DEPRESSION
)
•
IF YOU HAVE A CONDITION THAT CAUSES FITS _(SEIZURES),_
such as
EPILEPSY,
or if you have a history of
fits
•
IF YOU HAVE AN EATING DISORDER
, or had one in the past (for example, bulimia or anorexia nervosa)
•
IF YOU HAVE SEVERE LIVER PROBLEMS
, such as
_cirrhosis_
•
IF Y
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
03 October 2023
CRN00DKXN
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyban 150 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bupropion hydrochloride 150 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White, film-coated, biconvex, round tablet printed on one side with GX
CH7 and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zyban tablets are indicated as an aid to smoking cessation in
combination with motivational support in nicotine-dependent
patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
It is recommended that treatment is started while the patient is still
smoking and a "target stop date" set within the first two
weeks of treatment with Zyban, preferably in the second week.
The initial dose is 150 mg to be taken daily for six days, increasing
on day seven to 150 mg twice daily.
There should be an interval of at least 8 hours between successive
doses.
The maximum single dose must not exceed 150 mg and the maximum total
daily dose must not exceed 300 mg.
Insomnia is a very common adverse event which can be reduced by
avoiding bedtime doses of Zyban (provided there is at
least 8 hours between doses).
_Paediatric population_
_ _
Use in patients under 18 years of age is not recommended as the safety
and efficacy of Zyban tablets have not been evaluated
in these patients.
_Elderly_
Zyban should be used with caution in older people. Greater sensitivity
in some older individuals cannot be ruled out. The
recommended dose in older people is 150 mg once a day (see section
4.4).
_Hepatic impairment_
Zyban should be used with caution in patients with hepatic impairment.
Because of increased variability in the
pharmacokinetics in patients with mild to moderate impairment the
recommended dose in these patients is 150 mg once a
day.
_Renal impairment_
Zyban should be used with caution in patients with
Read the complete document
