ZYBAN 150 MG PROLONGED RELEASE FILM-COATED TABLETS

Active substance: BUPROPION HYDROCHLORIDE

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Package Leaflet: Information for the User

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GSK-ESP-Aranda-ESARA
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Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.

150 mg prolonged release
film-coated tablets
bupropion hydrochloride
- Keep this leaflet. You may need to read it again.

Zyban
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1. What Zyban is and what it is

- If you have any further questions, ask your doctor or
pharmacist.

used for

- 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

K

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.

What is in this leaflet

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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

2. What you need to know before you take Zyban
Don’t take Zyban:

Fits (seizures)

• f you are allergic to bupropion or any of the other
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ingredients of this medicine (listed in section 6)
• f you are taking any other medicines which contain
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bupropion
• f you have a condition that causes fits (seizures), such
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as epilepsy, or if you have a history of fits
• f you have an eating disorder or had one in the past
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(for example, bulimia or anorexia nervosa)
• f you have severe liver problems, such as cirrhosis
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• f you have a brain tumour
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• f you are usually a heavy drinker and you have just
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stopped drinking alcohol, or are going to stop while
you’re taking Zyban

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• f you have recently stopped taking sedatives or
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medicines to treat anxiety (especially benzodiazepines
or similar medicines), or if you are going to stop them
while you’re taking Zyban
• f you have a bipolar disorder (extreme mood swings)
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as Zyban could bring on an episode of this illness
• f you are taking medicines for depression or
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Parkinson’s disease called monoamine oxidase
inhibitors (MAOIs), or have taken them in the last
14 days. The timing may be shorter for some types of
MAOIs, your doctor will advise you.

Zyban has been shown to cause fits (seizures) in about
1 in 1,000 people. (See also Other medicines and Zyban
later in this section and section 4 Possible side effects, for
more information).
Fits are more likely:
• f you regularly drink a lot of alcohol
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• f you have diabetes for which you use insulin or tablets
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• f you have had a serious head injury or a history of
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head trauma
If any of these applies to you, don’t take Zyban unless
you have agreed with your doctor that there is a strong
reason for doing so.
If you have a fit (seizure) during treatment:
➔ Stop taking Zyban and don’t take any more. See your
doctor.

You may have more risk of side effects:
• f you have kidney or liver problems
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• f you are aged over 65.
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You will need to take a lower dose (see section 3) and be
checked closely while you are taking Zyban.

If you have had any mental health problems…
Some people taking Zyban have had hallucinations
or delusions (seeing, hearing or believing things that
are not there), disordered thoughts or extreme mood
swings. These effects are more likely in people who have
had mental health problems before.

➔ If any of these applies to you, talk to your doctor
straight away, and don’t take Zyban.

If you feel depressed or suicidal…

Take special care with Zyban
Talk to your doctor or pharmacist before taking Zyban.
This is because some conditions make it more likely that
you will have side effects (see also section 4).

Some people become depressed when they try to stop
smoking; very occasionally, they may think about
committing suicide, or try to do so. These symptoms have
affected people taking Zyban, most often in the first few
weeks of treatment.
If you feel depressed or think about suicide:
➔ Contact your doctor or go to a hospital straight away.

High blood pressure and Zyban…
Some people taking Zyban have developed high blood
pressure which needs treatment. If you already have
high blood pressure, it can become worse. This is more
likely if you are also using nicotine patches to help you
stop smoking.
➔ You will have your blood pressure checked before
you take Zyban and while you are taking it, especially
if you already have high blood pressure. If you are
also using nicotine patches, your blood
pressure needs to be checked every
week. If your blood pressure increases,
you may need to stop taking Zyban.
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The ingredients of Zyban can pass into breast milk. You
should ask your doctor or pharmacist for advice before
taking Zyban.

Section 2, What you need to know
before you take Zyban, continued…

Driving and using machines

Other medicines and Zyban

Some of the side effects of Zyban, such as feeling dizzy
or light-headed, may affect your concentration and
judgement.

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines you bought without a prescription.

There may be a higher than usual risk of fits if you take:
• edicines for depression or other mental health
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problems (see also Don’t take Zyban at the beginning
of section 2)
• heophylline for asthma or lung disease
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Zyban

• edicines against malaria
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• timulants or other medicines to control your weight
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or appetite
• teroids (except creams and lotions for eye and skin
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conditions)

When to start and how much to take
• et a Target Stop Smoking Day ideally during the
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second week you’re taking it

• ome types of anti-histamines mainly used to treat
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allergies, that can cause sleepiness

Week 1

• edicines for diabetes.
m
➔ If you take any medicines in this list, talk to your doctor
straight away, before you take Zyban (see section 3
under Some people need to take a lower dose).

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Zyban is not recommended for people under 18 years.

• tart taking Zyban while you are still smoking
S

• ntibiotics called quinolones
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3. How to take Zyban
Always take this medicine exactly as your doctor or
pharmacist has advised you. Check with your doctor or
pharmacist if you are unsure.

• ramadol, a strong painkiller
t

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If you are affected, don’t drive or operate machinery.

Some medicines can affect how Zyban works, or make it
more likely that you’ll have side effects. These include:
• edicines for depression (such as desipramine,
m
imipramine, paroxetine) or other mental health
problems (such as risperidone, thioridazine)

Ideally keep
smoking while
taking Zyban

Week 2

Days 1
to 6

Take one tablet (150 mg),
once a day

Day 7

Increase your dose to one
tablet, twice a day, at
least 8 hours apart, and
not near to bedtime

Carry on taking one tablet, twice a
day.
Stop smoking this week, on your
Target Stop Smoking Day.

• edicines for Parkinson’s disease (such as levodopa,
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amantadine or orphenadrine)

Weeks 3 to 9

• arbamazepine, phenytoin or valproate, to treat
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epilepsy or some mental health problems

Carry on taking one tablet, twice a
day for up to 9 weeks.
If you have not been able to stop
smoking after 7 weeks, your doctor
will advise you to stop taking Zyban.

• ome medicines used to treat cancer (such as
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cyclophosphamide, ifosphamide)

You may be advised to stop taking
Zyban gradually, after 7 - 9 weeks.

• iclopidine or clopidogrel, mainly used to treat heart
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disease or stroke
• ome beta blockers (such as metoprolol), mainly used
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to treat high blood pressure

Some people need to take a lower dose

• ome medicines for irregular heart rhythm (such as
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propafanone, flecainide)

• f you are aged over 65
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• itonavir or efavirenz, for treatment of HIV infection.
r
➔ If you take any medicines on this list, check with your
doctor. Your doctor will weigh up the benefits and
risks to you of taking Zyban, or may decide to change
the dose of the other medicine you are taking.

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as they may be more likely to get side effects.
• f you have liver or kidney disease
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• f you have a higher risk of fits (see Take special care
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with Zyban and Other medicines and Zyban in section
2)

Zyban may make other medicines less effective:

the maximum recommended dose for you is one 150 mg
tablet once a day.

• f you take tamoxifen used to treat breast cancer
i

How to take your tablets

➔ If this applies to you, tell your doctor. It may be
necessary to change to another treatment for
smoking cessation.

Take your Zyban tablets at least 8 hours apart. Don’t
take Zyban near to bedtime - it may cause difficulty in
sleeping.

The dose of some medicines may need to be reduced
when you stop smoking
When you smoke, the chemicals absorbed into your body
can cause some medicines to be less effective. When you
stop smoking, your dose of these medicines may need to
be reduced; otherwise, you may get side effects.

You can take Zyban with or without food.
Swallow your Zyban tablets whole. Don’t
chew them, crush them or split them - if you
do, the medicine will be released into your
body too quickly. This will make you more
likely to have side effects, including fits.

If you are taking any other medicines, check with your
doctor if you notice any new symptoms that you think
may be side effects.

If you take more Zyban than you
should

Zyban with alcohol

If you take too many tablets, you may be more likely to
have a fit or other side effects.

Some people find they are more sensitive to alcohol while
taking Zyban. Your doctor may suggest you do not drink
alcohol while you’re taking Zyban, or try to drink as little
as possible. If you do drink a lot now, don’t just stop
suddenly, because that may put you at risk of having a fit.

Effect on urine tests

➔ Don’t delay. Contact your doctor or your nearest
hospital emergency department immediately.

If you forget to take Zyban
If you miss a dose, wait and take your next tablet at the
usual time.
Don’t take an extra tablet to make up for the dose you
forgot.

Zyban may interfere with some urine tests to detect
other drugs. If you require a urine test, tell your doctor
or hospital that you are taking Zyban.

If you stop taking Zyban

Pregnancy and breast-feeding
Don’t take Zyban if you are pregnant, think you may be
pregnant or are planning to have a baby. Ask your doctor
or pharmacist for advice before taking this medicine.
Some, but not all studies have reported an increase in the
risk of birth defects, particularly heart defects, in babies
whose mothers were taking Zyban. It is not known if
these are due to the use of Zyban.

You may need to take Zyban for as long as 7 weeks to
have its full effect.
Don’t stop taking Zyban without talking to your doctor
first. You may need to reduce your dose gradually.
If you have any further questions about using this
medicine, ask your doctor or pharmacist.
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Zyban
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4. Possible side effects
Rare side effects

Like all medicines, this medicine can cause side effects,
although not everyone gets them.

Fits (seizures)
Approximately 1 in every 1,000 people taking Zyban is at
risk of having a fit.
Symptoms of a fit include convulsions and usually loss of
consciousness. Someone who has had a fit may be confused
afterwards and may not remember what has happened.
Fits are more likely if you take too much, if you take
some other medicines or if you are at higher than usual
risk of fits (see section 2).
➔ If you have a fit, tell your doctor when you have
recovered. Don’t take any more Zyban.

Allergic reactions
Rarely (up to 1 in 1,000) people may have potentially serious
allergic reactions to Zyban. Signs of allergic reactions include:
• kin rash (including itchy, bumpy rash). Some skin
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rashes may need hospital treatment, especially if you
also have a sore mouth or sore eyes
• nusual wheezing or difficulty in breathing
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• wollen eyelids, lips or tongue
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• ains in muscles or joints
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• ollapse or blackout.
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➔ If you have any signs of an allergic reaction, contact a
doctor at once. Don’t take any more tablets.

Very common side effects
These may affect more than one in 10 people:
• ifficulty in sleeping (make sure you don’t take Zyban
d
near to bedtime).

Common side effects
These may affect up to one in 10 people:
• eeling depressed (see also Take special care with
f
Zyban in section 2)
• eeling anxious or agitated
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• ifficulty concentrating
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• eeling shaky (tremor)
f
• eadache
h
• eeling sick (nausea), being sick (vomiting)
f
• tomach pain or other upsets (such as constipation),
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changes in the taste of food, dry mouth
• ever, dizziness, sweating, skin rash (sometimes due to
f
an allergic reaction), itching.

Uncommon side effects

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These may affect up to one in 100 people:
• inging in the ears, visual disturbances
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• ncrease in blood pressure (sometimes severe), flushing
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• oss of appetite (anorexia)
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• eeling weak
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• hest pain
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• eeling confused
f
• apid heartbeat.
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These may affect up to one in 1,000 people:
• its (see the beginning of this section)
f
• witching, muscle stiffness, uncontrolled movements,
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problems with walking or coordination (ataxia)
• alpitations
p
• ainting, feeling faint when you stand up suddenly,
f
because your blood pressure falls
• eeling irritable or hostile; strange dreams (including
f
nightmares)
• oss of memory
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• ingling or numbness
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• evere allergic reactions; rash together with joint and
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muscle pains (see the beginning of this section)
• rinating (passing water) more or less than usual
u
• evere skin rashes that may affect the mouth and
s
other parts of the body and can be life-threatening
• orsening of psoriasis (thickened patches of red skin)
w
• our skin or the whites of your eyes turning yellow
y
(jaundice), increase in liver enzymes, hepatitis
• hanges in blood sugar levels
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• eeling unreal or strange (depersonalisation); seeing
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or hearing things that are not there (hallucinations).

Very rare side effects
These may affect up to one in 10,000 people:
• eeling restless, aggressive
f
• ensing or believing things that are not true
s
(delusions); severe suspiciousness (paranoia).

Other side effects
Other side effects have occurred in a small number of
people but their exact frequency is unknown:
• houghts of harming or killing themselves while
t
taking Zyban or soon after stopping treatment (see
section 2, What you need to know before you take
Zyban). If you have these thoughts, contact your
doctor or go to a hospital straight away
• oss of contact with reality and unable to think or
l
judge clearly (psychosis); other symptoms may include
hallucinations and/or delusions.

Effects of giving up smoking
People who stop smoking are often affected by nicotine
withdrawal. This can also affect people taking Zyban.
Signs of nicotine withdrawal include:
• ifficulty in sleeping
d
• remor or sweating
t
• eeling anxious, agitated or depressed, sometimes
f
with thoughts of suicide.
Talk to your doctor if you have any concerns about how
you feel.
➔ If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
this leaflet.

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6. Contents of the pack and

5. How to store Zyban

1

Keep this medicine out of the sight and reach of children.

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Do not use this medicine after the expiry date which is
stated on the pack. The expiry date refers to the last day
of that month.

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Do not store this medicine above 25°C.
Store it in the original package.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

United Kingdom-GBR
Zyban

PHARMA CODE N° 4431

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What Zyban contains
Each tablet contains 150 mg of the active substance,
bupropion hydrochloride.
The other ingredients are:
Tablet core; microcrystalline cellulose, hypromellose,
cysteine hydrochloride monohydrate, magnesium
stearate.
Tablet coating; hypromellose, macrogol 400, titanium
dioxide (E171), carnauba wax.
Printing ink; hypromellose, iron oxide black (E172).

What Zyban looks like and contents of
the pack

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other information

Zyban 150 mg tablets are white, film-coated, biconvex,
round tablets imprinted with ‘GX CH7’ on one side. They
are available in cartons containing blisters of 60 tablets.

Marketing authorisation holder and
manufacturer
GlaxoSmithKline UK, Stockley Park West, Uxbridge,
Middlesex UB11 1BT is licensed to sell Zyban in the UK
The tablets are made by Glaxo Wellcome S.A.,
Avenida de Extremadura, 3, 09400 Aranda de Duero,
Burgos, Spain

Useful contacts
A number of organisations exist that can offer support
now that you have decided to stop smoking. Contact
details of some of these organisations are given below:
NHS Stop Smoking Service - http://smokefree.nhs.uk
(0800 022 4 332)
Action on Smoking and Health (ASH) http://www.ash.org.uk (0207 739 5902)
QUIT - http://www.quit.org.uk (0800 00 22 00)

Other formats
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name

Zyban 150 mg tablets

Reference number

10949/0340

This is a service provided by the Royal National Institute
of Blind People.
Leaflet date: November 2012

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Zyban and the Zyban logo are registered trademarks of
the GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of companies. All rights
reserved

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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