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ZYBAN 150 MG PROLONGED RELEASE FILM-COATED TABLETS

Active substance: BUPROPION HYDROCHLORIDE

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503800/PL1d

®

Zyban 150 mg Prolonged-Release
Film-Coated Tablets
(bupropion hydrochloride)

Patient Information Leaflet
The name of your medicine is Zyban 150 mg ProlongedRelease Film-Coated Tablets, throughout this leaflet it will be
referred to as Zyban.
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.
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
• 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 you have a brain tumour
• if you are usually a heavy drinker and you have just
stopped drinking alcohol, or are going to stop while
you’re taking Zyban
• if you have recently stopped taking sedatives or
medicines
to
treat
anxiety
(especially
benzodiazepines or similar medicines), or if you are
going to stop them while you’re taking Zyban
• if you have a bipolar disorder (extreme mood
swings) as Zyban could bring on an episode of this
illness
• if you are taking medicines for depression or
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.
 If any of these applies to you, talk to your doctor
straight away, and don’t take Zyban.

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.
Other medicines and Zyban
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:
• medicines for depression or other mental health
problems (see also Don’t take Zyban at the beginning
of section 2)
• theophylline for asthma or lung disease
• tramadol, a strong painkiller
• medicines against malaria
• stimulants or other medicines to control your weight
or appetite
• steroids (except creams and lotions for eye and skin
conditions)
• antibiotics called quinolones
• some types of anti-histamines mainly used to treat
allergies, that can cause sleepiness
• medicines for diabetes.
 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).
Some medicines can affect how Zyban works, or make it
more likely that you’ll have side effects. These include:
• medicines for depression (such as desipramine,
imipramine, paroxetine) or other mental health
problems (such as risperidone, thioridazine)
• medicines for Parkinson’s disease (such as
levodopa, amantadine or orphenadrine)
• carbamazepine, phenytoin or valproate, to treat
epilepsy or some mental health problems
• some medicines used to treat cancer (such as
cyclophosphamide, ifosphamide)
• ticlopidine or clopidogrel, mainly used to treat heart
disease or stroke
• some beta blockers (such as metoprolol), mainly
used to treat high blood pressure
• some medicines for irregular heart rhythm (such as
propafanone, flecainide)
• ritonavir or efavirenz, for treatment of HIV infection.
 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.
Zyban may make other medicines less effective:
• if you take tamoxifen used to treat breast cancer
 If this applies to you, tell your doctor. It may be
necessary to change to another treatment for smoking
cessation.
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.

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).

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

Fits (seizures)
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).

Zyban with alcohol
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.

Fits are more likely:
• if you regularly drink a lot of alcohol
• if you have diabetes for which you use insulin or
tablets
• if you have had a serious head injury or a history of
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:
• if you have kidney or liver problems
• if you are aged over 65.
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 you feel depressed or suicidal…
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.

Effect on urine tests
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.
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.
The ingredients of Zyban can pass into breast milk. You
should ask your doctor or pharmacist for advice before taking
Zyban.
Driving and using machines
Some of the side effects of Zyban, such as feeling dizzy or
light-headed, may affect your concentration and judgement.
If you are affected, don’t drive or operate machinery.
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.
Zyban is not recommended for people under 18 years.

continued overleaf

When to start and how much to take
• Start taking Zyban while you are still smoking
• Set a Target Stop Smoking Day ideally during the
second week you’re taking it
Week 1
Ideally keep
smoking while
taking Zyban

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.

Week 2

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

Weeks 3 to 9

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

Some people need to take a lower dose
as they may be more likely to get side effects.
• if you are aged over 65
• if you have liver or kidney disease
• if you have a higher risk of fits (see Take special care
with Zyban and Other medicines and Zyban in section
2)
the maximum recommended dose for you is one 150 mg
tablet once a day.
How to take your tablets
Take your Zyban tablets at least 8 hours apart. Don’t take
Zyban near to bedtime - it may cause difficulty in sleeping.
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 take more Zyban than you should
If you take too many tablets, you may be more likely to have a
fit or other side effects.
 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.
If you stop taking 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.
4) POSSIBLE 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:
• skin rash (including itchy, bumpy rash). Some skin
rashes may need hospital treatment, especially if you
also have a sore mouth or sore eyes
• unusual wheezing or difficulty in breathing
• swollen eyelids, lips or tongue
• pains in muscles or joints
• collapse or blackout.
 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:
• difficulty in sleeping (make sure you don’t take Zyban
near to bedtime).
Common side effects
These may affect up to one in 10 people:
• feeling depressed (see also Take special care with
Zyban in section 2)
• feeling anxious or agitated
• difficulty concentrating
• feeling shaky (tremor)
• headache
• feeling sick (nausea), being sick (vomiting)
• stomach pain or other upsets (such as constipation),
changes in the taste of food, dry mouth
• fever, dizziness, sweating, skin rash (sometimes due
to an allergic reaction), itching.

Uncommon side effects
These may affect up to one in 100 people:
• ringing in the ears, visual disturbances
• increase in blood pressure (sometimes severe), flushing
• loss of appetite (anorexia)
• feeling weak
• chest pain
• feeling confused
• rapid heartbeat.
Rare side effects
These may affect up to one in 1,000 people:
• fits (see the beginning of this section)
• twitching, muscle stiffness, uncontrolled movements,
problems with walking or coordination (ataxia)
• palpitations
• fainting, feeling faint when you stand up suddenly,
because your blood pressure falls
• feeling irritable or hostile; strange dreams (including
nightmares)
• loss of memory
• tingling or numbness
• severe allergic reactions; rash together with joint and
muscle pains (see the beginning of this section)
• urinating (passing water) more or less than usual
• severe skin rashes that may affect the mouth and
other parts of the body and can be life-threatening
• worsening of psoriasis (thickened patches of red skin)
• your skin or the whites of your eyes turning yellow
(jaundice), increase in liver enzymes, hepatitis
• changes in blood sugar levels
• feeling unreal or strange (depersonalisation); seeing or
hearing things that are not there (hallucinations).
Very rare side effects
These may affect up to one in 10,000 people:
• feeling restless, aggressive
• sensing or believing things that are not
(delusions); severe suspiciousness (paranoia).

true

Other side effects
Other side effects have occurred in a small number of people
but their exact frequency is unknown:
• thoughts of harming or killing themselves while 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
• loss of contact with reality and unable to think or 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:
• difficulty in sleeping
• tremor or sweating
• feeling anxious, agitated or depressed, sometimes with
thoughts of suicide.
Talk to your doctor if you have any concerns about how you
feel.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5) HOW TO STORE ZYBAN
• Keep out of the sight and reach of children.
• 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.
• Do not store above 25°C.
• Store in the original package.
• Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
• If you notice any sign of deterioration or discolouration
of your medicine, tell your pharmacist immediately.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
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:
propylene glycol, hypromellose, and iron oxide black (E172).
What Zyban looks like and contents of the pack
White, film-coated, biconvex, round tablets imprinted with
‘GX CH7’ on one side and plain on the other.
Zyban is available in cartons containing blisters of 30 or 60
tablets.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by GlaxoSmithKline Pharmaceuticals, Ulica
Grunwaldzka 189, Poznan, PL-60-322, Poland.
Zyban 150 mg Prolonged-Release Film-Coated Tablets
PL No: 18067/0379
POM
Zyban is a registered trademark of the Glaxo Group Ltd.
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This leaflet was last revised on 5 August 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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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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