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Zyban® 150 mg prolonged release film-coated tablets
(bupropion hydrochloride)
This medicine is available as the above name but will be referred to as Zyban throughout
the following leaflet.
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
 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
Warnings and Precautions
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).
Children and adolescents
Zyban is not recommended for people under 18 years.
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
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.

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
 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
 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.
If you are taking any other medicines, check with your doctor if you notice any new
symptoms that you think may be side effects.
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.
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 told you. Check
with your doctor or pharmacist if you are not sure.

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

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.

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

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.

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

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

Very rare side effects
These may affect up to one in 10,000 people:
 feeling restless, aggressive
 sensing or believing things that are not true (delusions); severe suspiciousness
Other side effects
Other side effects have occurred in a small number of people but their exact frequency is
 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.
 reduced number of red blood cells (anaemia), reduced number of white blood cells
(leucopenia) and reduced number of platelets (thrombocytopenia).

If you forget to take Zyban
If you miss a dose, wait and take your next tablet at the usual time.

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.

Do not take a double dose to make up for a forgotten dose.

Talk to your doctor if you have any concerns about how you feel.

If you stop taking Zyban
You may need to take Zyban for as long as 7 weeks to have its full effect.

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:

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.

By reporting side effects, you can help provide more information on the safety of this

4. Possible side effects

5. How to store Zyban

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

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 it in the original package.
If your tablets become discoloured, or show any signs of deterioration, consult your
pharmacist who will tell you what to do.
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.

6. Contents of the pack and other information
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
 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
 worsening of psoriasis (thickened patches of red skin)
 your skin or the whites of your eyes turning yellow (jaundice), increase in liver enzymes,
 changes in blood sugar levels
 feeling unreal or strange (depersonalisation); seeing or hearing things that are not there

What Zyban contains
The active ingredient is bupropion hydrochloride.
Each tablet contains 150 mg of bupropion hydrochloride.
The other ingredients are:
microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium
stearate, carnauba wax, titanium dioxide (E171),macrogol, black ink (purified water, black
iron oxide (E172), isopropyl alcohol, propylene glycol, hypromellose 2910/06).
What Zyban looks like and contents of the pack
Zyban are white, film-coated, biconvex, round tablets imprinted with "GX CH7" in black on
one side and plain on the other.
They are available in cartons containing blisters of 30 and 60 tablets.
PL No: 15814/1131


Zyban is manufactured by GlaxoSmithKline Pharmaceuticals S.A., Poznan, Poland.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
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 -
Action on Smoking and Health (ASH) -
Leaflet revision and issue date (Ref.): 19.05.2015.
Zyban is a registered trademark of the GlaxoSmithKline group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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.