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ZYBAN 150MG FILM-COATED TABLETS

Active substance(s): BUPROPION HYDROCHLORIDE / BUPROPION HYDROCHLORIDE / BUPROPION HYDROCHLORIDE

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Children and adolescents
6. Contents of the pack and other information

S1299 Leaflet Zyban 20170206

What Zyban contains


Each prolonged release, film-coated tablet contains 150mg of
the active ingredient bupropion hydrochloride.



Zyban also contains the following inactive ingredients:
Tablet core: magnesium stearate, cysteine hydrochloride
monohydrate, hypromellose, microcrystalline cellulose.
Film-coat: Opadry OY-7300 white or Opadry YS-1-18202 white:
macrogol 400, titanium dioxide E171, hypromellose, carnauba
wax.
Printing ink: Opacode WS NS-78-17821 Black ink: black iron
oxide (E172), propylene glycol, hypromellose.

ZYBAN® 150mg FILM-COATED TABLETS
(bupropion hydrochloride)

Zyban is white film-coated, biconvex, round tablet printed
‘GX CH7’ in black ink on one side and plain on the other side.



Zyban comes in blister packs containing 30 or 60 tablets.

Adults
Fits (seizures)

Your medicine is called Zyban150mg Film-coated Tablets but will
be referred to as Zyban throughout the remainder of the leaflet.

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).

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Fits are more likely:


if you regularly drink a lot of alcohol



Keep this leaflet. You may need to read it again.



if you have diabetes for which you use insulin or tablets



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



if you have had a serious head injury or a history of head
trauma



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 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 get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

 Stop taking Zyban and don’t take any more. See your
doctor.

What Zyban looks like and contents of the pack


Zyban is not recommended for people under 18 years.

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you have a fit (seizure) during treatment:

You may have more risk of side effects:
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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

Manufacturer

4. Possible side effects

Zyban are manufactured by GlaxoSmithKline Pharmaceuticals S.A.,
ul. Grunwaldzka 189, Poznan, 60-322 Poland.

5. How to store Zyban

POM

6. Contents of the pack and other information

PL 19488/1299
1. What Zyban is and what it is used for

Leaflet revision date: 06 February 2017
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
Action on Smoking and Health (ASH) - http://www.ash.org.uk
QUIT - http://www.quit.org.uk

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.

Don’t take Zyban:

Zyban® is a registered trademark of the GlaxoSmithKline group of
companies.
S1299 Leaflet Zyban 20170206

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.

2. What you need to know before you take Zyban

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



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.



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



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.

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

There may be a higher than usual risk of fits if you take:




if you have a bipolar disorder (extreme mood swings) as
Zyban could bring on an episode of this illness

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



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.



tramadol, a strong painkiller



medicines against malaria



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

stimulants or other medicines to control your weight or
appetite



steroids (except creams and lotions for eye and skin
conditions)

Warnings and Precautions



antibiotics called quinolones



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



medicines for diabetes.

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).

 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

 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).




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

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.

severe allergic reactions; rash together with joint and muscle
pains (see the beginning of this section)

Fits (seizures)



urinating (passing water) more or less than usual

Approximately 1 in every 1,000 people taking Zyban is at risk of
having a fit.



severe skin rashes that may affect the mouth and other parts of
the body and can be life-threatening

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.



worsening of psoriasis (thickened patches of red skin)



your skin or the whites of your eyes turning yellow (jaundice),
increase in liver enzymes, hepatitis

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).



changes in blood sugar levels



feeling unreal or strange (depersonalisation); seeing or hearing
things that are not there (hallucinations).

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

medicines for depression (such as desipramine, imipramine,
paroxetine) or other mental health problems (such as
risperidone, thioridazine)



tingling or numbness



4.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.

Some medicines can affect how Zyban works, or make it more
likely that you’ll have side effects. These include:




3. How to take Zyban

Week 1

Days

Ideally keep
smoking while
taking Zyban

1 to 6

Week 2

Day 7

Take one tablet (150 mg),
once a day
Increase your dose to one
tablet, twice a day, at least 8
hours apart, and not near to
bedtime

 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.

 If you have a fit, tell your doctor when you have recovered.
Don’t take any more Zyban.
Allergic reactions

Very rare side effects

Rarely (up to 1 in 1,000) people may have potentially serious
allergic reactions to Zyban. Signs of allergic reactions include:

These may affect up to one in 10,000 people:


feeling restless, aggressive



skin rash (including itchy, bumpy rash). Some skin rashes may
need hospital treatment, especially if you also have a sore
mouth or sore eyes



sensing or believing things that are not true (delusions); severe
suspiciousness (paranoia).

Carry on taking one tablet, twice a day
for up to 9 weeks.



unusual wheezing or difficulty in breathing

If you have not been able to stop
smoking after 7 weeks, your doctor will
advise you to stop taking Zyban.



swollen eyelids, lips or tongue



pains in muscles or joints

Other side effects have occurred in a small number of people but
their exact frequency is unknown:



collapse or blackout.



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).

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

Weeks 3 to 9

Possible side effects

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

 If you have any signs of an allergic reaction, contact a
doctor at once. Don’t take any more tablets.

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.


If you take digoxin for your heart

If this applies to you, tell your doctor. Your doctor may consider
adjusting the dose of digoxin.
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.

Some people need to take a lower dose

Very common side effects

as they may be more likely to get side effects.

These may affect more than one in 10 people:



if you are aged over 65



if you have liver or kidney disease



if you have a higher risk of fits (see Warnings and Precautions
and Other medicines and Zyban in section 2)

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 lightheaded, may affect your concentration and judgement.
If you are affected, don’t drive or operate machinery.



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:

Effects of giving up smoking



feeling depressed (see also Warnings and Precautions in
section 2)



feeling anxious or agitated

People who stop smoking are often affected by nicotine withdrawal.
This can also affect people taking Zyban. Signs of nicotine
withdrawal include:

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



difficulty concentrating



feeling shaky (tremor)

You can take Zyban with or without food.



headache

the maximum recommended dose for you is one 150 mg tablet
once a day.
How to take your tablets



difficulty in sleeping



tremor or sweating



feeling anxious, agitated or depressed, sometimes with
thoughts of suicide.



feeling sick (nausea), being sick (vomiting)

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.



stomach pain or other upsets (such as constipation), changes in
the taste of food, dry mouth

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



fever, dizziness, sweating, skin rash (sometimes due to an
allergic reaction), itching.

Reporting of side effects

If you take more Zyban than you should

Uncommon side effects

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

These may affect up to one in 100 people:


ringing in the ears, visual disturbances

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



increase in blood pressure (sometimes severe), flushing



loss of appetite (anorexia)



feeling weak



chest pain



feeling confused



rapid heartbeat.

If you forget to take Zyban
Pregnancy and breast-feeding

Other side effects

If you miss a dose, wait and take your next tablet at the usual time.
Do not take a double dose to make up for a forgotten dose.
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.

Rare side effects

If you get any side effects, talk to your doctor or pharmacist. This
includes any 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 store above 25°C. Store in the original package.



Do not use after the expiry date printed on the carton or blister
label.



If your doctor tells you to stop using your medicine, please take
it back to the pharmacist for safe disposal. Only keep your
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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

Expand Transcript

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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