Unknown

Package Leaflet: Information for the User
Read all of this leaflet carefully before
150 mg prolonged release
you start using this medicine because it
film-coated tablets
contains important information for you.
bupropion hydrochloride
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 Zyban is a medicine prescribed to help you stop smoking, their signs of illness are the same as yours.
when you also have motivational support such as taking part in a ‘stop smoking’ programme. - If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
Zyban will be most effective if you are fully committed
listed in this leaflet
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
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 Fits (seizures)
Ě if you are allergic to bupropion or any of the other
Zyban has been shown to cause fits (seizures) in about ingredients of this medicine (listed in section 6) 1 in 1,000 people. (See also Other medicines and Zyban later in this section and section 4, Possible side effects, Ě if you are taking any other medicines which contain
bupropion
Ě if you have a condition that causes fits (seizures), such
Ě if you regularly drink a lot of alcohol
as epilepsy, or if you have a history of fits
Ě if you have diabetes for which you use insulin or tablets
Ě if you have an eating disorder, or had one in the past
Ě if you have had a serious head injury or a history of
(for example, bulimia or anorexia nervosa) Ě if you have severe liver problems, such as cirrhosis
If any of these applies to you, don’t take Zyban unless Ě if you have a brain tumour
you have agreed with your doctor that there is a strong Ě if you are usually a heavy drinker and you have just
stopped drinking alcohol, or are going to stop while If you have a fit (seizure) during treatment: ➔ Stop taking Zyban and don’t take any more. See your
Ě 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 Ě if you have kidney or liver problems
Ě if you are aged over 65.
Ě if you have a bipolar disorder (extreme mood swings),
You will need to take a lower dose (see section 3) and be as Zyban could bring on an episode of this illness checked closely while you are taking Zyban. Ě if you are taking medicines for depression or
If you have had any mental health problems… Parkinson’s disease called monoamine oxidase inhibitors (MAOIs), or have taken them in the last Some people taking Zyban have had hallucinations 14 days. The timing may be shorter for some types of 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 ➔ If any of these applies to you, talk to your doctor
straight away, and don’t take Zyban.
Some people become depressed when they try to stop smoking; very occasionally, they may think about Talk to your doctor or pharmacist before taking Zyban.
committing suicide, or try to do so. These symptoms have This is because some conditions make it more likely that affected people taking Zyban, most often in the first few you will have side effects (see also section 4).
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.
Some of the side effects of Zyban, such as feeling dizzy or light-headed, may affect your concentration and If you are affected, don’t drive or operate machinery.
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:
Ě PHGLFLQHVIRU depression or other mental health
Always take this medicine exactly as your doctor or
problems (see also Don’t take Zyban at the beginning
pharmacist has advised you. Check with your doctor or
Ě theophylline for asthma or lung disease
Zyban is not recommended for people under 18 years.
Ě tramadol, a strong painkiller
Ě PHGLFLQHV against malaria
Ě 
Ě Start taking Zyban while you are still smoking.
stimulants or other medicines to control your weight
or appetite
Ě Set a Target Stop Smoking Day ideally during the
second week you’re taking it.
steroids (except creams and lotions for eye and skin
conditions)
Take one tablet (150 mg),
Ě antibiotics called quinolones
Ideally keep
once a day.
Ě some types of anti-histamines mainly used to treat
smoking while
Increase your dose to one
taking Zyban
tablet, twice a day, at
Ě PHGLFLQHVIRU diabetes.
not near to bedtime.
If you take any medicines in this list, talk to your doctor
straight away, before you take Zyban (see section 3
Carry on taking one tablet, twice a
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: Target Stop Smoking Day.
Ě PHGLFLQHVIRU depression (such as desipramine,
Carry on taking one tablet, twice a
imipramine, paroxetine) or other mental health
day for up to 9 weeks.
problems (such as risperidone, thioridazine)
Ě PHGLFLQHVIRU Parkinson’s disease (such as levodopa,
smoking after 7 weeks, your doctor
will advise you to stop taking Zyban.
Ě carbamazepine, phenytoin or valproate, to treat
epilepsy or some mental health problems
Ě VRPHPHGLFLQHVXVHGWRWUHDWcancer (such as
Ě ticlopidine or clopidogrel, mainly used to treat heart
… as they may be more likely to get side effects.
disease or stroke
Ě VRPHbeta blockers (such as metoprolol), mainly used
Ě VRPHPHGLFLQHVIRU irregular heart rhythm (such as
Ě LI\RXKDYHDKLJKHUULVNRIILWVVHH7DNHVSHFLDOFDUH with Zyban and Other medicines and Zyban in section 2) Ě ritonavir or efavirenz, for treatment of HIV infection.
➔
the maximum recommended dose for you is one 150 mg
If you take any medicines on this list, check with your
tablet once a day.
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.
Take your Zyban tablets at least 8 hours apart. Don’t
Zyban may make other medicines less effective: take Zyban near to bedtime - it may cause difficulty in
Ě If you take tamoxifen used to treat breast cancer
➔ If this applies to you, tell your doctor. It may be
You can take Zyban with or without food.
necessary to change to another treatment for Swallow your Zyban tablets whole. Don’t
chew them, crush them or split them - if you The dose of some medicines may need to be reduced do, the medicine will be released into your body too quickly. This will make you more When you smoke, the chemicals absorbed into your body likely to have side effects, including fits.
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 If you take too many tablets, you may be more likely to doctor if you notice any new symptoms that you think ➔ Don’t delay. Contact your doctor or your nearest
hospital emergency department immediately.
Zyban with alcohol Some people find they are more sensitive to alcohol while taking Zyban. Your doctor may suggest you do not drink If you miss a dose, wait and take your next tablet at the 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 Don’t take an extra tablet to make up for the dose you
suddenly, because that may put you at risk of having a fit.
Zyban may interfere with some urine tests to detect You may need to take Zyban for as long as 7 weeks to other drugs. If you require a urine test, tell your doctor or hospital that you are taking Zyban.
Don’t stop taking Zyban without talking to your doctor
first. You may need to reduce your dose gradually.
Don’t take Zyban if you are pregnant, think you may be
pregnant or are planning to have a baby. Ask your doctor
If you have any further questions about using this or pharmacist for advice before taking this medicine.
medicine, ask your doctor or pharmacist.
The ingredients of Zyban can pass into breast milk. You should ask your doctor or pharmacist for advice before taking Zyban. Like all medicines, this medicine can cause side effects, These may affect up to one in 1,000 people:
Ě ILWVVHHWKHEHJLQQLQJRIWKLVVHFWLRQ Approximately 1 in every 1,000 people taking Zyban is at Ě WZLWFKLQJPXVFOHVWLIIQHVVXQFRQWUROOHGPRYHPHQWV problems with walking or coordination (ataxia) Symptoms of a fit include convulsions, and usually loss of
consciousness. Someone who has had a fit may be confused Ě IDLQWLQJIHHOLQJIDLQWZKHQ\RXVWDQGXSVXGGHQO\ afterwards, and may not remember what has happened.
Fits are more likely if you take too much, if you take Ě IHHOLQJLUULWDEOHRUKRVWLOHVWUDQJHGUHDPVLQFOXGLQJ some other medicines, or if you are at higher than usual ➔ If you have a fit, tell your doctor when you have
recovered. Don’t take any more Zyban.
Ě VHYHUHDOOHUJLFUHDFWLRQVUDVKWRJHWKHUZLWKMRLQWDQG muscle pains (see the beginning of this section) Ě XULQDWLQJSDVVLQJZDWHUPRUHRUOHVVWKDQXVXDO Rarely (up to 1 in 1,000) people may have potentially serious allergic reactions to Zyban. Signs of allergic reactions include: Ě VHYHUHVNLQUDVKHVWKDWPD\DIIHFWWKHPRXWKDQG Ě VNLQUDVKLQFOXGLQJLWFK\EXPS\UDVK6RPHVNLQ other parts of the body and can be life-threatening rashes may need hospital treatment, especially if you Ě ZRUVHQLQJRISVRULDVLVWKLFNHQHGSDWFKHVRIUHGVNLQ Ě \RXUVNLQRUWKHZKLWHVRI\RXUH\HVWXUQLQJ\HOORZ Ě XQXVXDOZKHH]LQJRUGLIILFXOW\LQEUHDWKLQJ (jaundice), increase in liver enzymes, hepatitis Ě IHHOLQJXQUHDORUVWUDQJH(depersonalisation); seeing or hearing things that are not there (hallucinations).
➔ If you have any signs of an allergic reaction, contact a
doctor at once. Don’t take any more tablets.
These may affect up to one in 10,000 people:
These may affect more than one in 10 people:
Ě VHQVLQJRUEHOLHYLQJWKLQJVWKDWDUHQRWWUXH Ě GLIILFXOW\LQVOHHSLQJPDNHVXUH\RXGRQďWWDNH=\EDQ (delusions); severe suspiciousness (paranoia).
Other side effects have occurred in a small number of people but their exact frequency is unknown: These may affect up to one in 10 people:
Ě WKRXJKWVRIKDUPLQJRUNLOOLQJWKHPVHOYHVZKLOH Ě IHHOLQJGHSUHVVHGVHHDOVR7DNHVSHFLDOFDUHZLWK 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
Ě ORVVRIFRQWDFWZLWKUHDOLW\DQGXQDEOHWRWKLQNRU judge clearly (psychosis); other symptoms may include Ě IHHOLQJVLFNQDXVHDEHLQJVLFNYRPLWLQJ Ě VWRPDFKSDLQRURWKHUXSVHWVVXFKDVFRQVWLSDWLRQ Ě IHYHUGL]]LQHVVVZHDWLQJVNLQUDVKVRPHWLPHVGXHWR People who stop smoking are often affected by nicotine withdrawal. This can also affect people taking Zyban. Signs of nicotine withdrawal include: These may affect up to one in 100 people:
Ě ULQJLQJLQWKHHDUVYLVXDOGLVWXUEDQFHV Ě IHHOLQJDQ[LRXVDJLWDWHGRUGHSUHVVHGVRPHWLPHV Ě LQFUHDVHLQEORRGSUHVVXUHVRPHWLPHVVHYHUHIOXVKLQJ Talk to your doctor if you have any concerns about how
➔ If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
Keep this medicine 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 Each tablet contains 150 mg of the active substance, Tablet core: microcrystalline cellulose, hypromellose, Do not throw away any medicines via waste-water or cysteine hydrochloride monohydrate, magnesium household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will 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 packZyban 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 manufacturerGlaxoSmithKline 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 contactsA 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 formatsTo 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
This is a service provided by the Royal National Institute of Blind People.
Zyban and the Zyban logo are registered trademarks of the GlaxoSmithKline group of companies 2012 GlaxoSmithKline group of companies. All rights reserved

Source: http://johnsonsfriends.com/wp-content/uploads/2013/03/Zyban-150-mg-prolonged-release-film-coated-tablets-PIL.3957.16.pdf