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Document: leaflet MAH BRAND_PLPI 20636-2318 change

• leaflet MAH BRAND_PLPI 20636-2318
• leaflet MAH GENERIC_PL 00289-0816
• leaflet MAH GENERIC_PL 00427-0239
• leaflet MAH GENERIC_PL 04569-0809
• leaflet MAH GENERIC_PL 20117-0066
• leaflet MAH GENERIC_PL 29831-0349

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zyban® 150 mg prolonged release film-coated tablets

(bupropion hydrochloride)

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

•    The name of this medicine is Zyban 150 mg prolonged release film-coated tablets but will be referred to as Zyban throughout the remainder of this leaflet.

•    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

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:

•    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.

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.

Adults

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).

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.

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.

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.

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 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 Warnings and Precautions 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.

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.

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 Warnings and Precautions 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 true (delusions); severe suspiciousness (paranoia).

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.

•    reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia) and reduced number of platelets (thrombocytopenia).

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 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.

•    As with all medicines, it is important to keep Zyban out of the sight and reach of children.

•    Do not store Zyban above 25^oC. Store in the original pack.

•    Do not use Zyban after the expiry date printed on the carton or the foil blister strip.

•    If you have any Zyban tablets left after completing your course of treatment, please return them to your pharmacist who will get rid of them safely.

•    If your tablets become discoloured or show any sign of deterioration, return them to your pharmacist.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Zyban contains

Zyban contains 150 mg of the active ingredient bupropion hydrochloride, which is released slowly into the body.

Zyban also contains the following inactive ingredients: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate, macrogol 400, titanium dioxide (E171), hypromellose 2910 6 cP, carnauba wax and iron oxide black (E172).

What Zyban looks like and contents of the pack

Zyban 150 mg prolonged release film-coated tablets are provided as white, film-coated, biconvex, round tablets with ‘GX CH7' printed in black ink on one side and plain on the other side.

Zyban comes in foil blister strips, each containing 10 tablets and is available in packs of 30 or 60 tablets.

Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.

Manufactured by

GlaxoSmithKline Pharmaceuticals S.A., Poznan, Poland.

Repackaged by MPT Pharma Ltd.

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

PL: 33532/0072

Leaflet dated 14^th January 2016 Leaflet coded xxxxxxxxx

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