Zyban

Patient Information Leaflet

Zyban, 150 mg, prolonged-release tablets
Bupropion hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Zyban is and what it is used for
2. Important information before taking 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 people stop smoking, used together with motivational support such as participation in an appropriate treatment programme.
Treatment with Zyban is most effective in patients who are fully motivated to stop smoking.
Please consult your doctor or pharmacist for information on available treatments or other forms of support.

2. Important information before taking Zyban

When not to take Zyban

• if the patient is allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking any other medicine containing bupropion (e.g. Wellbutrin XR, a medicine used to treat depression)
• if the patient has a condition causing seizures (fits), such as epilepsy, or if they have had seizures in the past
• if the patient has a history of eating disorders (for example, bulimia or anorexia nervosa)
• if the patient has severe liver disease, such as cirrhosis of the liver
• if the patient has a brain tumour
• if the patient is an alcohol abuser, has recently stopped drinking alcohol, or intends to stop during treatment with Zyban
• if the patient has recently stopped taking sedatives or anxiolytics (particularly benzodiazepines or medicines acting similarly to benzodiazepines) or intends to do so during treatment with Zyban
• if the patient has bipolar affective disorder (extreme mood swings), because bupropion may trigger an episode of this condition
• if the patient is taking antidepressants or medicines for Parkinson's disease called monoamine oxidase inhibitors (MAOIs), or has taken them within the last 14 days. This period may be shorter for certain types of MAOIs, as advised by the doctor. If any of the above situations apply, the patient should immediately contact their doctor and must not take Zyban.

Warnings and precautions
Before starting Zyban, the patient should discuss this with their doctor or pharmacist. This is because
there is an increased risk of adverse effects in certain situations ( see also section 4).
Brugada syndrome

• if the patient has been diagnosed with Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or has a family history of cardiac arrest or sudden death.

Children and adolescents
Zyban is not recommended for use in patients under 18 years of age.
Adults
Seizures
Zyban has been shown to cause seizures in approximately 1 in 1,000 patients ( for further
information, see also “ Zyban and other medicines” later in this section and section 4: “Possible
side effects”). Seizures may occur more frequently:

• if the patient regularly drinks large amounts of alcohol
• if the patient has diabetes and is using insulin or oral antidiabetic medicines
• if the patient has had a severe head injury or a history of head trauma. If any of the above situations apply, the patient should not take Zyban unless otherwise advised by a doctor. If seizures occur during treatment: The patient must stop taking Zyban and must not take it again. The patient should see a doctor immediately.

The patient may be at increased risk of adverse effects:

• if the patient has liver or kidney disease
• if the patient is over 65 years of age. The patient may need to take a lower dose ( see section 3) and will require close medical supervision while taking Zyban.

If the patient has had any psychiatric disorders
Some patients taking Zyban have experienced hallucinations or delusions (seeing, hearing, or
believing in things that are not real), disturbances in thinking, or extreme mood swings. These
symptoms are more likely to occur in patients who have previously had psychiatric disorders.
If the patient feels depressed or has suicidal thoughts
Some patients trying to quit smoking may experience depression; very rarely, they may have
thoughts of suicide or attempt suicide. These symptoms have occurred in patients taking Zyban,
most often during the first few weeks of treatment.
If the patient feels depressed or has suicidal thoughts:
The patient should contact their doctor or go to hospital immediately.
If the patient is taking medicines for depression
Concomitant use of these medicines with Zyban may lead to serotonin syndrome, a potentially
life-threatening condition ( see “Zyban and other medicines” in this section ).
High blood pressure and Zyban
Some patients taking Zyban have developed high blood pressure requiring treatment. If the
patient previously had high blood pressure, it may worsen. This is more likely if the patient is also
using nicotine patches to help quit smoking.
The patient’s blood pressure will be checked before starting Zyban and monitored during
treatment, especially if they have previously had high blood pressure. If the patient is also using
nicotine patches, blood pressure should be monitored weekly. If blood pressure increases, Zyban
may need to be discontinued.
Laboratory tests
Zyban may interfere with urine drug screening tests. If the patient is due to have such a test, they
should inform their doctor or nurse that they are taking Zyban.
Zyban and other medicines
The patient should inform their doctor or pharmacist about all medicines they are currently or
recently taking, including those obtained without a prescription, as well as any medicines they
intend to take.
The risk of seizures may be higher than usual if the patient is taking:

• antidepressants or medicines used for other psychiatric disorders ( see also “When not to take Zyban” at the beginning of section 2)
• theophylline, used to treat asthma or lung diseases
• tramadol, a strong painkiller
• antimalarial medicines
• stimulants or other medicines used to control body weight or appetite
• steroids (except creams and eye/ear drops used for eye or skin conditions)
• antibiotics known as quinolones
• some antihistamines used mainly for allergies, which may cause drowsiness
• antidiabetic medicines, insulin. If the patient is taking any of these medicines, they should contact their doctor immediately before starting Zyban ( see section 3 “ Some patients may require a lower dose ”).

Some medicines may affect the action of Zyban or increase the risk of adverse effects. These
include:

• antidepressants (such as: desipramine, imipramine, paroxetine, citalopram, escitalopram, venlafaxine) or medicines used for other psychiatric disorders (such as: risperidone, thioridazine). Zyban may interact with medicines used to treat depression, and the patient may experience changes in mental state (e.g. agitation, hallucinations, coma), and other symptoms such as: body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea).
• medicines used to treat Parkinson’s disease (e.g. levodopa, amantadine or orphenadrine)
• carbamazepine, phenytoin or valproate used to treat epilepsy and certain psychiatric disorders
• some medicines used to treat cancer (e.g. cyclophosphamide, ifosfamide)
• ticlopidine or clopidogrel, mainly used to treat heart disease or strokes
• some beta-blockers (e.g. metoprolol), mainly used to treat high blood pressure
• some medicines used to treat irregular heart rhythms (e.g. propafenone, flecainide)
• ritonavir or efavirenz, used to treat HIV infection. If the patient is taking any of these medicines, they should contact their doctor. The doctor will assess the benefits and risks of taking Zyban or may recommend adjusting the dose of the other medicine.

Zyban may reduce the effectiveness of certain medicines:

• If the patient is taking tamoxifen, used to treat breast cancer
  If this applies to the patient, they should inform their doctor. It may be necessary to reconsider the method of quitting smoking.
• If the patient is taking digoxin for heart problems
  If this applies to the patient, they should inform their doctor. The doctor may consider adjusting the digoxin dose.

During smoking cessation, the dose of certain medicines may need to be reduced.
Chemicals absorbed into the body from smoking can reduce the effectiveness of certain medicines.
During smoking cessation, the dose of these medicines may need to be reduced; otherwise, adverse
effects may occur.
If the patient is taking any other medicines, they should contact their doctor if they notice any
new symptoms they believe may be side effects.
Zyban and alcohol
Some patients may be more sensitive to the effects of alcohol while taking Zyban. The doctor may
advise the patient to avoid alcohol or significantly reduce their alcohol intake during treatment
with Zyban. If the patient currently drinks large amounts of alcohol, they should not stop suddenly,
as this may increase the risk of seizures.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, Zyban
should not be taken. The patient should consult their doctor or pharmacist before using this
medicine.
Some studies suggest an increased risk of congenital malformations, particularly heart defects, in
babies whose mothers took Zyban. It has not been established whether these malformations are
related to Zyban use.
The ingredients of Zyban may pass into breast milk. The patient should consult their doctor or
pharmacist before taking Zyban.
Driving and operating machinery
Some of the side effects of Zyban, such as dizziness and a feeling of emptiness in the head, may
impair concentration and the ability to assess situations.
If these symptoms occur, the patient should not drive or operate machinery.

3. How to use Zyban

This medicine should always be taken as prescribed by a doctor. If in doubt, consult your doctor or pharmacist.

Some patients may require a lower dose
because they may experience adverse reactions more frequently. This applies to patients:

• aged over 65 years
• with liver or kidney disease
• with an increased risk of seizures ( see "Warnings and precautions" and "Zyban with other medicines" in section 2 ). The maximum recommended dose for a patient is one 150 mg tablet once daily.

How to take Zyban tablets
Zyban tablets should be taken with at least an 8-hour interval between doses. Avoid taking the medication close to bedtime –
as it may cause difficulty in falling asleep.
Zyban can be taken with or without food.
Zyban tablets should be swallowed whole. Do not chew, crush, or divide them –

as doing so will cause the drug to be released too quickly into the body. This may increase
the risk of adverse reactions, including seizures.
Taking more than the recommended dose of Zyban
Taking too many tablets may increase the risk of seizures or other adverse reactions.
Do not delay. Seek immediate medical advice from your doctor or the nearest hospital emergency department.
Missed dose of Zyban
If a dose is missed, wait and take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Stopping treatment with Zyban
To achieve the full therapeutic effect, treatment with Zyban may need to continue for 7 weeks.
Do not stop taking Zyban without consulting your doctor. Gradual dose reduction may be necessary.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Seizures

There is a risk of seizure occurring in approximately 1 in 1,000 patients taking Zyban medicine.
Symptoms of a seizure include convulsions and usually loss of consciousness. A patient who has had a seizure may subsequently be confused and have no memory of the event.
The risk of seizures is higher in patients taking higher than recommended doses, taking certain other medicines, or belonging to a group at increased risk of seizures (see section 2).
If a patient has a seizure, they should contact their doctor once they have recovered. Do not take any more Zyban medicine.

Allergic reactions

Rarely (in less than 1 in 1,000 patients), potentially severe allergic reactions to Zyban medicine may occur. Symptoms of an allergic reaction include:

• Skin rash (including itchy lumps). Some rashes may require hospitalization, especially if mouth pain or eye pain also occur.
• Unusual wheezing or breathing difficulties
• Swelling of the eyelids, lips, or tongue
• Muscle or joint pain
• Collapse or brief loss of consciousness. If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take any further doses of the medicine.

Lupus erythematosus or worsening of lupus symptoms

Frequency unknown – frequency cannot be estimated based on available data from patients taking Zyban medicine.
Lupus is an immune system disorder affecting the skin and other organs.
If lupus symptoms worsen, or if skin rash or skin lesions occur (especially on areas of skin exposed to sunlight) while taking Zyban medicine, contact your doctor immediately, as treatment may need to be discontinued.

Acute generalized pustular eruption

Frequency unknown – frequency cannot be estimated based on available data from patients taking Zyban medicine. Symptoms of acute generalized pustular eruption include skin rash with pustules/blisters filled with pus.
If a skin rash with pustules/blisters filled with pus occurs, contact your doctor immediately, as treatment may need to be discontinued.

Other adverse effects

Very common adverse effects
May occur in more than 1 in 10 patients:

• Difficulty sleeping (avoid taking Zyban medicine immediately before bedtime).

Common adverse effects
May occur in less than 1 in 10 patients:

• Depression (see also "Warnings and precautions" in section 2)
• Feelings of anxiety or agitation
• Difficulty concentrating
• Tremor
• Headache
• Nausea, vomiting
• Abdominal pain and other gastrointestinal complaints (constipation), altered taste perception, dry mouth
• Fever, dizziness, sweating, skin rash (sometimes associated with allergic reaction), itching.

Uncommon adverse effects
May occur in less than 1 in 100 patients:

• Tinnitus, visual disturbances
• Increased blood pressure (sometimes significant), skin redness
• Loss of appetite (anorexia)
• Weakness
• Chest pain
• Disorientation
• Increased heart rate.

Rare adverse effects
May occur in less than 1 in 1,000 patients:

• Seizure (see beginning of this section)
• Muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination (ataxia)
• Palpitations
• Fainting or feeling faint upon sudden change to upright position due to drop in blood pressure
• Feelings of irritability or hostility; strange dreams (including nightmares)
• Memory disturbances
• Tingling or numbness
• Severe allergic reactions; rash accompanied by joint and muscle pain (see beginning of this section)
• Urinating more or less frequently than usual
• Severe skin rashes, which may involve the mouth or other body parts and which may be life-threatening
• Worsening of psoriasis (red thickened areas of skin)
• Yellowing of the skin or whites of the eyes (jaundice), increased liver enzyme activity, hepatitis
• Changes in blood sugar (glucose) levels
• Feelings of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations).

Very rare adverse effects
May occur in less than 1 in 10,000 patients:

• Feelings of restlessness, aggression
• Experiencing or believing in things that are not real (delusions); excessive suspiciousness (paranoia)
• Urinary incontinence (involuntary urination, uncontrolled leakage of urine).

Frequency unknown
Other adverse effects have occurred in a small number of patients, but their exact frequency is unknown:

• Thoughts of self-harm or suicide during treatment with Zyban medicine or shortly after stopping it (see section 2). If the patient has such thoughts, contact a doctor or go immediately to a hospital.
• Loss of touch with reality and loss of thinking or judgment ability (psychosis); other symptoms may include hallucinations and (or) delusions.
• Sudden and intense fear (panic attack).
• Stuttering.
• Decreased number of red blood cells (anaemia), decreased number of white blood cells (leucopenia), and decreased number of platelets (thrombocytopenia).
• Low sodium levels in the blood (hyponatraemia).
• Changes in mental state (e.g. agitation, hallucinations, coma), and other symptoms such as: body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and (or) gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea) while taking Zyban medicine together with medicines used to treat depression (such as: paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Effects of smoking cessation
Patients who stop smoking usually experience symptoms of nicotine withdrawal. This may also affect patients taking Zyban medicine. Symptoms of nicotine withdrawal include:

• Difficulty sleeping
• Tremor or sweating
• Feelings of anxiety, agitation, or depression, sometimes accompanied by suicidal thoughts. Talk to your doctor if you have any concerns about the patient's well-being.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Zyban

Keep this medicine out of sight and reach of children.
Do not use Zyban after the expiry date stated on the packaging after:
EXP. The expiry date refers to the last day of the stated month. The code on the packaging marked as
'Lot' indicates the batch number.
Do not store above 25°C.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Zyban contains
The active substance is bupropion hydrochloride (150 mg per tablet).
The other ingredients are:
Tablet core
microcrystalline cellulose, hypromellose 2910, monohydrate cysteine hydrochloride, magnesium stearate, purified water.
Coating
white colour concentrate: Opadry OY-7300 white or Opadry YS-1-18202-A white, carnauba wax, purified water.
Composition of Opadry OY-7300 white and Opadry YS-1-18202-A white: hypromellose 2910 6cP, titanium dioxide (E 171), polyethylene glycol 400.
Composition of black ink Opacode WB NS-78-17821: purified water, iron oxide black (E 172), propylene glycol, isopropyl alcohol, hypromellose 2910 6cP.

What Zyban looks like and contents of the pack
Zyban tablets are white, film-coated, round, biconvex, with the imprint "GX CH7" on one side. The tablets are available in packs containing 30, 60 or 100 tablets in child-resistant blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer:
Glaxo Wellcome S.A.
Avenida de Extremadura, 3
09400 Aranda de Duero,
Burgos, Spain

For further information, contact the Marketing Authorisation Holder's representative:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (0-22) 576 9000