ZYBAN 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Zyban, 150 mg, prolonged-release tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Zyban is and what it is used for
   1. Treatment with Zyban is most successful in patients who are highly motivated to quit smoking.
4. Before you take Zyban
   1. When not to take Zyban
   2. If any of the above apply to you, do not take Zyban. Talk to your doctor.
   3. Warnings and precautions
   4. Brugada syndrome
   5. Children and adolescents
   6. Adults
   7. Seizures
   8. Stop taking Zyban and do not take it again. See your doctor.
   9. You may be at a higher risk of side effects:
   10. If you have had any mental health problems
   11. If you are feeling depressed or have thoughts of suicide
   12. Talk to your doctor or go to the hospital immediately.
   13. If you are taking antidepressant medicines
   14. High blood pressure and Zyban
   15. Lab tests
   16. Zyban and other medicines
   17. The risk of seizures may be higher than usual if you are taking:
   18. If you are taking any of these medicines, talk to your doctor before taking Zyban (see section 3 "Some patients may need a lower dose").
   19. If you are taking any of these medicines, talk to your doctor.
   20. Zyban may reduce the effectiveness of some medicines:
   21. When stopping smoking, you may need to reduce the dose of some medicines.
   22. Zyban and alcohol
   23. Pregnancy and breastfeeding
   24. Driving and using machines
   25. If you experience these symptoms, do not drive or operate machinery.
5. How to take Zyban
   1. Some patients may need a lower dose
   2. How to take Zyban tablets
   3. Zyban tablets should be taken with at least 8 hours between doses. Avoid taking it before bedtime
   4. Taking more than the recommended dose of Zyban
   5. Missing a dose of Zyban
   6. Stopping treatment with Zyban
6. Possible side effects
   1. Serious side effects Seizures
   2. If you experience any symptoms of an allergic reaction, talk to your doctor immediately. Do not take any more doses of Zyban. Stevens-Johnson syndrome or worsening of lupus
   3. If you experience a worsening of lupus, skin rash, or skin changes (especially on sun-exposed areas), talk to your doctor immediately, as you may need to stop treatment.
   4. Acute generalized exanthematous pustulosis
   5. If you experience a skin rash with pus-filled blisters, talk to your doctor immediately, as you may need to stop treatment.
   6. Other side effects
   7. Very common side effects
   8. Common side effects
   9. Uncommon side effects
   10. Rare side effects
   11. Very rare side effects
   12. Frequency not known
   13. Withdrawal symptoms from stopping smoking
   14. Reporting side effects
7. How to store Zyban
8. Contents of the pack and other information
   1. What Zyban contains
   2. What Zyban looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:

Package Leaflet: Information for the User

Zyban, 150 mg, prolonged-release tablets

Bupropion hydrochloride

Read all of this leaflet carefully before taking 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.

Contents of the pack and other information

• 1. What Zyban is and what it is used for
• 2. 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 prescription-only medicine to help you stop smoking when you are also receiving motivational support, for example, through a support program.

Treatment with Zyban is most successful in patients who are highly motivated to quit smoking.

to stop smoking. You should talk to your doctor or pharmacist for information about available treatments or other support methods.

2. Before you take Zyban

When not to take Zyban

• If you are allergicto bupropion or any of the other ingredients of this medicine (listed in section 6)
• If you are taking any other medicine containing bupropion(e.g. Wellbutrin XR, a medicine used to treat depression)
• If you have a seizure disorder(e.g. epilepsy) or have had seizures in the past
• If you have had an eating disorder(e.g. bulimia or anorexia nervosa)
• If you have severe liver disease, such as cirrhosis
• If you have a brain tumor
• If you are dependent on alcoholand are cutting down or stopping your alcohol intake
• If you are taking sedatives or benzodiazepinesand are stopping or reducing your dose
• If you have bipolar disorder, as bupropion may cause an episode of mania
• If you are taking antidepressant medicinesor have taken them in the last 14 days. This period may be shorter for some types of antidepressants, and your doctor will advise you.

If any of the above apply to you, do not take Zyban. Talk to your doctor.

Warnings and precautions

Before taking Zyban, talk to your doctor or pharmacist, as there may be a higher risk of side effects (see also section 4).

Brugada syndrome

• If you have been diagnosed with Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there is a family history of sudden death or cardiac arrest.

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 about 1 in 1,000 patients (see also "Zyban and other medicines" in section 2 and section 4 "Possible side effects"). Seizures can occur more frequently:

• If you regularly drink large amounts of alcohol
• If you have diabetesand are taking insulin or oral antidiabetic medicines
• If you have had a serious head injuryor have had a head injury in the past. If any of these apply to you, do not take Zyban unless your doctor advises you to do so. If you have a seizure while taking Zyban:

Stop taking Zyban and do not take it again. See your doctor.

You may be at a higher risk of side effects:

• If you have liver or kidney disease
• If you are over 65 years old.You may need to take a lower dose (see section 3) and be closely monitored by your doctor while taking Zyban.

If you have had any mental health problems

Some patients taking Zyban have had hallucinations or delusions (seeing, hearing, or believing things that are not there), disordered thinking, or extreme mood swings. These are more likely to occur in patients who have had mental health problems in the past.

If you are feeling depressed or have thoughts of suicide

Some patients trying to stop smoking have become depressed; very rarely, they may think about committing suicide or attempt to do so. These symptoms have occurred in patients taking Zyban, usually in the first few weeks of treatment. If you are feeling depressed or have thoughts of suicide:

Talk to your doctor or go to the hospital immediately.

If you are taking antidepressant medicines

Taking these medicines with Zyban may increase the risk of a potentially life-threatening condition called serotonin syndrome (see "Zyban and other medicines" in this section).

High blood pressure and Zyban

Some patients taking Zyban have had an increase in blood pressure that required treatment. If you have a history of high blood pressure, it may increase further. This is more likely if you are also using nicotine patchesto help you stop smoking.
Your blood pressure will be checkedbefore you start taking Zyban and monitored during treatment, especially if you have a history of high blood pressure.
If you are using nicotine patches, your blood pressure should be checked every week.
If your blood pressure increases, you may need to stop taking Zyban.

Lab tests

Zyban may interfere with the results of urine tests for other medicines. If you are going to have a urine test, tell your doctor or nurse that you are taking Zyban.

Zyban and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

The risk of seizures may be higher than usual if you are taking:

• antidepressant medicines or medicines used for other mental health conditions (see also "When not to take Zyban" at the beginning of section 2)
• theophyllineused for asthma or lung disease
• tramadol, a strong painkiller
• anti-malarial medicines
• stimulantsor other weight-control or appetite-suppressing medicines
• steroids(except for creams and eye drops used for skin or eye conditions)
• antibioticscalled quinolones
• certain antihistaminesused mainly for allergies, which can cause drowsiness
• antidiabetic medicines, insulin

If you are taking any of these medicines, talk to your doctor before taking Zyban (see section 3 "Some patients may need a lower dose").

Some medicines may affect how Zyban works or increase the risk of side effects. These include:

• antidepressant medicines (such as desipramine, imipramine, paroxetine, citalopram, escitalopram, venlafaxine) or medicines used for other mental health conditions (such as risperidone, thioridazine). Zyban may interact with antidepressant medicines, and you may experience changes in mental state (e.g., agitation, hallucinations, coma), and other symptoms such as: body temperature above 38°C, rapid heart rate, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea).
• medicines used to treat Parkinson's disease (e.g., levodopa, amantadine, orphenadrine)
• carbamazepine, phenytoin, or valproateused to treat epilepsy and some mental health conditions
• certain cancer medicines (e.g., cyclophosphamide, ifosfamide)
• ticlopidineor clopidogrel, mainly used to treat heart conditions or strokes
• certain beta-blockers (e.g., metoprolol), mainly used to treat high blood pressure
• certain medicines used to treat irregular heart rhythms (e.g., propafenone, flecainide)
• ritonaviror efavirenz, used to treat HIV infection

If you are taking any of these medicines, talk to your doctor.

Your doctor will assess the benefits and risks of taking Zyban or may advise you to change the dose of your other medicine.

Zyban may reduce the effectiveness of some medicines:

• If you are taking tamoxifen for breast cancer, tell your doctor.You may need to change your smoking cessation method.
• If you are taking digoxin for heart problems, tell your doctor.Your doctor may need to adjust your digoxin dose.

When stopping smoking, you may need to reduce the dose of some medicines.

Chemicals absorbed into the body while smoking can reduce the effectiveness of some medicines. When stopping smoking, you may need to reduce the dose of these medicines; otherwise, you may experience side effects. If you are taking any other medicines, talk to your doctor if you notice any new symptoms that you think may be side effects.

Zyban and alcohol

Some patients are more sensitive to the effects of alcohol while taking Zyban. Your doctor may advise you to stop drinking alcohol or reduce your intake while taking Zyban. If you are currently drinking a lot of alcohol, do not stop suddenly, as this may increase the risk of seizures.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take Zyban. Talk to your doctor or pharmacist before taking this medicine.
Some studies suggest an increased risk of birth defects, particularly heart defects, in babies whose mothers took Zyban. It is not known if this is due to Zyban.
Zyban ingredients may pass into breast milk. Talk to your doctor or pharmacist before taking Zyban.

Driving and using machines

Some side effects of Zyban, such as dizziness and feeling faint, may affect your ability to concentrate and react.

If you experience these symptoms, do not drive or operate machinery.

3. How to take Zyban

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Some patients may need a lower dose

as they may be more likely to experience side effects. This includes patients:

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

How to take Zyban tablets

Zyban tablets should be taken with at least 8 hours between doses. Avoid taking it before bedtime

as it may cause difficulty sleeping.
Zyban can be taken with or without food.
Zyban tablets should be swallowed whole. Do not chew, crush, or split them, as this may increase the risk of side effects, including seizures.

Taking more than the recommended dose of Zyban

Taking too many tablets may increase the risk of seizures or other side effects.

Do not delay.Talk to your doctor or go to the emergency room immediately.

Missing a dose of Zyban

If you miss a dose, wait and take the next dose at the usual time.
Do not take a double doseto make up for the missed dose.

Stopping treatment with Zyban

To get the full benefit of the treatment, you may need to take Zyban for 7 weeks.
Do not stop taking Zyban without talking to your doctor. You may need to gradually reduce your dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects Seizures

About 1 in 1,000 patients taking Zyban may have a seizure.
Seizure symptomsinclude convulsions and usually loss of consciousness. A patient who has had a seizure may be confused and not remember what happened afterward.
The risk of seizures is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures (see section 2).
If you have a seizure, talk to your doctor after you have recovered. Do not take Zyban again.
Allergic reactions
Rarely (in less than 1 in 1,000 patients), potentially serious allergic reactions to Zyban may occur. Symptoms of an allergic reaction include:

• skin rash (including itchy hives). Some rashes may need hospital treatment, especially if they are accompanied by mouth or eye pain.
• unusual wheezing or difficulty breathing
• swelling of the eyelids, lips, or tongue
• muscle or joint pain
• fainting or brief loss of consciousness.

If you experience any symptoms of an allergic reaction, talk to your doctor immediately. Do not take any more doses of Zyban. Stevens-Johnson syndrome or worsening of lupus

Frequency not known - frequency cannot be estimated from the available data.
Lupus is an immune system disorder that affects the skin and other organs.

If you experience a worsening of lupus, skin rash, or skin changes (especially on sun-exposed areas), talk to your doctor immediately, as you may need to stop treatment.

Acute generalized exanthematous pustulosis

Frequency not known - frequency cannot be estimated from the available data. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pus-filled blisters.

If you experience a skin rash with pus-filled blisters, talk to your doctor immediately, as you may need to stop treatment.

Other side effects

Very common side effects

May affect more than 1 in 10 patients:

• difficulty sleeping (avoid taking Zyban before bedtime).

Common side effects

May affect up to 1 in 10 patients:

• depression (see also "Warnings and precautions" in section 2)
• feeling anxious or agitated
• difficulty concentrating
• tremors
• headache
• nausea, vomiting
• abdominal pain and other symptoms (constipation), change in taste, dry mouth
• fever, dizziness, sweating, skin rash (sometimes with allergic reactions), itching.

Uncommon side effects

May affect up to 1 in 100 patients:

• ringing in the ears, vision disturbances
• increase in blood pressure (sometimes significant), flushing
• loss of appetite (anorexia)
• weakness
• chest pain
• disorientation
• rapid heart rate.

Rare side effects

May affect up to 1 in 1,000 patients:

• seizure (see the beginning of this section)
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination (ataxia)
• heart palpitations
• fainting or feeling faint when standing up, caused by a drop in blood pressure
• feeling irritable or hostile; unusual dreams (including nightmares)
• memory problems
• tingling or numbness
• severe allergic reactions; skin rash with accompanying joint or muscle pain (see the beginning of this section)
• increased urination or decreased urination
• severe skin reactions, which may involve the mouth or other parts of the body and may be life-threatening
• worsening of psoriasis (red thickening of the skin)
• jaundice (yellowing of the skin or whites of the eyes), increased liver enzyme activity, liver inflammation
• changes in blood sugar levels
• feeling unreal or strange (depersonalization), seeing or hearing things that are not there (hallucinations).

Very rare side effects

May affect less than 1 in 10,000 patients:

• feeling restless, aggressive
• feeling or believing things that are not real (delusions); exaggerated suspiciousness (paranoia)
• involuntary urination (incontinence, uncontrolled urine leakage).

Frequency not known

Other side effects have occurred in a small number of patients, but their frequency is not known:

• Thoughts of self-harm or suicide while taking Zyban or soon after stopping treatment (see section 2). If you have these thoughts, talk to your doctor or go to the hospital immediately.
• Loss of contact with reality and ability to think or assess situations (psychosis), other symptoms may include hallucinations and (or) delusions.
• Sudden and intense anxiety (panic attack).
• Stuttering.
• Decreased red blood cell count (anemia), decreased white blood cell count (leukopenia), and decreased platelet count (thrombocytopenia).
• Low sodium levels in the blood (hyponatremia).
• Changes in mental state (e.g., agitation, hallucinations, coma), and other symptoms such as: body temperature above 38°C, rapid heart rate, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea) when taking Zyban with antidepressant medicines (e.g., paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Withdrawal symptoms from stopping smoking

Patients stopping smoking may experience withdrawal symptoms from nicotine. This can also occur in patients taking Zyban. Symptoms of nicotine withdrawal include:

• difficulty sleeping
• tremors or sweating
• feeling anxious, agitated, or depressed, sometimes with suicidal thoughts. Talk to your doctorif you have any concerns about your condition.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zyban

Keep this medicine out of the sight and reach of children.
Do not take Zyban after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
The packaging is labeled with the batch number.
Do not store above 25°C.
Store in the original packaging.
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 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, cysteine hydrochloride monohydrate, magnesium stearate, purified water.
Coating
concentrate of white color: Opadry OY-7300 white or Opadry YS-1-18202-A white, carnauba wax, purified water.
Opadry OY-7300 white and Opadry YS-1-18202-A white contain: hypromellose 2910 6cP, titanium dioxide (E 171), macrogol 400.
The composition of the 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, biconvex, and round with "GX CH7" printed on one side. They are available in packs of 30, 60, or 100 tablets in child-resistant blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (0-22) 576 9000
Date of last revision of the leaflet:September 2023