150 mg prolonged-release tablet er
bupropion hydrochloride
What Zyban is and what it is used for
Zyban is a medicine prescribed for you to help you stop smoking, along with motivational support such as participation in a smoking cessation program.
Treatment with Zyban is most effective if you are completely convinced to stop smoking. Ask your doctor or pharmacist about treatments and other support to help you quit.
What you need to know before you use Zyban
Do not use 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 containing bupropion (such as Voxra, for the treatment of depression )
- if you have a condition that causes seizures, such as epilepsy, or if you have previously had seizures
- if you have or have had an eating disorder (for example bulimia or anorexia nervosa )
- if you have serious liver problems, such as cirrhosis
- if you have a brain tumor
- if you usually drink a lot of alcohol and have just stopped drinking alcohol or if you will stop while using Zyban
- if you have recently stopped using tranquilizers or medicines to treat anxiety (especially benzodiazepines or similar medicines) or if you will stop taking them while you are using Zyban
- if you have manic-depressive (bipolar) disorder (extreme mood swings). Zyban can induce an episode of this disorder.
- if you are using medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs ) or if you have taken such medicines within the last 14 days. The time may be shorter for some types of MAO inhibitors, ask your doctor.
- If any of these apply to you, talk to your doctor immediately and stop using Zyban.
Warnings and precautions
Talk to your doctor or pharmacist before using Zyban, as some conditions make you more likely to have side effects ( see also section 4).
Children and young people
Zyban is not recommended for people under 18 years of age.
Adults
Seizures
Zyban can cause seizures in about 1 in 1,000 people (For more information, see also “Other medicines and Zyban” later in this section and section 4, “Possible side effects”). Seizures are more likely:
- if you regularly drink a lot of alcohol
- if you have diabetes that you treat with insulin or tablets
- if you have ever had a serious head injury.
Do not use Zyban if any of these apply to you without first agreeing with your doctor that there are good reasons.
If you have a seizure during treatment:
- Stop using Zyban and do not take any more tablets. Contact your doctor.
You may be at greater risk of side effects:
- if you have kidney or liver problems
- if you are older than 65 years.
You will need to take a lower dose ( see section 3 ) and be closely monitored while taking Zyban.
If you have had any mental health problems
Some people using Zyban have experienced hallucinations or delusions (seeing, hearing, or believing things that aren’t there), thought disorders, or extreme mood swings. These effects are more likely in people with a history of mental health problems.
If you feel depressed or have suicidal thoughts
Some people may become depressed when trying to quit smoking and in very rare cases these people have had suicidal thoughts or attempted suicide. Such symptoms have occurred in people taking Zyban, and have been most common during the very first weeks of treatment.
If you feel depressed and have suicidal thoughts.
- Contact your doctor or see a hospital as soon as possible.
If you are taking medication for depression
These medicines together with Zyban can lead to serotonin syndrome, which is a potentially life-threatening condition (see “Other medicines and Zyban” in this section).
High blood pressure and Zyban
Some people using Zyban have developed high blood pressure that requires treatment. If you already have high blood pressure, it can get worse. This is more likely if you also use nicotine patches to help you quit smoking.
Your blood pressure will be checked before you start Zyban and while you are taking it, especially if you already have high blood pressure. If you use nicotine patches at the same time, your blood pressure needs to be checked every week. If your blood pressure increases, you may need to stop using Zyban.
Other medicines and Zyban
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
There may be an increased risk of seizures if you take:
- medicines to treat depression or other mental health problems ( see also “Do not use Zyban” at the beginning of section 2 )
- theophylline for the treatment of asthma or another lung disease
- tramadol, a strong pain-relieving drug
- drugs against malaria
- stimulants or other medicines to control your weight or appetite
- steroids (except ointments, creams, and lotions for eye and skin problems)
- antibiotics called quinolones _
- certain types of antihistamines that are mainly used to treat allergies and that can cause tiredness
- drugs for the treatment of diabetes.
- If you are using any medicine from this list, talk to your doctor immediately before you start using Zyban ( see section 3 under “Some people need to take a lower dose” ).
Some medicines can affect how Zyban works or make you more likely to get side effects, such as:
- medicines to treat depression (such as desipramine, imipramine, paroxetine, citalopram, escitalopram, and venlafaxine ) or other mental health problems (such as risperidone and thioridazine). Zyban can affect or be affected by some medicines used to treat depression, and you may experience changes in mental status (eg agitation, hallucinations, coma ), and other side effects such as body temperature above 38°C, increased heart rate, unsteady blood pressure, and overactive reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).
- medicines to treat Parkinson’s disease (such as levodopa, amantadine, or orphenadrine)
- carbamazepine, phenytoin, or valproate to treat epilepsy or certain mental health problems
- certain medicines to treat cancer (such as cyclophosphamide and ifosfamide)
- ticlopidine or clopidogrel which is mainly used to treat heart disease or stroke
- certain beta blockers (such as metoprolol ) which are mainly used to treat high blood pressure
- certain medicines to treat irregular heart rhythms (such as propafenone and flecainide )
- ritonavir or efavirenz, for the treatment of HIV infection.
- Contact your doctor if you are using any medicine from this list. Your doctor will weigh the benefits against the risks for you of using Zyban and the doctor may need to adjust the doses of the other medicines you are taking.
Zyban can reduce the effect of other medicines
- if you are using tamoxifen to treat breast cancer. If this applies to you, talk to your doctor. It may be necessary to switch to another treatment for your smoking cessation.
- if you use digoxin for the heart. If this applies to you, talk to your doctor. The doctor may consider changing the dose of digoxin.
The dose of some medicines may need to be reduced while you stop smoking
When you smoke, the chemicals absorbed by your body can make certain medicines less effective. When you stop smoking, the doses of these medicines may need to be reduced, otherwise, you may experience side effects.
If you are taking any other medicines, contact your doctor if you notice any new symptoms that you think may be side effects.
Zyban with alcohol
Some people may find that they are more sensitive to alcohol while taking Zyban. Your doctor may advise you not to drink alcohol or to drink as little as possible while using Zyban. If you drink a lot, do not stop suddenly, as there may be a risk of you having a seizure.
Effect on urine tests
Zyban may interfere with certain urine tests used to detect other drugs. If you need a urine test, tell your doctor or hospital that you are taking Zyban.
Pregnancy and breastfeeding
Do not use Zyban if you are pregnant, think you may be pregnant, or are planning to have a baby. Consult a doctor or pharmacist before taking this medicine. Some studies, but not all, have reported an increased risk of malformations, especially heart defects, in children whose mothers took Zyban. It is not known if this is due to the use of Zyban.
The ingredients in Zyban pass into breast milk. Consult a doctor or pharmacist before taking this medicine.
Driving ability and use of machinery
Some side effects of Zyban such as feeling dizzy or faint can affect your ability to concentrate and judge.
If you have these symptoms, you should not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Zyban
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
| When to start and how much to take start taking Zyban while you are still smoking set a date for smoking cessation which should be during the second week of treatment. | ||
| Week 1Continue to smoke while taking Zyban | Day 1 to 6 | Take one tablet (150 mg) once daily. |
| Day 7 | Increase your dose to one tablet twice daily. There should be at least 8 hours between doses and avoid doses close to bedtime. | |
| Week 2 | Continue to take one tablet twice daily. Quit smoking this week on the day you set for smoking cessation. | |
| Weeks 3 to 9 | Continue to take one tablet twice daily for up to 9 weeks. If you have not been able to stop smoking after 7 weeks, your doctor will advise you to stop using Zyban. You may be advised to gradually stop using Zyban after 7-9 weeks. |
Some people need to take a lower dose because they are more likely to have side effects:
- if you are older than 65 years
- if you have liver or kidney disease
- if you have a higher risk of seizures ( see “Warnings and precautions” and “Other medicines and Zyban” in section 2 ).
The recommended maximum dose in these cases is one 150 mg tablet once daily.
How to take your tablets
Take your Zyban tablets at least 8 hours apart. Do not take Zyban close to bedtime – it may lead to difficulty sleeping.
You can take Zyban with or without food.
Swallow the Zyban tablets whole. The tablets should not be crushed, chewed, or split – if you do, there is a risk of overdose, as the medicine will leave your body too quickly. It can lead to an increased risk of side effects, including seizures.
If you have taken too much Zyban
If you take too many tablets, you are more likely to have a seizure or other side effects.
- Without delay, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zyban
If you have forgotten a dose, wait and take the next tablet as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking Zyban
You may need to take Zyban for up to 7 weeks to get the full effect.
Do not stop taking Zyban without first talking to your doctor. You may need to reduce your dose gradually.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Seizures
About 1 in 1,000 people who use Zyban are at risk of having a seizure.
Symptoms of seizures include convulsions and usually unconsciousness. A person who has had a seizure may be confused afterward and may not be able to remember what happened.
The likelihood of having a seizure is greater if you take too many tablets, if you take other medicines or if you have a higher than usual risk of having a seizure ( see section 2 ).
- If you have a seizure, tell your doctor when you are better. Do not use any more Zyban.
Allergic reactions
In rare cases (up to 1 in 1,000) people may have serious allergic reactions to Zyban. Signs of allergic reactions are:
- skin rash (including itchy and pitted rash). Some skin rashes may require hospital care, especially if you also have a sore mouth/throat or sore eyes.
- unusual wheezing or trouble breathing
- swelling of the eyelids, lips, or tongue
- muscle or joint pain
- collapse, or temporary and sudden memory loss.
- If you have any signs of an allergic reaction, contact your doctor immediately, and do not take any more tablets.
Lupus skin rash or worsening lupus symptoms
Frequency not known – cannot be estimated from available data in people taking Zyban. Lupus is a disease of the immune system that affects the skin and other organs.
- If you experience lupus flares, skin rashes, or lesions (especially on areas exposed to sunlight) while taking Zyban, contact your doctor immediately, as it may be necessary to stop treatment.
Acute generalized exanthematous pustulosis (AGEP)
Frequency not known – cannot be estimated from available data in people taking Zyban. Symptoms of AGEP include a rash with blisters/blisters.
- If you get a rash with filled pimples/blisters, you should immediately contact a doctor as it may be necessary to stop the treatment.
Other side effects are
Very common side effects are
Occurs in more than 1 in 10 users:
- Difficulty sleeping (do not take Zyban near bedtime).
Common side effects are
Occurs in up to 1 in 10 users:
- feeling depressed ( see also “Warnings and precautions” in section 2 )
- feeling anxious or upset
- concentration difficulties
- tremors _ _
- headache
- nausea and vomiting
- stomach ache or other disturbances (such as constipation), taste changes, and dry mouth
- fever, dizziness, sweating, rash (sometimes due to an allergic reaction ), and itching.
Less common side effects are
Occurs in up to 1 in 100 users:
- tinnitus and vision changes
- increased blood pressure (sometimes severe) and convulsions
- loss of appetite ( anorexia )
- feeling of weakness
- pain in the chest
- confusion
- rapid heartbeat.
Rare side effects are
Occurs in up to 1 in 1,000 users:
- seizures (see the beginning of this section)
- twitching, muscle stiffness, uncontrolled movements, trouble walking, or problems with coordination ( ataxia )
- palpitation
- fainting and feeling faint when you stand up quickly because your blood pressure drops
- feeling irritated or hostile, unusual dreams (including nightmares)
- memory loss
- tingling or numbness
- severe allergic reactions and rashes in connection with joint and muscle pain ( see the beginning of this section)
- urinating (throwing water) more or less than usual
- severe skin rashes in the mouth and other parts of the body, which can be life-threatening
- worsening psoriasis (thickened patches of red skin)
- yellowing of your skin or the whites of your eyes (jaundice), increased liver enzyme levels, and hepatitis
- changes in blood sugar levels
- unreal or strange feelings ( depersonalization ), hearing and seeing things that are not there ( hallucinations ).
Very rare side effects
Occurs in up to 1 in 10,000 users:
- the feeling of restlessness, aggressiveness
- sensing or believing things that are not true ( delusions ), and severe suspiciousness ( paranoia ).
- urinary incontinence (involuntary emptying of the bladder, urine leakage)
No known frequency
Other side effects have occurred in a few users, but the exact frequency is not known:
- thoughts of harming yourself or of suicide while using Zyban or soon after stopping treatment (see section 2, What you need to know before you use Zyban ). If you have similar thoughts, you should immediately contact a doctor or go to a hospital.
- loss of contact with reality and inability to think or judge clearly ( psychosis ); other symptoms may include hallucinations and/or delusions.
- stuttering
- decreased number of red blood cells ( anemia ), decreased number of white blood cells ( leukopenia ), and decreased number of platelets ( thrombocytopenia )
- decreased sodium levels in the blood ( hyponatremia ) changes in mental status (eg agitation, hallucinations, coma ), and other side effects such as body temperature above 38 °C, increased heart rate, unstable blood pressure, overactive reflexes, muscle stiffness, lack of coordination and/ or gastrointestinal symptoms (eg nausea, vomiting, diarrhea), may occur if you take Zyban with medicines used to treat depression (eg paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine ).
Reactions to quitting smoking
People who stop smoking often experience withdrawal symptoms from nicotine. This can also affect people using Zyban. Signs of nicotine withdrawal symptoms are:
- difficulty sleeping
- tremors and sweating
- anxiety, agitation, and depression, sometimes with suicidal thoughts.
Talk to your doctor if you have any concerns about how you are feeling.
How to store Zyban
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
Store in the original packaging.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Each tablet contains 150 mg of the active substance bupropion hydrochloride.
Other ingredients are Tablet core: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, and magnesium stearate. Film coating: hypromellose, macrogol 400, titanium dioxide (E171), carnauba wax. Printing ink: hypromellose, black iron oxide (dye E172).
Appearance and package sizes of the medicine
Zyban 150 mg tablets are white, film-coated, biconvex, and round and marked with “GX CH7” on one side. They are available in cartons containing child-resistant blisters of 30, 40, 50, 60, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline AB, Box 516, 169 29 Solna
Phone: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer
Glaxo Wellcome SA, Avenida de Extremadura, 3, 09400 Aranda de Duero, Burgos, Spain.
This medicine is approved within the European Economic Area
and Great Britain (Northern Ireland) under the names:
Zyban: Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, United Kingdom (Northern Ireland), Sweden, and Germany
Zyntabac: The Netherlands and Spain