Prospecto:Information for the User

Zyntabac 150 mg prolonged-release tablets

bupropion hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey do not appear in this prospect.See section 4.

Zyntabac is a prescription medication prescribed by your doctor to help you quit smoking when you are motivated to do so or as part of smoking cessation support programs.

Zyntabac will be more effective if you are completely sure you want to quit smoking.Ask your doctor or pharmacist about treatments and other aids to help you quit smoking.

Do not take Zyntabac:

• if you are allergicto bupropion or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking other medicines that contain bupropion(such as Elontril,for the treatment of depression)

• if you have a condition that causes seizures (convulsions),such as epilepsy,or if you have a history of seizures
• if you have,or have had,any eating disorder(such as bulimia or anorexia nervosa)
• if you have a severe liver dysfunction,such as cirrhosis

• if you have a brain tumor
• if you drink a lot of alcohol regularlyand decide to stop drinking or if you are going to stop drinking alcohol during treatment with Zyntabac
• if you have recently stopped taking sedatives or medicines for the treatment of anxiety(especiallybenzodiazepinesor similar drugs), or if you decide to stop taking these medicines during treatment with Zyntabac

• if you have bipolar disorder(sudden changes in mood), as Zyntabac may lead to the onset of an episode of this disease

• if you are taking,or have taken in the last 14 days,medicines for depressionor Parkinson's disease calledmonoamine oxidase inhibitors(MAOIs). Your doctor will inform you that this period of time may be shorter for some types of MAOIs.

• Inform your doctor immediately if you are in any of these situations and do not take Zyntabac.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zyntabac. This is because some conditions make it more likely that you will have side effects (see also section 4).

Brugada syndrome

If you have a condition called Brugada syndrome (a rare inherited condition that affects heart rhythm) or if there has been a cardiac arrest or sudden death in your family.

Children and adolescents

Zyntabac is not recommended for people under 18 years of age.

Adults

Seizures (convulsions)(convulsions)

Zyntabac has been shown to cause seizures (convulsions) in about 1 in 10,000 people (see also “Other medicines and Zyntabac” in this section and section 4, “Possible side effects”, for more information). You are more likely to have seizures:

• if you drink a lot of alcohol regularly
• if you have diabetesthat is being treated with insulin or oral tablets
• if you have had a severe head injuryor have had a head injury in the past.

If you are in any of these situations, do not take Zyntabac unless you have agreed with your doctor that there is a good reason to do so.

If you experience seizures (convulsions) during treatment:

• Stop taking Zyntabac and do not take it again. Consult your doctor.

You may be at a higher risk of having side effects:

• if you have kidney or liver problems
• if you are over 65 years old.

You will need to take a lower dose (see section 3) and be closely monitored while taking Zyntabac.

If you have had any mental illness…

During treatment with Zyntabac, some people have had hallucinations or delusions (seeing, hearing, or believing things that are not there), thought disorders, or sudden changes in mood. This is more likely to happen in people who have had mental illnesses before.

If you feel depressed or have thoughts of suicide…

Some people become depressed when they try to quit smoking; very occasionally, they may think about or attempt suicide. These symptoms have appeared in people taking Zyntabac, especially in the first few weeks of treatment.

If you feel depressed or think about suicide:

• Get in touch with your doctor or go to the hospital immediately.

If you are taking medicines for depression…

The use of these medicines with Zyntabac can cause serotonin syndrome, a potentially fatal condition (see “Other medicines and Zyntabac” in this section).

High blood pressure and Zyntabac…

During treatment with Zyntabac, some people have needed treatment for high blood pressure. If you already have high blood pressure, this may get worse. This is more likely to happen if you are also usingnicotine patchesto help you quit smoking.

You will need to check your blood pressurebefore taking Zyntabac and while you are taking it, especially if you already had high blood pressure. If you are also using nicotine patches, you will need to check your blood pressure every week. If your blood pressure increases, you may need to stop taking Zyntabac.

Other medicines and Zyntabac

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medicine, even those bought without a prescription.

You may be at a higher risk of having seizures if you take:

• medicines for depressionor other mental illnesses(see also “do not take Zyntabac” at the beginning of section 2)
• theophyllinefor asthma or lung disease
• tramadol,a powerful painkiller
• medicines for malaria
• stimulantsor other medicines to controlweightorappetite
• steroids(except creams and lotions for eye and skin diseases)
• antibioticscalledquinolones
• some types of antihistaminesused mainly to treat allergies, which can cause drowsiness
• medicines for diabetes.

• Inform your doctor immediately if you are taking any of these medicines,before taking Zyntabac (see section 3 below “Some people need to take a lower dose”).

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

• medicinesfor treating depression(such as desipramine, imipramine, paroxetine,citalopram, escitalopram, venlafaxine) orother mental illnesses(such as risperidone, thioridazine).Zyntabac may interact with some medicines used to treat depression and may experience changes in mental state (for example, agitation, hallucinations, coma) and other side effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea)
• medicines for Parkinson's disease(such as levodopa, amantadine, orphenadrine)
• carbamazepine, phenytoinorvalproate,for treating epilepsy or somemental illnesses
• some medicines used to treat cancer(such as cyclophosphamide, ifosfamide)
• ticlopidineorclopidogrel,used mainly to treat heart disease or stroke
• somebeta-blockers(such as metoprolol), used mainly to treat high blood pressure
• some medicines for irregular heart rhythm(such as propafenone, flecainide)
• ritonavirorefavirenz,for treating HIV infection.

• Inform your doctor if you are taking any of these medicines.Your doctor will assess the benefits and risks of you taking Zyntabac, or may decide to change the dose of other medicines you are taking.

Zyntabac may make other medicines less effective:

• if you take tamoxifen used to treat cancer.

Inform your doctor if you are in this situation.You may need to change your treatment to quit smoking.

• if you take digoxin for the heart.

Inform your doctor if you are in this situation.Your doctor may consider adjusting the dose of digoxin.

You may need to reduce the dose of some medicines when you stop smoking

When you smoke, the chemicals absorbed into your body can make some medicines less effective. When you stop smoking, you may need to reduce the dose of these medicines, otherwise, you may experience side effects.

Inform your doctor if you are taking other medicines and experience any new symptoms that you think may be a side effect.

Use of Zyntabac with alcohol

Some people are more sensitive to alcohol during treatment with Zyntabac.Your doctor may suggest that you do not drink alcohol while taking Zyntabac, or that you try to drink as little as possible. If you currently drink a lot of alcohol, do not stop drinking suddenly, as you may be at risk of having a seizure.

Effect on urine tests

Zyntabac may interfere with some urine tests used to detect other medicines or substances.Inform your doctor or the hospital that you are taking Zyntabac if you need a urine test.

Pregnancy and breastfeeding

Do not take Zyntabac if you are pregnant, think you may be pregnant, or plan to become pregnant. Consult your doctor or pharmacist before using this medicine.Some studies, not all, have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers were taking Zyntabac. It is not known if this is due to the use of Zyntabac.

The components of Zyntabac may pass into breast milk. Ask your doctor or pharmacist for advice before taking Zyntabac.

Driving and operating machines

Some of the side effects of Zyntabac, such as dizziness or feeling unwell, may affect your concentration and judgment.

Do not drive or operate machinesif this affects you.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Some people need to take a lower dose

… as they have a higher probability of suffering adverse effects.

• If you are over 65 years old
• If you have liver or kidney disease
• If you have a higher risk of suffering epileptic seizures (see “Warnings and precautions” and “Other medications and Zyntabac” in section 2).

For these people, the maximum recommended dose isone tablet of 150 mg per day.

How to take your tablets

Take your Zyntabac tablets with at least 8 hours of difference between one and another. Do not take Zyntabac before going to bed -it may cause you difficulty sleeping.

You can take Zyntabac with or without food.

Swallow the Zyntabac tablets whole.Do not chew, crush, or divide them - if you do, the medication will be released in your body too quickly and you are more likely to have adverse effects, including epileptic seizures.

If you take more Zyntabac than you should

If you take more tablets than indicated by your doctor, you are more likely to have epileptic seizures or other adverse effects.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Zyntabac

If you forget to take a dose, wait and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you discontinue treatment with Zyntabac

You may need to take Zyntabac for more than 7 weeks for it to have its full effect.

Do not discontinue treatment with Zyntabac without having consulted your doctor first.You may need to reduce your dose gradually.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Seizures (convulsions)

About 1 in 1,000 people who take Zyntabac have a risk of having seizures.

Between the symptoms of seizuresinclude convulsions and often loss of consciousness. After a seizure, you may feel confused and may not remember what happened.

You are more likely to have a seizure if you take more tablets than you should, if you are taking other medicines or if you have a higher risk than usual of having a seizure (see section 2).

• If you have a seizure,tell your doctor as soon as you have recovered.Do not take more Zyntabac.

Allergic reactions

Rarely (up to 1 in 1,000) some people may have potentially severe allergic reactions to Zyntabac. The signs of allergic reactions include:

• skin rash (including itching, blisters or hives on the skin). Some skin rashes may require hospitalization, especially if they are accompanied by swelling of the mouth and eyes
• abnormal appearance of “pops” in the chest or difficulty breathing
• swelling of eyelids, lips or tongue
• muscle or joint pain
• syncope or fainting.

• If you have any sign of an allergic reaction, contact a doctor immediately. Do not take more tablets.

Systemic lupus erythematosus or worsening of lupus symptoms

Frequency not known: the frequency cannot be estimated with the available data from people taking Zyntabac. Lupus is an autoimmune disorder that affects the skin and other organs.

• If you experience an exacerbation of lupus, skin rash or lesions (particularly in exposed areas) while taking Zyntabac, contact your doctor immediately, as it may be necessary to interrupt treatment.

Generalized Acute Exanthematous Pustulosis (GPE)

Frequency not known: the frequency cannot be estimated with the available data from people taking Zyntabac.

The symptoms of GPE include a rash with pus-filled blisters.

• If you experience a rash with pus-filled blisters, contact your doctor immediately, as it may be necessary to interrupt treatment.

Other side effects

Very common side effects

These may affect more than 1 in 10 people:

• difficulty sleeping (make sure not to take Zyntabac in the hours leading up to bedtime).

Common side effects

These may affect up to 1 in 10 people:

• feeling depressed (see also “Warnings and precautions” in section 2)
• feeling anxious or agitated
• difficulty concentrating
• agitation (tremors)
• headache
• nausea, vomiting
• stomach pain or other disorders (such as constipation), altered sense of taste, dry mouth
• fever, dizziness, sweating, skin rash (sometimes due to an allergic reaction), itching.

Uncommon side effects

These may affect up to 1 in 100 people:

• ringing in the ears, visual disturbances
• elevated blood pressure (sometimes severe), flushing
• loss of appetite (anorexia)
• weakness
• chest pain
• confusion
• rapid heartbeat (tachycardia).

Rare side effects

These may affect up to 1 in 10,000 people:

• seizures (see the beginning of this section)
• muscle spasms, muscle stiffness, lack of coordination of movements, problems walking or coordination (ataxia)
• palpitations
• syncope or fainting, feeling faint when standing up suddenly due to low blood pressure
• irritability or hostility; rare dreams (including nightmares)
• memory loss
• tingling or numbness
• severe allergic reactions; skin rashes accompanied by muscle and joint pain (see the beginning of thissection)
• urinating more or less than usual
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening
• worsening of psoriasis (plaques of thickening or redness of the skin)
• change in skin or eye white to yellow (jaundice), elevated liver enzymes, hepatitis
• changes in blood sugar levels
• sensations of feeling unreal or strange (depersonalization); seeing or hearing things that do not exist (hallucinations).

Very rare side effects

These may affect up to 1 in 10,000 people:

• feeling anxious, aggressive
• feeling or believing things that are unreal (delusions), severe distrust (paranoia)
• urinary incontinence (involuntary urination, loss of urine)
• unusual loss or thinning of hair (alopecia).

Frequency not known

Other side effects have occurred in a small number of people, but the exact frequency is unknown:

• thoughts of self-harm or suicide during treatment with Zyntabac or shortly after stopping treatment (see section 2,“What you need to know before starting to take Zyntabac”). If you have these thoughts,contact your doctor or go to the hospital immediately
• loss of contact with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delirium
• sudden intense fear (panic attack)
• stammering
• reduction in red blood cells (anemia), white blood cells (leucopenia) and platelets (thrombocytopenia)
• decrease in sodium in the blood (hyponatremia)
• changes in mental state (e.g. agitation, hallucinations, coma) and other side effects such as high body temperature, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea), while taking Zyntabac with other medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).

Effects of quitting smoking

Some people who quit smoking are affected by nicotine withdrawal. This can also affect people taking Zyntabac. Among the signs of nicotine withdrawal are:

• difficulty sleeping
• tremors or sweating
• feeling anxious, agitated or depressed, sometimes with suicidal thoughts.

Consult your doctorif you are concerned about how you feel.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store this medication at a temperature above 25°C.

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zyntabac

The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.

The other components are:

Tablet core: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate.

Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), carnauba wax.

Printing ink: hypromellose, iron oxide black (E172).

Appearance of the product and contents of the packaging

Zyntabac 150 mg prolonged-release tablets are white, biconvex, round tablets marked on one face with “GX CH7”. They are available in boxes containing blisters of 30, 40, 50, 60 or 100 tablets.

Only some packaging sizes may be marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing

This medicine is authorized in the member states of the European Economic Areawith the following names:

Zyban: Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal, Sweden, Netherlands.

Zyntabac: Spain,Netherlands.

Last review date of this leaflet:March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/