ZYNTABAC 150 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Zyntabac

Do not take Zyntabac:

• to bupropion or any of the other components of this medication (listed in section 6)
• (such as Elontril, for the treatment of depression)

• such as epilepsy, or if you have a history of seizures
• (such as bulimia or anorexia nervosa)
• such as cirrhosis

• and decide to stop drinking alcohol or if you are going to stop drinking alcohol during treatment with Zyntabac
• (especially benzodiazepines or similar medications), or if you decide to stop taking these medications during treatment with Zyntabac

• (sudden mood changes), as Zyntabac may lead to the onset of an episode of this disease

• or have taken in the last 14 days medications for depressionor Parkinson's disease called monoamine oxidase inhibitors (MAOIs). Your doctor will inform you that this time period 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. The reason is that some diseases 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 hereditary syndrome 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)

It has been shown that Zyntabac can cause seizures (convulsions) in about 1 in 1,000 people (see also "Other medications and Zyntabac" in this section and section 4, "Possible side effects", for more information). You are more likely to have seizures:

• that is being treated with insulin or oral tablets
• or have had a head trauma 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 never take it again. Consult your doctor.

You may have a higher risk of having side effects:

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 delusional ideas (seeing, hearing, or believing things that do not exist), thought disorders, or sudden mood changes. These effects are more likely to occur in people who have had mental illnesses in the past.

If you feel depressed or have suicidal thoughts…

Some people become depressed when trying to quit smoking; very occasionally, they may think about suicide or attempt it. 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 medications for depression…

The use of these medications along with Zyntabac can cause serotonin syndrome, a potentially life-threatening condition (see "Other medications 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 worsen. It is more likely to happen if you are also using nicotine patches to help you quit smoking.

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

Other medications and Zyntabac

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

There may be a higher than usual risk of having seizures if you take:

• medications for depression or other mental illnesses (see also "do not take Zyntabac" at the beginning of section 2)
• theophyllinefor asthma or pulmonary disease
• tramadol,a potent pain reliever
• medications against malaria
• stimulantsor other medications to control weight or appetite
• steroids(except creams and lotions for eye and skin diseases)
• antibioticscalled quinolones
• certain types of antihistaminesused mainly to treat allergies, which can cause drowsiness
• medications for diabetes.

• If you are taking any of the medications on this list, inform your doctor immediately,before taking Zyntabac (see section 3 below "Some people need to take a lower dose").

Some medications may affect the functioning of Zyntabac or increase the risk of having side effects. These include:

• medications to treat depression (such as desipramine, imipramine, paroxetine, citalopram, escitalopram, venlafaxine) or other mental illnesses (such as risperidone, thioridazine). Zyntabac may interact with some medications used to treat depression, and you may experience changes in mental state (such as agitation, hallucinations, coma) and other side effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea)
• medications for Parkinson's disease (such as levodopa, amantadine, or orphenadrine)
• carbamazepine, phenytoinor valproate,to treat epilepsy or some mental illnesses
• certain medications used to treat cancer (such as cyclophosphamide, ifosfamide)
• ticlopidineor clopidogrel,mainly used to treat heart diseases or stroke
• certain beta-blockers (such as metoprolol), mainly used to treat high blood pressure
• certain medications for irregular heart rhythm (such as propafenone, flecainide)
• ritonaviror efavirenz,for the treatment of HIV infection.

• If you are taking any medication on this list, consult your doctor.Your doctor will assess the benefits and risks of you taking Zyntabac, or may decide to change the dose of other medications you are taking.

Zyntabac may make other medications less effective:

Inform your doctor if you are in this situation.It may be necessary to change your treatment to quit smoking.

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

It may be necessary to reduce the dose of some medications when you quit smoking

When you smoke, the chemicals absorbed into your body can make some medications less effective. When you quit smoking, you may need to reduce the dose of these medications; otherwise, you may have side effects.

If you are taking other medications, consult your doctor if you 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 abruptly, 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 medications or substances. If you need a urine test, inform your doctor or hospital that you are taking Zyntabac.

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 medication. 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 using machines

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

If this affects you, do not drive or operate machinery.

3. How to take Zyntabac

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

Some people need to take a lower dose

… because they are more likely to have side effects.

• if you are over 65 years old
• if you have liver or kidney disease
• if you have a higher risk of having seizures (see "Warnings and precautions" and "Other medications and Zyntabac" in section 2).

For these people, the maximum recommended dose is one 150 mg tablet per day.

How to take your tablets

Take your Zyntabac tablets with at least 8 hours between them. Do not take Zyntabac before going to bed -it may cause 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 into your body too quickly and you are more likely to have side effects, including seizures.

If you take more Zyntabac than you should

If you take more tablets than prescribed by your doctor, you are more likely to have seizures or other side 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 Toxicology 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 doseto make up for missed doses.

If you stop treatment with Zyntabac

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

Do not stop treatment with Zyntabac without consulting your doctor first.You may need to gradually reduce your dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Epileptic Seizures (Convulsions)

Approximately 1 in every 1,000 people taking Zyntabac are at risk of having epileptic seizures.

Among the symptoms of epileptic seizuresare convulsions and often loss of consciousness. After an epileptic seizure, you may feel confused and may not remember what happened.

It is more likely that you will have an epileptic seizure if you take more tablets than you should, if you are taking other medicines, or if you have a higher than usual risk of having an epileptic seizure (see section 2).

• If you have an epileptic seizure,inform your doctor once you have recovered. Do not take any more Zyntabac.

Allergic Reactions

Rarely (up to 1 in every 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 "wheezing" in the chest or difficulty breathing.
• swelling of eyelids, lips, or tongue.
• muscle or joint pain.
• fainting or loss of consciousness.

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

Cutaneous Lupus Erythematosus or Worsening of Lupus Symptoms

Unknown frequency: the frequency cannot be estimated with the available data from people taking Zyntabac. Lupus is an immune system disorder that affects the skin and other organs.

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

Acute Generalized Exanthematous Pustulosis (AGEP)

Unknown frequency: the frequency cannot be estimated with the available data from people taking Zyntabac.

The symptoms of AGEP include a rash with pus-filled blisters/grains.

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

Other Adverse Effects

Very Common Adverse Effects

May affect more than 1 in every 10people:

• difficulty sleeping (make sure not to take Zyntabac in the hours before going to bed).

Common Adverse Effects

May affect up to 1 in every 10people:

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

Uncommon Adverse Effects

May affect up to 1 in every 100people:

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

Rare Adverse Effects

May affect up to 1 in every 1,000people:

• epileptic seizures (see the beginning of this section).
• muscle spasms, muscle stiffness, lack of coordination, walking or coordination problems (ataxia).
• palpitations.
• fainting or feeling faint when standing up suddenly due to a drop in blood pressure.
• irritability or hostility; unusual dreams (including nightmares).
• memory loss.
• tingling or numbness.
• severe allergic reactions; rashes associated with muscle and joint pain (see the beginning of this section).
• 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 (thickening or reddening of the skin).
• change in skin or eye color to yellow (jaundice), elevation of liver enzymes, hepatitis.
• changes in blood sugar levels.
• feelings of unreality or strangeness (depersonalization); seeing or hearing things that do not exist (hallucinations).

Very Rare Adverse Effects

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

• feeling of restlessness, aggression.
• feeling or believing unreal things (delusional ideas), severe distrust (paranoia).
• urinary incontinence (involuntary urination, loss of urine).
• loss or unusual thinning of hair (alopecia).

Unknown Frequency

Other adverse effects have occurred in a small number of people, but their 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 taking 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 delusions.
• sudden feeling of intense fear (anxiety crisis).
• stuttering.
• reduction in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).
• decrease in sodium levels in the blood (hyponatremia).
• changes in mental state (e.g., agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, increased heart rate, 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 Adverse Effects

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

5. Storage of Zyntabac

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

Do not use this medicine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

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

Store in the original packaging.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Zyntabac Composition

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

The other ingredients are:

Core of the tablet: microcrystalline cellulose, hypromellose, cysteine hydrochloride monohydrate, magnesium stearate.

Coating of the tablet: hypromellose, macrogol 400, titanium dioxide (E171), carnauba wax.

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

Appearance of the Product and Package Contents

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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

Zyntabac: Spain, Netherlands.

Date of the last revision of this leaflet:March 2024

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