BUPROPION SUN 300 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Bupropion SUN 150 mg modified-release tablets EFG

Bupropion SUN 300 mg modified-release tablets EFG

bupropion hydrochloride

Read all of this leaflet carefully before you start 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

1. What Bupropion SUN is and what it is used for
2. What you need to know before you take Bupropion SUN
3. How to take Bupropion SUN
4. Possible side effects
5. Storage of Bupropion SUN
6. Contents of the pack and other information

1. What Bupropion SUN is and what it is used for

Bupropion is a medicine prescribed by your doctor to treat depression. It is thought to work on certain substances in the brain called noradrenalineand dopamine.

2. What you need to know before you take Bupropion SUN

Do nottakeBupropion SUN

• If you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)
• If you are taking other medicines containing bupropion
• If you have been diagnosed with epilepsy or have a history of seizures
• If you have, or have had, any eating disorder (e.g. bulimia or anorexia nervosa)
• If you have a brain tumor
• If you are taking large amounts of alcohol and have started, or are about to start, alcohol withdrawal
• If you have severe liver disease
• If you have stopped taking sedatives, or are about to stop taking them while taking bupropion (see also section 2 "Do not take Bupropion SUN")
• If you are taking or have taken in the last two weeks other medicines for depression called monoamine oxidase inhibitors(MAOIs)

If you are in any of these situations, tell your doctor immediately and do not take bupropion.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bupropion.

Brugada syndrome

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

Children and adolescents

Bupropion is not recommended for the treatment of children under 18 years of age.

In patients under 18 years, there is an increased risk of suicidal thoughts and attempts when treated with antidepressants.

Adults

Tell your doctor before starting to take bupropion:

• If you regularly drink a lot of alcohol
• If you have diabetes that is being treated with insulin or oral tablets
• If you have had a severe head injury or have had a head trauma in the past.

It has been observed that bupropion can cause seizures (convulsions) in approximately 1 in 1,000 people. This side effect is more likely to occur in people who are in the situations mentioned above. If you have a seizure while taking bupropion, stop treatment. Do not take it again and visit your doctor.

• If you have bipolar disorder (very pronounced mood swings), bupropion may cause episodes of this illness
• If you are taking other medicines for depression, the use of these medicines together with bupropion may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Bupropion SUN" in this section)
• If you have any liver or kidney disease, the likelihood of having side effects is higher

If you are in any of these situations, consult your doctor before taking bupropion, who may decide to monitor you more closely or recommend another treatment.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks, but sometimes can be longer.

It is likely that you will experience this:

• If you have previously had thoughts of suicide or self-harm
• If you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were being treated with some antidepressants.

If you have thoughts of harming or killing yourself at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to explain to a family member or close friendthat you are depressed or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Other medicines and Bupropion SUN

Stop your treatment with bupropion and inform your doctor if you are taking or have taken antidepressant medicines called monoamine oxidase inhibitors(MAOIs) during the last two weeks (see also section 2 "Do not take Bupropion SUN").

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicines, including those obtained without a prescription. Your doctor may change the dose of bupropion or suggest a change in the other medicines.

Some medicines interact with bupropion. Some of them may increase the likelihood of having seizures or convulsions, and others may increase the risk of having other side effects. The following are some examples, although the list is not complete.

May increase the possibility of having seizures

• if you take other medicines for depression or other mental illnesses
• if you take theophylline used to treat asthma or other lung diseases
• if you take tramadol, a strong pain reliever
• if you have been taking sedatives, or if you are going to stop taking them while taking bupropion (see also section 2 "Do not take Bupropion SUN")
• if you take medicines to treat malaria (such as mefloquine or chloroquine)
• if you take stimulants or other medicines to control your weight or appetite
• if you use corticosteroids (by mouth or injectable)
• if you use antibiotics called quinolones
• if you use certain antihistamines that can cause drowsiness
• if you use medicines to treat diabetes.

If you are in any of these situations, inform your doctor immediately before taking bupropion. Your doctor will assess the risks and benefits of taking this medicine.

May increase the possibility of having other side effects

• if you take other medicines for depression (amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine, or imipramine) or other mental illnesses (clozapine, risperidone, thioridazine, or olanzapine). Bupropion may interact with some medicines used to treat depression and may experience changes in mental status (e.g. 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 (e.g. nausea, vomiting, diarrhea)
• if you take antiparkinsonian medicines (levodopa, amantadine, or orphenadrine)

• if you take medicines that affect your body's ability to eliminate bupropion (carbamazepine, phenytoin, valproate)

• if you take some medicines used to treat cancer (such as cyclophosphamide or ifosfamide)

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• if you take any beta-blocker medicine (metoprolol)
• if you take medicines to treat heart rhythm disorders (propafenone, flecainide)

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If you are in any of these situations, inform your doctor immediately before taking bupropion.

Bupropion SUN may be less effective

• if you take ritonavir or efavirenz, medicines to treat HIV (AIDS) infection.

Tell your doctor if you are taking any of these medicines. Your doctor will check if bupropion is working properly in you. It may be necessary to increase the dose or change to another treatment for your depression. Do not increase the dose of bupropion unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Bupropion SUN may make other medicines less effective

• If you take tamoxifen used to treat cancer.

Tell your doctor if you are in this situation. It may be necessary to change your treatment for depression.

• If you take digoxin for your heart.

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

Use of Bupropion SUN and alcohol

Alcohol may affect how bupropion works and, when taken together, can rarely affect your nerves or mental state. Some people have noticed that they are more sensitive to alcohol during treatment with bupropion. Your doctor may recommend that you do not drink alcohol (beer, wine, liquor) or that you drink very small amounts while taking bupropion. If you currently drink a lot of alcohol, do not stop suddenly, as you may be at risk of having a seizure.

Consult your doctor about alcohol consumptionbefore starting treatment with bupropion.

Effect on urine tests

Bupropion may interfere with some urine tests used to detect other medicines or substances. If you need a urine test, tell your doctor or hospital that you are taking bupropion.

Pregnancy and breastfeeding

Do not take bupropion if you are pregnant, think you may be pregnant, or plan to become pregnant unless your doctor prescribes it. 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 bupropion. It is not known if this is due to the use of bupropion.

The components of Bupropion may pass into breast milk. Consult your doctor or pharmacist before taking Bupropion.

Driving and using machines

Do not drive or use tools or machines if bupropion makes you feel dizzy or drowsy.

3. How to take Bupropion SUN

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. The recommended doses are included below, but your doctor will advise you on the appropriate dose for you. If in doubt, consult your doctor or pharmacist again.

It may take some time before you start to feel better.The medicine takes time to work fully, which can be weeks or months. When you start to feel better, your doctor may advise you to continue treatment with bupropion to prevent depression from coming back.

What dose to take

The usual recommended dose in adults is one 150 mg tablet per day.

If after several weeks you do not start to feel better, your doctor may increase the dose to 300 mg per day.

Take the bupropion tablets in the morning. Do not take bupropion more than once a day.

The tablet is covered by a film that slowly releases the medicine in your body. Sometimes you may notice that a kind of tablet appears in your stool. This is the empty coating that has passed through your intestine.

Swallow the tablets whole. Do not chew, crush, or divide them, as this can lead to an overdose due to the rapid release of the medicine in your body, increasing the likelihood of having side effects, including seizures.

Some people may maintain a dose of one 150 mg tablet per day throughout treatment. Your doctor may prescribe this dose in patients with liver or kidney problems.

Duration of treatment

Consult your doctor, who will indicate the duration of treatment with bupropion in agreement with you. It may take several weeks or months before you notice any improvement. Keep your doctor informed about your symptoms so that they can decide on the duration of treatment. Although you may start to feel better, your doctor may recommend continuing treatment with bupropion to prevent the symptoms of depression from coming back.

If you take more Bupropion SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to the emergency room or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you take more tablets than prescribed by your doctor, you may increase the risk of having seizures or convulsions.

If you forget to take Bupropion SUN

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Bupropion SUN

Do not stop treatment with bupropion or reduce the dose without consulting your doctor first.

If you have any other questions about the use of 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 or convulsions

Approximately 1 in 1,000 people taking bupropion have a risk of having a seizure (a fit or convulsion). This risk is higher if you take more tablets than you should, if you are taking certain medicines, or if you have a higher than usual risk of having fits. If you have any doubts, ask your doctor.

? Consult your doctor if you have a seizureand do not take any more tablets.

Allergic reactions

Some people may have allergic reactions to bupropion, including:

• Redness or skin rash (urticaria), 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
• Pain in muscles or joints
• Fainting or fainting spells

? Consult your doctor if you have an allergic reactionand do not take any more tablets.

Allergic reactions can last a long time.If your doctor prescribes any medicine for this, make sure to complete the treatment.

Discoid lupus erythematosusor worsening of lupus symptoms

Frequency not known: the frequency cannot be estimated from the available data from people taking bupropion. Lupus is a disorder of the immune system 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 bupropion sun, contact your doctor immediately, as it may be necessary to stop treatment.

Acute Generalized Exanthematous Pustulosis (AGEP)

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

The symptoms of AGEP include a rash with pus-filled bumps/vesicles.

What to do if you experience a rash with gravity

Other adverse effects

Very common adverse effects. These may affect more than 1 in 10 people:

• difficulty sleeping. Make sure to take bupropion in the morning
• headache
• dry mouth
• nausea, vomiting

Common adverse effects

These may affect up to 1 in 10 people:

• fever, dizziness, itching, sweating, and skin rash (sometimes due to allergic reactions)
• instability, tremor, weakness, fatigue, chest pain
• feeling anxious or agitated
• stomach pain or digestive discomfort (constipation), taste disturbances, loss of appetite (anorexia)
• increased blood pressure (sometimes severe), flushing
• ringing in the ears, vision disturbances

Uncommon adverse effects

These may affect up to 1 in 100 people:

• feeling depressed (see also section 2 "Special precautions for use of Bupropion SUN", in "Suicidal thoughts and worsening of depression")
• confusion
• difficulty concentrating
• rapid heartbeat
• weight loss

Rare adverse effects

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

• seizures

Very rare adverse effects

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

• palpitations, fainting
• muscle spasms, muscle stiffness, lack of coordination, walking or coordination problems
• feeling restless, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss
• yellowing of the skin or whites of the eyes (jaundice) that may be associated with increased liver enzymes, hepatitis
• severe allergic reactions; skin rash along with joint and muscle pain
• changes in blood sugar levels
• increased or decreased frequency of urination
• urinary incontinence (involuntary urination, loss of urine)
• severe skin rashes that can affect the mouth or other parts of the body and can be life-threatening
• worsening of psoriasis (thickening or reddening of the skin)
• feeling unreal or strange (dissociation); seeing or hearing things that do not exist (hallucinations); feeling or believing unrealistic things (delusional ideas); severe distrust (paranoia)

Frequency not known

Other adverse effects have occurred in a small number of people, but their exact frequency is not known:

• thoughts of self-harm or suicide during treatment with Bupropion SUN or soon after stopping treatment (see section 2, "What you need to know before taking Bupropion SUN"). 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 illusions, 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 bupropion with other medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine)

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bupropion SUN

Keep this medication out of 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.

Store in the original packaging to protect it from moisture and light.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bupropion Sun

The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg or 300 mg of bupropion hydrochloride.

The other ingredients are:

Core of the tablet: hydroxypropylcellulose, glycerol dibehenate, stearic acid

Coating film: hypromellose, ethylcellulose, povidone K90, lactose monohydrate, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1) Dispersion 30%, macrogol 6000, and colloidal hydrated silica.

Printing ink: Shellac, black iron oxide (E 172), propylene glycol.

Appearance of the product and package contents

Bupropion SUN 150 are film-coated, round, white to pale yellow tablets, approximately 7.7 mm in diameter, printed with a "T" in black ink on one side and smooth on the other side.

Bupropion SUN 300 are film-coated, round, white to pale yellow tablets, approximately 9.6 mm in diameter, printed with a "T1" in black ink on one side and smooth on the other side.

Bupropion SUN is presented in white plastic bottles that include a desiccant container containing activated silica gel and activated carbon. Please, DO NOT INGEST the desiccant. The bottle is closed with a child-resistant plastic cap that includes an induction seal coating.

150 mg: 30, 60, 90 tablets.

300 mg: 30, 60, 90 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007- Barcelona

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: BUPROPION BASICS 150 mg Tabletten mit veränderter Wirkstofffreizetsung

BUPROPION BASICS 300 mg Tabletten mit veränderter Wirkstofffreizetsung

Spain: Bupropión SUN 150 mg comprimidos de liberación modificada EFG

Italy: Bupropione SUN

Netherlands: Bupropion HCl SUN 150 mg tabletten met gereguleerde afgifte

Poland: Sentaro

Romania: AXABAL 150 mg comprimate cu eliberare modificata

AXABAL 300 mg comprimate cu eliberare modificata

Date of the last revision of this prospectus:July 2025

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