BUPROPION ACCORD 150 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Bupropion Accord 150 mg prolonged-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 and other information

1. What is Bupropion Accord and what is it used for
2. What you need to know before you take Bupropion Accord
3. How to take Bupropion Accord
4. Possible side effects
5. Storing Bupropion Accord

1. Contents of the pack and further information

1. What is Bupropion Accord and what is it 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, which are related to depression.

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

Do not take Bupropion Accord:

• 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 tumour
• if you drink a lot 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 Accord
• if you are taking, or have taken in the last 14 days, 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

Talk to 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 use in children under 18 years of age.

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

Adults

Tell your doctor before starting to take Bupropion Accord:

• if you regularly drink a lot of alcohol
• if you have diabetes that is being treated with insulin or tablets
• if you have had a severe head injury or have had a previous head trauma.

It has been seen that bupropion can cause seizures (convulsions) in about 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 taking Bupropion Accord. Do not take any more and see 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, taking these medicines with bupropion may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Bupropion Accord" 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 the situations mentioned above, talk to 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 start of treatment with antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer. This is more likely to happen:

• 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 behaviour in adults under 25 years with psychiatric conditions who were being treated with some antidepressants.

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

It may be helpful for you to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Other medicines and Bupropion Accord

If you are taking or have taken in the last 14 days medicines for depression calledmonoamine oxidase inhibitors(MAOIs), tell your doctor and do not take bupropion(see also "Do not take Bupropion Accord" in section 2).

Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines, herbal products or vitamins, including those bought without a prescription. Your doctor may change your dose of Bupropion Accord or suggest a change in the other medicines.

Some medicines must not be taken with Bupropion Accord.Some of them can increase the chance of having seizures or convulsions and others can increase the risk of having other side effects. The following are some examples, although the list is not complete:

May increase the chance 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 painkiller
• if you have been taking sedatives, or if you are going to stop taking them while taking bupropion (see also "Do not take Bupropion Accord" in section 2)
• 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 injection)
• 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, tell your doctor immediately before taking bupropion. Your doctor will weigh up the risks and benefits of you taking bupropion.

May increase the chance 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 you may experience changes in mental state (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, diarrhoea)
• if you take medicines for Parkinson's disease (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)
• if you take ticlopidine or clopidogrel, mainly used to prevent stroke
• if you take any beta-blocker medicine (such as metoprolol)
• if you take medicines to treat heart rhythm problems (propafenone or flecainide)
• if you use nicotine patches to help you stop smoking.

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

Bupropion Accord may be less effective

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

Tell your doctor if you are in this situation. 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 Accord unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Bupropion Accord 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.

Using Bupropion Accord 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 advise you not to drink alcohol (beer, wine, spirits) or to drink very small amounts while taking Bupropion Accord. But if you currently drink a lot of alcohol, do not stop suddenly, as you may be at risk of having a seizure.

Talk to your doctor about drinking alcohol before 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 Accord.

Pregnancy and breastfeeding

Do not take bupropion if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor prescribes it for you. Talk to 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. Talk to 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 Accord

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 dose that is right 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 taking bupropion to prevent your depression from coming back.

What dose to take

The usual recommended dose in adults is one150 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 Accord 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 stools. This is the empty film 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 medicine being released too quickly in your body, increasing the risk of having side effects, including seizures.

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

Duration of treatment

Only you and your doctor can decide the duration of treatment with Bupropion Accord. It may take several weeks or months before you notice any improvement. Discuss your symptoms with your doctor regularly so that they can decide the duration of treatment.

When you start to feel better, your doctor may advise you to continue taking bupropion to prevent your depression from coming back.

If you take more Bupropion Accord than you should

If you take too many tablets, you may increase the risk of having seizures or convulsions.

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

If you forget to take Bupropion Accord

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 Accord

Do not stop taking bupropion or reduce the dose without talking to your doctor first.

If you have any further questions on 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

About 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 seizures. If you have any doubts, ask your doctor.

If you have a seizure, talk to your doctor when you have recovered. Do not take any more tablets.

Allergic reactions

Some people may have allergic reactions to bupropion, including:

• Redness or skin rash (hives), blisters or hives on the skin. Some skin rashes may require hospital treatment, especially if they are accompanied by swelling of the mouth and eyes.
• Abnormal appearance of "wheezing" in the chest or difficulty breathing.
• Swelling of the eyelids, lips or tongue.
• Pain in muscles or joints.
• Fainting or fainting spells.

If you have any type of allergic reaction, talk to your doctor immediately. Do not take any more tablets.

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

Cutaneous lupus erythematosus and 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.

Acute Generalized Exanthematous Pustulosis (AGEP)

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

AGEP symptoms include a rash with pus-filled bumps/blisters.

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

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

Other Adverse Effects

Very Common:may affect more than 1 in 10 people.

• Difficulty sleeping. Make sure to take bupropion in the morning.
• Headache.
• Dry mouth.
• Nausea, vomiting.

Common:may affect up to 1 in 10 people.

• Fever, dizziness, itching, sweating, and skin rash (sometimes due to allergic reactions).
• Instability, tremors, weakness, fatigue, chest pain.
• Feeling anxious or agitated.
• Stomach pain or digestive discomfort (constipation), alterations in taste, loss of appetite (anorexia).
• Increased blood pressure, sometimes severe, flushing.
• Sensation of ringing in the ears, vision disturbances.

Uncommon:may affect up to 1 in 100 people.

• Feeling depressed (see also section 2 "Special warnings and precautions for use, Suicidal thoughts and worsening of depression").
• Feeling confused.
• Difficulty concentrating.
• Accelerated heart rate.
• Weight loss.

Rare:may affect up to 1 in 1,000 people.

• Seizures.

Very Rare:may affect up to 1 in 10,000 people.

• Palpitations, fainting.
• Muscle contractions, muscle stiffness, lack of coordination, walking or coordination problems.
• Sensation of restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss.
• Yellowing of the skin or whites of the eyes (jaundice) that may be associated with an increase in 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 (thickened red skin plaques).
• Loss or unusual thinning of hair (alopecia)
• Sensation of 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(cannot be estimated from the available data):

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 Accord or soon after stopping treatment (see section 2, "What you need to know before you start taking Bupropion Accord"). If you have these thoughts, contact your doctor or go immediately to a hospital.

Special warnings and precautions for useare described in section 2.

• Loss of contact with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delusions.
• Sudden sensation of intense fear (panic attack)
• 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 along with other medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of 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 medication.

5. Storage of Bupropion Accord

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Bupropion Accord

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

The other ingredients are:

Core of the tablet: povidone, monohydrate hydrochloride of cysteine, anhydrous colloidal silica, dibehenate of glycerol, and magnesium stearate (E 470b)

Coating film: ethylcellulose, povidone, macrogol, copolymer of methacrylic acid and ethyl acrylate (1:1) that contains sodium lauryl sulfate and polysorbate 80, hydrated colloidal silica, and triethyl citrate.

Printing ink: shellac, black iron oxide (E172), and propylene glycol

Appearance of the Product and Package Contents

Bupropion Accord 150 mg is a white-cream to light yellow, round tablet, with one face marked with "GS3" and the other smooth.

The diameter of the tablet is approximately 7.2 mm.

OPA/Alu/PVC-Alu blister pack containing 10, 30, 60, and 90 tablets. Also available in precut unit-dose OPA/Alu/PVC-Alu blisters containing 10x1, 30x1, 60x1, and 90x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U

World Trade Center, Moll de Barcelona,

s/n, Edifici Est, 6th floor, Barcelona

08039, Spain

Manufacturer

Accord Healthcare B.V.

Winthontlaan 200, Utrecht,

Netherlands

O

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona 08040, Spain

O

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

O

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009, Greece

This medication is authorized in the Member States of the European Economic Areaunder the following names

Date of the Last Revision of this Leaflet:February 2025

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