Bupropion Accord

Leaflet accompanying the packaging: patient information

Bupropion Accord, 150 mg, tablets with modified release

Bupropion hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Bupropion Accord and what is it used for
• 2. Important information before taking Bupropion Accord
• 3. How to take Bupropion Accord
• 4. Possible side effects
• 5. How to store Bupropion Accord
• 6. Contents of the pack and other information

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

Bupropion Accord is a prescription-only medicine used to treat depression. It works with chemicals in the brain called norepinephrineand dopamine, which are related to depression.

2. Important information before taking Bupropion Accord

When not to 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 any other medicines containing bupropion;
• if you have epilepsy or have had seizures;
• if you have had or have eating disorders (such as bulimia or anorexia nervosa);
• if you have a brain tumor;
• if you are an alcoholic who has just stopped drinking or plans to do so;
• if you have severe liver disease;
• if you have recently stopped taking sedatives or plan to do so while taking Bupropion Accord (see also "When not to take Bupropion Accord" in section 2);
• if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs), a type of antidepressant.

If any of the above situations apply to you, you should contact your doctor immediately without taking Bupropion Accord.

Warnings and precautions

Before starting treatment with Bupropion Accord, discuss it with your doctor or pharmacist.

Brugada syndrome

• if you have a rare genetic heart condition known as Brugada syndrome or if there have been cases of sudden death in your family.

Children and adolescents

Bupropion Accord is not recommended for children under 18 years of age.
Children under 18 years of age treated with antidepressants may have an increased risk of
suicidal thoughts and behaviors.

Adults

Tell your doctor before starting treatment with Bupropion Accord:

• if you regularly drink large amounts of alcohol,
• if you have diabetes and are taking insulin or oral hypoglycemic agents,
• if you have had a serious head injury or brain trauma in the past.

Bupropion Accord may cause seizures in about 1 in 1000 patients. The risk of this side effect is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you have any doubts, consult your doctor.
If seizures occur during treatment, discontinue Bupropion Accord and contact your doctor.

• If you have bipolar disorder (extreme mood swings), as Bupropion Accord may trigger an episode of this condition
• If you are taking other antidepressants, as concurrent use with Bupropion Accord may lead to serotonin syndrome, a potentially life-threatening condition (see "Bupropion Accord and other medicines" in this section).
• If you have liver or kidney disease, as you may be more likely to experience side effects.

If any of the above situations apply to you, you should contact your doctor before starting treatment with Bupropion Accord. Your doctor may decide to monitor you closely or recommend alternative treatment.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes experience suicidal thoughts or behaviors. Such behaviors may worsen when the patient starts taking antidepressants, as these medicines may take some time to work, usually about two weeks, but sometimes longer.
Such thoughts may occur more frequently:

• if you have had suicidal thoughts or self-harm in the past.
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants.

If you experience suicidal thoughts or self-harm at any time, contact your doctor immediately or go to the hospital.
It may be helpful to inform a relative or friend that you are depressed and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Bupropion Accord and other medicines

If you are currently taking or have taken in the last 14 days other antidepressants called monoamine oxidase inhibitors(MAOIs), you should contact

your doctor without taking Bupropion Accord(see also "When not to take Bupropion Accord" in section 2).

Tell your doctor or pharmacist about all medicines you are taking now or have taken

recently, and those you plan to take, including herbal medicines or vitamins, including those bought without a prescription. Your doctor may change the dose of Bupropion Accord, recommend a change in dosage, or discontinue other medicines you are taking.
Some medicines should not be taken with Bupropion Accord. Some of them may increase the risk of seizures or other side effects. Examples of such medicines are listed below, but this is not an exhaustive list.

Seizures may occur more frequently than usual:

• if you are taking other antidepressants or medicines for mental disorders,
• if you are taking theophylline, a medicine for asthma or lung disease,
• if you are taking tramadol, a strong painkiller,
• if you have recently stopped taking sedatives or plan to do so while taking Bupropion Accord (see also "When not to take Bupropion Accord" in section 2),
• if you are taking antimalarial medicines (such as mefloquine or chloroquine),
• if you are taking stimulants or other medicines that control weight or appetite,
• if you are taking steroids (orally or by injection),
• if you are taking antibiotics called quinolones,
• if you are taking certain antihistamines that can cause drowsiness,
• if you are taking antidiabetic medicines.

If any of the above situations apply to you, you should contact your doctor before starting treatment with Bupropion Accord. Your doctor will assess the risks and benefits of using Bupropion Accord.

The risk of other side effects may increase:

• if you are taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Bupropion Accord may interact with antidepressants and you may experience changes in mental state (such as agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea).
• if you are taking medicines for Parkinson's disease (levodopa, amantadine, orphenadrine),
• if you are taking medicines that affect the metabolism of Bupropion Accord (carbamazepine, phenytoin, valproic acid),
• if you are taking certain medicines for cancer (such as cyclophosphamide or ifosfamide),
• if you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if you are taking beta-blockers (such as metoprolol),
• if you are taking certain medicines for irregular heart rhythm (propafenone and flecainide),
• if you are using nicotine patches as an aid to stop smoking.

If any of the above situations apply to you, you should contact your doctor before starting treatment with Bupropion Accord.

Bupropion Accord may be less effective:

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infection.

If this situation applies to you, you should inform your doctor.
Your doctor will assess the effectiveness of Bupropion Accord in your case. It may be necessary to increase the dose or change the treatment for depression. Do not increase the dose of Bupropion Accord without your doctor's advice, as this may increase the risk of side effects, including seizures.

Bupropion Accord may reduce the effectiveness of certain medicines

• If you are taking tamoxifen, used to treat breast cancer.

If this situation applies to you, you should tell your doctor. It may be necessary to change the treatment for depression.

• If you are taking digoxin due to heart problems.

If this situation applies to you, you should tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Bupropion Accord with alcohol

Alcohol may affect the action of Bupropion Accord and their concurrent use may, although rarely, cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking Bupropion Accord. Your doctor may advise you to avoid drinking alcohol (beer, wine, spirits) or to significantly reduce its consumption while taking Bupropion Accord.
If you are currently drinking large amounts of alcohol, do not stop suddenly, as this may cause seizures.
You should discuss drinking alcohol with your doctor before starting treatment with Bupropion Accord.

Effect on urine tests

Bupropion Accord may affect the results of laboratory tests for other medicines. If you are undergoing such a test, you should inform your doctor or nurse that you are taking Bupropion Accord.

Pregnancy and breastfeeding

Do not take Bupropion Accord during pregnancy, if you are pregnant or plan to become pregnant, unless your doctor advises you to do so. Before taking any medicine during pregnancy, consult your doctor or pharmacist. Some studies suggest an increased risk of birth defects, particularly heart defects, in children whose mothers took Bupropion Accord. It is not known if this was caused by the use of this medicine.
The ingredients of Bupropion Accord may pass into breast milk. Before taking Bupropion Accord, consult your doctor or pharmacist.

Driving and using machines

If Bupropion Accord causes dizziness or a feeling of emptiness in the head, do not drive or operate machinery.

3. How to take Bupropion Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Your doctor will recommend a dose individually for you. If you are unsure, ask your doctor or pharmacist.
Improvement in your condition may not occur until some time has passed. The full effect of the medicine may not be apparent until several weeks or months have passed. Even if you start to feel better, your doctor may recommend continuing treatment with Bupropion Accord to prevent a relapse of depression.

What dose to take

The recommended dose for adults is one150 mg tablet once a day.
Your doctor may recommend increasing the dose to 300 mg once a day if you do not improve after several weeks of treatment.
The dose of Bupropion Accord should be taken in the morning. Do not take Bupropion Accord more than once a day.
The tablet is coated with a shell that slowly releases the medicine into the digestive tract. You may notice something in your stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
Bupropion Accord tablets should be swallowed whole. Do not chew, crush, or divide them – if this happens, there is a risk of overdose due to the rapid release of the medicine into the body. This may increase the risk of side effects, including seizures.
For some patients, a dose of 150 mg once a day is sufficient throughout the treatment period. Your doctor may recommend this dosage if you have liver or kidney disease.

How long to take the treatment

Only your doctor, together with you, can decide how long to take the treatment with Bupropion Accord. It may take weeks or months before any improvement is seen. You should regularly discuss your symptoms with your doctor to decide how long you should be treated. If you feel better, your doctor may recommend continuing treatment with Bupropion Accord to prevent a relapse of depression.

Taking a higher dose of Bupropion Accord than recommended

Taking too many tablets may cause seizures or a seizure. Do not delay. Contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Bupropion Accord

If you miss a dose, wait until the next scheduled dose and take the medicine. Do not take a double dose to make up for the missed dose.

Stopping treatment with Bupropion Accord

Do not stop treatment with Bupropion Accord or reduce the dose without first discussing it with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bupropion Accord can cause side effects, although not everybody gets them.

Severe side effects

Seizures

About 1 in 1000 patients taking Bupropion Accord may experience seizures (seizures). The risk of this side effect is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you have any doubts, consult your doctor.
If seizures occur, contact your doctor. Do not continue taking Bupropion Accord.

Allergic reactions

Some patients may experience allergic reactions to Bupropion Accord. These include:

• redness of the skin or rash (like a nettle rash), blisters or itchy lumps (hives) on the skin; some rashes may require hospitalization, especially if they are accompanied by mouth or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or brief loss of consciousness.

If you experience any symptoms of an allergic reaction, contact your doctor immediately. Do not continue taking Bupropion Accord.
Allergic reactions may last for a long time. If your doctor has prescribed medicines to relieve allergic symptoms, you should take the full course.

Stevens-Johnson syndrome or worsening of symptoms

Frequency not known - cannot be estimated from the available data.
Stevens-Johnson syndrome is a disorder of the immune system that affects the skin and other organs.
If you experience worsening of symptoms, rash, or skin changes (especially on areas of skin exposed to sunlight) while taking Bupropion Accord, you should contact your doctor immediately, as it may be necessary to discontinue treatment.

Acute generalized exanthematous pustulosis

Frequency not known - frequency cannot be estimated from the available data from patients taking Bupropion Accord. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules/blisters filled with pus.
If you experience a skin rash with pustules/blisters filled with pus, you should contact your doctor immediately, as it may be necessary to discontinue treatment.

Other side effects

Very common side effects: may affect more than 1 in 10 patients.

• difficulty sleeping; make sure Bupropion Accord is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common side effects: may affect up to 1 in 10 patients.

• fever, dizziness, itching, sweating, and skin rash (sometimes due to an allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• abdominal pain or other disorders (constipation), change in taste, loss of appetite (anorexia),
• increased blood pressure, sometimes significant, flushing of the face,
• ringing in the ears, vision disturbances.

Uncommon side effects: may affect up to 1 in 100 patients.

• feeling depressed (see also section 2: Warnings and precautions),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects: may affect up to 1 in 1,000 patients.

• seizures.

Very rare side effects: may affect up to 1 in 10,000 patients.

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking or coordination problems,
• feeling anxious, irritated, hostile, aggressive, unusual dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be caused by increased liver enzyme activity, liver inflammation,
• severe allergic reactions; rash with accompanying muscle and joint pain,
• changes in blood sugar levels,
• increased or decreased urination,
• incontinence (involuntary urination, uncontrolled urine leakage),
• severe skin rashes that may involve the mouth and other parts of the body and may be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• unusual hair loss or thinning (alopecia)
• feeling unreal or strange ( depersonalization), seeing or hearing things that do not exist ( hallucinations), feeling or believing in things that are not real ( delusions), exaggerated suspicion ( paranoia).

Frequency not known (cannot be estimated from the available data):

Other side effects have occurred in an unknown, but small number of patients:

• thoughts of self-harm or suicide during treatment with Bupropion Accord or soon after its discontinuation (see section 2 "Important information before taking Bupropion Accord"). If you have such thoughts, you should contact your doctor or go to the hospital immediately.
• loss of contact with reality and ability to think or assess the situation (psychosis); other symptoms may include hallucinations and (or) delusions.
• feeling of sudden and intense fear (panic attack)
• stuttering
• decreased red blood cell count (anemia), decreased white blood cell count (leukopenia), and decreased platelet count (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental state (such as agitation, hallucinations, coma), and other symptoms, such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea) when taking Bupropion Accord with antidepressants (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bupropion Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Bupropion Accord contains

The active substance is bupropion hydrochloride.
Each tablet contains 150 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core: povidone cysteine hydrochloride monohydrate, colloidal silica anhydrous, glyceryl dibehenate, magnesium stearate
Coating: ethylcellulose, povidone, macrogol, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (containing sodium lauryl sulfate and polysorbate 80), colloidal silica hydrated, triethyl citrate.
Ink: shellac, iron oxide black (E 172), propylene glycol.

What Bupropion Accord looks like and contents of the pack

Bupropion Accord is a cream-white to light yellow round tablet with the inscription "GS3" on one side, smooth on the other side.
The diameter of the tablet is approximately 7.2 mm.
The medicine is packed in blisters of OPA/Aluminum/PVC/Aluminium foil.
Pack sizes: 10, 30, 60, 90 tablets
or single-dose blisters of OPA/Aluminium/PVC/Aluminium foil.
Pack size: 10x1, 30x1, 60x1, 90x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/Importer:

Laboratori Fundació Dau
C/C, 12-14 Pol. Industrial Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200, Utrecht,
3526KV, Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, 32009, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State

Date of last revision of the leaflet: February 2025