Bupropion Neuraxpharm

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Bupropion Neuraxpharm, 300 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, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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 Neuraxpharm and what is it used for
• 2. Important information before taking Bupropion Neuraxpharm
• 3. How to take Bupropion Neuraxpharm
• 4. Possible side effects
• 5. How to store Bupropion Neuraxpharm
• 6. Contents of the pack and other information

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

Bupropion Neuraxpharm is a prescription-only medicine used to treat depression. It works with chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking Bupropion Neuraxpharm

When not to take Bupropion Neuraxpharm

• 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),
• 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 Neuraxpharm (see also "When not to take Bupropion Neuraxpharm" in section 2),
• if you are taking or have taken within the last two weeks medicines called monoamine oxidase inhibitors(MAOIs).

If any of the above situations apply to you, do not take Bupropion Neuraxpharm and consult your doctor immediately.

Warnings and precautions

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

Children and adolescents

Bupropion Neuraxpharm is not recommended for children under 18 years of age. In children under 18 years of age treated with antidepressants, there is an increased risk of suicidal thoughts and behaviors.

Adults

Tell your doctor before starting Bupropion Neuraxpharm:

if you regularly drink large amounts of alcohol,

if you have diabetes and are taking insulin or oral antidiabetic medicines,

if you have had a serious head injury or brain trauma,

if you have Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family history.

• if you have a history of bipolar disorder, as Bupropion Neuraxpharm may trigger an episode of this condition,
• if you are taking other antidepressants, as taking them together with Bupropion Neuraxpharm may lead to serotonin syndrome, a potentially life-threatening condition (see "Bupropion Neuraxpharm and other medicines" in section 2),
• 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, consult your doctor before starting Bupropion Neuraxpharm. Your doctor may decide to monitor your treatment closely or recommend alternative treatment.

Suicidal thoughts and worsening of depression symptoms

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen when the patient first starts taking antidepressants, as it may take some time (usually about two weeks, but sometimes longer) for these medicines to start working.

• if you have had suicidal thoughts or self-harm thoughts before,
• 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 thoughts at any time, contact your doctor immediately or go to the hospital.

It may be helpful to inform a relative or friend that you have depression 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 Neuraxpharm and other medicines

If you are currently taking or have taken other antidepressants called monoamine oxidase inhibitors(MAOIs) within the last 14 days, consult your doctor before taking Bupropion Neuraxpharm (see also "When not to take Bupropion Neuraxpharm" in section 2).

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, or plan to take,

including herbal medicines or vitamins, including those bought without a prescription.Your doctor may need to change the dose of Bupropion Neuraxpharm, recommend a change in dosing, or stop other medicines you are taking.

Some medicines must not be taken with Bupropion Neuraxpharm.

Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Examples of such medicines are listed below, but this is not a complete list.

Seizures may occur more frequently than usual:

• if you are taking other antidepressants or medicines used to treat mental illnesses,
• if you are taking theophylline, an asthma or lung disease medicine,
• if you are taking tramadol, a strong painkiller,
• if you have recently stopped taking sedatives or plan to do so while taking Bupropion Neuraxpharm (see also "When not to take Bupropion Neuraxpharm" 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 types of antihistamines that can cause drowsiness,
• if you are taking antidiabetic medicines. If any of the above situations apply to you, consult your doctor before starting Bupropion Neuraxpharm. Your doctor will assess the risks and benefits of using Bupropion Neuraxpharm.

The risk of other side effects may increase:

• if you are taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, duloxetine, desipramine, or imipramine) or medicines used to treat other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine). Bupropion Neuraxpharm may interact with some medicines used to treat depression and may cause changes in mental state (such as agitation, hallucinations, coma) and other side effects, such as body temperature above 38°C, accelerated heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disorders (such as nausea, vomiting, diarrhea),
• if you are taking medicines used to treat Parkinson's disease (levodopa, amantadine, orphenadrine),
• if you are taking medicines that affect the metabolism of Bupropion Neuraxpharm (carbamazepine, phenytoin, valproic acid),
• if you are taking certain medicines used to treat 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 used to treat 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, consult your doctor before starting Bupropion Neuraxpharm.

Bupropion Neuraxpharm may be less effective:

• if you are taking ritonavir or efavirenz, medicines used to treat HIV infections.

If this situation applies to you, inform your doctor. Your doctor will assess the effectiveness of Bupropion Neuraxpharm in your case. There may be a need to increase the dose or change the treatment of depression. Do not increase the dose of Bupropion Neuraxpharm without your doctor's recommendation, as this may increase the risk of side effects, including seizures.

Bupropion Neuraxpharm may reduce the effectiveness of some medicines

• if you are taking tamoxifen, used to treat breast cancer. If this situation applies to you, tell your doctor. There may be a need to change the treatment of depression.
• if you are taking digoxin due to heart problems. If this situation applies to you, tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Bupropion Neuraxpharm with alcohol

Alcohol may affect the action of Bupropion Neuraxpharm, and their concurrent use may, although rarely, cause nervousness or change mental state. Some patients become more sensitive to alcohol while taking Bupropion Neuraxpharm. Your doctor may recommend avoiding alcohol (beer, wine, vodka) or significantly reducing its consumption while taking Bupropion Neuraxpharm. If you currently drink large amounts of alcohol, do not stop drinking suddenly, as this may cause a seizure. Discuss your alcohol consumption with your doctor before starting Bupropion Neuraxpharm.

Effect on urine tests

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

Pregnancy and breastfeeding

Do not take Bupropion Neuraxpharm during pregnancy, if you are suspected to be pregnant, or if you plan to become pregnant, unless your doctor recommends otherwise. Before taking any medicine during pregnancy, consult your doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers took Bupropion Neuraxpharm. It is not known whether this was caused by the use of this medicine. The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion Neuraxpharm, consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Bupropion Neuraxpharm

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 take some time. The full effect of the medicine may only be apparent after a few weeks or months. Even if you start to feel better, your doctor may recommend continuing treatment with Bupropion Neuraxpharm to prevent a relapse of depression.

What dose to take

Bupropion Neuraxpharm is available in a dose of 300 mg. For a dose of 150 mg, use another suitable product available on the market. The usual 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, after a few weeks of treatment, there is no improvement in your condition. Take the dose of Bupropion Neuraxpharm in the morning. Do not take Bupropion Neuraxpharm 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 Neuraxpharm 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 dosing 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 Neuraxpharm. It may take weeks or months before any improvement is seen. You should regularly discuss your depression symptoms with your doctor to decide how long you should be treated. If you feel better, your doctor may recommend continuing treatment with Bupropion Neuraxpharm to prevent a relapse of depression.

Taking a higher dose of Bupropion Neuraxpharm than recommended

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

Missing a dose of Bupropion Neuraxpharm

If you miss a dose, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Bupropion Neuraxpharm

Do not stop treatment with Bupropion Neuraxpharm 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 Neuraxpharm can cause side effects, although not everybody gets them.

Severe side effects

Seizures or convulsions

About 1 in 1000 patients taking Bupropion Neuraxpharm may experience seizures (convulsions). The risk of this happening is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you are unsure, consult your doctor. If you experience a seizure, contact your doctor. Do not take any more of the medicine.

Allergic reactions

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

• redness of the skin or rash (like a nettle rash), blisters or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they are accompanied by mouth pain 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 take any more of the medicine. Allergic reactions can last a long time. If your doctor has prescribed medicines to relieve allergy symptoms, take the full course.

Stevens-Johnson syndrome or worsening of symptoms

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

Acute generalized exanthematous pustulosis (AGEP)

Frequency not known – frequency cannot be estimated from the available data. Symptoms of AGEP include a rash with pus-filled blisters.

If you have a rash with pus-filled blisters, contact your doctor immediately, as treatment may need to be discontinued.

Other side effects

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

• difficulty sleeping; make sure to take Bupropion Neuraxpharm in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

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

• 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 significantly, flushing,
• ringing in the ears, vision disturbances.

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

• feeling depressed (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depression symptoms),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss. Rare side effects:may affect up to 1 in 1000 people.
• seizures.

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

• heart palpitations, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking or coordination problems,
• feeling restless, irritated, hostile, aggressive, having strange 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,
• urinating more or less often than usual,
• incontinence (involuntary urination, uncontrolled urine flow),
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• feeling unreal or different (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:

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

• thoughts of self-harm or suicide during treatment with Bupropion Neuraxpharm or soon after stopping it (see section 2 "Important information before taking Bupropion Neuraxpharm"). If you have such thoughts, 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.
• 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, accelerated heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disorders (such as nausea, vomiting, diarrhea) when taking Bupropion Neuraxpharm with medicines used to treat depression (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 or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bupropion Neuraxpharm

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. There are no special storage precautions. Translation of some information on the immediate packaging: Ch.-B./verwendbar bis siehe Prägung– batch number/expiry date see imprint. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bupropion Neuraxpharm contains

The active substance of the medicine is bupropion hydrochloride. Each tablet contains 300 mg of bupropion hydrochloride (which corresponds to 260.40 mg of bupropion). The other ingredients are: Tablet core: povidone K 90, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate. Coating: ethyl cellulose 100 mPas, povidone K 90, macrogol 1450, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80, colloidal hydrated silica, triethyl citrate. Ink: shellac, iron oxide black (E 172), and propylene glycol.

What Bupropion Neuraxpharm looks like and contents of the pack

Bupropion Neuraxpharm 300 mg tablets are cream-white to light yellow, round, with the imprint "GS2" in black on one side of the tablet, and the other side is smooth. The diameter of the tablet is approximately 9.3 mm. OPA/Al/PVC//Al blisters containing 30 or 90 tablets, in a cardboard box. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Straße 23, 40764 Langenfeld, Germany

Manufacturer:

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Straße 23, 40764 Langenfeld, Germany, Neuraxpharm Pharmaceuticals, S.L., Avda. Barcelona, 69, 08970 Sant Joan Despí, Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw Austrian marketing authorization number:140370

Parallel import authorization number: 136/25

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

Austria: Bupropion neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung, Czech Republic: Bupropion Neuraxpharm, Netherlands: Bupropion HCl Neuraxpharm 300 mg tabletten met gereguleerde afgifte, Germany: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung, Poland: Bupropion Neuraxpharm, Slovakia: Bupropion 300 mg Tablety s riadeným uvoľňovaním

Date of leaflet approval: 10.04.2025