Bupropion Neuraxpharm

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language

Bupropion Neuraxpharm,

150 mg, tablets with modified release

Bupropion hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. 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 acts on 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, you should contact your doctor immediately without taking Bupropion Neuraxpharm.

Warnings and precautions

Before starting to take Bupropion Neuraxpharm, you should discuss it with your doctor or pharmacist.

Children and adolescents

Bupropion Neuraxpharm is not recommended for the treatment of 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

You should inform your doctor before starting to take 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 (severe mood swings), as Bupropion Neuraxpharm may trigger an episode of this condition,
• if you are taking other antidepressants, as taking these medicines 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, you should contact your doctor before starting to take Bupropion Neuraxpharm.
Your doctor may decide to monitor your treatment closely or recommend a different treatment.

Suicidal thoughts and worsening of depression

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, before these medicines start to work.
Such thoughts may occur more frequently:

• if you have had suicidal thoughts or self-harm 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 ever have thoughts of self-harm or suicide, you should 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 worried about changes in your behavior.

Bupropion Neuraxpharm and other medicines

If you are currently taking or have taken within the last 14 days other antidepressants called monoamine oxidase inhibitors(MAOIs), you should contact your doctor without taking Bupropion Neuraxpharm(see also "When not to take Bupropion Neuraxpharm" in section 2).

You should tell your doctor or pharmacist about all medicines you are taking now

or have recently taken, as well as those you plan to take, including herbal medicines or vitamins, including those bought without a prescription. Your doctor may change the dose of Bupropion Neuraxpharm, recommend a change in dosing, or stop taking other medicines.

Some medicines cannot 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 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 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, you should contact your doctor immediately before starting to take Bupropion Neuraxpharm.
Your doctor will assess the risk and benefits of taking Bupropion Neuraxpharm.

The likelihood 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 for other mental disorders (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 (e.g., 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 symptoms (e.g., 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, you should contact your doctor immediately before starting to take Bupropion Neuraxpharm.

Bupropion Neuraxpharm 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 Neuraxpharm in you.
There may be a need to increase the dose or change the treatment of depression. You should 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, you should 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, you should 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 are currently drinking large amounts of alcohol, you should not stop drinking suddenly, as this may cause a seizure. You should talk to your doctor about drinking alcohol before starting to take 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, you should inform your doctor or nurse that you are taking Bupropion Neuraxpharm.

Pregnancy and breastfeeding

You should 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, you should consult your doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital defects, particularly heart defects, in children whose mothers took Bupropion Neuraxpharm. It is not known whether this was caused by the use of this medicine.
Ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion Neuraxpharm, you should consult your doctor or pharmacist.

Driving and using machines

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

3. How to take Bupropion Neuraxpharm

This medicine should always be taken exactly as your doctor or pharmacist has told you. Your doctor will recommend a dose that is right for you. If you are unsure, you should ask your doctor or pharmacist.
Improvement in your condition may not occur until after some time. The full effect of the medicine may only become apparent after several weeks or months. Even if you start to feel better, your doctor may recommend continuing to take Bupropion Neuraxpharm to prevent a relapse of depression.

What dose to take

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 several weeks of treatment, you do not show improvement.
The dose of Bupropion Neuraxpharm should be taken in the morning. You should not take Bupropion Neuraxpharm more than once a day.
The bottle contains a small, tightly closed container containing activated carbon and silica gel to keep the tablets dry. You should keep the container in the bottle. Do not swallow it.
The tablet is coated with a coating 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 coating that has been eliminated from your body.
Bupropion Neuraxpharm tablets should be swallowed whole. You should 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 dose 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 symptoms of depression with your doctor to decide how long you should be treated. If you feel better, your doctor may recommend continuing to take 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.
You should contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Bupropion Neuraxpharm

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

Stopping treatment with Bupropion Neuraxpharm

You should 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, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 likelihood 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, you should contact your doctor.
If you experience a seizure, you should contact your doctor. You should not take the medicine again.

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 occur with mouth ulcers 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, you should contact your doctor immediately. You should not take the medicine again.
Allergic reactions can last 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 lupus

Frequency not known - frequency cannot be estimated from the available data from people taking Bupropion Neuraxpharm. Lupus is an immune system disorder that affects the skin and other organs. If you experience worsening of lupus, skin rash, or skin changes (especially on skin areas exposed to sunlight) while taking Bupropion Neuraxpharm, you should contact your doctor immediately, as it may be necessary to stop the treatment.
Acute generalized exanthematous pustulosis (AGEP)
Frequency not known – frequency cannot be estimated from the available data from people taking Bupropion Neuraxpharm.
Symptoms of AGEP include a rash with pus-filled blisters.

If you have a rash with pus-filled blisters, you should contact your doctor immediately, as it may be necessary to stop the treatment.

Other side effects

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

• difficulty sleeping; you should make sure that Bupropion Neuraxpharm is taken 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 severe, 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),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects:may affect up to 1 in 1,000 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 may involve the mouth and other parts of the body and may be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• 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 suspiciousness ( paranoia).

Frequency not known:

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

• thoughts of self-harm or suicide while taking Bupropion Neuraxpharm or shortly after stopping it (see section 2 "Important information before taking Bupropion Neuraxpharm"). 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.
• stuttering.
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental state (e.g., agitation, hallucinations, coma), and other symptoms, such as body temperature above 38°C, accelerated heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., 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 those not listed in this leaflet, you should tell your doctor or pharmacist or nurse.
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, phone: +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

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Store in the original bottle to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 150 mg of bupropion hydrochloride (which corresponds to 130.20 mg of bupropion).
The other ingredients are:
Tablet core:povidone K 90, sodium stearyl fumarate.
Coating:ethylcellulose, hydroxypropylcellulose, methacrylic acid, and ethyl acrylate copolymer (1:1) type A, colloidal anhydrous silica, macrogol 1500, triethyl citrate, hypromellose, macrogol 400, macrogol 8000.

What Bupropion Neuraxpharm looks like and contents of the pack

Bupropion Neuraxpharm, 150 mg tablets with modified release, are white to light yellow, round, and biconvex.
The medicine is available in a high-density polyethylene (HDPE) bottle containing a desiccant container (a combination of activated carbon and silica gel), closed with a child-resistant polypropylene (PP) cap and a tear-off foil, in a cardboard box. Each bottle contains 30 tablets.

Marketing authorization holder in the Czech Republic, the country of export:

Neuraxpharm Bohemia s.r.o.
náměstí Republiky 1078/1
110 00 Praha 1 – Nové Město
Czech Republic

Manufacturer:

Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Strasse 23
40764 Langenfeld
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing authorization number in the Czech Republic, the country of export:

30/269/20-C

Parallel import authorization number: 51/25

Date of approval of the leaflet: 05.02.2025

[Information about the trademark]