Bupropion Neuraxpharm

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Bupropion Neuraxpharm, 300 mg, modified-release tablets

Bupropion hydrochloride

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, 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 works with chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking Bupropion Neuraxpharm

When not to take Bupropion Neuraxpharm

• if the patient is allergic to bupropion or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking any other medicines containing bupropion,
• if the patient has epilepsy or has had seizures,
• if the patient has or has had eating disorders (such as bulimia or anorexia),
• if the patient has a brain tumor,
• if the patient is an alcoholic who has just stopped drinking or plans to do so,
• if the patient has severe liver disease,
• if the patient has recently stopped taking sedatives or plans to do so while taking Bupropion Neuraxpharm,
• if the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs), a type of antidepressant.

If any of the above situations apply to the patient, they should contact their doctor immediately without taking Bupropion Neuraxpharm.

Warnings and precautions

Before starting to take Bupropion Neuraxpharm, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

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

Adults

The patient should inform their doctor before starting to take Bupropion Neuraxpharm:

About:

• regularly drinking large amounts of alcohol,
• having diabetes and taking insulin or oral hypoglycemic agents,
• having had a serious head injury or brain trauma in the past,
• having Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or having a family history of sudden cardiac death.

Bupropion Neuraxpharm may cause seizures in about 1 in 1000 patients.
The occurrence of this side effect is more likely in patients with the above-mentioned conditions. If seizures occur during treatment, the patient should stop taking Bupropion Neuraxpharm and contact their doctor.

• If the patient has bipolar disorder (severe mood swings), as Bupropion Neuraxpharm may trigger an episode of this condition,
• If the patient is 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 the patient has liver or kidney disease, as they may be more likely to experience side effects.

If any of the above situations apply to the patient, they should contact their doctor before starting to take Bupropion Neuraxpharm. The doctor may decide to monitor the patient closely or recommend alternative treatment.

Suicidal thoughts and worsening of depressive 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 the patient has had suicidal thoughts or self-harm thoughts before,
• if the patient is 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 suicidal thoughts or self-harm thoughts occur, the patient should contact their doctor immediately or go to the hospital.

It may be helpful to inform a relative or friend that the patient has depression and ask them to read this leaflet. The patient may ask them to tell them if they notice that their depression is getting worse or if there are any worrying changes in their behavior.

Bupropion Neuraxpharm and other medicines

If the patient is currently taking or has taken within the last 14 days other antidepressants called monoamine oxidase inhibitors (MAOIs), they should contact their doctor without taking Bupropion Neuraxpharm(see also: "When not to take Bupropion Neuraxpharm", in section 2).

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as those they plan to take,

including herbal medicines or vitamins, including those bought without a prescription. The doctor may change the dose of Bupropion Neuraxpharm, recommend a change in dosing, or stop other medicines being taken.
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Some medicines cannot be taken at the same time as 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 the patient is taking other antidepressants or medicines used to treat mental illnesses,
• if the patient is taking theophylline, a medicine for asthma or lung disease,
• if the patient is taking tramadol, a strong painkiller,
• if the patient has recently stopped taking sedatives or plans to do so while taking Bupropion Neuraxpharm (see also "When not to take Bupropion Neuraxpharm", in section 2),
• if the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
• if the patient is taking stimulants or other medicines that control weight or appetite,
• if the patient is taking steroids (orally or by injection),
• if the patient is taking quinolone antibiotics,
• if the patient is taking certain types of antihistamines that can cause drowsiness,
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take Bupropion Neuraxpharm. The doctor will assess the risk and benefits of taking Bupropion Neuraxpharm.

The risk of other side effects may increase:

• if the patient is taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, duloxetine, desipramine, or imipramine) or medicines for 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 status (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 symptoms (such as nausea, vomiting, diarrhea),
• if the patient is taking medicines for Parkinson's disease (levodopa, amantadine, orphenadrine),
• if the patient is taking medicines that affect the metabolism of Bupropion Neuraxpharm (carbamazepine, phenytoin, valproic acid),
• if the patient is taking certain medicines for cancer (such as cyclophosphamide or ifosfamide),
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if the patient is taking beta-blockers (such as metoprolol),
• if the patient is taking certain medicines for irregular heart rhythm (propafenone and flecainide),
• if the patient is using nicotine patches as an aid to stop smoking.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take Bupropion Neuraxpharm.

Bupropion Neuraxpharm may be less effective:

• If the patient is taking ritonavir or efavirenz, medicines used to treat HIV infection.

If this situation applies to the patient, they should inform their doctor. The doctor will assess the effectiveness of Bupropion Neuraxpharm in the patient.
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It may be necessary to increase the dose or change the treatment for depression. The patient should not increase the dose of Bupropion Neuraxpharm without their doctor's recommendation, as this may increase the risk of side effects, including seizures.

Bupropion Neuraxpharm may reduce the effectiveness of some medicines

• If the patient is taking tamoxifen, used to treat breast cancer. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the treatment for depression.
• If the patient is taking digoxin for heart problems. If this situation applies to the patient, they should tell their doctor. The doctor may consider adjusting the dose of digoxin.

Bupropion Neuraxpharm and alcohol

Alcohol may affect the action of Bupropion Neuraxpharm, and taking them together may, although rarely, cause nervousness or change mental status. Some patients become more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Bupropion Neuraxpharm. If the patient is currently drinking large amounts of alcohol, they should not stop suddenly, as this may cause a seizure.
The patient should discuss drinking alcohol with their doctor 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 the patient is undergoing such a test, they should inform their doctor or nurse that they are taking Bupropion Neuraxpharm.

Pregnancy and breastfeeding

Bupropion Neuraxpharm should not be taken during pregnancy, if the patient is suspected to be pregnant, or if they plan to become pregnant, unless their doctor recommends otherwise. Before taking any medicine during pregnancy, the patient should consult their 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 if this was caused by the medicine itself.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion Neuraxpharm, the patient should consult their doctor or pharmacist.

Driving and using machines

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

3. How to take Bupropion Neuraxpharm

This medicine should always be taken as directed by the doctor or pharmacist. The doctor will recommend a dose individually for the patient. In case of doubts, the patient should consult their doctor or pharmacist.
Improvement in the patient's condition may occur only after some time. The full effect of the medicine may only become apparent after several weeks or months. Even if the patient starts to feel better, the doctor may recommend continuing to take 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, the patient should use another suitable product available on the market.
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The recommended dose for adults is one150 mg tablet once a day.
The doctor may recommend increasing the dose to 300 mg once a day if the patient does not improve after several weeks of treatment.
The dose of Bupropion Neuraxpharm should be taken in the morning. The patient should 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. The patient may notice something in their 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. They should not be chewed, crushed, or divided – 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. The doctor may recommend this dosing if the patient has liver or kidney disease.

How long to take the treatment

Only the doctor, together with the patient, can decide how long to take Bupropion Neuraxpharm. It may take weeks or months before any improvement is seen. The patient should regularly consult their doctor about their depressive symptoms to decide how long they should be treated. If the patient feels better, the 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. The patient should not delay and should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of Bupropion Neuraxpharm

If the patient misses a dose, they should wait and take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Bupropion Neuraxpharm

The patient should not stop taking Bupropion Neuraxpharm or reduce the dose without first discussing it with their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their 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 is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If in doubt, the patient should contact their doctor.
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If a seizure occurs, the patient should contact their doctor. They should not take Bupropion Neuraxpharm 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 the patient experiences any symptoms of an allergic reaction, they should contact their doctor immediately. They should not take Bupropion Neuraxpharm again.
Allergic reactions can last a long time. If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the whole 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 the patient experiences worsening of lupus, skin rash, or skin changes (especially on sun-exposed areas) while taking Bupropion Neuraxpharm, they should contact their doctor immediately, as it may be necessary to stop 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, contact your doctor immediately, as it may be necessary to stop treatment.

Other side effects

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

• difficulty sleeping; the patient should make sure that Bupropion Neuraxpharm is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common side effects:may occur in 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 gastrointestinal 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 occur in up to 1 in 100 patients.

• feeling depressed (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depressive symptoms),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

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

• seizures.

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

• irregular heartbeat, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, walking difficulties 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 strange (depersonalization), seeing or hearing things that do not exist (hallucinations), feeling or believing in things that are not real (delusions), exaggerated suspiciousness (paranoia).

Unknown frequency:

Other side effects have occurred in an unknown, but 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 the patient has such thoughts, they should contact their 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 status (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 symptoms (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather 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.
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The patient should not take 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 precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Bupropion Neuraxpharm 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 silica anhydrous, glycerol dibehenate, magnesium stearate.
Coating: ethyl cellulose, povidone K 90, macrogol 1500, 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), 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.
Blister: OPA/Al/PVC-Al blisters containing 30 or 90 tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

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

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

Manufacturer:

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert Str. 23, 40764 Langenfeld, Germany
Laboratorios Lesvi, S.L., Avda. de Barcelona 69, Sant Joan Despí, 08970 Barcelona, Spain

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 30/274/20-C

Parallel import authorization number: 138/23

This medicinal product 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
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Date of approval of the leaflet: 13.07.2023

[Information about the trademark]
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