Bupropion neuraxpharm

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Bupropion Neuraxpharm, 150 mg, modified-release tablets
Bupropioni hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

Bupropion Neuraxpharm is a prescription medicine used to treat depression. It works by affecting chemical substances in the brain called noradrenaline and 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 experienced seizures,
• if the patient currently has or has previously had eating disorders (e.g. bulimia or mental anorexia - anorexia nervosa),
• if the patient has a brain tumour,
• if the patient who abuses alcohol has recently stopped drinking alcohol or intends to do so,
• if the patient has severe liver disease,
• if the patient has recently stopped taking sedative medicines or intends to stop taking them during treatment with Bupropion Neuraxpharm,
• if the patient is taking or has taken within the last two weeks antidepressant medicines known as monoamine oxidase inhibitors (MAOIs).

If any of the above situations apply to the patient, the patient should immediately contact their doctor
and must not take Bupropion Neuraxpharm.
Warnings and precautions
Before starting treatment with Bupropion Neuraxpharm, discuss this with your doctor or
pharmacist.
Children and adolescents
Bupropion Neuraxpharm is not recommended for use in children under 18 years of age.
In children under 18 years of age treated with antidepressant medicines, there is an increased risk
of suicidal thoughts and behaviours.
Adults
The patient should inform their doctor before starting treatment with Bupropion Neuraxpharm:

• if the patient regularly drinks large amounts of alcohol,
• if the patient has diabetes and is using insulin or oral antidiabetic medicines,
• if the patient has previously had a serious head injury or head trauma,
• if the patient has Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or if there is a family history of cardiac arrest or sudden death.

Bupropion Neuraxpharm may cause seizures in approximately 1 in 1000 patients.
The occurrence of this adverse effect is more likely in patients from the groups
listed above. If seizures occur during treatment, the patient must stop taking
Bupropion Neuraxpharm. The patient must not take any more of this medicine and should
contact their doctor immediately.

• If the patient has bipolar disorder (extreme mood swings), because Bupropion Neuraxpharm may trigger an episode of this condition,
• If the patient is taking other antidepressant medicines, because taking these medicines together with Bupropion Neuraxpharm may lead to serotonin syndrome, a potentially life-threatening condition (see “Bupropion Neuraxpharm with other medicines” in section 2),
• If the patient has liver or kidney disease, because adverse effects may be more likely to occur.

If any of the above situations apply to the patient, the patient should contact their
doctor again before starting treatment with Bupropion Neuraxpharm. The doctor
may decide that treatment should be carried out under close supervision or may recommend alternative treatment.
Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. Such
behaviours may worsen when the patient first starts taking antidepressant
medicines, because it takes some time before these medicines begin to work, usually about two
weeks, but sometimes longer.
Such thoughts may occur more frequently:

• if the patient previously had suicidal thoughts or thoughts of self-harm,
• if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviours in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If thoughts of self-harm or suicide occur at any time, the patient should contact their doctor immediately or go to hospital.

It may be helpful to inform a relative or friend that the patient has depression,
and to ask them to read this leaflet. The patient may ask them to inform the patient if
they believe the patient's depression is worsening or if changes in their behaviour become
concerning.
Bupropion Neuraxpharm with other medicines
If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), the patient 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 currently being taken or recently taken, as well as any medicines they plan to take, including herbal remedies or vitamins, even those purchased without a prescription. The doctor may adjust the dose of Bupropion Neuraxpharm, change the dosing schedule, or recommend discontinuation of other medicines being taken.
Some medicines must not be taken together with Bupropion Neuraxpharm.
Some of these may increase the risk of seizures or convulsive episodes. Other medicines
may increase the risk of other adverse 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 antidepressant medicines or medicines used to treat psychiatric disorders,
• 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 taken or is currently taking sedative medicines or intends to stop taking them during treatment with 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 stimulant medicines or other medicines that control body weight or appetite,
• if the patient is taking corticosteroids (orally or by injection),
• if the patient is taking antibiotics known as quinolones,
• if the patient is taking certain types of antihistamines that may cause drowsiness,
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, the patient should contact their
doctor immediately before starting treatment with Bupropion Neuraxpharm. The doctor
will assess the risks and benefits of using Bupropion Neuraxpharm.
The likelihood of other adverse effects may increase:

• if the patient is taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, doxepin, desipramine or imipramine) or medicines for other psychiatric disorders (such as clozapine, risperidone, thioridazine or olanzapine). Bupropion Neuraxpharm may interact with some medicines used to treat depression, leading to changes in mental state (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea),
• if the patient is taking medicines used to treat 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 used to treat malignant tumours (such as cyclophosphamide, ifosfamide),
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if the patient is taking β-blockers (such as metoprolol),
• if the patient is taking certain medicines used to treat 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, the patient should contact their
doctor immediately before starting treatment with 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, the patient should inform their doctor. The doctor will
evaluate the effectiveness of Bupropion Neuraxpharm in the patient.
It may be necessary to increase the dose or change the method of treating depression. The patient must not
increase the dose of Bupropion Neuraxpharm without the doctor's recommendation, because this may
increase the risk of adverse effects, including seizures.
Bupropion Neuraxpharm may reduce the effectiveness of certain medicines

• If the patient is taking tamoxifen, used in the treatment of breast cancer. If this applies to the patient, the patient should inform their doctor. It may be necessary to change the method of treating depression.
• If the patient is taking digoxin for heart problems. If this applies to the patient, the patient should inform 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 alter mental state. Some patients become
more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may
recommend abstaining from alcohol (beer, wine, spirits) or significantly reducing alcohol
consumption during treatment with Bupropion Neuraxpharm. If the patient currently drinks large amounts
of alcohol, the patient should not suddenly stop drinking, as this may trigger a seizure.
The patient should discuss alcohol consumption with their doctor before starting treatment with Bupropion Neuraxpharm.
Effect on urine tests
Bupropion Neuraxpharm may affect laboratory test results for the presence of other
medicines. If the patient undergoes such a test, they should inform the doctor or
nurse that they are taking Bupropion Neuraxpharm.
Pregnancy and breastfeeding
The patient should not take Bupropion Neuraxpharm during pregnancy, if pregnancy is suspected,
or when planning a pregnancy, unless the doctor advises 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 malformations, particularly heart defects, in children whose
mothers used 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, the patient should consult their doctor or pharmacist.
Driving and operating machinery
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 exactly as directed by the doctor or pharmacist. The treating
physician will individually determine the appropriate dose for the patient. If in doubt, consult the
doctor or pharmacist.
Improvement in the patient's well-being may occur only after some time. The full effect of the
medicine may not become apparent until several weeks or months have passed. Even when the
patient starts feeling better, the treating physician may recommend continuing treatment with
Bupropion Neuraxpharm to prevent a recurrence of depression.

What doses should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
The treating physician may recommend increasing the dose to 300 mg once daily if there is no
improvement after several weeks of treatment.
The dose of Bupropion Neuraxpharm should be taken in the morning. Do not take Bupropion
Neuraxpharm more frequently than once daily.

The bottle contains a small, tightly sealed desiccant containing charcoal and silica gel to keep the
tablets dry. Keep the desiccant in the bottle. Do not swallow it.

The tablet has a coating that slowly releases the medicine into the gastrointestinal tract. The patient
may notice in the stool something that looks like a tablet. This is the empty coating shell that has
been excreted from the body.

Bupropion Neuraxpharm tablets should be swallowed whole. Do not chew, crush, or divide them –
doing so may lead to overdose due to too rapid release of the medicine into the body. This may
increase the risk of adverse effects, including seizures.

For some patients, a dose of 150 mg once daily may be sufficient for the entire duration of treatment.
The treating physician may recommend this dosing if the patient has liver or kidney disease.

How long to continue treatment
Only the doctor together with the patient can decide how long treatment with Bupropion Neuraxpharm
should continue. It may take weeks or even months before any improvement is observed. The patient
should regularly discuss depressive symptoms with the treating physician so that decisions can be
made regarding the duration of treatment. If the patient feels better, the treating physician may
recommend continuing Bupropion Neuraxpharm to prevent a relapse of depression.

Taking more than the recommended dose of Bupropion Neuraxpharm
Taking too many tablets may cause seizures or a seizure attack. Do not delay. Seek immediate
medical attention from a doctor or the nearest hospital emergency department.

Missing a dose of Bupropion Neuraxpharm
If a dose is missed, 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 taking Bupropion Neuraxpharm or reduce the dose without first discussing it with the
treating physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Seizures or epileptic fits
Seizures (epileptic fits or convulsions) may occur in approximately 1 in 1,000 patients taking Bupropion Neuraxpharm. The likelihood is higher in patients taking higher than recommended doses, taking certain other medicines, or who are in a group at increased risk of seizures. If in doubt, contact your doctor.

If a seizure occurs, contact your doctor immediately. Do not take the medicine again.

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

• skin redness or rash (such as erythematous rash), blisters, or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if mouth pain or eye pain also occur,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• collapse or brief loss of consciousness.

If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take the medicine again.

Allergic reactions may be prolonged. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.

Lupus-like skin rash or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated based on available data from patients taking Bupropion Neuraxpharm. Lupus is an autoimmune disorder affecting the skin and other organs. If lupus flares, skin rash, or skin changes (especially in areas of skin exposed to sunlight) occur during treatment with Bupropion Neuraxpharm, contact your doctor immediately, as discontinuation of treatment may be necessary.

Acute generalized exanthematous pustulosis (AGEP)
Frequency unknown – frequency cannot be estimated based on available data from patients taking Bupropion Neuraxpharm.

AGEP symptoms include a rash with pustules (pus-filled spots/blisters).

If you develop a rash with pus-filled pimples/blisters, contact your doctor immediately, as discontinuation of treatment may be necessary.

Other adverse effects

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

• difficulty sleeping; ensure that Bupropion Neuraxpharm is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

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

• fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes marked), facial flushing,
• ringing in the ears, visual disturbances.

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

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

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

• seizures.

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

• palpitations, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be due to increased liver enzyme activity, hepatitis,
• severe allergic reactions; rash accompanied by muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less frequently than usual,
• urinary incontinence (involuntary urination, uncontrolled leakage of urine),
• severe skin reactions, which may involve the mouth and other parts of the body and may be life-threatening,
• worsening of psoriasis (red, thickened skin lesions),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).

Frequency unknown:
Other adverse effects have occurred in an unknown, although small, number of patients:

• thoughts of self-harm or suicide during treatment with Bupropion Neuraxpharm or shortly after stopping it (see section 2 “Important information before taking Bupropion Neuraxpharm”). If you have such thoughts, contact your doctor or go to hospital immediately.
• loss of contact with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions,
• stuttering,
• reduced number of red blood cells (anaemia), reduced number of white blood cells (leukopenia), and reduced 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, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) when taking Paritdam together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting adverse effects helps to 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 stated month.
Store in the original bottle to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Bupropion Neuraxpharm contains
The active substance is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride (equivalent to 130.20 mg of bupropion).
The other ingredients are:
Tablet core: povidone K 90, sodium stearyl fumarate.
Coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1), colloidal anhydrous silica, macrogol 1500, triethyl citrate, hypromellose 2910/6, macrogol 400, macrogol 8000.

What Bupropion Neuraxpharm looks like and contents of the pack
Bupropion Neuraxpharm 150 mg tablets are white to light yellow, round, and biconvex.
The medicine is available in a high-density polyethylene (HDPE) bottle containing a desiccant (a combination of activated carbon and silica gel), closed with a child-resistant PP cap and a tamper-evident foil, with 30 tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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

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

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

Marketing Authorisation Number in the Czech Republic, country of export: 30/269/20-C
Parallel Import Licence Number: 230/23

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Bupropion neuraxpharm 150 mg Tabletten mit veränderter Wirkstofffreisetzung
Czech Republic: Bupropion Neuraxpharm
Germany: Bupropion-neuraxpharm 150 mg Tabletten mit veränderter Wirkstofffreisetzung
Poland: Bupropion Neuraxpharm
Slovakia: Bupropion 150 mg Tablety s riadeným uvoľňovaním