Patient Information Leaflet

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

Keep this leaflet so that you can read it again if necessary.
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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Bupropion Neuraxpharm is and what it is used for
What you need to know before taking Bupropion Neuraxpharm
How to take Bupropion Neuraxpharm
Possible side effects
How to store Bupropion Neuraxpharm
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 acts on 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 had seizures,
if the patient has or has previously had eating disorders (e.g. bulimia or 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 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 (MAO inhibitors).

If any of the above situations apply to the patient, contact the doctor immediately
and do not take Bupropion Neuraxpharm.
Warnings and precautions
Before starting to take 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 behaviour.
Adults
You should inform your 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, discontinue
treatment with Bupropion Neuraxpharm. Do not take any more of this medicine and contact your doctor.

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

if the patient previously had suicidal thoughts or thoughts about self-harm,
if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If thoughts about self-harm or suicide occur at any time, contact your doctor immediately or go to 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 inform him or her if they
notice that the patient's depression worsens or if changes in 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 (MAO inhibitors), contact the doctor
without taking Bupropion Neuraxpharm (see also: When not to take Bupropion Neuraxpharm, in section 2).
Tell your doctor or pharmacist about all medicines currently taken or
taken recently, as well as any medicines the patient plans to take, including herbal remedies or
vitamins, even those purchased without a prescription. The doctor may adjust the dose of Bupropion
Neuraxpharm, recommend changing the dosing regimen or discontinuation of other medicines.
Some medicines must not be taken together with Bupropion Neuraxpharm.
Some of these may increase the risk of seizures or convulsive fits. 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 diseases,
if the patient is taking tramadol, a strong painkiller,
if the patient has recently stopped or is currently taking sedative medicines or intends to stop 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 steroids (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, contact the
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 and may cause changes in mental state (e.g. agitation, hallucinations, stupor) and other adverse effects such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle stiffness, 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-adrenergic blocking agents (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, contact the
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 infections.

If this situation applies to the patient, inform the doctor. The doctor will
assess the effectiveness of Bupropion Neuraxpharm in the patient.
It may be necessary to increase the dose or change the treatment for depression. Do not
increase the dose of Bupropion Neuraxpharm without the doctor's advice, as 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 to treat breast cancer. If this applies to the patient, inform the doctor. It may be necessary to change the treatment for depression.
If the patient is taking digoxin for heart problems. If this applies to the patient, inform the doctor. The doctor may consider adjusting the digoxin dose.

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 may become
more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may
advise 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, do not stop drinking suddenly, as this may trigger a seizure.
Talk to the doctor about alcohol consumption 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, he or she should inform the doctor or
nurse that he or she is taking Bupropion Neuraxpharm.
Pregnancy and breastfeeding
Do not take Bupropion Neuraxpharm during pregnancy, if pregnancy is suspected or if the
woman plans to become pregnant, unless otherwise advised by a doctor. Before taking
any medicine during pregnancy, consult a 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 due to the use of this
medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion
Neuraxpharm, consult a doctor or pharmacist.
Driving and operating machinery
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

This medicine should always be taken as directed by the physician or pharmacist. The treating physician will determine the dose individually for each patient. If in doubt, consult your doctor or pharmacist.
Improvement in the patient's condition may only become apparent after some time. The full effect of the medicine may not become evident until several weeks or months have passed. Even when the patient starts to feel 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 increase 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 a day.

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 is coated with a special layer that slowly releases the medicine into the gastrointestinal tract. The patient may notice something resembling a tablet in the stool. This is the empty coating that has been eliminated 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 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 treatment period. The treating physician may recommend this dosing if the patient has liver or kidney disease.

How long to continue treatment
Only the physician, 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 consult with the treating physician about depressive symptoms to determine the appropriate duration of treatment. Even if the patient feels better, the treating physician may recommend continuing treatment with Bupropion Neuraxpharm to prevent recurrence 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 doubts 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 convulsions
Seizures (convulsions or fits) may occur in approximately 1 in 1,000 patients taking Bupropion Neuraxpharm.
The likelihood is higher in patients who take higher doses than recommended, are taking certain other medicines, or belong to a group at increased risk of seizures. If in doubt, consult 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 skin lumps (urticaria); 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 persist for a long time. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.
Drug-induced lupus erythematosus or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated from available data in patients taking Bupropion Neuraxpharm. Lupus is an immune system disorder affecting the skin and other organs. If lupus flares, skin rash or skin lesions (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 from available data in patients taking Bupropion Neuraxpharm.
Symptoms of AGEP include a rash with pustules or blisters filled with pus.
If you develop a rash with pus-filled pimples or 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 and skin rash (sometimes due to allergic reaction),
chills, tremors, weakness, fatigue, chest pain,
feeling of anxiety or agitation,
abdominal pain or other gastrointestinal complaints (constipation), altered taste sensation, loss of appetite (anorexia),
increased blood pressure (sometimes significantly), 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 or 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 rashes, which may involve the mouth and other body parts and may be life-threatening,
worsening of psoriasis (red, thickened skin lesions),
feeling 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 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 ability to think or assess situations (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 status (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 disturbances (e.g. nausea, vomiting, diarrhoea) when taking Bupropion Neuraxpharm 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 or pharmacist. 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 gather 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 container. 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 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 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 PP screw cap and a tamper-evident foil, child-resistant, packed in a cardboard box.
The pack contains 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:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorisation number in the Czech Republic, country of export: 30/269/20-C
Parallel import authorisation number: 405/24

This medicinal product is authorised for sale 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