Bupropion neuraxpharm: detailed information

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, because 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 give it to others. It may harm someone else, even if their symptoms are similar.
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

What Bupropion Neuraxpharm is and what it is used for
Important information 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. 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 mental anorexia),
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 during treatment with Bupropion Neuraxpharm,
if the patient is taking or has taken within the last two weeks antidepressant medicines called 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 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 antidepressants, there is an increased risk of
suicidal thoughts and behaviours.
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 about 1 in 1000 patients. This adverse effect is more likely in patients from the groups listed above. If seizures occur during treatment, discontinue Bupropion Neuraxpharm immediately. 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 disorder,
If the patient is taking other antidepressants, because combining these medicines 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.

If any of the above situations apply to the patient, contact the
doctor again before starting Bupropion Neuraxpharm. The doctor
may decide that treatment should be carried out under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depressive symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These
behaviours 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 be more common:

if the patient has 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 behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants. If thoughts of self-harm or suicide ever occur, 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/her if they consider that the patient's depression is worsening 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 called monoamine oxidase inhibitors (MAO inhibitors), contact your doctor
without taking Bupropion Neuraxpharm (see also: When not to take Bupropion Neuraxpharm in section 2).
Tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, as well as those you plan to take, including herbal remedies or
vitamins, even those purchased without a prescription. The doctor may change the dose of Bupropion
Neuraxpharm, recommend changing the dosing regimen, or discontinuation of other medicines being taken.
Some medicines must not be taken at the same time as Bupropion Neuraxpharm.
Some of these may increase the risk of seizures or convulsive attacks. 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 antidepressants 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 steroids (orally or by injection),
if the patient is taking antibiotics called 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 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 antidepressants (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 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-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, contact the
doctor immediately before starting Bupropion Neuraxpharm.
Bupropion Neuraxpharm may be less effective:

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

If this 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 way depression is treated. 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, tell the doctor. It may be necessary to change the way depression is treated.
If the patient is taking digoxin for heart problems. If this applies to the patient, tell 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 your doctor about alcohol consumption before starting Bupropion Neuraxpharm.
Effect on urine tests
Bupropion Neuraxpharm may affect laboratory test results for the presence of other
drugs. If the patient undergoes such a test, he/she should inform the doctor or
nurse that he/she is taking Bupropion Neuraxpharm.
Pregnancy and breastfeeding
Do not take Bupropion Neuraxpharm during pregnancy, if pregnancy is suspected, or when planning a pregnancy, unless your doctor advises 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 taking 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

This medicine should always be taken exactly as directed by the doctor or pharmacist. The treating doctor will prescribe the dose individually for each patient. If in doubt, consult the doctor or pharmacist.

Improvement in the patient's well-being may only occur 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 to feel better, the treating doctor 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 doctor 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 daily.

The bottle contains a small, tightly sealed desiccant containing activated 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 active substance into the gastrointestinal tract. The patient may notice in the stool something that looks like a tablet. This is the empty coating shell, which has been eliminated from the body.

Bupropion Neuraxpharm tablets should be swallowed whole. Do not chew, crush, or divide them—if this occurs, there is a risk of 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 throughout the entire treatment period. The treating doctor may recommend this lower dose 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 consult the treating doctor about depressive symptoms so that decisions can be made regarding the duration of treatment. If the patient feels better, the treating doctor may recommend continuing treatment with Bupropion Neuraxpharm to prevent a recurrence of depression.

Taking more than the recommended dose of Bupropion Neuraxpharm

Taking too many tablets may cause seizures or a seizure episode. Do not delay. Contact a doctor immediately or go to 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 a missed dose.

Stopping treatment with Bupropion Neuraxpharm

Do not stop taking Bupropion Neuraxpharm or reduce the dose without first discussing it with the treating doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
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 taking higher than recommended doses, taking certain other medicines, or belonging to groups at increased risk of seizures. If in doubt, contact your treating physician.
If a seizure occurs, contact your doctor immediately. Do not take any more of the medicine.
Allergic reactions
Some patients may experience allergic reactions to Bupropion Neuraxpharm. These include:

skin redness or rash (such as erythema multiforme), 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 breathing difficulties,
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.
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 autoimmune disorder affecting the skin and other organs. If lupus flare-ups, skin rash or skin lesions (especially on 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/pus-filled blisters.
If you develop a rash with pus-filled pimples/blisters, contact your doctor immediately, as discontinuation of treatment may be necessary.
Other adverse reactions
Very common adverse reactions: may occur in more than 1 in 10 patients.

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

Common adverse reactions: may occur in 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 perception, loss of appetite (anorexia),
increased blood pressure, sometimes significantly, facial flushing,
ringing in the ears, visual disturbances.

Uncommon adverse reactions: may occur in 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 reactions: may occur in up to 1 in 1,000 patients.

seizures.
Very rare adverse reactions: may occur in 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 body parts and may be life-threatening,
worsening of psoriasis (red, scaly patches on the skin),
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 reactions 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 the patient has such thoughts, contact a 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 (hyponatraemia),
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 disturbances (e.g. nausea, vomiting, diarrhoea) while taking Paritdam together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions 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 reactions helps to provide more information on the safety of the 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 month indicated.
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 will help protect the environment.

6. Package contents 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).
Other components are:
Tablet core: povidone K 90, sodium stearyl fumarate.
Coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid and 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 prolonged-release tablets are white to pale yellow, round, and biconvex.
The medicine is available in an HDPE bottle containing a desiccant container (carbon/silica gel), closed with a child-resistant PP cap and a tamper-evident seal, placed in a cardboard box with 30 tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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

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

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

Austrian Marketing Authorisation Number (country of export): 140416
Parallel Import Authorisation Number: 151/25

This medicinal product is authorised for marketing 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