Bupropion neuraxpharm

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 the medicine, as it contains important information for the patient.

• 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 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 to 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 had in the past 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 do so 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, do 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 antidepressants, there is an increased risk of
suicidal thoughts and suicidal 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 belonging to the groups
mentioned 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 antidepressants, because concomitant use of 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
your doctor 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 of self-harm or suicide. Such
behaviour may worsen when the patient first starts taking
antidepressant medicines, as it takes some time, usually about two
weeks, but sometimes longer, before these medicines begin to work.
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 behaviour 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, 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 believe
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 known as 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 currently being taken or recently taken, 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 a change in dosing schedule, or discontinuation of other medicines.
Some medicines must not be taken at the same time as 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 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 stopped or is currently taking sedative medicines or intends to discontinue 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 used to 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, contact your
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 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, increased heart rate, 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 ß-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 your
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 applies to the patient, inform the doctor. The doctor will
evaluate the effectiveness of Bupropion Neuraxpharm in the patient.
It may be necessary to increase the dose or change the treatment approach 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 in the treatment of breast cancer. If this applies to the patient, inform the doctor. It may be necessary to change the treatment approach 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 become
more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may
recommend abstaining from alcohol (beer, wine, spirits) or significantly reducing its consumption
during treatment with Bupropion Neuraxpharm. If the patient currently drinks large amounts
of alcohol, do not suddenly stop drinking, as this may trigger a seizure.
Talk to your doctor about alcohol consumption before starting treatment with Bupropion
Neuraxpharm.
Effect on urine tests
Bupropion Neuraxpharm may affect the results of laboratory tests for the presence of other
drugs. If the patient is undergoing 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 if planning pregnancy, unless otherwise advised by a doctor. 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 due to the use of this medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion
Neuraxpharm, consult your 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 exactly as directed by your doctor or pharmacist. Your doctor will prescribe the dose individually for each patient. If in doubt, consult your doctor or pharmacist.
Improvement in the patient's condition may take 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 doctor may recommend continuing treatment with Bupropion Neuraxpharm to prevent recurrence of depression.

What dose should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
Your 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 than once a day.

The bottle contains a small, tightly sealed desiccant containing activated charcoal and silica gel to keep the tablets dry. Keep this 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, which has been excreted from the body.

Bupropion Neuraxpharm tablets should be swallowed whole. Do not chew, crush, or divide the tablets – 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 throughout the treatment period. Your doctor may recommend this dose if the patient has liver or kidney disease.

How long to continue treatment
Only your doctor, in consultation 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 doctor to determine how long treatment should last. Even if the patient starts to feel better, the doctor 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 episode. Do not delay. Contact your 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 the missed dose.

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

If you have any further doubts about using 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 1000 patients taking Bupropion Neuraxpharm. The likelihood is higher in patients who take higher than recommended doses, 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 this 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 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 this medicine again.

Allergic reactions may last a long time. If your doctor has prescribed medication to relieve allergic symptoms, take the full course as directed.

Drug-induced lupus erythematosus or worsening of lupus symptoms

Frequency unknown – frequency cannot be determined from available data in patients taking Bupropion Neuraxpharm. Lupus is an autoimmune disorder affecting the skin and other organs. If lupus symptoms worsen, or if skin rash or skin lesions (especially on areas of skin exposed to sunlight) develop 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 determined from available data in patients taking Bupropion Neuraxpharm.

AGEP symptoms include a rash with pustule-filled eruptions/blisters.

If you develop a rash with pus-filled pimples/blisters, contact your doctor immediately, as treatment discontinuation 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, skin rash (sometimes due to allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feelings of anxiety or agitation,
• abdominal pain or other gastrointestinal complaints (constipation), altered taste perception, loss of appetite (anorexia),
• increased blood pressure (sometimes marked), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon adverse reactions: may occur in up to 1 in 100 patients.

• feelings of depression (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depressive symptoms),
• feeling disoriented,
• 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 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),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not real (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 such thoughts occur, 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 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 reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 provide more information on the safety of this medicine.

5. How to store Bupropion Neuraxpharm

Keep this 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 packaging 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 ingredients are:
Tablet core: povidone K 90, sodium stearyl fumarate.
Coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1), colloidal anhydrous silica, polyethylene glycol 1500, triethyl citrate, hypromellose 2910/6, polyethylene glycol 400, polyethylene glycol 8000.

What Bupropion Neuraxpharm looks like and contents of the pack
Bupropion Neuraxpharm 150 mg 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, packed in a cardboard box. The pack contains 30 tablets.

For further 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:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

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

Marketing Authorisation Number in Austria, the country of export: 140416
Parallel Import Licence Number: 152/25

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