Bupropion neuraxpharm

Package leaflet: Information for the user

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, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. 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 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 suffers from epilepsy or has had seizures,
• if the patient currently 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 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).

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 the treatment of 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, treatment with Bupropion Neuraxpharm should be discontinued. Do not take any more of this medicine and contact your 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 and 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
behaviours may worsen when the patient first starts taking antidepressant medicines, because it takes some time – usually about two weeks, but sometimes longer – before these medicines start to work.
Such thoughts may be more common:

• if the patient has 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 the patient ever experiences thoughts about self-harm or suicide, contact the 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 and other medicines If the patient is currently taking or has taken within the last fourteen days other medicines known as monoamine oxidase inhibitors (MAO), contact the doctor immediately 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 any medicines you plan 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 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 convulsions. 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 mental illnesses,
• 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 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 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 antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, doxepin, desipramine or imipramine) or medicines for other psychiatric conditions (such as clozapine, risperidone, thioridazine or olanzapine). Bupropion Neuraxpharm may interact with certain 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 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 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 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 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 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 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 may become more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may advise avoiding 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 suddenly stop drinking, as this may trigger a seizure. Discuss alcohol consumption with the doctor before starting treatment with Bupropion Neuraxpharm.

Effect on urine tests
Bupropion Neuraxpharm may affect the results of laboratory tests for the presence of other medicines.
If the patient undergoes such a test, he or she should inform the doctor or nurse that Bupropion Neuraxpharm is being taken.
Pregnancy and breastfeeding
Do not take Bupropion Neuraxpharm during pregnancy, if there is suspicion that the woman is pregnant or if pregnancy is planned, 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 caused by taking this medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion Neuraxpharm, consult a 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 your doctor or pharmacist.
Your doctor will prescribe an individual dose for you. 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 after several weeks or months. 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 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 sachet containing activated charcoal and silica gel to keep the tablets dry. Keep the sachet in the bottle. Do not swallow it.
The tablet is coated with a special layer that slowly releases the active substance into the gastrointestinal tract. You may notice something in your stool that looks like a tablet. This is the empty tablet shell, which has been eliminated from the body.

Bupropion Neuraxpharm tablets must 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 duration of treatment. Your doctor may recommend this dose if you have liver or kidney disease.

How long to continue treatment
Only your doctor, together with you, can decide how long treatment with Bupropion Neuraxpharm should continue. It may take weeks or months before any improvement is observed. You should regularly discuss your depressive symptoms with your doctor to determine how long treatment should last. Even if you start to feel better, your doctor may recommend continuing treatment with Bupropion Neuraxpharm to prevent recurrence of depression.

Taking more Bupropion Neuraxpharm than recommended
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.

If you miss a dose of Bupropion Neuraxpharm
If you miss a dose, wait and take the next dose at your 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 your doctor.

If you have any further questions 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 they do not occur in everyone.
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 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 erythema multiforme), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if accompanied by mouth pain or eye pain,
• 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 last a long time. If your doctor has prescribed medicines to relieve allergic symptoms, take the full course as directed.

Lupus-like skin rash or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated from the available data in patients taking Bupropion Neuraxpharm. Lupus is an autoimmune disorder affecting the skin and other organs. If lupus flares, 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 the available data in patients taking Bupropion Neuraxpharm.
Symptoms of AGEP include a rash with pustules (pus-filled spots) or blisters.
If you develop a rash with pus-filled pimples or blisters, contact your doctor immediately, as discontinuation of treatment may be necessary.
Other adverse reactions
Very common adverse reactions: may affect more than 1 in 10 patients.

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

Common adverse reactions: 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 significant), facial flushing,
• ringing in the ears, visual disturbances.

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

• seizures.

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

• palpitations, fainting,
• muscle twitches, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• feeling of 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 parts of the body 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 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 (leucopenia) 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 of the 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Bupropion Neuraxpharm

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following:
EXP. 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 will 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) 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 HDPE bottles containing a desiccant container (carbon/silica gel) and closed with a PP child-resistant screw cap and a tamper-evident seal, containing 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Strasse 23
40764 Langenfeld
Germany

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
Poleczki 35
02-822 Warsaw
[email protected]

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