Bupropion neuraxpharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging 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, 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 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 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 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 behaviour.
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 likelihood of this adverse effect is higher in patients from the groups listed above.
If seizures occur during treatment, discontinue use of 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 combining these medicines 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.

If any of the above situations apply to the patient, contact the treating doctor again
before starting Bupropion Neuraxpharm.
The doctor may decide that treatment should be closely monitored or recommend alternative
treatment.
Suicidal thoughts and worsening of depression 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 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 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 worsening depression or concerning changes in behaviour.
Bupropion Neuraxpharm and 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 the doctor or pharmacist about all medicines currently or recently taken,
including those planned for future use, 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.
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 antidepressants or medicines used to treat psychiatric conditions,
• 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 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 controlling 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 treating 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, dothiepin, desipramine or imipramine) or medicines for other psychiatric conditions (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-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 treating 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.
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 changes in mental state. Some patients become more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may advise avoiding 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 stop suddenly, as this may trigger a seizure. Discuss alcohol consumption with the doctor 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 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 pregnancy is suspected, or if planning pregnancy, unless the doctor advises otherwise. 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. Consult a doctor or pharmacist before using Bupropion Neuraxpharm.
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 the doctor or pharmacist. The treating physician will determine the dose individually for each patient. If in doubt, consult the 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 treating physician 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.
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 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 an extended-release film 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 tablet shell, which has been eliminated from the body.

Bupropion Neuraxpharm tablets should be swallowed whole. Do not chew, crush, or divide the tablets—if this happens, 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 is sufficient throughout the treatment period. 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 months before any improvement is observed. The patient should regularly discuss depressive symptoms with the treating physician to determine how long treatment should be continued. If the patient feels better, the treating physician 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 attack. Do not delay. Contact a doctor or the nearest hospital emergency department immediately.

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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions

Seizures or convulsions

Seizures (convulsive or epileptic seizures) may occur in approximately 1 in 1,000 patients treated with Bupropion Neuraxpharm. The likelihood of seizures is higher in patients taking higher than recommended doses, taking certain other medications, or who 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 any more of the medicine.

Allergic reactions

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

• skin redness or rash (such as maculopapular rash), 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 any more of the medicine.

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 symptoms of lupus flare-up, 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 from available data in patients taking Bupropion Neuraxpharm.

AGEP symptoms include a rash with pustules or pustule-filled blisters.

If you develop a rash with pustule-filled pimples or 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, 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 marked), 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 twitches, 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,
• exacerbation of psoriasis (red, thickened skin lesions),
• feeling 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 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 reactions

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

Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 the medicine.

5. How to store Bupropion Neuraxpharm

Keep this medicine out of 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 practices 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: ethyl cellulose, hydroxypropyl cellulose, 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 modified-release tablets are white to slightly yellowish, round, and biconvex tablets.
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 screw cap and a tamper-evident foil, packed in a cardboard box with 30 tablets.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Neuraxpharm Bohemia s.r.o.
náměstí Republiky 1078/1
110 00 Praha 1 – Nové Město
Czech Republic

Manufacturer:
Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Strasse 23
40764 Langenfeld
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, the country of export:
30/269/20-C

Parallel Import Authorisation Number: 51/25