Bupropion neuraxpharm: detailed information

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Bupropion Neuraxpharm, 300 mg, modified-release tablets
Bupropion hydrochloride
Please read the entire leaflet carefully before taking this medicine, as 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 share it with 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

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. 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 experienced seizures,
if the patient currently 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 stop,
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 (MAOIs).

If any of the above situations apply, the patient should immediately contact their doctor
and must 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 behaviours.
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 trauma,
if the patient has Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or has a family history of cardiac arrest or sudden death.

Bupropion Neuraxpharm may cause seizures in approximately 1 in 1,000 patients.
The occurrence of this adverse effect is more likely in patients from the groups mentioned above.
If seizures occur during treatment, the use of Bupropion Neuraxpharm should be discontinued.
The patient must not take any more of this medicine and should contact their 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 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.

If any of the above situations apply, the patient should contact their doctor again before starting
treatment with Bupropion Neuraxpharm. The doctor may decide that treatment should be conducted
under close supervision or may 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, as it takes
some time before these medicines begin to work, usually about two weeks, but sometimes longer.
Such thoughts may be more common:

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, the patient should immediately contact their doctor or go to a 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 (MAOIs), the patient should contact their
doctor without taking Bupropion Neuraxpharm (see also: When not to take Bupropion Neuraxpharm,
in section 2).
The patient should tell their doctor or pharmacist about all medicines currently taken or
recently taken, as well as any medicines they plan to take, including herbal remedies or
vitamins, even those purchased without a prescription. The doctor may adjust the dose of
Bupropion Neuraxpharm, change the dosing regimen, or recommend stopping other medicines.
Some medicines must not be taken together with 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 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 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 used to 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, the patient should contact their 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, 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, the patient should contact their 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, they should inform their 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. The
patient must 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, the patient should inform their doctor. It may be necessary to change the treatment approach for depression.
If the patient is taking digoxin for heart problems. If this applies, the patient should inform their 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 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, they should not suddenly
stop drinking, as this may trigger a seizure.
The patient should discuss alcohol consumption with their doctor 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, they should inform the doctor or nurse that they are taking
Bupropion Neuraxpharm.
Pregnancy and breastfeeding
Do not take Bupropion Neuraxpharm during pregnancy, if pregnancy is suspected, or when
planning a pregnancy, unless advised otherwise by a doctor. Consult a doctor or pharmacist before
taking any medicine during pregnancy. 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. Consult a doctor or
pharmacist before taking Bupropion Neuraxpharm.
Driving and using machines
If Bupropion Neuraxpharm causes dizziness or a feeling of emptiness in the head, the patient should
not drive or operate machinery.

3. How to take Bupropion Neuraxpharm

This medicine should always be taken according to the instructions given 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 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 recurrence of depression.

What doses should be taken

Bupropion Neuraxpharm is available in a 300 mg strength. For a dose of 150 mg, another suitable product available on the market should be used.

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 a day.

The tablet has a coating 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 shell that has been excreted 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 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 treatment. Your treating doctor may recommend this dosage 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 treating doctor so that decisions about the duration of treatment can be made. If you start to feel better, your doctor may still 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. Contact your doctor or the nearest hospital emergency department immediately.

Missing 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 treating doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side 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 taking higher than recommended doses, taking certain other medicines, or who are in a group at increased risk of seizures. If in doubt, contact 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 erythema multiforme), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if there is also mouth pain or eye pain,
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 any more of the medicine.
Allergic reactions may last a long time. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.

Lupus-like skin rash 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 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 available data in patients taking Bupropion Neuraxpharm.
Symptoms of AGEP include a rash with pustules or pus-filled blisters.

If you develop a rash with pus-filled pimples or blisters, contact your doctor immediately, as treatment discontinuation may be necessary.

Other side effects

Very common side effects: 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 side effects: 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 anxious or agitated,
abdominal pain or other gastrointestinal disturbances (constipation), altered taste sensation, loss of appetite (anorexia),
increased blood pressure (sometimes marked), facial flushing,
ringing in the ears, visual disturbances.

Uncommon side effects: may occur in up to 1 in 100 patients.

feeling depressed (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depression symptoms),
feeling disoriented,
difficulty concentrating,
increased heart rate,
weight loss.

Rare side effects: may occur in up to 1 in 1,000 patients.

seizures.

Very rare side effects: 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,
passing urine more or less frequently than usual,
urinary incontinence (involuntary urination, uncontrolled leakage of urine),
severe skin reactions, which may involve the mouth and other parts of the body and may be life-threatening,
worsening of psoriasis (red, thickened skin patches),
feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), experiencing or believing in unreal things (delusions), excessive suspicion (paranoia).

Frequency unknown:
Other side effects 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 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 (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) when taking Paritdam together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also 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 side effects 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.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system 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 300 mg of bupropion hydrochloride (equivalent to 260.40 mg of bupropion).
Other components are:
Tablet core: povidone K 90, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate.
Coating: ethylcellulose 100 mPas, povidone K 90, macrogol 1450, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80, colloidal hydrated silica, triethyl citrate.
Printing ink: shellac, black iron oxide (E 172), and propylene glycol.

What Bupropion Neuraxpharm looks like and contents of the pack
Bupropion Neuraxpharm 300 mg tablets are cream-white to light yellow, round, with a black "GS2" imprint on one side of the tablet; the other side is smooth. The tablet diameter is approximately 9.3 mm.
Blister packs: OPA/Al/PVC-Al blisters containing 30 or 90 tablets, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the 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
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona 69, 08970 Sant Joan Despí, Barcelona, Spain

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, the country of export: 30/274/20-C
Parallel Import Marketing Authorisation Number: 359/24

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Bupropion neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Czech Republic: Bupropion Neuraxpharm
Netherlands: Bupropion HCl Neuraxpharm 300 mg tabletten met gereguleerde afgifte
Germany: Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Poland: Bupropion Neuraxpharm
Slovakia: Bupropion 300 mg Tablety s riadeným uvoľňovaním