Bupropion neuraxpharm

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Bupropion Neuraxpharm, 300 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 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Bupropion Neuraxpharm is and what it is used for
2. What you need to know 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 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, the patient should immediately contact their doctor
and must not take Bupropion Neuraxpharm.
Warnings and precautions
Before starting treatment with Bupropion Neuraxpharm, the patient should discuss this with their 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 occurrence of this adverse effect is more likely in patients from the groups
mentioned above. If seizures occur during treatment, the patient should stop
taking Bupropion Neuraxpharm. The patient should 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 disorder,
• 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 to occur.

If any of the above situations apply to the patient, the patient should contact their
doctor before starting treatment with Bupropion Neuraxpharm. The doctor
may decide that treatment should be closely monitored or recommend alternative therapy.
Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. Such
behaviours may increase 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, the patient should immediately contact their doctor 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 the patient if they
notice that the patient's depression worsens or if changes in their 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), 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 they are currently taking or
have 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, recommend changing the dosing schedule, or discontinuing other medicines.
Some medicines must not be taken together with 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 antidepressant medicines 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 stopped 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 corticosteroids (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, the patient should immediately contact their
doctor 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 antidepressant medicines (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, the patient should immediately contact their
doctor 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, the patient should inform their 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. The patient should not
increase the dose of Bupropion Neuraxpharm without the doctor's advice, 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 in the treatment of breast cancer. If this applies to the patient, the patient should inform their 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, the patient should inform their 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 become
more sensitive to alcohol while taking Bupropion Neuraxpharm. The doctor may
advise abstaining from alcohol (beer, wine, spirits) or significantly reducing alcohol intake
during treatment with Bupropion Neuraxpharm. If the patient currently drinks large amounts
of alcohol, the patient should not suddenly stop drinking, as this may trigger a seizure.
The patient should talk to their doctor about alcohol consumption 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
The patient should not take Bupropion Neuraxpharm during pregnancy, if the patient suspects
they are pregnant or if they are planning a pregnancy, unless the doctor advises otherwise. Before taking
any medicine during pregnancy, the patient should consult their 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 taking this medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Before taking Bupropion
Neuraxpharm, the patient should consult their doctor or pharmacist.
Driving and operating machinery
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 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 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 feeling better, the treating physician 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 150 mg dose, another suitable product available on the market should be used.

The usual recommended dose for adults is one 150 mg tablet once daily.

The treating physician may recommend increasing the dose to 300 mg once daily if there is no improvement after several weeks of treatment.

Bupropion Neuraxpharm should be taken in the morning. Do not take Bupropion Neuraxpharm more than once daily.

The tablet has a special coating that slowly releases the medicine into the gastrointestinal tract. The patient may notice something in the stool 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 treatment. The treating physician may recommend this dosing if the patient has impaired liver or kidney function.

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 discuss depressive symptoms with the treating physician to determine the appropriate duration of treatment. If the patient feels better, the treating physician may recommend continuing 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 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 consulting the treating physician.

If there are any further doubts regarding the use of this medicine, consult the 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 who take higher than recommended doses, are taking certain other medicines, or belong to a group 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 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 the medicine again.
Allergic reactions may last a long time. 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 the available data in patients taking Bupropion Neuraxpharm. Lupus is an immune system disorder affecting the skin and other organs. If lupus flares, skin rash or skin lesions (particularly on sun-exposed areas of skin) occur during treatment with Bupropion Neuraxpharm, contact your doctor immediately, as treatment discontinuation 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 (pimples or blisters filled with pus).
If you develop a rash with pus-filled pimples or 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 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.

• feelings of depression (see also section 2: Warnings and precautions, Suicidal thoughts and worsening of depressive symptoms),
• feelings 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,
• feelings 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 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 suspicion (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 Paritdam is taken 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 Drug Reactions at 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
Reporting adverse reactions helps provide more information on the safe use 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.
No special storage instructions are required.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/expiry date: see imprint.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 300 mg of bupropion hydrochloride (equivalent to 260.40 mg of bupropion).
The other ingredients are:
Tablet core: povidone K 90, L-cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate (E 470b).
Inner coating: ethylcellulose 100 mPas, povidone K 90, macrogol 1450.
Outer coating: copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80, hydrated colloidal silica, macrogol 1450, triethyl citrate.
Printing ink: shellac, iron oxide black (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 in colour, round, with a black "GS2" imprint on one side and the other side smooth. The tablet diameter is approximately 9.3 mm.
Blister packs made of OPA/Aluminium/PVC/Aluminium in cardboard boxes containing 30 or 90 tablets.

For further information, please contact the responsible party 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 Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí, Barcelona, Spain

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

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

Austrian Marketing Authorisation Number (country of export): 140370
Parallel Import Authorisation Number: 325/25

This medicinal product is authorised for sale in the European Economic Area (EEA) 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