Bupropion neuraxpharm

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Bupropion Neuraxpharm, 300 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. It may harm other people, 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

1. What is Bupropion Neuraxpharm and what is it 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 is Bupropion Neuraxpharm and what is it used for

Bupropion Neuraxpharm is a prescription medicine used to treat depression. It works 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 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 do so,
• if the patient has severe liver disease,
• if the patient has recently stopped taking sedative medicines or intends to stop them 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 it 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
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 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, stop taking Bupropion Neuraxpharm immediately. 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 antidepressant medicines, because using these medicines 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, contact the doctor again before starting
treatment with Bupropion Neuraxpharm. The doctor may decide that treatment should be conducted under close supervision or recommend alternative therapy.
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 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 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 ever occur, 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 notice that the patient’s depression worsens 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 the doctor
immediately and do not take 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,
including those 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 regimen, or discontinuation of 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 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 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 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 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 and may cause 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, 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 situation 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 to treat 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 changes in 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 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 laboratory test results for the presence of other drugs. If the patient undergoes 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 there is suspicion of pregnancy or if planning a pregnancy, unless otherwise advised by a doctor. Consult your 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 due to the use of this medicine.
The ingredients of Bupropion Neuraxpharm may pass into breast milk. Consult your doctor or pharmacist before taking 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 your doctor or pharmacist. Your doctor will prescribe the individual dose appropriate for you. If you have any doubts, 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 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.

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 frequently than once daily.

The tablet has a special coating that slowly releases the active substance into the gastrointestinal tract. You may notice something in your stool that looks like a whole tablet. This is the empty coating shell, which has been eliminated from the body.

Bupropion Neuraxpharm tablets must be swallowed whole. Do not chew, crush, or divide the tablets. Doing so may result in an overdose due to too rapid release of the active substance 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 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 be continued. It may take weeks or months before any improvement is observed. You should regularly discuss your depressive symptoms with your 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 Bupropion Neuraxpharm than recommended

Taking too many tablets may cause seizures or a seizure episode. 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 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 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 will experience them.
Serious adverse reactions
Seizures or convulsive seizures
Seizures (convulsive seizures or convulsions) may occur in approximately 1 in 1,000 patients taking Bupropion Neuraxpharm. The likelihood of seizures is higher in patients who take higher than recommended doses, are taking certain other medicines, or belong to groups at increased risk of seizures. If in doubt, consult your treating physician.
If a convulsive seizure occurs, contact your doctor immediately. Do not take this medicine again.
Allergic reactions
Some patients may experience allergic reactions to Bupropion Neuraxpharm. These may include:

• skin redness or rash (such as erythematous rash), blisters or itchy bumps (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 medications 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 lupus flares, skin rash, or skin lesions (especially on sun-exposed areas of skin) 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 rash with pustule-filled blisters.
If you develop a rash with pus-filled pimples/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,
• feelings of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (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.

• 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.

• convulsive 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, 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 parts of the body and may be life-threatening,
• exacerbation 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 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
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia).
• low sodium levels in 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, diarrhea) 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 to provide more information on the safety of the 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 instructions apply.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis siehe Prägung – batch number/expiry date see embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 bupropion).
The other ingredients are:
Tablet core: povidone K 90, L-cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate.
Coating: ethylcellulose 100 mPas, povidone K 90, macrogol 1450, methacrylic acid-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 prolonged-release tablets are cream-white to light yellow, round tablets, printed with "GS2" in black on one side, the other side being smooth. The tablet diameter is approximately 9.3 mm.
Available in blisters made of OPA/Al/PVC//Al, containing 30 or 90 tablets, packed in a cardboard carton.
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 Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld, Germany
Neuraxpharm Pharmaceuticals, S.L.
Avda. 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 Austria, the country of export: 140370
Parallel Import Authorisation Number: 136/25

This medicinal product is authorised in the Member States of the European Economic Area 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