Bupropion neuraxpharm

Patient Information Leaflet

Bupropion Neuraxpharm, 300 mg, modified-release tablets
Bupropioni hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 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 suffers from 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 do so during treatment with Bupropion Neuraxpharm,
• if the patient is taking or has taken within the last two weeks antidepressant medicines called 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 suicidal 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 listed above. If seizures occur during treatment, the patient must stop taking Bupropion Neuraxpharm. The patient must not take any more of this medicine and should contact their doctor immediately.
• If the patient has bipolar disorder (extreme mood swings), because Bupropion Neuraxpharm may trigger an episode of this condition,
• If the patient is taking other antidepressant medicines, because concomitant use of 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 to occur. If any of the above situations apply to the patient, the patient should contact their doctor again before starting treatment with Bupropion Neuraxpharm. The doctor may decide that treatment should be carried out under close supervision or recommend alternative treatment.

Suicidal thoughts and worsening of depressive symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. Such
behaviours may worsen when the patient first starts taking antidepressant medicines, because it takes some time before these medicines begin to work, usually about two weeks, but sometimes longer.
Such thoughts may occur more frequently:

• 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 young adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If the patient ever experiences thoughts of self-harm or suicide, they should contact their 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 the patient if they consider that the patient's depression is worsening or if changes in their behaviour are concerning. Bupropion Neuraxpharm and other medicines If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines called monoamine oxidase inhibitors (MAO inhibitors), the patient must 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 a change in dosing regimen, or discontinuation of other medicines.

Some medicines must not be taken at the same time as Bupropion Neuraxpharm.
Some of these may increase the risk of seizures or convulsions. Other medicines may increase the risk of other adverse effects. Examples of such medicines are listed below,
but this is not a complete list.
Seizures may occur more frequently than usual:

• if the patient is taking other 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 used to control body weight or appetite,
• if the patient is taking steroids (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 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 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 certain medicines used to treat depression, leading to changes in mental state (e.g. agitation, hallucinations, stupor) 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 beta-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 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 infections. 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 must 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 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 is undergoing 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 pregnancy is suspected, or when 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 as directed by the physician or pharmacist. The treating physician will determine the dose individually for each patient. If in doubt, consult the physician 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.

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 daily.

The tablet has a coating that slowly releases the medicine into the gastrointestinal tract. The patient may notice something resembling a tablet in the stool. This is the empty shell that has been expelled from the body.

Bupropion Neuraxpharm tablets should be swallowed whole. Do not chew, crush, or divide them—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 may be sufficient throughout the entire treatment period. The treating physician may recommend this dosage if the patient has liver or kidney disease.

How long to continue treatment

Only the physician 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 the appropriate duration of treatment. If the patient feels better, the treating physician may still 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 attack. Do not delay. Seek immediate medical attention from a physician or the nearest hospital emergency department.

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 you have any further doubts about the use of this medicine, consult your physician 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 the medicine again.
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 be prolonged. If your doctor has prescribed medicines to relieve allergic symptoms, take the full course as directed.

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

• difficulty sleeping; ensure 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 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 side effects: 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 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,
• feeling of restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be due to increased liver enzyme activity, 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,
• worsening of psoriasis (red, scaly patches on the skin),
• feeling of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).
  Frequency not known: 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 touch 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 stiffness, 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 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Bupropion Neuraxpharm

Keep the 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.
There are no special requirements for storage of this medicinal product.
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 of bupropion).
Other ingredients 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, copolymer of methacrylic acid and ethyl acrylate (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 tablets, printed with "GS2" in black on one side, the other side is smooth. The tablet diameter is approximately 9.3 mm.
Blister: OPA/Aluminium/PVC/Aluminium blister containing 30 or 90 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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. de Barcelona, 69
08970 Sant Joan Despí, Barcelona
Spain

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

This medicinal product is authorised for marketing 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