Bupropion accord

Patient Information Leaflet

Bupropion Accord, 150 mg, modified-release tablets
Bupropion hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Accord is and what it is used for
2. What you need to know before you take Bupropion Accord
3. How to take Bupropion Accord
4. Possible side effects
5. How to store Bupropion Accord
6. Contents of the pack and other information

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

Bupropion Accord is a prescription medicine used to treat depression. It works on chemical substances in the brain called noradrenaline and dopamine, which are involved in depression.

2. Important information before using Bupropion Accord

When not to use Bupropion Accord:

• if the patient is allergic to bupropion or to 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 has or has previously had eating disorders (e.g. bulimia or anorexia nervosa);
• if the patient has a brain tumour;
• if the patient is an alcohol abuser who 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 Accord;
• 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 to the patient, contact the doctor immediately
without taking Bupropion Accord.
Warnings and precautions
Before starting treatment with Bupropion Accord, discuss this with your doctor or pharmacist.
Brugada syndrome

• if the patient has a condition called Brugada syndrome (a rare inherited condition affecting heart rhythm), or if there has been a history of cardiac arrest or sudden death in the patient’s family.

Children and adolescents
Bupropion Accord is not recommended for use in children under 18 years of age.
In children under 18 years of age treated with antidepressants, there is an increased risk of
suicidal thoughts and behaviours.
Adults
Inform your doctor before starting treatment with Bupropion Accord:

• 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.

Bupropion Accord 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, stop taking Bupropion Accord immediately.
Do not take more of this medicine and contact your doctor.

• If the patient has bipolar disorder (extreme mood swings), because Bupropion Accord may trigger an episode of this condition.
• If the patient is taking other medicines used to treat depression, concomitant use of these medicines with Bupropion Accord may lead to serotonin syndrome, a potentially life-threatening condition (see “Bupropion Accord and other medicines” in this section).
• If the patient has liver or kidney disease, as adverse effects may be more likely.

If any of the above situations apply to the patient, contact the doctor again before starting
treatment with Bupropion Accord. The doctor may decide that treatment should be conducted
under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts about self-harm or suicide. These
behaviours may worsen when patients start taking antidepressant medicines, as it takes 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 about 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 the patient ever experiences thoughts about self-harm or suicide, contact the doctor immediately
or go to hospital.
It may be helpful to inform a relative or friend that the patient has depression and ask them to read
this leaflet. The patient may ask them to inform him/her if they believe the patient’s depression is
worsening or if changes in behaviour become concerning.
Bupropion Accord and other medicines
If the patient is currently taking or has taken within the last fourteen days other antidepressant
medicines known as monoamine oxidase inhibitors (MAOIs), contact the doctor immediately
without taking Bupropion Accord (see also: When not to take Bupropion Accord, in section 2).
Tell the doctor or pharmacist about all medicines currently taken or recently taken,
including herbal remedies or vitamins, even those purchased without a prescription. The doctor may
adjust the dose of Bupropion Accord, recommend changing the dosing regimen, or discontinuation of
other medicines.
Some medicines must not be taken together with Bupropion Accord. Some of them may increase
the risk of seizures or convulsive episodes. Other medicines may increase the risk of other adverse
effects. Examples of such medicines are listed below, but this is not a complete list.
Seizures may occur more frequently than usual:

• if the patient is taking other antidepressants or medicines used to treat psychiatric 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 Accord (see also When not to take Bupropion Accord, 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 to the patient, contact the doctor immediately before starting
treatment with Bupropion Accord. The doctor will assess the risks and benefits of using Bupropion
Accord.
The likelihood of other adverse effects may increase:

• if the patient is taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other psychiatric conditions (such as clozapine, risperidone, thioridazine or olanzapine). Bupropion Accord may interact with medicines used to treat depression, and the patient may experience 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).
• 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 Accord (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 Accord.
Bupropion Accord may be less effective:

• If the patient is taking ritonavir or efavirenz, medicines used to treat HIV infection.

If this applies to the patient, inform the doctor.
The doctor will assess the effectiveness of Bupropion Accord 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 Accord without the doctor’s advice, as this may increase the risk of adverse effects,
including seizures.
Bupropion Accord 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 Accord and alcohol
Alcohol may affect the action of Bupropion Accord, and taking them together may, although rarely,
cause nervousness or alter mental state. Some patients may become more sensitive to alcohol while
taking Bupropion Accord. The doctor may advise avoiding alcohol (beer, wine, spirits) or significantly
reducing its consumption during treatment with Bupropion Accord.
If the patient currently drinks large amounts of alcohol, do not suddenly stop drinking, as this may
trigger a seizure.
Discuss alcohol consumption with the doctor before starting treatment with Bupropion Accord.
Effect on urine tests
Bupropion Accord 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 Accord.
Pregnancy and breastfeeding
Do not take Bupropion Accord during pregnancy, if there is suspicion of pregnancy, or when planning
pregnancy, unless otherwise advised 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 Accord. It is not known whether this was caused by taking this medicine.
The ingredients of Bupropion Accord may pass into breast milk. Consult a doctor or pharmacist before
taking Bupropion Accord.
Driving and operating machinery
If Bupropion Accord causes dizziness or a feeling of emptiness in the head, do not drive or operate
machinery.

3. How to take Bupropion Accord

This medicine should always be taken exactly as directed by your doctor or pharmacist. Your doctor will determine the dose individually for each patient. If in doubt, 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 several weeks or months have passed. Even if the patient starts to feel better, your doctor may recommend continuing treatment with Bupropion Accord to prevent recurrence of depression.

What dose should be taken
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 Accord should be taken in the morning. Do not take Bupropion Accord more than once a day.

The tablet has a 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 Accord 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 for the entire duration of treatment. Your doctor may recommend this dosing if the patient has liver or kidney disease.

How long to continue treatment
Only your doctor, together with the patient, can decide how long treatment with Bupropion Accord should continue. It may take weeks or months before any improvement is observed. The patient should regularly discuss symptoms of depression with the doctor to determine how long treatment should last. If the patient feels better, the doctor may still recommend continuing treatment with Bupropion Accord to prevent recurrence of depression.

Taking more Bupropion Accord than recommended
Taking too many tablets may cause seizures or a convulsive seizure. Do not delay. Contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Bupropion Accord
If a dose is missed, wait until the next scheduled dose and take the medicine then. Do not take a double dose to make up for a missed dose.

Stopping treatment with Bupropion Accord
Do not stop treatment with Bupropion Accord 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
Seizures (epileptic fits) may occur in approximately 1 in 1,000 patients taking Bupropion Accord. The likelihood is higher in patients receiving higher than recommended doses, taking certain other medicines, or belonging to groups at increased risk of seizures. If in doubt, consult your doctor.
If a seizure occurs, contact your doctor immediately. Do not continue taking Bupropion Accord.

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

• skin redness or rash (such as erythema multiforme), blisters or itchy skin lumps (urticaria); some rashes may require hospitalization, especially if accompanied by 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 continue taking Bupropion Accord.
Allergic reactions may be prolonged. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.

Drug-induced lupus erythematosus or worsening of lupus symptoms
Frequency unknown – cannot be estimated from available data.
Lupus is an autoimmune disorder affecting the skin and other organs. If lupus flares, skin rash, or skin lesions (especially on sun-exposed areas) occur during treatment with Bupropion Accord, contact your doctor immediately, as discontinuation of treatment may be necessary.

Acute generalized exanthematous pustulosis
Frequency unknown – cannot be estimated from available data in patients taking Bupropion Accord. Symptoms of acute generalized exanthematous pustulosis include skin rash with pustules or pus-filled blisters.
If a skin rash with pustules or pus-filled blisters develops, contact your doctor immediately, as treatment discontinuation may be necessary.

Other adverse reactions

Very common adverse reactions: may affect more than 1 in 10 patients.

• difficulty sleeping; ensure Bupropion Accord is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common adverse reactions: may affect 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 sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes marked), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon adverse reactions: may affect up to 1 in 100 patients.

• feeling of depression (see also section 2: Warnings and precautions),
• feeling of disorientation,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare adverse reactions: may affect up to 1 in 1,000 patients.

• seizures.

Very rare adverse reactions: may affect up to 1 in 10,000 patients.

• palpitations, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• restlessness, irritability, hostility, aggression, unusual 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),
• unusual hair loss or thinning (alopecia),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), believing in or experiencing things that are not real (delusions), excessive suspiciousness (paranoia).

Frequency unknown (cannot be estimated from available data):
Other adverse reactions have occurred in an unknown, though small, number of patients:

• thoughts of self-harm or suicide during treatment with Bupropion Accord or shortly after stopping (see section 2 "Important information before taking Bupropion Accord"). 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.
• sudden and intense fear (panic attack)
• stuttering
• reduced number of red blood cells (anaemia), reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental state (e.g. agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) when Bupropion Accord is taken together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bupropion Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should 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. Contents of the pack and other information

What Bupropion Accord contains
The active substance is bupropion hydrochloride.
Each tablet contains 150 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica,
glycerol dibehenate, magnesium stearate.
Coating: ethylcellulose, povidone, macrogol, methacrylic acid and ethyl acrylate copolymer (1:1)
30% dispersion (containing sodium lauryl sulfate and polysorbate 80), colloidal hydrated silica,
triethyl citrate.
Ink: shellac, iron oxide black (E 172), propylene glycol.

What Bupropion Accord looks like and contents of the pack
Bupropion Accord is cream-white to pale yellow, round tablets, printed with "GS3" on one side and smooth on the other.
The tablet diameter is approximately 7.2 mm.
The medicine is packed in blisters made of OPA/Aluminum/PVC/Aluminium foil.
Pack sizes: 10, 30, 60, 90 tablets
or single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium foil.
Pack sizes: 10x1, 30x1, 60x1, 90x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:
Laboratori Fundació Dau
C/C, 12-14 Pol. Industrial Zona Franca
08040 Barcelona
Spain

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
Poland

Accord Healthcare B.V.
Winthontlaan 200
3526KV Utrecht
The Netherlands

Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia
32009 Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names: