BUCIDAR 150 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Bucidar, 150 mg, modified-release tablets
3. Bucidar, 300 mg, modified-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Bucidar and what is it used for
5. Important information before taking Bucidar
   1. When not to take Bucidar
   2. Warnings and precautions
   3. Brugada syndrome
   4. Children and adolescents
   5. Adults
   6. Suicidal thoughts and worsening of depressive symptoms
   7. Bucidar and other medicines
   8. It may increase the likelihood of other side effects:
   9. Bucidar may be less effective
   10. Bucidar may reduce the effectiveness of some medicines
   11. Taking Bucidar with alcohol
   12. Effect on urine tests
   13. Pregnancy and breastfeeding
   14. Driving and using machines
   15. Bucidar contains lactose
6. How to take Bucidar
   1. Taking a higher dose of Bucidar than recommended
   2. Missing a dose of Bucidar
   3. Stopping treatment with Bucidar
7. Possible side effects
   1. Severe side effects Seizures or convulsions
   2. Do not take this medicine again.
   3. Allergic reactions
   4. Other side effects
   5. Very common side effects
   6. Common side effects
   7. Uncommon side effects
   8. Rare side effects
   9. Very rare side effects
   10. Frequency not known
   11. Reporting side effects
8. How to store Bucidar
9. Contents of the pack and other information
   1. What Bucidar contains
   2. What Bucidar looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Bucidar, 150 mg, modified-release tablets

Bucidar, 300 mg, modified-release tablets

Bupropion hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Bucidar and what is it used for
• 2. Important information before taking Bucidar
• 3. How to take Bucidar
• 4. Possible side effects
• 5. How to store Bucidar
• 6. Contents of the pack and other information

1. What is Bucidar and what is it used for

Bucidar is a prescription-only medicine used to treat depression. It works with chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking Bucidar

When not to take Bucidar

• 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 eating disorders (such as bulimia or anorexia nervosa),
• If the patient has a brain tumor,
• If the patient is an alcohol addict who has just stopped drinking or plans to do so,
• If the patient has severe liver disease,
• If the patient has recently stopped taking sedatives or plans to do so while taking Bucidar (see also "When not to take Bucidar" in section 2),
• If the patient is taking or has taken in the last two weeks medicines for depression called monoamine oxidase inhibitors(MAO). If any of the above situations apply to the patient, they should contact their doctor immediately without taking Bucidar.

Warnings and precautions

Before starting treatment with Bucidar, the patient should discuss it with their doctor or pharmacist.

Brugada syndrome

Before starting treatment with Bucidar, the patient should discuss it with their doctor if they have been diagnosed with Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there is a history of cardiac arrest or sudden death in their family.

Children and adolescents

Bucidar is not recommended for the treatment of children and adolescents under 18 years of age.
In children under 18 years of age treated with antidepressants, there is an increased risk of suicidal thoughts and behaviors.

Adults

The patient should inform their doctor before starting treatment with Bucidar:

• •If the patient regularly drinks large amounts of alcohol,
• •If the patient has diabetes and is taking insulin or oral hypoglycemic agents,
• •If the patient has had a serious head injury or brain trauma. Bucidar may cause seizures in about 1 in 1000 patients. The occurrence of this side effect is more likely in patients in the above groups. If seizures occur during treatment, Bucidar should be discontinued. Do not take this medicine again and consult a doctor.
• •If the patient has bipolar affective disorder (extreme mood swings), as Bucidar may trigger an episode of this condition.
• •If the patient is taking other medicines used to treat depression, as concurrent use of these medicines with Bucidar may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Bucidar and other medicines" in this section)
• •If the patient has liver or kidney disease, as they may be more likely to experience side effects. If any of the above situations apply to the patient, they should consult their doctor before starting treatment with Bucidar. The doctor may decide to monitor the patient closely or recommend alternative treatment.

Suicidal thoughts and worsening of depressive symptoms

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen when the patient first starts taking antidepressants, as it takes some time, usually about two weeks, but sometimes longer, for these medicines to start working.
Such thoughts may occur more frequently:

• If the patient has had suicidal thoughts or self-harm thoughts before.
• If the patient is a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants. If suicidal thoughts or self-harm thoughts occur at any time, the patient should contact their doctor immediately or go to the hospital. It may be helpful to inform a relative or friendthat the patient has depression, and ask them to read this leaflet. The patient may ask them to tell them if they notice that their depression is getting worse or if there are any worrying changes in their behavior.

Bucidar and other medicines

If the patient is currently taking or has taken in the last 14 days other antidepressants called monoamine oxidase inhibitors(MAO), they should contact their doctor without taking Bucidar (see also "When not to take Bucidar" 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 medicines or vitamins, including those available without a prescription. The doctor may change the dose of Bucidar or recommend changing the dose or discontinuing other medicines being taken.
Some medicines should not be taken with Bucidar. Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Examples of such medicines are listed below, but this is not an exhaustive list.
Seizures may occur more frequently than usual:

• •If the patient is taking other antidepressants or medicines for mental disorders,
• •If the patient is taking theophylline, a medicine for asthma or lung disease,
• •If the patient is taking tramadol, a strong painkiller,
• •If the patient has recently stopped taking sedatives or plans to do so while taking Bucidar (see also "When not to take Bucidar" in section 2),
• •If the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
• •If the patient is taking stimulants or other medicines that control 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 can cause drowsiness,
• •If the patient is taking antidiabetic medicines. If any of the above situations apply to the patient, they should contact their doctor immediately before starting treatment with Bucidar. The doctor will assess the risk and benefits of using Bucidar.

It may increase the likelihood of other side effects:

• •If the patient is taking other antidepressants (such as: amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental disorders (such as: clozapine, risperidone, thioridazine, or olanzapine). Bucidar 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, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (e.g., nausea, vomiting, diarrhea),
• •If the patient is taking medicines for Parkinson's disease (levodopa, amantadine, orphenadrine),
• •If the patient is taking medicines that affect the metabolism of Bucidar (carbamazepine, phenytoin, valproic acid),
• •If the patient is taking certain medicines for cancer (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, they should contact their doctor immediately before starting treatment with Bucidar.

Bucidar 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, they should inform their doctor. The doctor will assess the effectiveness of Bucidar in the patient. It may be necessary to increase the dose or change the treatment for depression. Do not increase the dose of Bucidar without the doctor's recommendation, as this may increase the risk of side effects, including seizures.

The doctor will assess the effectiveness of Bucidar in the patient. It may be necessary to increase the dose or change the treatment for depression. Do not increase the dose of Bucidar without the doctor's recommendation, as this may increase the risk of side effects, including seizures.

Bucidar may reduce the effectiveness of some medicines

• •If the patient is taking tamoxifen, used to treat breast cancer. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the treatment for depression.
• •If the patient is taking digoxin for heart problems. If this situation applies to the patient, they should tell their doctor. The doctor may consider adjusting the dose of digoxin.

Taking Bucidar with alcohol

Alcohol may affect the action of Bucidar, and taking them together may, although rarely, cause nervousness or change the mental state. Some patients become more sensitive to alcohol while taking Bucidar. The doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Bucidar.
If the patient is currently drinking large amounts of alcohol, they should not stop suddenly, as this may cause a seizure.
The patient should discuss drinking alcohol with their doctorbefore starting treatment with Bucidar.

Effect on urine tests

Bucidar may affect the results of laboratory tests for the presence of other substances in the urine.
If the patient is undergoing such a test, they should inform their doctor or nurse that they are taking Bucidar.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should not take Bucidar unless their doctor recommends it. Before taking this medicine during pregnancy, the patient should consult their doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital defects, particularly heart defects, in children whose mothers took Bucidar. It is not known whether this was caused by the use of this medicine.
The ingredients of Bucidar may pass into breast milk. Before taking Bucidar, the patient should consult their doctor or pharmacist.

Driving and using machines

If Bucidar causes dizziness or a feeling of emptiness in the head, the patient should not drive or operate machinery.

Bucidar contains lactose

Bucidar contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Bucidar

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. The doctor will recommend a dose individually for the patient. In case of doubts, the patient should consult their doctor or pharmacist.
Improvement in the patient's condition may occur only after some time.The full effect of the medicine may only become apparent after a few weeks or months. Even if the patient starts to feel better, the doctor may recommend continuing treatment with Bucidar to prevent a relapse of depression.
What dose to take
Usually, the recommended dose for adults is one 150 mg tablet once a day.
The doctor may recommend increasing the dose to 300 mg once a day if the patient does not improve after a few weeks of treatment.
The dose of Bucidar should be taken in the morning. Do not take Bucidar more than once a day.
The tablet is coated with a shell that slowly releases the medicine into the digestive tract. The patient may notice something in their stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
Bucidar tablets should be swallowed whole. Do not chew, crush, or divide them, as this may lead to an overdose due to the rapid release of the medicine into the body. This may increase the risk of side effects, including seizures.
For some patients, a dose of 150 mg once a day is sufficient for the entire treatment period.
The doctor may recommend this dosage if the patient has liver or kidney disease.
How long to take the treatment
Only the doctor, together with the patient, can decide how long to take the treatment with Bucidar.
It may take weeks or months before any improvement is observed. The patient should regularly consult their doctor to assess their depressive symptoms, so that it can be decided how long they should be treated. If the patient feels better, the doctor may recommend continuing treatment with Bucidar to prevent a relapse of depression.

Taking a higher dose of Bucidar than recommended

Taking too many tablets may cause seizures or convulsions. Do not delay. The patient should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of Bucidar

In case of a missed dose, the patient should 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 Bucidar

The patient should not stop treatment with Bucidar or reduce the dose without first discussing it with their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bucidar can cause side effects, although not everybody gets them.

Severe side effects Seizures or convulsions

About 1 in 1000 patients taking Bucidar may experience seizures (convulsions). The likelihood of this is higher in patients who take higher doses than recommended, take certain medicines, or are in a group with an increased risk of seizures. In case of doubts, the patient should consult their doctor.
→ If a seizure occurs, the patient should contact their doctor.

Do not take this medicine again.

Allergic reactions

Some patients may experience allergic reactions to Bucidar. These include:

• skin redness or rash (like a nettle rash), blisters, or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they are accompanied by mouth pain or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or brief loss of consciousness. → If any symptoms of an allergic reaction occur, the patient should contact their doctor immediately. Do not take this medicine again.Allergic reactions can last a long time. If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the entire course.

Systemic lupus erythematosus or worsening of lupus symptoms
Frequency not known - the frequency cannot be estimated from the available data from patients taking Bucidar. Lupus is an immune system disorder that affects the skin and other organs.
→ If lupus symptoms worsen, a skin rash occurs, or skin changes appear(especially in areas of the skin exposed to sunlight) while taking Bucidar, the patient should contact their doctor immediately, as it may be necessary to stop the treatment.
Acute generalized exanthematous pustulosis
Frequency not known - the frequency cannot be estimated from the available data from patients taking Bucidar. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules/blisters filled with pus.
→ If a skin rash with pustules/blisters filled with pus occurs, the patient should contact their doctor immediately, as it may be necessary to stop the treatment.

Other side effects

Very common side effects

May occur in more than 1 in 10 patients:

• difficulty sleeping. The patient should make sure that Bucidar 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, and skin rash (sometimes due to an allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• abdominal pain or other disorders (constipation), change in taste, loss of appetite (anorexia),
• increased blood pressure, sometimes significantly, facial flushing,
• ringing in the ears, vision disturbances.

Uncommon side effects

May occur in up to 1 in 100 patients:

• feeling depressed (see also section 2: "Important information before taking Bucidar" under 'Suicidal thoughts and worsening of depressive symptoms'),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects

May occur in up to 1 in 1,000 patients:

• seizures.

Very rare side effects

May occur in up to 1 in 10,000 patients:

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking or coordination problems,
• feeling restless, irritated, hostile, aggressive, having strange dreams, tingling, or numbness, memory loss,
• yellowing of the skin or whites of the eyes ( jaundice), which may be caused by increased liver enzyme activity, liver inflammation,
• severe allergic reactions; rash with accompanying muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less often than usual,
• incontinence (involuntary urination, uncontrolled urine flow),
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• feeling unreal or strange ( depersonalization), seeing or hearing things that do not exist ( hallucinations), feeling or believing in things that are not real ( delusions), exaggerated suspicion ( paranoia).

Frequency not known

Other side effects have occurred in a small number of patients, but their exact frequency is unknown:

• thoughts of self-harm or suicide during treatment with Bucidar or soon after its completion (see section 2 "Important information before taking Bucidar"). If the patient has such thoughts, they should contact their doctor or go to the hospital immediately.
• loss of contact with reality and ability to think or assess the situation (psychosis); other symptoms may include hallucinations and (or) delusions,
• stuttering,
• decreased red blood cell count (anemia), decreased white blood cell count (leukopenia), and decreased platelet count (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, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (e.g., nausea, vomiting, diarrhea) when taking Bucidar with medicines used to treat depression (such as: paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bucidar

The medicine should be stored out of sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original packaging to protect from moisture and light.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bucidar contains

The active substance of Bucidar is bupropion hydrochloride. Each tablet contains 150 or 300 mg of bupropion hydrochloride, respectively.
Other ingredients are:
Tablet core: hydroxypropyl cellulose, glycerol dibehenate, stearic acid
Tablet coating: hypromellose, ethyl cellulose, povidone K90, lactose monohydrate, triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, macrogol 6000, and colloidal silica, hydrated
Ink: shellac, iron oxide black (E 172), propylene glycol

What Bucidar looks like and contents of the pack

Bucidar 150 mg: White to light yellow, round, approximately 7.7 mm in diameter, film-coated tablets with a black ink imprint "T" on one side and smooth on the other.
Bucidar 300 mg: White to light yellow, round, approximately 9.6 mm in diameter, film-coated tablets with a black ink imprint "T1" on one side and smooth on the other.
Bucidar is available in a pack containing:
White, non-transparent plastic bottles with a desiccant container containing activated silica gel and activated carbon. The bottle is closed with a child-resistant plastic cap containing a sealing ring.
150 mg: 30, 60, 90 tablets.
300 mg: 30, 60, 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
phone: +48 22 642 07 75

Manufacturer/Importer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87,
2132 JH Hoofddorp
Netherlands
Terapia SA
124 Fabricii Street,
400632, Cluj-Napoca,
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain: Bupropión SUN 150 mg, 300 mg comprimidos de liberación modificada EFG
Netherlands: Bupropion HCl SUN 150 mg, 300 mg tabletten met gereguleerde afgifte
Germany: BUPROPION BASICS 150 mg, 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Romania: AXABAL 150 mg, 300 mg comprimate cu eliberare modificată
Sweden: Bupropion SUN 150 mg, 300 mg Tablett med modifierad frisättning
Italy: Bupropione SUN

Date of last revision of the leaflet: