Bucidar

Leaflet accompanying the packaging: patient information

Bucidar, 150 mg, modified-release tablets

Bucidar, 300 mg, modified-release tablets

Bupropion hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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 you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any other medicines containing bupropion,
• if you have epilepsy or have had seizures,
• if you have had or have eating disorders (such as bulimia or anorexia nervosa),
• if you have a brain tumor,
• if you are an alcoholic who has just stopped drinking or plans to do so,
• if you have severe liver disease,
• if you have recently stopped taking sedatives or plan to do so while taking Bucidar (see also "When not to take Bucidar" in section 2),
• if you are taking or have taken in the last two weeks medicines for depression called monoamine oxidase inhibitors(MAO). If any of the above situations apply to you, you should contact your doctor immediately without taking Bucidar.

Warnings and precautions

Before starting treatment with Bucidar, you should discuss it with your doctor or pharmacist.

Brugada syndrome

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

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

You should inform your doctor before starting treatment with Bucidar:

• •if you regularly drink large amounts of alcohol,
• •if you have diabetes and are taking insulin or oral hypoglycemic agents,
• •if you have had a serious head injury or head trauma. Bucidar may cause seizures in about 1 in 1000 patients. The occurrence of this side effect is more likely in patients with the above-mentioned groups. If seizures occur during treatment, you should stop taking Bucidar. Do not take this medicine again and consult your doctor.
• •If you have bipolar affective disorder (extreme mood swings), as Bucidar may trigger an episode of this condition.
• •If you are taking other medicines used to treat depression, as concurrent use of these medicines with Bucidar may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Bucidar and other medicines" in this section)
• •If you have liver or kidney disease, as you may be more likely to experience side effects. If any of the above situations apply to you, you should consult your doctor before starting treatment with Bucidar. Your doctor may decide to monitor your therapy 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 you have had suicidal thoughts or self-harm thoughts before.
• If you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants. If you ever have thoughts of self-harm or suicide, you should contact your doctor immediately or go to the hospital. It may be helpful to inform a relative or friendthat you have depression, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Bucidar and other medicines

If you are currently taking or have taken in the last 14 days other antidepressant medicines called monoamine oxidase inhibitors(MAO), you should contact your doctor without taking Bucidar (see also "When not to take Bucidar" in section 2).
You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including herbal medicines or vitamins, including those available without a prescription. Your doctor may change the dose of Bucidar or recommend changing the dose or discontinuing other medicines you are taking.
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 you are taking other antidepressant medicines or medicines used to treat mental disorders,
• •if you are taking theophylline, a medicine for asthma or lung disease,
• •if you are taking tramadol, a strong painkiller,
• •if you have recently taken or are currently taking sedatives or if you plan to stop taking them while taking Bucidar (see also "When not to take Bucidar" in section 2),
• •if you are taking antimalarial medicines (such as mefloquine or chloroquine),
• •if you are taking stimulants or other medicines that control weight or appetite,
• •if you are taking steroids (orally or by injection),
• •if you are taking antibiotics called quinolones,
• •if you are taking certain types of antihistamines that can cause drowsiness,
• •if you are taking antidiabetic medicines. If any of the above situations apply to you, you should contact your doctor immediately before starting treatment with Bucidar. Your doctor will assess the risk and benefits of using Bucidar.

It may increase the likelihood of other side effects:

• •if you are taking other antidepressant medicines (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 you 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 you are taking medicines used to treat Parkinson's disease (levodopa, amantadine, orphenadrine),
• •if you are taking medicines that affect the metabolism of Bucidar (carbamazepine, phenytoin, valproic acid),
• •if you are taking certain medicines used to treat cancer (such as: cyclophosphamide, ifosfamide),
• •if you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• •if you are taking beta-blockers (such as metoprolol),
• •if you are taking certain types of medicines used to treat irregular heart rhythm (propafenone and flecainide),
• •if you are using nicotine patches, as an aid to stop smoking. If any of the above situations apply to you, you should contact your doctor immediately before starting treatment with Bucidar.

Bucidar may be less effective

• •If you are taking ritonavir or efavirenz, medicines used to treat HIV infections. If this situation applies to you, you should inform your doctor. Your doctor will assess the effectiveness of Bucidar in you. It may be necessary to increase the dose or change the treatment of depression. Do not increase the dose of Bucidar without your doctor's recommendation, as this may increase the risk of side effects, including seizures.

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

Bucidar may reduce the effectiveness of some medicines

• •If you are taking tamoxifen, used to treat breast cancer. If this situation applies to you, you should tell your doctor. It may be necessary to change the treatment of depression.
• •If you are taking digoxin due to heart problems. If this situation applies to you, you should tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Taking Bucidar with alcohol

Alcohol may affect the action of Bucidar, and their concurrent use may, although rarely, cause nervousness or change mental state. Some patients become more sensitive to alcohol while taking Bucidar. Your doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Bucidar.
If you are currently drinking large amounts of alcohol, you should not stop drinking suddenly, as this may cause a seizure.
You should discuss drinking alcohol with your 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 you are undergoing such a test, you should inform your doctor or nurse that you are taking Bucidar.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should not take Bucidar unless your doctor recommends it. Before taking this medicine during pregnancy, you should consult your 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, you should consult your doctor or pharmacist.

Driving and using machines

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

Bucidar contains lactose

Bucidar contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Bucidar

This medicine should always be taken exactly as recommended by your doctor or pharmacist. Your doctor will recommend a dose individually for you. If you are unsure, you should consult your doctor or pharmacist.
Improvement in your condition may not occur until some time has passed.The full effect of the medicine may only become apparent after several weeks or months. Even if you start to feel better, your 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.
Your doctor may recommend increasing the dose to 300 mg once a day if, after several weeks of treatment, you do not show improvement.
The dose of Bucidar should be taken in the morning. You should not take Bucidar more than once a day.
The tablet is coated with a shell that slowly releases the medicine into the digestive tract. You may notice something in your stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
Bucidar tablets should be swallowed whole. You should 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 throughout the treatment period.
Your doctor may recommend this dosage if you have liver or kidney disease.
How long to take the treatment
Only your doctor, together with you, can decide how long to take the treatment with Bucidar.
It may take weeks or months before any improvement is observed. You should regularly consult your doctor about your depressive symptoms, so that it can be decided how long you should be treated. If you feel better, your 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. You should contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Bucidar

If you miss a dose, you should wait and take the next dose at the usual time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Bucidar

You should not stop treatment with Bucidar or reduce the dose without first discussing it with your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 happening is higher if you take higher doses than recommended, take certain medicines, or are in a group at increased risk of seizures. If you are unsure, you should consult your doctor.
→ If you experience a seizure, you should contact your doctor.

Do not take this medicine again.

Allergic reactions

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

• redness of the skin 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 you experience any symptoms of an allergic reaction, you should contact your doctor immediately. Do not take this medicine again.Allergic reactions can last a long time. If your doctor has prescribed medicines to relieve allergic symptoms, you should take the entire course.

Systemic lupus erythematosus or worsening of lupus symptoms
Frequency not known - 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 you experience worsening of lupus or a skin rash or skin changes(especially on areas of skin exposed to sunlight) while taking Bucidar, you should contact your doctor immediately, as it may be necessary to stop treatment.
Acute generalized exanthematous pustulosis
Frequency not known - 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 you experience a skin rash with pustules/blisters filled with pus, you should contact your doctor immediately, as it may be necessary to stop treatment.

Other side effects

Very common side effects

May occur in more than 1 in 10 patients:

• difficulty sleeping. You 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, flushing of the face,
• 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:

• palpitations, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• 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, hepatitis,
• severe allergic reactions; rash with accompanying muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less frequently than usual,
• incontinence (involuntary urination, uncontrolled urine flow),
• severe skin rashes that may involve the mouth and other parts of the body and may 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 you have such thoughts, you should contact your 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 number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased 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, 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 you experience any side effects, including those not listed in this leaflet, you should tell your 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, tel.: + 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. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging 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.
The 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, opaque 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
tel. + 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: